Cancer Guide - William S. Rosenberg, MD
Transcription
Cancer Guide - William S. Rosenberg, MD
ISSN 2152-0577 F Ta R ke E on E e A Tr e a t m e n t a n d F a c i l i t i e s G u i d e f o r P a t i e n t s a n d T h e i r F a m i l i e s PAT I ENT RESOURCE Cancer Guide Interviews with cancer survivors KAREEM ABDUL-JABBAR & JACLYN SMITH Content reviewed by a distinguished medical advisory board Seventh Edition, Vol. 2 November 2013 – April 2014 PRP PATIENT RESOURCE PUBLISHING ® Helping to make access to the therapies you need easier Novartis Oncology is committed to helping patients living with cancer receive the medicines they need. Patient Assistance NOW Oncology offers quick and easy access to information about the broad array of support and reimbursement programs available. You can get information about our Patient Assistance NOW Oncology support programs in 2 ways: r Call 1-800-282-7630 to speak with a member of our knowledgeable staff dedicated to making access to our programs as simple and convenient as possible; or r Visit our website at: www.OncologyAssistanceNow.com Support for Patients Includes: r Insurance verification r Assistance with denials/appeals r Coding/billing questions r Patient assistance for low-income and uninsured patients r Medicare education r Therapy-specific support programs for out-of-pocket costs r Alternative assistance searches and referrals to federal or state assistance programs r Referrals to independent charitable foundations for assistance with co-pay costs Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080 r Patients prequalified via phone screening for the Patient Assistance Program (PAP) will be sent a 30-day supply of their needed medication while completing the application r Convenient provider portal to access program services or check the status of patients enrolled © 2012 Novartis 10/12 T-PAN-1052066 PA T I E N T R E S O U R C E CANCER GUIDE Seventh Edition, Vol. 2 Advisory Boards Editor-in-Chief Charles M. Balch, MD, FACS Professor of Surgery, University of Texas Southwestern Medical Center Medical Advisory Board Chief Executive Officer Publisher Editor-in-Chief Senior Vice President Vice President Operations Managing Editor Contributing Writers Graphic Designer Production Manager Senior Director of Sales Advertising Sales Director Account Executives Office Address For Additional Information Advisory Board Mark A. Uhlig Linette Atwood Charles M. Balch, MD, FACS Debby Easum Leann Sandifar Matt Smithmier Lori Alexander, MTPW, ELS Anna Braunsdorf Kelli Schmidt Jennifer Hiltunen Stephanie Kenney Amy Galey Kathy Hungerford Jessica Morrow 8455 Lenexa Drive Overland Park, KS 66214 [email protected] Visit our website at PatientResource.com to read bios of our medical and patient advisory board members. For Additional Copies: To order additional copies of Patient Resource Cancer Guide, visit www.patientresource.com, call 913-725-1600 or email [email protected]. Editorial Submissions: Editorial submissions should be sent to [email protected]. Disclaimer: Information presented in Patient Resource Cancer Guide is not intended as a substitute for the advice given by your health care provider. The opinions expressed in Patient Resource Cancer Guide are those of the authors and do not necessarily reflect the views of the publisher. Although Patient Resource Cancer Guide strives to present only accurate information, readers should not consider it as professional advice, which can only be given by a health care provider. Patient Resource, its authors, and its agents shall not be responsible or in any way liable for the continued currency of the information or for any errors, omissions or inaccuracies in this publication, whether arising from negligence or otherwise or for any consequences arising therefrom. Patient Resource, its authors, and its agents make no representations or warranties, whether express or implied, as to the accuracy, completeness or timeliness of the information contained herein or the results to be obtained from using the information. The publisher is not engaged in rendering medical or other professional services. The publication of advertisements, whether paid or not, and survivor stories is not an endorsement. If medical or other expert assistance is required, the services of a competent professional person should be sought. © 2013 Patient Resource LLC. All rights reserved. PRP PATIENT RESOURCE PUBLISHING® For reprint information, email [email protected]. Pa t ie n tResource.com James O. Armitage, MD Professor, Internal Medicine, Section of Hematology & Oncology, The Nebraska Medical Center University Hospital J. Max Austin Jr., MD Professor of Gynecologic Oncology, Department of Obstetrics and Gynecology, U.A.B. Medical Center Al B. Benson III, MD, FACP Professor of Medicine, Associate Director for Clinical Investigations, Robert H. Lurie Comprehensive Cancer Center of Northwestern University Thomas A. Buchholz, MD, FACR Professor and Chair, Department of Radiation, The University of Texas MD Anderson Cancer Center Paul A. Bunn, MD Executive Director, International Association for the Study of Lung Cancer James Dudley Endowed Professor of Lung Cancer Research, University of Colorado School of Medicine Frederick L. Greene, MD Clinical Professor of Surgery, University of North Carolina School of Medicine Jay R. Harris, MD Professor and Chair, Department of Radiation Oncology, Dana-Farber Cancer Institute, Brigham and Women’s Hospital at Harvard Medical School Jimmie C. Holland, MD Chairperson, Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center Waun Ki Hong, MD Chair of Medical Oncology, The University of Texas MD Anderson Cancer Center Gabriel N. Hortobagyi, MD, FACP Professor of Medicine, Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center Mario E. Lacouture, MD Dermatology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center LaSalle D. Leffall Jr., MD, FACS Charles R. Drew Professor of Surgery, Howard University Martin A. Makary, MD, MPH, FACS Minimally Invasive Cancer Surgeon, Associate Professor of Surgery and Public Health, Johns Hopkins University John E. Niederhuber, MD Executive Vice President and CEO, Inova Translational Medicine Institute CEO, Director, Inova Cancer Institute Nicholas J. Petrelli, MD Medical Director, Helen F. Graham Cancer Center Raphael E. Pollock, MD Chair of Surgery, The University of Texas MD Anderson Cancer Center Richard B. Reiling, MD Medical Director, Presbyterian Cancer Center, Charlotte, N.C. William S. Rosenberg, MD Neurosurgeon, Founder, Center for the Relief of Pain, Kansas City, Mo. President and Founder, Cancer Pain Research Consortium Thomas R. Russell, MD, FACS Chairman of the Board of Directors, American College of Surgeons Foundation Peter T. Scardino, MD Chair of Surgery, Chief of Urologic Oncology, Head of the Prostate Cancer Research Program, Memorial Sloan-Kettering Cancer Center Donald L. Trump, MD, FACP President and CEO, Roswell Park Cancer Institute Terry T. Tsue, MD, FACS Physician-in-Chief, University of Kansas Cancer Center David P. Winchester, MD Director of Cancer Department, American College of Surgeons Chair Emeritus, Department of Surgery, Evanston Northwestern Medical Center Global Medical Advisory Board Antonio Carlos Buzaid, MD Chairman, Oncology Center of the Hospital São José da Beneficencia Portuguesa de São Paulo, Brazil Eduardo Cazap, MD, PhD President, Union for International Cancer Control (UICC-Geneva) Founder, First President, Latin American & Caribbean Society of Medical Oncology (SLACOM) Alexander M.M. Eggermont, MD, PhD General Director, Cancer Institute Gustave Roussy, Villejuif-Paris Jaime G. de la Garza, MD Clinical Research Investigator, Instituto Nacional de Cancerología, Mexico Yuko Kitagawa, MD, PhD, FACS Professor and Chairman, Department of Surgery, Director of Keio Cancer Center, Vice President of Keio University Hospital (Tokyo) John F. Thompson, MD, FRACS, FACS Professor of Melanoma and Surgical Oncology, The University of Sydney, Australia Umberto Veronesi, MD Founder, European School of Oncology and European Society of Surgical Oncology Yi-Long Wu, MD Vice-President, Guangdong General Hospital & Guangdong Academy of Medical Sciences Director, Guangdong Lung Cancer Institute Patient Advisory Board Alan J. Balch, PhD CEO, National Patient Advocate Foundation and Patient Advocate Foundation Diane S. Blum, MSW Past CEO, Lymphoma Research Foundation Rosalie Canosa, MSW, LCSW-R, MPA Program Division Director, CancerCare Peggy Conlon President and CEO, Ad Council Nancy Davenport-Ennis Founder and Chairman, Board of Directors, National Patient Advocate Foundation and Patient Advocate Foundation Sam Donaldson ABC Newscaster Brian Garofalo President, Patient Alliances, LLC Lisa Greaves Director, Integrated Media and Technology, American Society of Clinical Oncology Linda House, RN, BSN, MSM Executive Vice President, External Affairs, Cancer Support Community Lillie D. Shockney, RN, BS, MAS University Distinguished Service Associate Professor of Breast Cancer Director, Johns Hopkins Avon Foundation Breast Center Director, Johns Hopkins Survivorship Programs Doug Ulman President, LIVESTRONG Foundation Louise Villejo Executive Director for Patient Education, The University of Texas MD Anderson Cancer Center Armin D. Weinberg, PhD CEO, Life Beyond Cancer Foundation Professor of Medicine, Baylor College of Medicine Co-Founder, Intercultural Cancer Council 1 Education Leads to Empowerment Table of Contents What You Should Know to Understand Cancer ........................3 It’s OK to Seek a Second Opinion.................................................3 Dear Reader, Cate Edwards: A Caregiver’s Perspective ....................................4 If you’ve recently been told you have cancer, you might be wondering, “Now what?” You want to educate yourself about your diagnosis, but the amount of information available – both printed and online – can be overwhelming. Of the many emotions a cancer diagnosis can elicit, at Patient Resource, we believe that confusion and isolation don’t have to be among them. This guide and our companion website, PatientResource.com, will point you toward reliable resources that will help you understand, confront and take control of your disease. This is not your battle to fight alone. An enormous and active cancer community stands ready to help you meet the challenges ahead. Should You Participate In a Clinical Trial? ...............................10 Types of Treatments: Learn About Your Options ....................12 A Personalized Approach to Cancer Treatment .......................16 Finding Relief from Cancer Pain................................................18 Prevent or Control Side Effects...................................................22 Jaclyn Smith: Breast Cancer Patient Story.................................26 Types of Cancer Lung Cancer Overview and Staging ..........................................28 Lung Cancer Treatment Options................................................30 Elizabeth Lacasia: Lung Cancer Patient Story ..........................31 Breast Cancer Overview and Staging.........................................32 In addition to support, self-education is also important. Education leads to empowerment, and empowerment leads to self-advocacy. By learning about your options, you will enable yourself to make informed decisions about your care and treatment at every step of your cancer journey. And your cancer team becomes immeasurably stronger and more effective when you assume the role of an educated, active partner. Breast Cancer Treatment Options ..............................................34 You can rely on the information in this Cancer Guide to be current, medically accurate and understandable. You will not only find practical suggestions for finding a medical team, a second opinion and the best treatment facilities for your needs, but you also will read inspiring stories from survivors who have been in your shoes. In addition, this guide includes an extensive directory of trusted resources for medical, psychological and financial information. Colorectal Cancer Treatment Options ......................................43 At Patient Resource, we are grateful and fortunate to benefit from the remarkable breadth of knowledge and expertise of the distinguished Medical Advisory Board and Patient Advisory Board. You can learn more about their accomplishments on our website. We also thank our industry partners and advertisers, without whom Cancer Guide would not be possible, and a special thanks to TEVA Oncology, the exclusive distribution partner for this edition. Finally, we extend our sincere gratitude to you for reading and learning as you embark on your cancer journey. Melanoma Overview and Treatment Options ..........................53 We know that your best outcome depends on education, empowerment and advocacy throughout your cancer treatment. Knowledge leads to sound choices, which in turn bring comfort and hope. Misty Smith: Breast Cancer Patient Story .................................36 Prostate Cancer Overview and Staging .....................................37 Prostate Cancer Treatment Options ..........................................38 Len Dawson: Prostate Cancer Patient Story .............................40 Colorectal Cancer Overview and Staging .................................42 Mary Ellen Fleming-Jones: Colon Cancer Patient Story.........44 Leukemias and Multiple Myeloma .............................................45 Kareem Abdul-Jabbar: CML Patient Story ...............................46 Gynecologic Cancers Overview and Treatment Options........51 Anissa Norris: Cervical Cancer Patient Story...........................52 LeAnn Hankel: Melanoma Patient Story...................................54 Patient Resources Financial Help for Patients & Families ......................................56 Advocacy & Assistance Resource Groups .................................61 Cancer Treatment Facilities NCI-Designated Cancer Centers................................................72 Treatment Facilities by State .......................................................73 All the best, Linette Atwood Publisher 2 Charles M. Balch, MD, FACS Editor-in-Chief See page 112 to order additional guides. Pa t i e n t Re s o u r ce .co m understanding cancer | general information What You Should Know W to Understand Cancer While learning about cancer can seem like a daunting task, it’s best to start with the basics. And with this disease, it all begins with cells. Normal human cells, which are the basic units of the body, grow, divide and die in a predictable and orderly way. As our bodies develop in childhood and adolescence, our cells divide rapidly, but once we become adults, most cells divide only to replace dying cells or repair injuries. Cancer cells, however, are abnormal cells of the human body that grow and divide out of control quickly. When cells continue to multiply even when our body does not need new cells, they can form a disorganized mass composed of billions of cells called a tumor. A tumor can be harmful (malignant) or harmless (benign) to your body. Cancer cells become malignant because of changes or damage to the genetic material (DNA) in the cell that affects normal cell growth. A malignant tumor is called cancer. Benign tumors, such as warts, polyps and cysts, can usually be removed from the body and ordinarily do not return. Cancer cells, however, can penetrate and damage adjacent organs and tissues, a process known as invasion. Cancer cells may also break away from a malignant tumor and spread to other parts of the body through the bloodstream or lymphatic system, a process known as metastasis. Types of cancers • Carcinomas are the most common cancers and include breast, lung and colon cancers. Carcinomas grow from cells that cover the outside of the body, such as cells in the skin, as well as cells that cover the internal body surfaces, such as cells lining the lungs. These cancers can invade surroundTypes of cancers ing tissues and organs and spread to the lymph nodes. • Melanomas are serious forms of skin cancer. They initially appear on the surface of the skin as a change in the shape, size, color or feel of a mole. Most malignant melanomas have an area that is black or blue-black in color. If detected when they first appear, they are easy to treat. However, if left untreated, they can grow down into the skin, reach blood ©Patient Resource LLC vessels and lymphatic vessels and spread through the body. • Sarcomas grow from cells in connective • Leukemias are immature cells arising in or supportive tissue in the body, such bone marrow that should have become as bone, cartilage, joints, muscle, fat, functioning white blood cells. If you nerves, deep skin tissues and blood veshave leukemia, your bone marrow sels. These are relatively rare, accounting produces abnormally large numbers of for about 1 percent of all cancers. They white blood cells that block the producinclude bone tumors called osteosarcotion of the normal white blood cells, mas, fat-tissue tumors called liposarcowhich help you fight infections, as well mas and smooth-muscle tumors called as red blood cells, which carry oxygen leiomyosarcomas. to tissues throughout your body. • Lymphomas arise in lymph nodes and other tissues of your immune system, ADDITIONAL RESOURCES which is the body’s defense against infecAmerican Society of Clinical Oncology tions and some cancers. Immune system (patient website): www.cancer.net tissues, or lymphoid tissues, include your National Cancer Institute: www.cancer.gov tonsils and adenoids, spleen, thymus and National Comprehensive Cancer Network: bone marrow. The two major types of www.nccn.org lymphomas include Hodgkin lymphomas OncoLink: www.oncolink.org and non-Hodgkin lymphomas. It’s OK to Seek a Second Opinion A cancer treatment plan can be difficult to understand, so you may decide you’d like to consult with another doctor before or even after you begin treatment. Hearing a new perspective can be helpful, even if you have complete confidence in your doctor’s judgment. A second opinion involves asking another cancer specialist to review your medical records, confirm your doctor’s diagnosis and treatment plan, verify your pathology report and stage of cancer, and suggest alternatives to the proposed Pa t ie n tResource.com treatment plan. Another doctor might suggest a different treatment approach that your first doctor was not aware of, and a new outlook may even change your diagnosis. It’s important to hear arguments for all of your treatment options. Many people feel worried to tell their doctor they’re seeking a second opinion, but second opinions are a normal part of cancer care, and some insurance companies even require one. Most doctors are comfortable with such requests, and yours may even help you find other specialists to see. After you decide which specialist you want to trust with your second opinion, ask your doctor to share the results of any previous tests so you can avoid repeating them. New treatment information is continuously discovered, so it’s OK to look at all of your options and speak to several specialists before choosing the treatment that’s best for you. It’s a very important decision, and a second opinion could better protect your quality of life or even save it. 3 general information caregiver story | subject A Caregiver’s Perspective Cate Edwards helped her mom, Elizabeth Edwards, through two battles with breast cancer ate Edwards is the daughter of former U.S. Senator and vice presidential candidate John Edwards and author and health care activist Elizabeth Edwards. She graduated with honors with a degree in political economics from Princeton University and later graduated with a law degree from Harvard Law School. Cate is currently practicing law as well as serving as president of the Elizabeth Edwards Foundation, which she started in her mother’s honor. Cate Edwards was just 22 years old when her mother, Elizabeth, was first diagnosed with breast cancer in November 2004. After getting over the initial shock, Cate, who had just graduated from Princeton, returned home to help her mom figure out the next steps. “We decided to gear up and fight this thing,” Cate said. “We figured it was going to be a short-term experience that would hopefully end with her being cured.” After undergoing treatment, Elizabeth’s cancer went into remission in 2006, but a follow-up scan a year later revealed that the cancer had returned. The official diagnosis was Stage IV metastatic breast cancer. “The mentality in terms of her life and living was very different because it wasn’t like we were going to stop everything to deal with this cancer, which it was in the initial diagnosis period,” Cate said. “Instead it was like we’re going to continue to live and live life actually to its fullest. It was her goal to make every single day count, so that was a different mentality in a lot of ways.” Cate was one of her mom’s primary caregivers while she was undergoing treatment with chemotherapy, hormone therapy and radiation therapy—as well as fighting side effects such as fatigue and back pain. “There were days where she had trouble moving around a lot, and that just meant I had to be a support for her in a different way,” Cate said. “So I’d crawl into bed with her and watch HGTV C at e How to Offer Your Help to a Loved One As a patient’s loved one, you undoubtedly have wonderful intentions when you ask, “How can I help?” And you truly mean it when you say, “Call me if you need anything.” However, patients often have a hard time figuring out exactly what they need help with while undergoing treatment. Then, if they do decide, they have difficulty deciding how to delegate. The solution? Be direct about what you would like to do and Photo: David Plakke when you’re available to do it. The more specific you are, the more likely your loved one will accept your offer of assistance. When deciding what help to offer, think about how much time you have and what you are good at doing. The following chart can help you generate some possibilities. Both big and small gestures will be appreciated, so make sure you only commit to tasks with which you’re sure you can follow through. Ideas for offering help Talent: Task: If you’re good at… Volunteer to… How to ask/offer Communicating Be the spokesperson This can alleviate the patient’s burden of telling the same story multiple times to different family members and friends. “Would you like me to set up a blog or email group and send out daily/weekly updates to your family and friends?” Cooking Cook meals (using Healthy eating is important during treatment; in addition, cooking takes time and energy, which patients often don’t have. “I’m going to swing by with a few frozen meals that you can easily reheat. Do you have any preferences or food allergies?” disposable containers if possible) 4 Why it is helpful Organizing Help with paperwork Disease comes with a lot of paperwork, which can quickly become overwhelming. Help your loved one fill out forms, get bills ready to mail, track insurance claims and more, and/or assist with setting up an organizational filing system. “I swung by the store on my way over and picked up some organizational supplies for you. Do you want any other help staying on top of all your medical paperwork?” Driving Drive the patient Patients often have numerous doctors’ appointments and sometimes can’t drive themselves. “I’m home all day anyway, so if you give me your appointment schedule, I’ll be happy to drive you.” Drive the patient’s family Patients may not have the time or energy to drive themselves places, let alone their families. “Because our children are in the same activities, don’t worry about driving. I’ll just plan to drop off and pick up both of them unless you tell me differently!” Pa t i e n t Re s o u r ce .co m subject | general information or a ‘House’ marathon—that was one of her favorite shows. We did a lot of just cozying up and being lazy together, and that was really meaningful in its own way.” Elizabeth also suffered from extreme skin dryness and flaking on her hands and feet. “She used to do this thing where she would rub her feet with Udder Cream, and then wrap them in Saran Wrap and put on socks to help moisturize them,” Cate said. “So we did that together a few times. And my husband actually came to stay with her, and she made him do it, too. I walked in one day and saw him with his Udder Cream and his socks on the couch with my mom. So sometimes it was little things that made a difference and sort of made her feel more normal.” While Cate’s focus was solely on taking care of her mom, she later realized it was just as important to take care of herself. “It’s difficult when your loved one is going through cancer to say, ‘What about me?’” Cate said. “But the reality is that’s not the right mentality. It’s also hard on us as family members and loved ones, and that’s okay. To be there the best I could for her, I think it would have been smarter of me to try to take better care of myself.” Fortunately, Cate did receive a lot of support from her husband, family and friends even when she didn’t ask for it. But now, as part of the Count Us, Know Us, Join Us advanced breast cancer community, Cate encourages caregivers to actively seek support. “Looking for a support system is one thing that’s really important, and I’m not sure caregivers recognize that,” Cate said. “Our website (www.advancedbreastcancercommunity.org) provides resources and support that are really useful for everyone in this community, including caregivers and family members. So Talent Task If you’re good at… Volunteer to… Cate and her mom Elizabeth enjoy spending time together. I would encourage people to go there to find out more about what they can do.” As for knowing what to expect as a caregiver, Cate says it’s hard to predict. “Every patient is different. Their needs are different. So keeping the line of communication open and being willing to talk about the disease, how the patient is feeling on a day-to-day basis and what their needs are is vital,” Cate said. “Even if it’s something like mowing the lawn; even if it’s making a grocery store run; even if it’s picking up prescriptions. Those things make a big difference. But every patient is different, so talking to them about their needs I think is a really important aspect of being a good caregiver.” Why it is helpful How to ask/offer Cleaning Take on some household chores Household chores often take a backseat to everything else that comes with a serious illness. “I just finished washing my windows and I’m in the zone. Can I come over and do yours, too?” Caring for children Babysit Children have a lot of energy and crave fun and attention. Patients who are parents sometimes can’t provide that and/or simply need a break. “I’ve really been wanting to see that new animated movie. Do you think your children would want to come along?” Loving on animals Help with the family pets Pets can be affected by the stress of the situation, too, so a little love and attention can go a long way. “I usually have some extra time during my lunch breaks. Could I borrow your dog for a walk around noon on weekdays?” Educating or advocating Tag along to doctor’s appointments Doctor’s appointments can be extremely overwhelming and anxiety-inducing for patients. Four ears are better than two for listening and remembering. In addition, your loved one may want or need some help advocating for his or her wishes. “I can never remember anything my doctor says. Do you want me to tag along to your next appointment and take some notes?” Crafting Teach and/or share a hobby Patients often get restless when they’re stuck at home. If you “I never knew how relaxing knitting could be! I have some know how to knit, sew, paint, bead, quilt or something else, extra needles and would be happy to teach you. How does teach your loved one. You will not only create a reason to spend Tuesday night sound?” time together, you will also alleviate boredom. Working outdoors Mow the lawn Yard work is physically exhausting, and many patients don’t have the stamina for it. “The weather is beautiful and I’m looking for an excuse to be outside. Does your lawn need mowing?” Shovel snow from the sidewalk and driveway During the winter, shoveling is a necessary task, but it can be an impossible one for patients. Something like this is sometimes better done without asking. Shopping Grocery shop The need to eat never goes away, but it is sometimes too difficult for patients to get to the store. “I’m heading to the grocery store and only have a few things on my list. Can I pick up anything for you while I’m there?” Fixing things Repair broken items around the house Serious illness can quickly strain a patient’s budget, leaving little room to pay a handyman. “I just fixed my garbage disposal. Who knew I was so handy? Does anything at your house need to be repaired?” Pa t ie n tResource.com 5 Persons shown are not actual patients. Currently available data have not shown an increase in overall survival. Additional data will be available in the future. I think of AFINITOR as hormone therapy PLUS— combined with exemestane, it gives me MORE. MORE out of my hormone treatment. MORE time before progression. MORE in the moment. AFINITOR® (everolimus) Tablets is a prescription medicine used to treat advanced hormone receptor-positive, HER2-negative breast cancer, along with the medicine exemestane, in postmenopausal women who have already received certain other medicines for their cancer. If you’re a postmenopausal woman with advanced hormone receptor-positive, HER2-negative breast cancer, you now have a treatment choice that offers you MORE than hormone therapy alone: AFINITOR combined with exemestane tablets. AFINITOR is the first treatment in 10 years to be specifically approved for HR+, HER2metastatic breast cancer patients. Adding AFINITOR to the hormone therapy exemestane is proven to extend the hormone therapy’s benefits, more than doubling the time before cancer progression compared to exemestane alone. The median progression-free period was 7.8 months with AFINITOR plus exemestane vs 3.2 months with exemestane alone. AFINITOR is offered in a once-daily dose. Learn MORE. Ask your doctor about AFINITOR. Important Safety Information Patients should not take AFINITOR if they are allergic to AFINITOR or to any of its ingredients. Patients should tell their healthcare provider before taking AFINITOR if they are allergic to sirolimus (Rapamune®) or temsirolimus (Torisel®). Learn more at PLUS-AFINITOR.com. Hormone therapy Exemestane is available in the US under the brand name Aromasin® from Pfizer. It is also available in generic form. PLUS. IMPORTANT SAFETY INFORMATION Patients should not take AFINITOR if they are allergic to AFINITOR or to any of its ingredients. Patients should tell their healthcare provider before taking AFINITOR if they are allergic to sirolimus (Rapamune®) or temsirolimus (Torisel®). AFINITOR can cause serious side effects, which can even lead to death. If patients experience these side effects, they may need to stop taking AFINITOR for a while or use a lower dose. Patients should follow their healthcare provider’s instructions. Serious side effects include: Lung or Breathing Problems: In some patients, lung or breathing problems may be severe and can even lead to death. Patients should tell their healthcare provider right away if they have any of these symptoms: new or worsening cough, shortness of breath, chest pain, difficulty breathing, or wheezing. Infections: AFINITOR may make patients more likely to develop an infection, such as pneumonia, or a bacterial, fungal, or viral infection. Viral infections may include reactivation of hepatitis B in people who have had hepatitis B in the past. In some people these infections may be severe and can even lead to death. Patients may need to be treated as soon as possible. Patients should tell their healthcare provider right away if they have a temperature of 100.5˚F or above, chills, or do not feel well. Symptoms of hepatitis B or infection may include the following: fever, chills, skin rash, joint pain and inflammation, tiredness, loss of appetite, nausea, pale stools or dark urine, yellowing of the skin, or pain in the upper right side of the stomach. Kidney Failure: Patients taking AFINITOR may develop kidney failure. In some people this may be severe and can even lead to death. Patients should have tests to check their kidney function before and during their treatment with AFINITOR. Before taking AFINITOR, tell your healthcare provider about all your medical conditions, including if you: Have or have had kidney problems Have or have had liver problems Have diabetes or high blood sugar Have high blood cholesterol levels Have any infections Previously had hepatitis B Are scheduled to receive any vaccinations. You should not receive a live vaccine or be around people who have recently received a live vaccine during your treatment with AFINITOR. If you are not sure about the type of vaccine, ask your healthcare provider Have other medical conditions Are pregnant or could become pregnant. AFINITOR can cause harm to your unborn baby. You should use effective birth control while using AFINITOR and for 8 weeks after stopping treatment Are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take AFINITOR or breastfeed. You should not do both Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080 and herbal supplements. Using AFINITOR with certain other medicines can cause serious side effects. Keep a list of medicines you take and show it to your healthcare provider when you get a new medicine. Especially tell your healthcare provider if you take St. John’s wort (Hypericum perforatum), medicines that weaken your immune system (your body’s ability to fight infections and other problems), or medicines for: Seizures Fungal infections HIV-AIDS Bacterial infections Heart conditions or high Tuberculosis blood pressure If you are taking any medicines for the conditions previously listed, your healthcare provider might need to prescribe a different medicine or your dose of AFINITOR may need to be changed. Tell your healthcare provider before you start taking any new medicine. Common Side Effects: Common side effects include mouth ulcers. AFINITOR can cause mouth ulcers and sores. Tell your healthcare provider if you have pain, discomfort, or open sores in your mouth. Your healthcare provider may tell you to use a special mouthwash or gel that does not contain alcohol, peroxide, iodine, or thyme. Other common side effects include: Infections Feeling weak or tired Cough, shortness of breath Diarrhea and constipation Rash, dry skin, and itching Nausea and vomiting Fever Loss of appetite, weight loss Swelling of arms, hands, feet, ankles, face, or other parts of the body Abnormal taste Dry mouth Inflammation of the lining of the digestive system Headache Nose bleeds Pain in arms and legs, mouth and throat, back or joints High blood glucose High blood pressure Difficulty sleeping Hair loss Muscle spasms Feeling dizzy Nail disorders Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of AFINITOR. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see Brief Summary of Prescribing Information on adjacent pages. The brands listed are the trademarks or registered trademarks of their respective owners and are not trademarks or register marks of Novartis. © 2013 Novartis 3/13 AFB-1052568 Brief Summary of Important Risk Information. This information does not take the place of talking with your doctor about your medical condition or treatment. AFINITOR® (everolimus) Tablets What is AFINITOR? AFINITOR® (everolimus) Tablets is a prescription medicine used to treat advanced hormone receptor-positive, HER2-negative breast cancer, along with the medicine exemestane, in postmenopausal women who have already received certain other medicines for their cancer. What is the most important information I should know about AFINITOR? AFINITOR can cause serious side effects. These serious side effects include: 1. You may develop lung or breathing problems. In some people lung or breathing problems may be severe and can even lead to death. Tell your healthcare provider right away if you have any of these symptoms: s.EWORWORSENINGCOUGH s3HORTNESSOFBREATH s#HESTPAIN s$IFFICULTYBREATHING s7HEEZING 2. You may be more likely to develop an infection, such as pneumonia, or a bacterial, fungal, or viral infection. Viral infections may include active hepatitis B in people who have had hepatitis B in the past (reactivation). In some people these infections may be severe and can even lead to death. You may need to be treated as soon as possible. Tell your healthcare provider right away if you have a temperature of 100.5°F or above, chills, or do not feel well. 3. You may develop kidney failure. In some people this may be severe and can even lead to death. Your healthcare provider should do tests to check your kidney function before and during your treatment with AFINITOR. 3YMPTOMSOFHEPATITIS"ORINFECTIONMAYINCLUDE the following: s Pale stools or s Fever dark urine s #HILLS s Yellowing of the s 3KINRASH skin s Joint pain and s Pain in the upper inflammation right side of the s Tiredness stomach s Loss of appetite s Nausea If you have any of the serious side effects listed above, you may need to stop taking AFINITOR for a while or use a lower dose. Follow your healthcare provider’s instructions. Who should not take AFINITOR? $ONOTTAKE!&).)4/2IFYOUAREALLERGICTOEVEROLIMUSORTOANYOFTHEINGREDIENTSIN!&).)4/23EEFULL0RESCRIBING)NFORMATIon for a complete list of ingredients in AFINITOR. Talk to your healthcare provider before taking this medicine if you are allergic to: sSIROLIMUS2APAMUNE®) sTEMSIROLIMUSTorisel®) Ask your healthcare provider if you do not know. What should I tell my healthcare provider before taking AFINITOR? Tell your healthcare provider about all of your medical conditions, including if you (check all that apply): Have high blood cholesterol levels Are scheduled to receive any vaccinations. You should not receive a live vaccine or be around people who have recently received a live vaccine during your treatment with AFINITOR. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. Have any infections Have other medical conditions Have or have had kidney problems Have or have had liver problems Have diabetes or high blood sugar Previously had hepatitis B Are pregnant, or could become pregnant. AFINITOR can cause harm to your unborn baby. You should use effective birth control while using AFINITOR and for 8 weeks after stopping treatment. Are breastfeeding or plan to breastfeed. It is not known if AFINITOR passes into your breast milk. You and your healthcare provider should decide if you will take AFINITOR or breastfeed. You should not do both. If you have checked any of the boxes above, be sure to discuss with your doctor before taking AFINITOR. Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. AFINITOR may affect the way other medicines work, and other medicines can affect how AFINITOR works. Using AFINITOR with other medicines can cause serious side effects. Know the medicines you take. Keep a list of them, and show it to your healthcare provider and pharmacist when you get a new medicine. Especially tell your healthcare provider if you take: s St. John’s wort (Hypericum perforatum) s Medicine for: s Medicines that weaken your immune system (your body’s ability to fight infections and other – HIV-AIDS – Fungal infections problems) – Heart conditions – Bacterial infections or high blood – Tuberculosis pressure – Seizures Ask your healthcare provider or pharmacist if you are not sure if your medicine is one of those taken for the conditions listed above. If you are taking any medicines for the conditions listed above, your healthcare provider might need to prescribe a different medicine or your dose of AFINITOR may need to be changed. You should also tell your healthcare provider before you start taking any new medicine. How should I take AFINITOR? Your healthcare provider will prescribe the dose of AFINITOR that is right for you. Take AFINITOR exactly as your healthcare provider tells you to. Your healthcare provider may change your dose of AFINITOR if needed. s Use scissors to open the blister pack s Swallow AFINITOR tablets whole with a glass of water. Do not take any tablet that is broken or crushed s Take AFINITOR 1 time each day at about the same time s Take AFINITOR the same way each time, either with food or without food s If you take too much AFINITOR contact your healthcare provider or go to the nearest hospital emergency department right away. Take the pack of AFINITOR with you s If you miss a dose of AFINITOR, you may still take it up to 6 hours after the time you normally take it. If it is more than 6 hours after you normally take your AFINITOR, skip the dose for that day. The next day, take AFINITOR at your usual time. Do not take 2 doses to make up for the 1 that you missed. If you are not sure about what to do, call your healthcare provider s You should have blood tests before you start AFINITOR and as needed during your treatment. These will include tests to check your blood cell count, kidney and liver function, cholesterol, and blood sugar levels What should I avoid while taking AFINITOR? You should not drink grapefruit juice or eat grapefruit during your treatment with AFINITOR. It may make the amount of AFINITOR in your blood increase to a harmful level. What are the possible side effects of AFINITOR? AFINITOR can cause serious side effects. See “What is the most important information I should know about AFINITOR?” for more information. Common side effects of AFINITOR in people with advanced hormone receptor-positive, HER2-negative breast cancer include: s Mouth ulcers. AFINITOR can cause mouth ulcers and sores. Tell your healthcare provider if you have pain, discomfort, or open sores in your mouth. Your healthcare provider may tell you to use a special mouthwash or mouth gel that does not contain alcohol, peroxide, iodine, or thyme s Infections s Feeling weak or tired s Cough, shortness of breath s Diarrhea and constipation s s s s s s s s s s Rash, dry skin, and itching Nausea and vomiting Fever Loss of appetite, weight loss Swelling of arms, hands, feet, ankles, face or other parts of the body Abnormal taste Dry mouth Inflammation of lining of the digestive system Headache Nose bleeds s Pain in arms and legs, mouth and throat, back or joints s High blood glucose s High blood pressure s Difficulty sleeping s Hair loss s Muscle spasms s Feeling dizzy s Nail disorders Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of AFINITOR. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Keep AFINITOR and all medicines out of the reach of children. General information about AFINITOR Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use AFINITOR for a condition for which it was not prescribed. Do not give AFINITOR to other people, even if they have the same symptoms or condition you have. It may harm them. This leaflet summarizes the most important information about AFINITOR. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information written for healthcare professionals. For more information call 1-888-423-4648 or go to www.AFINITOR.com. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080 © 2013 Novartis 3/13 The brands listed are the trademarks or registered trademarks of their respective owners and are not trademarks or register marks of Novartis. AFB-1052568 general information | clinical trials N Should You Participate in a Clinical Trial? Nearly all of the cancer-fighting drugs and devices currently available exist only because they were thoroughly tested beforehand. These tests, known as clinical trials, are research studies designed to evaluate the safety and effectiveness of new drugs or other types of therapies. They are conducted in humans only after they have been tested and found to be safe and promising in laboratory and animal studies. The trials, which are generally conducted in academic and community cancer centers, are developed to evaluate different methods of treatment. Before deciding whether or not to participate, learn how clinical trials are carried out, the types and phases of trials, and the benefits and risks. Types of cancer clinical trials Five types of cancer clinical trials exist. Treatment trials and quality-of-life trials are specifically for individuals who have cancer. Prevention, screening and diagnostic trials are often done among broader groups of individuals, many of whom do not have cancer. The information here is limited to treatment trials. These evaluate whether a new treatment (e.g., drug, surgery, radiation therapy) or new combination of treatments is better than the treatment currently considered to be the standard of care. Biologic therapies Many of the clinical trials conducted in the last several years have focused on biologic therapies. Some biologics work with your immune system while others act directly against the cancer cell. The purpose of biologic trials is to find the specific weakness of cancer cells to different agents. Biologic trials may examine how effective multiagent biologics are with or without standard chemotherapy treatments. Understanding treatment trials Most treatment trials are done as part of the development of a new drug or therapy after the agent has been shown to destroy cancer cells in studies of animal models or cancer cells grown in the laboratory. The U.S. Food and Drug Administration (FDA) reviews the results and approves (or rejects) the use of the drug in studies with humans. Some cancer treatment clinical trials involve a drug that has already been approved by the FDA but for a type of cancer different from the one to be studied in the current clinical trial. Cancer treatment trials are designed in phases, with each trial providing the building blocks of knowledge for the next trial 10 phase. These clinical trials are classified as phase I, II or III. Phase I trials are the first studies in which a new drug or treatment is evaluated in humans. The goal is to determine how the drug should be given (e.g., orally or intravenously), how often the drug should be given and what dosage is most effective for killing cancer cells while causing the fewest side effects. The goal of phase II trials is to determine how well a drug works and how safe it is in a greater number of patients. Phase II trials usually involve participants that have the same type of cancer. Phase III trials compare the new drug with the current standard of care. Phase III trials are also done to evaluate other types of treatment, such as radiation and surgery, and combinations of treatments. Phase III participants are randomly assigned to receive either the experimental drug or treatment or the current standard treatment. Phase III trials often involve patients treated at many different treatment facilities to determine the benefit among a broad representation of participants. Patients are usually followed for several years after treatment so that long-term survival benefit and other outcomes (such as late side effects) can be determined. Most studies are blinded, which means information about which treatment group each study participant is in is not given to researchers or participants. Blinding helps prevent the results from being influenced by the expectations of the researchers or participants. When the results of a phase III trial indicate that a new drug leads to better outcomes for patients and is safe (the side effects are minimal and/or manageable), a special committee reviews the results and then recommends approval of the drug by the FDA. Ensuring your safety Every trial has several levels of safeguards and follows a set of rules called a protocol. The protocol defines the eligibility criteria, specifies the tests to be done and the procedures to be used, describes the medications and their doses, and decides the length of the study. Before the study begins, a scientific review panel evaluates the protocol carefully to make sure the trial is based on sound science. An institutional review board (IRB) also evaluates the protocol to ensure that patients will be treated ethically and that the risks involved in the trial are reasonable compared with the possible benefits. A second safeguard is the informed consent process, which requires that the research team explain all the details about the trial, including the purpose, tests and treatment involved, and possible risks and benefits, so that you can make an informed decision about volunteering for the trial. The third safeguard is safety monitoring throughout the trial. Both the IRB and a special committee monitor the trial to reduce potential risks. The committee will stop a trial if safety concerns arise or if either the experimental treatment or the standard treatment is overwhelmingly more beneficial than the trial agents. What to expect if you participate The research team will give you specific instructions, evaluate your health at the beginning of the trial, monitor it carefully during the trial, and stay in touch after it ends. To receive the greatest benefit, you should carefully follow the instructions and remain in contact with the research staff. Trials may be conducted in a hospital, doctor’s office or community clinic, and health insurance usually covers the costs of treatment. Evaluating benefits vs. risks There is a risk that a new treatment may not be effective for you. You may experience serious, unpleasant or life-threatening side effects from the treatment. In addition, your protocol may require more time spent at the study site, additional hospitalization or complex dosage requirements. However, clinical trials also give you access to new treatments not widely available as well as cutting-edge medical care. By participating in medical research, you also help others with a similar disease to share the benefits of new discoveries. ADDITIONAL RESOURCES BreastCancerTrials.org: www.breastcancertrials.org Center for Information and Study on Clinical Research Participation: www.searchclinicaltrials.org CenterWatch: www.centerwatch.com Clinical Trials Advocacy Group (Prostate Cancer): www.cancertrials4prostate.org Clinical Trials Search: www.clinicaltrialssearch.org Coalition of Cancer Cooperative Groups: www.cancertrialshelp.org EmergingMed Navigator: www.emergingmed.com My Clinical Trial Locator: http://myclinicaltriallocator.com National Cancer Institute: www.cancer.gov/clinicaltrials/search National Comprehensive Cancer Network: www.nccn.org/patients/default.asp National Institutes of Health: www.clinicaltrials.gov Pa t i e n t Re s o u r ce .co m Investigational Clinical Study Now Enrolling ALTERNATIVE (EGF114299): A Phase III Open-Label Study of Lapatinib, Trastuzumab, and Endocrine Therapy in Patients Who Received Neo-/Adjuvant or First-line Trastuzumab (IV) and Endocrine Therapy You may be eligible for the study if you meet the following requirements: U You are a postmenopausal woman with breast cancer tumors that are HER2+/HR+ (ER+ and/or PR+) that have spread to other parts of your body (metastatic breast cancer, MBC) U You have previously received endocrine therapy (antihormonal therapies such as aromatase inhibitors and selective estrogen receptor modulators) U You have previously received treatment with trastuzumab in combination with chemotherapy (directly before or after breast cancer surgery [neoadjuvant or adjuvant] and/or as first-line treatment for MBC) – You have received no more than one trastuzumabcontaining regimen for MBC – If this clinical trial would provide your second-line of therapy for MBC, your MBC must have progressed during or following the first-line therapy U You have adequate organ function, as determined by your study doctor U Your study doctor determines that you should not receive chemotherapy at this time for treatment of your MBC 1st or 2nd line MBC Target enrollment: 525 patients You would not be eligible for the study if you meet any of the following requirements: U Your breast cancer has spread to your brain and/or central nervous system U You have any of the following serious heart conditions – Irregular heartbeat (arrhythmia) that is not under control with medications – Chest pain (angina) that is not under control with medications – A history of congestive heart failure – A heart attack (myocardial infarction) within 6 months of entering the trial U You have current, active liver or bile duct disease Monthly study-related medical procedures that are not standard of care are provided at no cost to participants. Study Design Each of the drugs provided in this study are approved to treat MBC in the US. However, some of the drug combinations provided in this study (lapatinib+anastrozole, lapatinib+exemestane, trastuzumab+AI and lapatinib+ trastuzumab+AI) are considered investigational. If you can participate, you will receive 1 of 3 possible treatments. You have the same chance of receiving any of these treatments. Lapatinib + Trastuzumab + AI* Trastuzumab + AI* Lapatinib + AI* *AI = Aromatase Inhibitor chosen by your doctor - letrozole, anastronzole, or exemestane Contact: US GSK Clinical Trials Call Center 877-379-3718 or [email protected] For more information, please visit: www.clinicaltrials.gov (identifier NCT01160211) general information | types of treatment Types of Treatments T Learn About Your Options The type of cancer treatment or combination of treatments your doctor recommends depends on several factors. These include the type of cancer you have, the stage of disease, your age, overall health and family history. The three main cancer treatments are surgery, chemotherapy and radiation therapy. However, new drugs and other types of treatments are continually being developed – such as targeted therapy, hormone therapy, biologic therapy, stem cell transplantation and ultrasound therapy – which provide more options and can be used alone or in combination with the three main treatment types. These new options offer renewed hope of better outcomes for cancer patients. Your treatment plan will include the primary treatment, which is the definitive treatment designed to potentially eliminate the disease. Often, surgery is the primary treatment, but radiation therapy or chemotherapy also may be primary treatment approaches. In some cases, your treatment plan will include an additional treatment, known as adjuvant therapy. Adjuvant therapy is given after primary treatment to destroy any microscopic deposits of cancer cells that may remain or that may be too small for laboratory testing or imaging studies to detect. This follow-up treatment decreases the risk of your cancer coming back (recurring), which can help increase your survival. Finally, your treatment plan may include neoadjuvant therapy, which is given before the primary treatment. The purpose of neoadjuvant therapy is to help shrink a tumor, often to make it easier to surgically remove. Surgery The treatment for most people with a solid cancerous tumor is some type of surgical procedure. Surgically removing a tumor offers the best chance for cure, especially if cancer cells have not spread beyond the original site to other parts of the body. Surgery also may be useful in staging a cancer and in relieving or preventing symptoms that might otherwise occur later. Many advances have been made in the techniques used for removing tumors, including minimally invasive approaches such as laparoscopy and robotic surgery. These new techniques increase the likelihood of a shorter recovery time with fewer side effects, but they may not be the best option for some people. Radiation therapy Radiation therapy is the use of high-energy X-rays or proton beams to destroy or damage cancer cells. These treatments are given either externally with radiation machines called linear accelerators or cobalt machines, or given internally through radioactive material implanted in the body, swallowed or injected. External-beam radiation therapy is the most common type and is used for a wide variety of cancers. This type of treatment is similar to a conventional X-ray, except the radiation beams are strong enough to kill cancer cells. New techniques, such as intensity-modulated radiation therapy, enable doctors to target the radiation dose directly on the precise site of the tumor, causing less damage to healthy cells in the pathway of the radiation beam. Radiation therapy can also be delivered directly through radioactive seeds implanted in or near a tumor, known as brachytherapy. The radioactive seeds may stay in place either temporarily or permanently. Temporary radioactive seeds are implanted and removed with a catheter inserted into the part of the body with the tumor. Permanent seeds are inserted into tissues and will stop giving off radiation after a few weeks or months. Brachytherapy is done most often for prostate, head and neck, gynecologic and lung cancers, and most recently, for some cases of early-stage breast cancer. Radiopharmaceuticals are another type of radiation therapy, known as systemic radiation therapy. These substances include a radioactive component, such as radioactive iodine, that destroys cancer cells. A patient either swallows the substance or receives it by injection. Radiopharmaceuticals are used most often for bone and thyroid cancers and lymphomas. The latest development in radiation therapy is proton-beam therapy. Protons are atomic particles that are e-asier to control than X-rays. This therapy can therefore avoid a lot of damage to healthy tissue or organs surrounding a tumor by precisely targeting the location and size of the tumor. Proton-beam therapy is ideal for treating oddly shaped tumors or tumors located in areas where X-ray therapy can damage healthy tissue in critical places, such as the brain. Conventional chemotherapy Conventional chemotherapy is also known as systemic therapy because the drugs travel through the bloodstream to all parts of the body. Chemotherapy may be given intravenously through a small tube inserted into a vein, or orally by a pill. Conventional chemotherapy is usually delivered in cycles, with treatment periods followed by recovery periods in an on-again, off-again manner. Treatment often consists of combinations of drugs, sometimes given simultaneously and at other times given one 12 Pa t i e n t Re s o u r ce .co m types of treatment | general information after another. A combination of chemotherapy drugs is known as a regimen. virus, which can cause liver cancer, and human papillomavirus types 16 and 18, which are responsible for about 70 percent of cervical cancer cases. Vaccines for other cancer types are under investigation. Targeted therapy Targeted therapy is treatment with drugs or other substances that block the growth and progression of cancer. They do so by interfering with specific molecules involved in tumor growth and progression. The targeted therapy agents block or modify the molecules on or inside cancer cells that alter signaling pathways, which are complex systems that direct basic cell functions, such as cell division and death. Targeted therapy is used for a wide variety of cancer types, including breast, lung, colon and kidney cancers, as well as certain types of leukemia. Many types of targeted therapy drugs can be taken by mouth and are usually given in combination with another type of therapy—most often conventional chemotherapy. Most targeted therapy drugs are either small-molecule drugs or monoclonal antibodies. Both types are made in a laboratory and are designed to locate and bind to specific substances inside or on the cancer cells. Small-molecule drugs can pass through the cell membrane and act on a target inside the cell. Many small-molecule drugs are tyrosine kinase inhibitors (TKIs), which act against specific signaling pathways involved in tumor growth. Some examples of TKIs are imatinib (Gleevec), sunitinib (Sutent), erlotinib (Tarceva) and dasatinib (Sprycel). Monoclonal antibodies cannot pass through the cell membrane and instead are used against targets found on the cell surface. Examples of these include trastuzumab (Herceptin), rituximab (Rituxan), cetuximab (Erbitux), panitumumab (Vectibix) and alemtuzumab (Campath-1H). Some monoclonal antibodies target proteins involved in the development of blood vessels within a tumor. Targeting these proteins blocks the growth of new blood vessels, thereby cutting off the blood supply to the tumor. Without a blood supply, the tumor cannot grow. The formation of new blood vessels is known as angiogenesis, and these drugs are known as antiangiogenic agents. Bevacizumab (Avastin) is an example of an antiangiogenic agent. Hormone therapy Hormones that occur naturally in the body drive the growth of some cancers. For example, estrogen fuels the growth of some breast cancers, and testosterone aids in the growth of prostate cancer. Hormone therapy acts to block the stimulating effect of hormones, thereby slowing or stopping the progression of cancer. Hormone therapy for breast cancer, also known as endocrine therapy, includes Pa t ie n tResource.com Hematopoietic stem cell transplantation tamoxifen (Nolvadex) and aromatase inhibitors (Arimidex, Aromasin, Femara). These drugs are called antiestrogen agents because they inhibit the production of estrogen or interfere with its action. Hormone therapy for prostate cancer involves either surgery or drugs and is often called androgen-deprivation therapy. Surgical removal of the testicles eliminates the source of about 90 percent of testosterone in a man. Alternatively, several drugs are available to interfere with the production of testosterone. Biologic therapy Biologic therapy, also called immunotherapy, helps repair or stimulate a person’s own immune system, which is the body’s defense against harmful organisms or substances such as bacteria, viruses and cancer cells. Biologic therapy is either active or passive; active therapy stimulates a person’s own immune system to fight cancer, and passive involves the use of parts of the immune system, such as antibodies made in a lab. The most common type of passive immunotherapy is treatment with a monoclonal antibody. Some antibodies used for biologic therapy are radiolabeled, which means that they contain a radioactive substance. These antibodies attach to cancer cells and kill them. This treatment, also known as radioimmunotherapy, has primarily been used for some types of non-Hodgkin lymphoma. Another form of biologic therapy is treatment with cytokines, which are special proteins on white blood cells that help stimulate an immune response. Interleukin-2 and interferon-alpha are two cytokines that have been approved for treatment of metastatic melanoma and kidney cancer. Cancer vaccines are an additional form of biologic therapy. A recently developed vaccine is sipuleucel-T (Provenge), which is FDA-approved for the treatment of advanced prostate cancer. The FDA also has approved vaccines against the hepatitis B Hematopoietic stem cell transplantation helps the body produce new blood cells. Stem cells are found in the bone marrow, and they have a special feature that enables them to develop into any one of the three types of blood cells – red blood cells, white blood cells and platelets (clotting cells). There are two types of stem cell transplantation: autologous and allogeneic. With autologous stem cell transplantation, a person’s own stem cells are removed and preserved so that very high doses of chemotherapy and/or radiation therapy can be given to attack cancer cells without destroying the stem cells. After the conclusion of the intensive therapy, the person’s stem cells are infused back into the body. An allogeneic stem cell transplantation is the use of stem cells obtained from a donor with healthy bone marrow whose stem cells are a close match to those of the person to be treated. Allogeneic stem cell transplantation also is considered to be a form of immunotherapy because it establishes a new immune system for a person. Stem cell transplantation and high-dose chemotherapy and/or radiation therapy are used most often for leukemias, lymphomas, multiple myeloma, germ-cell tumors and pediatric tumors. High-intensity focused ultrasound therapy With this therapy, high-intensity ultrasound waves are focused on a tumor to heat it to high temperatures and destroy it. Guided by magnetic resonance imaging, high-intensity focused ultrasound has been used to successfully treat localized prostate cancer, but it is not yet FDA-approved for this use. The procedure is also under investigation for the treatment of breast, liver, brain, bone, pancreas, kidney and testicular cancer. ADDITIONAL RESOURCES American Cancer Society: www.cancer.org American Society for Radiation Oncology: www.astro.org CancerCare: www.cancercare.org The National Association for Proton Therapy: www.proton-therapy.org National Cancer Institute: www.cancer.gov Patient Resource: www.PatientResource.com/Cancer_ Treatments.aspx 13 What if you could help the immune system respond to cancer cells? PD-L1 expression helps tumor cells evade the immune system programmed death-ligand 1 (PD-L1), which binds to the PD-1 and B7.1 receptors on Tumor expression of T cells, deactivates T-cell–mediated cytotoxicity. This inhibits the immune system and allows the tumor to continue to grow.1 Nearly all cancer types show increased expression of PD-L1.2 PD-1 Inactivated T cell PD-L1 TCR B7.1 MHC Tumor cell PD-L1 References: 1. Mellman I, Coukos G, Dranoff G. Cancer immunotherapy comes of age. Nature. 2011;480:480-489. 2. Blank C, Gajewski TF, Mackensen A. Interaction of PD-L1 on tumor cells with PD-1 on tumor-specific T cells as a mechanism of immune evasion: implications for tumor immunotherapy. Cancer Immunol Immunother. 2005;54:307-314. 3. Pardoll DM. Immunology beats cancer: a blueprint for successful translation. Nat Immunol. 2012;13:1129-1132. © 2013 Genentech USA, Inc. All rights reserved. BIO0001911700 Printed in USA. Blocking PD-L1 may restore the body’s adaptive immune response Genentech is investigating the strategy of inhibiting the interaction between tumor-expressed PD-L1 and its receptors on T cells; blocking this interaction may restore the body’s adaptive immune system to respond to cancer cells.1 Research is also under way to validate PD-L1 as a potential biomarker for cancer immunotherapy.3 Activated T cell B7.1 TCR MHC Tumor cell death PD-1 Explore the role of cancer immunotherapy and PD-L1 inhibition at ResearchCancerImmunotherapy.com general information | personalized medicine A Personalized Approach P to Cancer Treatment Personalized medicine – sometimes known as precision medicine – is an approach to medical care that uses information about an individual’s genes and personal environment, as well as the behavior of certain proteins, to understand risk and to prevent, diagnose and treat disease. This approach has grown in use in recent years thanks to advances in science and technology. Before the development of personalized medicine, cancer treatment decisions were based on the cancer’s site of origin rather than on the unique biologic characteristics of an individual and their disease. Personalized medicine includes new generations of highly targeted therapies, drugs or other substances (such as biologics) that block the growth and spread of cancer by interfering with specific molecules – as well as critical communication pathways within the cell and between cells – involved in tumor growth and progression. Targeted therapies are possible because of a better understanding of biomarkers, which are proteins and other molecules found in tissue, blood or other body fluids that are a sign of a normal or abnormal process or of a condition or disease. A biomarker may also be used to see how well the body responds to a treatment for a disease or condition. For people with cancer, targeted therapy represents a significant medical advance because the treatment targets their specific cancer. Once the biology of specific cancer cells and certain unique molecules can be identified in a person with cancer, doctors can use specific drugs to stop the cancer cells from reproducing or surviving. More specifically, targeted therapy drugs interfere with the cell growth-signaling mechanism. Targeted therapy may also limit the blood supply to cancer cells, preventing them from growing. It also may promote the death of specific cancer cells, stimulate the immune system to destroy specific cancer cells or help deliver toxic drugs to cancer cells. Biomarkers are used to identify the best type of targeted therapy to treat your disease. Protein biomarkers found in the blood or urine include substances that are either produced by cancer cells themselves or by other cells in response to cancer. Most protein biomarkers related to cancer are used to monitor response and/or detect recurrence or progression of cancer after treatment (Table 1). Molecular biomarkers are a result of mutations (changes) in genes or in receptors on cells that have been found to identify a subtype of cancer. Identifying subtypes is important for determining your prognosis and guiding treatment. Testing for molecular biomarkers is usually done on samples of tissue taken from the tumor. Limitations of personalized medicine Unfortunately, personalized medicine isn’t an effective treatment for every type of cancer because only some cancers have at least one identified treatment target. In addition, not every target has a drug effective in limiting cancer growth. Because many mutations in cancer cells can occur over time, the cancer may have different properties in different locations in the body and may respond differently to targeted agents. While the cancer may initially respond to targeted therapy, over time this response may not last and the tumor cells may find new ways to escape the treatment. Patients seem to be unique in both their response to the drugs and the duration of that response. Table 1. Biomarkers according to type of cancer Biomarker Type of sample Function Use ER/PR (estrogen receptor/ progesterone receptor) Tumor tissue Guide treatment Routine testing at time of diagnosis is highly recommended, as presence of receptors is associated with response to hormone therapy. HER2 Tumor tissue Guide treatment Routine testing at time of diagnosis for all patients with invasive breast cancer (early-stage or recurrence) is highly recommended, as overexpression of gene is associated with response to specific targeted therapy. BRCA1 and BRCA2 Blood Detect genetic risk/ guide treatment Mutations in these genes indicate an increased risk of breast cancer and/or ovarian cancer. Gene expression analysis Tumor tissue Determine prognosis/ guide treatment Testing recommended for distinct population (women with early-stage ER+/PR+ cancer with no evidence of disease in the lymph nodes). Low-risk score indicates that adjuvant chemotherapy will offer little benefit. CA (cancer antigen) 15-3 or CA 27.29 Blood Monitor response May be used in conjunction with diagnostic imaging, history and physical examination. Breast Cancer CEA (carcinoembryonic antigen) Blood Monitor response May be used in conjunction with diagnostic imaging, history and physical examination. uPA (urokinase-type plasminogen activator), PAI-1 Tumor tissue Determine prognosis/ guide treatment Testing recommended for newly diagnosed ER+/PR+ cancer that has not spread to lymph nodes. Low level (low risk) indicates that adjuvant chemotherapy will offer minimal benefit. Chronic Myeloid Leukemia BCR-ABL Blood Aid diagnosis Testing done routinely, as presence of gene is distinguishing feature of the disease. Guide treatment Gene is associated with response to specific targeted therapy. Determine prognosis Testing recommended during initial workup. High level before treatment may indicate cancer has spread. Monitor response Biomarker of choice for monitoring metastatic colorectal cancer during chemotherapy. Detect recurrence/ progression Testing recommended during follow-up of nonmetastatic disease to detect recurrence or metastasis. Colorectal Cancer CEA 16 Blood Pa t i e n t Re s o u r ce .co m personalized medicine | general information Biomarker Type of sample Function Use KRAS Tumor tissue Guide treatment Testing recommended, as overexpression of gene is associated with lack of response to some targeted therapies. MMR Tumor tissue Determine prognosis Testing recommended, as the mutation is associated with good prognosis. Gene expression analysis Tumor tissue Determine prognosis/ guide treatment Testing recommended for distinct population (people with Stage II disease); low-risk score indicates that adjuvant chemotherapy will offer little benefit. Tumor tissue Aid diagnosis Testing done routinely, as presence of mutation is distinguishing feature of the tumor. Guide treatment Presence of mutation associated with response to specific targeted therapies. Blood Aid diagnosis Testing recommended at initial workup; very high levels can indicate liver cancer (but high levels can be increased in other noncancerous conditions). Detect recurrence/ progression Testing done throughout follow-up if level was initially elevated. Colorectal Cancer (continued) Gastrointestinal Stromal Tumor KIT Liver Cancer AFP (alpha-fetoprotein) Melanoma LDH (lactate dehydrogenase) Blood Determine prognosis Testing recommended at initial workup, as level is a factor in determining stage of disease. Testing done throughout follow-up of Stage IV disease (metastatic melanoma); high level is predictor of poor prognosis. BRAF Tumor tissue Guide treatment Testing recommended for metastatic melanoma, as gene mutation is associated with response to specific targeted therapies. S-100 Blood Determine progression Evidence is currently insufficient to recommend testing, but level is elevated in most individuals with metastatic melanoma. Multiple Myeloma Beta-2-microglobulin Blood Determine prognosis Testing recommended at initial workup, as level is a factor in determining stage of disease. Monitor response Measured throughout follow-up; high level indicates high tumor burden (and poor prognosis). Non-Small Cell Lung Cancer EGFR Tumor tissue Guide treatment Testing is recommended, as some targeted therapies are more effective when gene is overexpressed. KRAS Tumor tissue Guide treatment Testing recommended, as overexpression is associated with lack of response to some targeted therapies. ALK-EML4 Tumor tissue Guide treatment Testing recommended, as presence of gene mutation is associated with response to a specific targeted therapy. Blood Aid diagnosis Testing recommended at initial workup (if symptoms suggest ovarian cancer). Detect recurrence/ progression Testing done throughout follow-up. Ovarian Cancer CA (cancer antigen) 125 Pancreatic Cancer CA (cancer antigen) 19-9 Blood Determine prognosis Testing recommended at initial workup; high level is associated with poor prognosis. Monitor response Testing done during active treatment for locally advanced metastatic disease; increase in level may indicate recurrence. (Decreased level after surgery or chemotherapy indicates better survival.) Screening Usefulness as screening tool is debated, as the level is elevated in benign conditions of the prostate. Aid diagnosis Testing recommended at initial workup, as level is factor in determining stage of disease. Detect recurrence/ progression Testing done throughout follow-up. Prostate Cancer Prostate-specific antigen (PSA) Blood Testicular Cancer AFP Blood Aid diagnosis Testing recommended at initial workup, as level is a factor in determining stage of disease. hCG (human chorionic gonadotropin) Blood/ urine Aid diagnosis Testing recommended at initial workup, as level is a factor in determining stage of disease. LDH Blood Guide treatment More aggressive treatment is recommended if elevated levels persist. Blood Detect recurrence/ progression Testing done throughout follow-up. Thyroid Cancer Thyroglobulin Pa t ie n tResource.com 17 general information | pain management P Finding Relief From Cancer Pain Pain is a leading fear for many people with cancer. But cancer doesn’t have to mean pain. You are entitled to having a doctor who is totally committed to relieving any pain you may experience as a result of cancer and its treatments, and one who also makes sure that any side effects from attempts at pain control are acceptable to you. So, if you don’t already have someone like that on your multidisciplinary health care team, ask for a referral. Improved pain control can lead to improved survival, so the more in check you and your doctor can keep your pain, the better your overall outlook. Causes of cancer pain For many people, cancer pain can come from the cancer itself. As a tumor spreads, it can press on an internal organ, bone or joint, creating pressure that leads to pain. A tumor can also cause pain by damaging nearby tissues and nerves as it grows into them, and by producing chemicals that disrupt the balance of that area of the body. While cancer treatments can be beneficial, they can sometimes cause pain as well. For example, if you have surgery to treat your cancer, you may experience pain as your body heals and recovers from the procedure. Chemotherapy and radiation therapy can also cause pain by damaging healthy cells, which can result in painful side effects such as burning sensations, mouth sores, diarrhea, nerve damage and more. You should not avoid these treatments because they may cause pain. Rather, you should keep an open dialogue with your doctor about any pain you experience so it can be controlled. 18 Types of cancer pain Everyone experiences pain in different ways, but it’s useful to distinguish among the main types: • Acute pain usually comes from injury or damage to bodily tissues. It comes on as a direct result of a trauma – surgery, for example – so the cause can usually be readily diagnosed. Standard pain medication is often effective. • Chronic pain, also called persistent pain, lasts long after the bodily injury heals and can be more resistant to medical treatments. It can be very taxing on both your body and your emotional state. However, using the various treatments available today, chronic pain can be effectively managed in the vast majority of people. • Breakthrough pain includes severe flares of pain that “break through” regular pain medications. Sometimes these flares are related to an event, such as coughing, and sometimes they’re sudden and unpredictable. These outbreaks can be mild to severe and can last for up to an hour a few times a day, but breakthrough pain can still be managed using various techniques. Confronting the myths of pain medication ✖ ✔ ✖ ✔ ✖ ✔ Management of cancer pain The options for managing cancer pain are numerous, and it can be helpful to think of them as tools in a toolbox. Sometimes just one tool can fix the problem, but other times the whole toolbox will be required. In addition, you’ll sometimes need to use tools in a particular sequence, while other times you may need to jump back and forth between tools. The following descriptions of various pain relief techniques are meant to provide you with a general overview of what’s available. That way, if your doctor doesn’t mention one or more of them as options for your care, you’ll be equipped to ask whether they might be right for you. • Pharmacotherapy is the treatment of cancer pain through the administration of medications, including non-opioid, opioid, adjuvant and topical analgesics. ! Non-opioid analgesics are often available over-the-counter and include aspirin, ibuprofen (Advil, Motrin), acetaminophen (Tylenol), etc. ! Opioid analgesics require a prescription and help decrease both the perception of pain and the reaction to pain. Codeine, oxycodone and morphine are all examples of opioid analgesics. ! Adjuvant analgesics, including certain ✖ ✔ ✖ ✔ Myth: If I take narcotics regularly, I may become addicted. Fact: While people can become tolerant to a pain medication (meaning ever-increasing doses are required to achieve the same effect), it is not the same as addiction. People with cancer who take pain medication as directed by their doctors usually do not become addicted. Myth: If I start taking pain medication early on, I will run out of options for pain relief in the future. Fact: Many pain-relieving medications and procedures are available. There will almost always be options if pain becomes more severe. Myth: I don’t want to have unpleasant side effects from pain medications. Fact: Side effects do occur with some pain medications, but they can be managed and some will decrease or disappear over time. Unacceptable side effects are a reason to ask your doctor about formulating an alternative plan for pain relief. Myth: Increasing pain means the disease is getting worse. Fact: Pain and severity of disease are not necessarily related, but increasing pain should prompt a conversation with your doctor to evaluate the cause and develop a plan for more acceptable pain relief. Myth: I don’t want to bother the doctor. Having pain should be expected. Fact: Although pain is common, your doctor and other members of your treatment team should always be willing to help find ways to control your pain so you can enjoy a better quality of life. antidepressants and anticonvulsants, aren’t primarily designed to control pain, but they can sometimes be used for this purpose, especially in cases where damaged nerve cells result in neuropathic pain. See RELIEF FROM CANCER PAIN, page 21 Pa t i e n t Re s o u r ce .co m For Adults on Strong Chemotherapy Help Boost Your Natural Defenses with Neulasta® (pegfilgrastim) After Every Chemo Cycle What Can Happen to White Blood Cells During Strong Chemo Strong chemotherapy can lower the QXPEHURILQIHFWLRQÀJKWLQJZKLWH blood cells in your body, putting you at risk of infection. Neulasta® Helps Boost White Blood Cells Injected 24 hours after each cycle of chemotherapy, Neulasta® may help boost your white blood cell count, and reduce your risk of infection while undergoing strong chemotherapy. Indication Neulasta® is a prescription medication used to reduce the risk of infection (initially marked by fever) in patients with some tumors receiving strong chemotherapy that decreases the number of infectionÀJKWLQJZKLWHEORRGFHOOV1HXODVWD® may not prevent all infections. Important Safety Information Do not take Neulasta® if you have had an allergic reaction to Neulasta®SHJÀOJUDVWLPRUWR NEUPOGEN® (Filgrastim). Tell your doctor if you have a sickle cell disorder before using Neulasta®. Ruptured spleen (including fatal cases), a serious lung problem called acute respiratory distress syndrome (ARDS), serious allergic reactions, and sickle cell crises can occur. Call your doctor or seek emergency care right away if you have: pain in the left upper stomach area or left shoulder tip pain (symptoms of an enlarged or ruptured spleen); shortness of breath, trouble breathing, or a fast rate of breathing (symptoms of ARDS); shortness of breath, wheezing, dizziness, swelling around the mouth or H\HVIDVWSXOVHVZHDWLQJDQGKLYHVV\PSWRPVRIDQDOOHUJLFUHDFWLRQRULI\RXKDYHSDLQRUGLIÀFXOW\ breathing (symptoms of sickle cell crises). The most common side effect you may experience is aching in the bones and muscles. If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see brief summary of Important Product Information on the previous page. You may be at risk of infection throughout all of your chemotherapy treatment. Discuss infection risk factors with your healthcare provider, and ask if Neulasta® is right for you. Help limit your co-pay (based on eligibility) Co-Pay Coupon Card The Amgen FIRST STEP™ Program can help eligible patients with commercial insurance cover their deductible, co-insurance, and/or co-pay requirements. Certain limitations apply. Log on to www.AmgenFIRSTSTEP.com or call 1-888-657-8371 for a complete list of eligibility requirements and program restrictions. Learn more at www.Neulasta.com © 2012 Amgen Inc. All rights reserved. 65494-R3-V2 BRIEF SUMMARY OF PATIENT PACKAGE INSERT Neulasta® (pegfilgrastim) This brief summary of the patient package insert provides information and instructions for people who will be receiving Neulasta or their caregivers. This brief summary does not tell you everything about Neulasta. You should discuss any questions you have about treatment with Neulasta with your doctor. What is Neulasta? sSickle Cell Crises. You may have a serious sickle cell crisis if you have a sickle cell disorder and take Neulasta. Serious and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, a medicine similar to Neulasta (pegfilgrastim). Call your doctor right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing. What are the most common side effects of Neulasta? Neulasta is a man-made form of granulocyte colony-stimulating factor (G-CSF), which is made using the bacteria Escherichia coli. G-CSF is a substance produced by the body. It stimulates the growth of neutrophils (nu-tro-fils), a type of white blood cell important in the body’s fight against infection. The most common side effect you may experience is aching in the bones and muscles. If this happens, it can usually be relieved with a non-aspirin pain reliever, such as acetaminophen. Who should not take Neulasta? What about pregnancy or breastfeeding? Do not take Neulasta if you have had: Neulasta has not been studied in pregnant women, and its effects on unborn babies are not known. If you take Neulasta while you are pregnant, it is possible that small amounts of it may get into your baby’s blood. It is not known if Neulasta can get into human breast milk. If you are pregnant, plan to become pregnant, think you may be pregnant, or are breastfeeding, you should tell your doctor before using Neulasta. If you become pregnant during Neulasta treatment, you are encouraged to enroll in Amgen’s Pregnancy Surveillance Program. You should call 1-800-77-AMGEN (1-800-772-6436) to enroll. sA serious allergic reaction to Neulasta® (pegfilgrastim) or to Neupogen® (filgrastim). What important information do I need to know about receiving Neulasta? Occasionally pain and redness may occur at the injection site. If there is a lump, swelling, or bruising at the injection site that does not go away, talk to the doctor. Neulasta should only be injected on the day the doctor has determined and should not be injected until approximately 24 hours after receiving chemotherapy. The needle cover on the single-use prefilled syringe contains dry natural rubber (latex), which should not be handled by persons sensitive to this substance. What should I tell my healthcare provider before taking Neulasta? If you have a sickle cell disorder, make sure that your doctor knows about it before you start using Neulasta. If you have a sickle cell crisis after getting Neulasta, tell your doctor right away. If you have any questions, talk to your doctor. How should Neulasta be stored? Neulasta should be stored in the refrigerator at 2° to 8°C (36° to 46°F), but not in the freezer. Neulasta should be protected from light, so you should keep it in its carton until you are ready to use it. Avoid shaking Neulasta. If Neulasta is accidentally frozen, allow it to thaw in the refrigerator before injecting. However, if it is frozen a second time, do not use. Neulasta can be left out at room temperature for up to 48 hours. Do not leave Neulasta in direct sunlight. For all questions about storage, contact your doctor, nurse or pharmacist. What are the ingredients in Neulasta? Each syringe contains pegfilgrastim in a sterile, clear, colorless, preservative-free solution containing acetate, sorbitol, polysorbate 20, and sodium. What are possible serious side effects of Neulasta? sSpleen Rupture. Your spleen may become enlarged and can rupture while taking Neulasta. A ruptured spleen can cause death. The spleen is located in the upper left section of your stomach area. Call your doctor right away if you have pain in the left upper stomach area or left shoulder tip area. This pain could mean your spleen is enlarged or ruptured. sA serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your doctor or seek emergency care right away if you have shortness of breath, trouble breathing, or a fast rate of breathing. sSerious Allergic Reactions. Neulasta can cause serious allergic reactions. These reactions can cause shortness of breath, wheezing, dizziness, swelling around the mouth or eyes, fast pulse, sweating, and hives. If you start to have any of these symptoms, call your doctor or seek emergency care right away. If you have an allergic reaction during the injection of Neulasta, stop the injection. Call your doctor right away. Neulasta® (pegfilgrastim) Manufactured by: Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 This product, its production, and/or its use may be covered by one or more US Patents, including US Patent Nos. 5,824,784; 5,582,823; 5,580,755, as well as other patents or patents pending. © 2012 Amgen Inc. All rights reserved. www.neulasta.com 1-800-77-AMGEN (1-800-772-6436) v 9.0 XXXXX-RX-VX pain management | general information Relief from Cancer Pain continued from page 18 Keeping Track of Cancer Pain A pain diary is an easy way to track what pain you’re experiencing and what painrelief methods are working, and it will help your medical team modify your care to make you as comfortable as possible. Use a consistent pain scale, like rating your pain from 0 to 10 (with 0 being no pain and 10 being the worst pain imaginable), and write down answers to questions like: • What does the pain feel like? Topical analgesics are either sprayed on or rubbed into the skin, directly over the painful area. They can include one or more medications and are often made-to-order by a compounding pharmacy. Topical analgesics may cause less severe side effects than other analgesics because they’re not ingested. • Percutaneous pain techniques refer to procedures that access inner organs and tissues by puncturing the skin with a needle. They include ablative techniques, nerve blocks, kyphoplasty, vertebroplasty and sacroplasty. ! Ablative techniques include various procedures used to turn off nerves that signal pain, thereby providing pain relief. ! Nerve blocks usually involve injecting a pain-killing medication around certain nerves that send pain signals to your brain. Nerve blocks can be used on sympathetic, peripheral and cranial nerves. ! Kyphoplasty, vertebroplasty and sacroplasty are all procedures in which bone cement is injected into the spine or sacrum to stabilize the area and relieve pain. • Neurosurgical approaches to pain relief seek to lessen pain at its source—in the neural pathways and processing centers of the spine and brain. Recent medical innovations have opened up many more neurosurgical pain relief options than were available in the past, including electrical stimulation, which can “jam” pain pathways and block pain, as well as intracranial and spinal ablation, which can turn off specific brain and spinal cord fibers that include pain-carrying nerves. • Intrathecal drug delivery, also called a “pain pump,” sends pain medication directly to your spinal cord using a small • • • • • • • • ! Pa t ie n tResource.com • • • • Is it mild or severe? Is it constant or does it come and go? Is it dull or sharp? When do you feel pain (morning, night, random times)? Are there specific triggers, like bending or stooping? How long does the pain usually last? What helps relieve your pain? Are you experiencing any side effects from your pain medications? pump that’s surgically placed in the abdominal wall. Because the medication goes directly to your spinal cord rather than first traveling through your entire system, it’s effective in much lower doses than oral medications and without the usual side effects. Palliative oncology, also called supportive oncology, can help mitigate cancer pain through palliative surgery, radiation therapy and chemotherapy. Palliative radiation therapy and chemotherapy can shrink a tumor that is causing pain, or palliative surgery can be done to remove part or all of such a tumor, stabilize the spine and keep organs functioning, thereby reducing pain. Palliative radiation therapy may also relieve pain caused by bone metastases (the spread of cancer to bone). Physiatry, or physical medicine and rehabilitation, helps relieve pain through customized therapy programs designed to enhance mobility, overcome disabilities and avoid painful activities when cancer or its treatments have affected how you move and function. Anti-inflammatory injections are also a part of this technique. Alternative and complimentary strategies include yoga, acupuncture, reflexology, massage therapy, aromatherapy, art therapy, music therapy and animal therapy. While these strategies may not single-handedly solve cancer pain, they do have role in pain management. Psycho-behavioral strategies involve activities such as deep relaxation and meditation. They are useful in calming psychological symptoms such as anxiety and depression, which often accompany cancer pain and can get in the way of its treatment. Keep in mind that there are risks and benefits associated with all types of pain re- lief techniques, so always review them with your health care team before beginning any type of regimen. Speak up about cancer pain Cancer pain is often undertreated because many patients are reluctant to discuss it. Don’t fall into that category. Ask about pain management right from the start, and continually alert your doctor at the first sign of pain. A pain diary, as discussed in the box below, can help you monitor your pain, know what to report and decide when to call your doctor. Pain relief works best when it’s done proactively rather than reactively, and ideally, pain should be addressed long before it becomes an emergency. In addition, if you’re having unacceptable side effects from pain medications, such as extreme fatigue, constipation, etc., discuss those issues with your doctor as well. Efforts can be made to employ different strategies to both get you the necessary pain relief and avoid unacceptable side effects. The goal is a satisfactory quality of life. ADDITIONAL RESOURCES American Chronic Pain Association: www.theacpa.org Cancer Pain Research Consortium: www.facebook.com/ cancerpainresearchconsortium; for questions, you can reach the administrative center of the Consortium at the Center for the Relief of Pain, at 816-363-2500 Cancer Support Community: www.cancersupportcommunity.org Pain National Cancer Institute: www.cancer.gov Coping with Cancer: Supportive and Palliative Care (Managing Physical Effects) Pain Control: Support for People with Cancer PainfromCancer.org: www.painfromcancer.org U.S. Pain Foundation: http://uspainfoundation.org 21 general information | side effects U Prevent or Control Side Effects Unfortunately, cancer treatment can cause unpleasant side effects, but they don’t have to be debilitating. New drugs and medication methods have shown improvement in quality-of-life issues in recent years. And your health care team can help you prevent, manage and reduce the amount and duration of your side effects during and after treatment. The key is to practice prevention whenever possible because prevention is easier than controlling symptoms once they have begun. A number of options can help you prevent, minimize or control some of the most common side effects of cancer treatment. Reduce nausea and vomiting Depending on how likely nausea and vomiting are to occur after your particular treatment, your doctor may prescribe a combination of antiemetic drugs. These drugs are commonly prescribed even before side effects begin as a way to prevent them from happening at all. For antiemetics to be effective, you must take them “around the clock” as your doctor has ordered and not on an “asneeded” basis. Some other practical tips can help minimize nausea and vomiting: • Eat several small meals throughout the day rather than three big meals. • Try eating a light meal a few hours before your scheduled treatment. • Drink plenty of fluids in small amounts throughout the day. • Avoid unpleasant and strong odors. • Keep hard candy or mints around to eat periodically. • Rest after eating, but don’t lie flat. Some people have also been helped by progressive muscle relaxation, biofeedback, guided imagery, acupuncture and self-hypnosis. Fight fatigue Fatigue is another common but manageable side effect. To fight it: • Conserve energy by setting priorities for activities and asking friends and family for help. • Balance activity and rest by participating in regular physical activity, such as power walking and bike riding, taking frequent rest periods or short naps, and getting eight hours of sleep each night. Remaining active has been scientifically proven to reduce fatigue caused by common cancer treatments. • Engage in activities that provide relaxation or distraction from fatigue, such as deep-breathing exercises, yoga, imagery 22 techniques, reading, playing games, praying or meditating. • Talk to your doctor about managing symptoms that may contribute to fatigue, such as pain, nausea, vomiting and depression. • Eat a well-balanced diet to promote healing. • Ask your doctor about psychostimulant drugs if your fatigue is severe; these can help counteract drowsiness and raise your energy level. Handle hair loss The best way to manage hair loss is to think about what will make you feel most comfortable with your appearance. Some people choose to wear a wig or head covering, such as a scarf or hat. Others choose to cut their hair short or shave their head completely before treatment begins so that hair loss will not be as noticeable. Ask your doctor or nurse when to anticipate hair loss. Most chemo drugs generally trigger the hair to begin falling out 10 to 15 days after the first cycle of treatment. Being gentle with your hair may help make hair loss more gradual and improve the regrowth of your hair. Use a soft brush or wide-toothed comb; use a gentle, pHbalanced shampoo; and avoid hair coloring and heating devices, including dryers, rollers and irons. Your hair may start to grow back curly while you’re still on chemotherapy, but it likely will return to its natural texture in eight to nine months. If you plan to wear a wig, ask your oncologist to give you a prescription for a “skull prosthesis due to alopecia caused by chemotherapy.” You can then try submitting your wig bill to your insurance company for partial or full payment, depending on your health care plan. It’s important that the prescription reads “skull prosthesis” instead of just “wig” so the claim is not rejected. It is difficult to prevent chemo-related hair loss, but scalp cooling, also known as cold cap therapy, has been effective in preventing hair loss in 80 to 90 percent of people receiving chemotherapy. It involves wearing a helmet-shaped cap filled with -27 F soft gel packs before, during and after chemotherapy for a total of eight hours. The cold temperature reduces blood flow to the scalp, which means the chemotherapy drugs don’t reach the hair follicles to destroy those cells. While not recommended by all oncologists, you should talk to your doctor if you’re interested in learning more. How you ultimately choose to handle hair loss is a personal decision, and the right choice is the one that makes you feel best. Minimize diarrhea You can prevent or minimize diarrhea through small changes to your eating habits: • Drink six to eight glasses of fluid per day. • Avoid beverages with alcohol or caffeine. • Eat bland, low-fiber foods. • Eat foods high in protein, calories and potassium that are easy to digest. • Eat more frequently but in smaller amounts. • Avoid foods that are high in fat. • Avoid very hot and cold beverages. Some medicines to control diarrhea are available over the counter, but you should not take these without first talking to your doctor, who may give you instructions for taking these drugs that differ from the drug label. If your diarrhea is severe, your doctor can prescribe other medications. Severe diarrhea may cause discomfort in the rectal area. To help soothe the area, clean the external rectal area with warm water and soap after bowel movements, soak in a warm bath or use a water-repellent cream. Focusing on foods that match the previously listed recommendations will not only help you combat diarrhea but also will help you avoid gaining weight during treatment, which is a common occurrence. Counter constipation If you are at risk for constipation, your doctor may tell you to take a stool softener, such as docusate (Colace), and a gentle laxative, such as senna (Senekot, ex-lax, Correctol) or bisacodyl (Dulcolax), on a regular basis. You should use a laxative only if your doctor has ordered it. You can help avoid constipation by drinking plenty of fluids; eating foods high in fiber, such as fresh fruits, vegetables and whole grains; and exercising as much as possible. Power walking is a great exercise to keep your GI tract on track. Cope with “chemo-brain” Chemotherapy can often cause “chemobrain,” which is commonly described as a “mental fog.” Other treatments, such as radiation therapy or some types of immunotherapy, can also cause some cognitive dysfunction. Use the following measures to help you cope with chemo-brain and improve your mental processing: See CONTROL SIDE EFFECTS, page 24 Pa t i e n t Re s o u r ce .co m WE BELIEVE YOUR IMMUNE SYSTEM MAY HELP FIGHT CANCER. And through clinical trials we are assessing investigational cancer therapies that work with the body’s immune system. JOIN AN IMMUNO-ONCOLOGY CLINICAL TRIAL. At Bristol-Myers Squibb, we are researching immuno-oncology, a new area of cancer research that involves investigational agents that are designed to work directly with the body’s immune system. If you or someone you love has been diagnosed with cancer, ask your oncologist if enrolling in a clinical trial involving an immuno-oncology agent would be an appropriate option. Now enrolling adults with advanced or metastatic disease in: s,UNGCANCER s-ELANOMA s2ENALCELLCARCINOMA s/THERCANCERTYPES Ask your oncologist if enrolling in a clinical trial would be right for you. And visit BMSStudyConnect.com for help in finding a clinical trial near you. Make the Connection at "-33TUDY#ONNECTCOM For instant access to BMSStudyConnect.com on your mobile device, scan here. © 2013 Bristol-Myers Squibb Company. All Rights Reserved. 137901 08/2013 general information | side effects Control Side Effects • Use a calendar or daily planner to keep all of your important information in one place. Write down all appointments, activities, medication schedules, important dates (such as birthdays and anniversaries), to-do lists, phone numbers and addresses, and names of movies you want to see and books you want to read. • Exercise your brain to strengthen your mental ability. Do crossword puzzles or other word or number games, complete jigsaw puzzles, play card games, play a musical instrument, learn a new hobby or learn a new language. • Get physical exercise to improve your mental alertness. Walk, swim, ride a bike, do aerobics, practice yoga or garden. • Don’t try to multitask. Focus on one thing at a time. • Ask for support. Tell friends and family that you’re having cognitive problems; laugh about your memory and attention problems together; ask people to repeat information or to write down new information, such as phone numbers and dates. If your chemo-brain gets worse or continues for many months after treatment, additional treatment options exist. A drug commonly used to treat Alzheimer’s disease – donepezil hydrochloride (Aricept) – has been effective for some people as have stimulant drugs, such as methylphenidate (Ritalin). Occupational therapy or vocational rehabilitation may also be helpful in improving the skills you need for daily living or for performing your job. Battle neutropenia Neutropenia is a low number of neutrophils, a type of white blood cell that helps prevent infections throughout the body. Neutropenia increases your risk of infection and also makes it more difficult for an infection to resolve if bacteria enter the body. The lower the neutrophil count, the greater the infection risk. During treatment, your white blood cell count will be checked often so that precautions or treatment can be started if appropriate. Neutropenia cannot be prevented, but studies have shown that the most effective way to prevent infection is frequent handwashing. If your neutrophil count is extremely low, your doctor may delay your next treatment and have you follow “neutropenic precautions,” or extra measures to prevent infection. 24 continued from page 23 Some people with an extremely low neutrophil count may benefit from treatment with a growth factor. These are special proteins that can stimulate the bone marrow to produce more white blood cells and are usually given as an injection under the skin. Monitor mouth sores Visit your dentist before starting any cancer treatment to get your gums and teeth as healthy as possible. Once you begin treatment, check your mouth twice a day so that you can detect mouth sores early. In addition, brush your teeth and apply lip balm 30 minutes after eating and every four hours in between. Also avoid products that may dry or irritate your mouth, such as lemon glycerin swabs or mouthwashes that contain alcohol. If you develop mouth sores, your doctor may suggest rinsing your mouth with special solutions. You also may receive a prescription for a topical pain medication or a medication that coats the lining of your mouth. To help minimize discomfort and promote healing, follow these tips: • Drink plenty of fluids each day. • Use a straw. • Eat soft foods, cut in small pieces. • Avoid foods that may irritate the mouth, such as hot, spicy, greasy or fried foods; salty or high-sugar foods; sharp or crunchy foods; citrus fruits and juices; alcohol, caffeine and carbonated beverages. • Do not use tobacco. Remedy dry mouth Ease the discomfort of dry mouth by keeping your mouth moist. Try sucking on ice cubes or taking frequent small sips of liquids. Use gravy, sauce or broth to make food easier to swallow, and chew sugar-free gum or suck on sugar-free hard candies. If you have severe dry mouth, your doctor or dentist may prescribe a drug, such as pilocarpine (Salagen), to stimulate the production of saliva, or an artificial saliva substitute in the form of a spray, gel or tablet. Address skin and nail reactions Skin reactions are usually mild to moderate but can become severe if not treated early. It’s important to note that skin reactions are side effects of treatment, not allergic or infectious reactions. Skin reactions caused by radiation therapy are usually minor and do not require treatment, but reactions caused by targeted therapy drugs can range from mild to severe. Rashes that are in a limited area, do not cause discomfort and are not infected usually do not need to be treated. If the rash spreads over a larger area and causes itchiness or pain, however, your doctor may prescribe a mild corticosteroid cream, such as hydrocortisone, or an antibiotic gel, such as clindamycin gel. Severe rashes usually are also treated with an oral antibiotic and perhaps an oral corticosteroid, such as methylprednisolone (Medrol) or prednisone. Taking special care of your skin can help also ease discomfort from reactions. Use gentle soaps and moisturizers, bathe in lukewarm – not hot – water, pat your skin dry rather than rubbing it, and wear loose-fitting clothing. Also avoid scratching areas of dry skin, using skin care products that contain alcohol and being in the sun without protective clothing and sunscreen. In addition, take extra care of your nails by keeping them short, using cuticle removers and cuticle cream, and wearing nail polish. Excessive exposure to water can lead to fungal infections of the nail bed, so wear gloves when doing chores, such as washing dishes, washing the car or gardening. Comfort flu-like syndrome If your treatment is likely to cause flu-like syndrome, your doctor may recommend acetaminophen (Tylenol) or an anti-inflammatory drug, such as ibuprofen or naproxen, before treatment begins. Once the syndrome occurs, your doctor will manage it by targeting the symptoms: acetaminophen for fever, nonsteroidal anti-inflammatory drugs for muscle aches, and antiemetics for nausea and vomiting. Drinking plenty of fluids, taking cool baths and resting can help you feel more comfortable. ADDITIONAL RESOURCES American Cancer Society: www.cancer.org Coping with Physical & Emotional Changes Symptoms and Side Effects American Society of Clinical Oncology (patient website): www.cancer.net Managing Side Effects Look Good…Feel Better: http://lookgoodfeelbetter.org National Cancer Institute: www.cancer.gov (Search “side effects”) National Center for Complementary and Alternative Medicine: www.nccam.nih.gov/health/cancer Patient Resource: www.PatientResource.com/Treatment_ Side_Effects.aspx The Rapunzel Project: www.rapunzelproject.org Pa t i e n t Re s o u r ce .co m Committed to the ever-changing world of cancer care Teva Oncology, a top 10 oncology company in the US,*1 offers multiple therapies for hematologic malignancies and has an approved product for supportive cancer care. Our diverse pipeline of compounds and biologics holds great promise for future therapies in hematologic malignancies, solid tumors, and supportive care. By combining our global heritage with therapeutic innovation, we provide more treatment choices for patients with cancer. Explore the depth of Teva Oncology. Visit TevaOncology.com *Excluding supportive care. Reference: 1. EvaluatePharma®, March 2013. ©2013 Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. All rights reserved. ONC-40170 April 2013. Printed in USA. breast cancer patient story Glamorous AMERICAN ICON CONFRONTED FEAR to fight breast cancer J Jaclyn Smith burst onto the American scene in 1976 when she played the calm and cool Kelly Garrett in the original “Charlie’s Angels” television series. She went on to portray strong characters in more than 50 film and television appearances, including Jacqueline Bouvier Kennedy and Florence Nightingale. Also well known for her business savvy, she trailblazed her own selfbranded clothing and home décor products with Kmart as well as her own lines of skin care products, fabrics and wigs, which are available at www.jaclynsmith.com. However, when the award-winning icon faced a breast cancer diagnosis in 2002 at the age of 55, she had to battle back fear. “Once you hear the word ‘cancer,’ you are paralyzed,” she said. “Your world stops spinning and the first thing you ask is, ‘Am I going to make it? Am I going to be here for my children and my family?’” Fortunately for Jaclyn, she trusted her doctor and had a supportive close-knit family and girlfriends surrounding her. And perhaps most importantly, the cancer was detected early. “Fear is the worst,” she said. “You have to face it because if you don’t, it just bites you in the back and stops you in your tracks. But as I talked with my doctor and my husband, Brad – who is a surgeon and researcher – and shared my concerns with my close friends, I educated myself and that helped calm my fears.” Calming those fears, she said, was also crucial for her children. “It was important to me to not show my fear to my kids. Cancer is a family affair and affects everyone. If they saw me as normal as I could be, with my head held high, that spilled over.” Summer 2002: diagnosis and treatment It was more than a decade ago when Jaclyn was in the middle of a busy spring at home in Los Angeles, preparing to take her teenage daughter to New York City to attend a dance camp. She was checking tasks off her to-do list, and one of those was her annual mammogram. The scan showed something suspicious, but Jaclyn was in excellent health and wasn’t concerned. The follow-up tests included a needle biopsy, an ultrasound and a core biopsy, but she was still so sure that everything was fine she went back for the results by herself. “My doctor is a good friend of ours,” she said. “When the results came back, he told me that he had mixed news. The bad news was that I had cancer. The good was we had caught it early at Stage I and it was very small – the size of a point of a pencil. At that point, I guess I sort of panicked. I told him, ‘Just take my breast off.’ You don’t hear anything after you are told you have cancer. That’s why you should never go back for the results alone.” Jaclyn was ready to act quickly, but her doctor and husband 26 cautioned her to slow down and consider her options. She and Brad both did extensive research and chose the recommended treatment of a lumpectomy and radiation. “I had the surgery and was fortunate because that summer when I had radiation, I was surrounded by my family and my girlfriends,” she said. “They were so supportive that I did not go to a single radiation appointment by myself. Not everyone has the luxury of those kinds of friends, but there’s a large number of support groups where you can make good friends.” The summer of 2002 turned out to be extremely busy for Jaclyn, and in hindsight, she views it as a blessing. She had just launched a furniture line, made a cameo appearance in the new “Charlie’s Angels” movie and also had a recurring role on CBS’ “The District.” During this same time, she also went for her radiation treatments. “My career had a resurgence, and for some reason, I had an abundance of energy—despite the radiation,” she said. “It was almost like God said, ‘You aren’t going to sit around and feel sorry for yourself. You are going to work!’ My daughter decided to forego her camp so she could be home with me. My son was at ease once I assured him that everything was going to be fine. Plus, everyone on the set of ‘The District’ could not have been more supportive.” Survivor and advocate After completing radiation, Jaclyn was cancer-free and has remained that way since 2002. Maintaining a balance of work and family, she continues to make television appearances and expand her retail lines. Because she had always made her health a priority, Jaclyn did not have to make substantial lifestyle changes. However, she did take anastrozole (Arimidex) for five years as adjuvant therapy and also began her personal regimen of alternating mammograms and MRIs every six months, which she still continues. In 2006, Jaclyn was ready to share what she had learned from her experience and crisscrossed the country for two years with the Strength in Knowing program. She told her story to encourage and help educate women about breast cancer and its risk factors. She also feels strongly about annual mammograms. “Early detection is the key,” she said. “If I had waited another year, the cancer would have been more advanced. The most important thing is to have a doctor you trust who advises you, have a mammogram every year and do self-examinations as well.” In retrospect, Jaclyn said that cancer changed her, and while challenging, the change was for the better. “Having cancer can make you a stronger, braver person. I was always pretty positive, but I am a private person as well. I found strength and healing in reaching out to others. But it also taught me that I could overcome my fears, to never give up and always have hope.” Pa t i e n t Re s o u r ce .co m Types of Cancer Inside this section Lung Cancer Breast Cancer Prostate Cancer Colorectal Cancer Leukemias & Multiple Myeloma Gynecologic Cancers Melanoma types of cancer | lung cancer L Lung Cancer Overview and Staging Lung cancer is the second most commonly diagnosed cancer in both men and women, and the most lethal in both genders in the United States. This type of cancer forms in cells that line the airways (bronchi) of the lung. Four main pathologic types of lung cancer exist: adenocarcinoma, squamous cell carcinoma, large cell carcinoma and small cell carcinoma. Small cell carcinoma most often spreads to other sites and may grow much faster than the other types. At one time, the other three types were classified together as non-small cell lung cancer. However, this term is no longer used when pathologists classify lung cancers because researchers have found differences in the way each type of non-small cell lung cancer develops and how it is best treated depending on its histology (microscopic characteristics). Lung cancer is usually staged twice. The first staging produces a “clinical stage,” which is based on the results of your physical exam and imaging tests. A pathologist will then assign a pathologic stage after examining tissue from the tumor, lymph nodes and other sites taken by biopsy. This examination provides more details about the Table 1. AJCC system for classifying lung cancer Classification Definition Tumor (T) Tx The primary tumor cannot be assessed OR there is evidence of cancer according to laboratory studies but no tumor seen on imaging studies or with bronchoscopy T0 No evidence of primary tumor Tis Carcinoma in situ (in place) T1 Tumor is 3 centimeters (about 1 inch) or smaller in its largest dimension, surrounded by lung or visceral pleura (lining covering the outside of the lung), with no evidence of tumor in the main bronchus (airway) T1a Tumor is 2 cm (about 3/4 inch) or smaller in its largest dimension T1b Tumor is more than 2 cm (but not more than 3 cm) in its largest dimension T2 Tumor is more than 3 cm but not more than 7 cm (about 2-3/4 inches); OR tumor has any of the following features: • Involves main bronchus, 2 cm or more below the carina • Invades visceral pleura • Associated with atelectasis (collapse of part of the lung) or obstructive pneumonitis (inflammation of lung tissue) that extends to the hilar region but does not involve the entire lung T2a Tumor is more than 3 cm but not more than 5 cm (about 2 inches) in largest dimension T2b Tumor is more than 5 cm but not more than 7 cm in largest dimension T3 T4 Tumor is more than 7 cm OR directly invades any of the following: chest wall, diaphragm, phrenic nerve, mediastinal pleura, parietal pericardium; OR tumor in the main bronchus less than 2 cm distal to the carina but without involvement of the carina; OR associated atelectasis or obstructive pneumonitis of the entire lung or separate tumor nodule(s) in the same lobe as the primary tumor Tumor of any size that invades any of the following: mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, carina OR presence of separate tumor nodule(s) in a different lobe of the lung with the primary tumor Nodes (N) cancer. The accuracy of the pathologic stage is important for choosing the best treatment options and predicting the outcome. Lung cancer is staged according to a system developed by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC). The system is based on data from around the world collected by the International Association for the Study of Lung Cancer (IASLC). This “TNM” system classifies the cancer by tumor (T), node (N) and metastasis (M) and is used as the foundation for the overall stage of lung cancer (Table 1). The T (tumor) category describes the size and location of the primary tumor. The N (node) category describes lymph node involvement, or whether cancer cells are found in nearby lymph nodes. The location of these nodes shows how much the disease has spread. The M (metastasis) category describes distant metastasis, or how much the cancer has spread to other parts of the body. Once the lung cancer has been classified according to this system, an overall stage is assigned. These are further subdivided to group tumors that are associated with similar outcomes. This grouping allows doctors to more accurately predict the outcome according to the stage (Table 2). The TNM classification and the staging system for lung cancer were updated in 2009 and the updated system stages both non-small cell and small cell lung cancer. Talk with your doctor to make sure that your lung cancer is staged according to the updated system, which can provide a more accurate prediction of outcome and suggest different treatment options. Table 2: Stages of lung cancer according to AJCC classification Stage TNM classifications 0 Tis, N0, M0 IA T1 (T1a or T1b), N0, M0 IB T2a, N0, M0 IIA T1 (T1a or T1b), N1, M0 T2a, N1, M0 T2b, N0, M0 Nx Regional lymph nodes cannot be assessed N0 No regional lymph node metastasis N1 Cancer cells are found in peribronchial and/or hilar lymph nodes and intrapulmonary nodes on the same side as the lung with the primary tumor IIB T2b, N1, M0 T3, N0, M0 N2 Cancer cells are found in mediastinal and/or subcarinal lymph nodes on the same side as the lung with the primary tumor IIIA N3 Cancer cells are found in mediastinal or hilar lymph nodes on the opposite side from the primary tumor OR in the scalene or supraclavicular lymph node(s) on the same or opposite side as the lung with the primary tumor T1 (T1a or T1b), N2, M0 T2 (T2a or T2b), N2, M0 T3, N1 or N2, M0 T4, N0 or N1, M0 IIIB Any T, N3, M0 T4, N2 or N3, M0 No distant metastasis IV Any T, any N, M1a or M1b Metastasis (M) M0 28 Pa t i e n t Re s o u r ce .co m Helping to make access to the therapies you need easier Novartis Oncology is committed to helping patients living with cancer receive the medicines they need. Patient Assistance NOW Oncology offers quick and easy access to information about the broad array of support and reimbursement programs available. You can get information about our Patient Assistance NOW Oncology support programs in 2 ways: r Call 1-800-282-7630 to speak with a member of our knowledgeable staff dedicated to making access to our programs as simple and convenient as possible; or r Visit our website at: www.OncologyAssistanceNow.com Support for Patients Includes: r Insurance verification r Assistance with denials/appeals r Coding/billing questions r Patient assistance for low-income and uninsured patients r Medicare education r Therapy-specific support programs for out-of-pocket costs r Alternative assistance searches and referrals to federal or state assistance programs r Referrals to independent charitable foundations for assistance with co-pay costs Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080 r Patients prequalified via phone screening for the Patient Assistance Program (PAP) will be sent a 30-day supply of their needed medication while completing the application r Convenient provider portal to access program services or check the status of patients enrolled © 2012 Novartis 10/12 T-PAN-1052066 types of cancer | lung cancer F Lung Cancer Treatment Options Four types of treatments are most often used in some combination for lung cancer: surgery, radiation therapy, chemotherapy and targeted therapy. The specific treatment approach depends on: • Type of lung cancer (adenocarcinoma, squamous cell carcinoma, large cell carcinoma or small cell carcinoma) • Stage of disease • Location of the tumor • Overall lung function and general health of the patient Also, recent studies show that certain genetic mutations (changes) in the tumor tissue are important in selecting effective treatment. Surgery Surgery offers the best chance for cure of early-stage (Stage I or II) cancers. Some types of surgery to remove a lung tumor include: • Sublobar resection (wedge resection) – A small part of the lung containing the tumor is removed. • Lobectomy – The lobe of the lung containing the tumor is removed. • Pneumonectomy – The entire lung is removed. During any of these operations, the surgeon also removes nearby lymph nodes to see if cancer cells have spread beyond the lung. Surgery may also be part of a multidisciplinary approach for Stage IIIA adenocarcinoma, squamous cell carcinoma or large cell carcinoma, but it is rarely used for Stage IV disease. Surgery is also done for Stage I or IIA small cell lung cancer, but this type is usually not detected until a later stage. Lobectomy is considered the standard surgical option, but sublobar resection is often used when the lesions are very small or when lung function is poor. Chemotherapy For Stage III patients, chemotherapy is given with chest radiotherapy at the same time or occasionally before or after surgery, and adjuvant chemotherapy (chemotherapy given after surgery) is the standard treatment for Stage II and III (and sometimes Stage IB) adenocarcinoma, squamous cell carcinoma and large cell carcinoma. Chemotherapy may also be given before surgery or radiation therapy to help shrink the tumor first. This is known as neoadjuvant chemotherapy treatment. Chemotherapy with supportive care is also given for Stage IV cancer of any type (including small cell lung cancer), and chemotherapy may also be given as maintenance therapy after the end of standard chemotherapy to 30 help delay the progression of cancer. For Stage IV patients, targeted therapies may be given alone or with chemotherapy. The choice of specific drugs depends on the histologic type of lung cancer. For example, the drug pemetrexed (Alimta) has been less effective for squamous cell carcinoma than for adenocarcinoma or large cell carcinoma. When chemotherapy is the initial treatment, it is usually given as a combination of two drugs. One of these is a platinum drug such as cisplatin or carboplatin. Adding a third chemotherapy drug, however, has not been shown to increase survival. If the cancer does not respond to the initial treatment or if the cancer progresses, different chemotherapy drugs may be tried. The targeted therapy bevacizumab (Avastin) may also be given with chemotherapy for selected patients. Other chemotherapy drugs used for lung cancer include paclitaxel (Taxol), docetaxel (Taxotere), nab-paclitaxel (Abraxane), etoposide, pemetrexed (Alimta), gemcitabine (Gemzar), ifosfamide, irinotecan (Camptosar), mitomycin and vinblastine. For advanced non-small cell lung cancer, researchers have also found that some chemotherapy drugs, such as pemetrexed or the targeted drug erlotinib, given as maintenance therapy (beyond the traditional number of chemotherapy cycles) may help improve survival. Maintenance therapy is used primarily for people with advanced non-small cell lung cancer that has not spread or grown after treatment with certain types of chemotherapy drugs. Radiation therapy Radiation treatment is delivered from a machine outside of the body, called externalbeam radiation therapy, and is usually used in combination with chemotherapy (known as chemoradiation therapy) and/or surgery. Chemoradiation therapy gives the best outcomes for most patients with Stage III lung cancer of all types. Chemoradiation therapy is also the most commonly used treatment for Stage IIB or III small cell lung cancer and is sometimes given in combination with surgery. A special type of localized radiotherapy called stereotactic body radiotherapy is sometimes used for people with Stage I or II disease who are not eligible for surgery. This type of radiation to localized sites may help alleviate symptoms. Radiation to the brain is often given after treatment for small cell lung cancers. Targeted therapy Targeted therapy is treatment with drugs that target a specific cell pathway in the body and block signals that cause cancer cells to multiply. The type of targeted therapy used may depend on specific genetic mutations (changes) in the tumor tissue. Some examples of targeted drugs include: • Erlotinib (Tarceva) – This drug inhibits the epidermal growth factor receptor (EGFR), blocking a signal that tells the cells to grow. It’s most effective when an EGFR mutation is present in the lung tumor and is the initial therapy for these patients. For patients without this mutation, it is used for cancer that has spread or grown after receiving at least one course of chemotherapy, or as maintenance after initial chemotherapy. • Afatinib (Gilotrif) – This drug was recently approved as first-line (initial) treatment of metastatic non-small cell lung cancer that tests positively for an EGFR mutation. • Crizotinib (Xalkori) – This drug inhibits another recently identified genetic change, a fusion of the ALK and EML4 genes (ALK-EML4). Crizotinib targets the pathway that helps cancer cells to grow in tumors that have this genetic change. This drug is used to treat advanced non-small cell lung cancer that has tested positively for ALK-EML4. It may be used before or after chemotherapy in these patients. • Bevacizumab (Avastin) – This drug inhibits a signal protein called vascular endothelial growth factor (VEGF), which stops the blood supply to the tumor. It’s used to treat advanced nonsquamous non-small cell lung cancer in combination with carboplatin and paclitaxel in people who have not received prior chemotherapy. Current targeted therapy drugs are not effective for small cell lung cancer. Talk openly with your doctors about treatment options and their side effects, and ask about the effect of treatment on your daily activities and quality of life. Lung cancer is difficult to control with the treatments currently available, so many doctors encourage people to consider a clinical trial for the opportunity to receive the newest possible treatment (see page 10). ADDITIONAL RESOURCES International Association for the Study of Lung Cancer: www.iaslc.org Lung Cancer Action Network (LungCAN): http://lungcan.org Lung Cancer Alliance: www.lungcanceralliance.org National Lung Cancer Partnership: www.nationallungcancerpartnership.org Pa t i e n t Re s o u r ce .co m lung cancer patient story She Took Control and Her Persistance Paid Off Elizabeth Lacasia worked for a biotech company as an oncology product strategist before she herself was diagnosed with nonsmall cell adenocarcinoma in 2007. She and her husband were married two years before her diagnosis, and they live in a house they recently designed and built together. Elizabeth enjoys gardening, traveling and creative writing, and through persistent selfadvocacy at every step, she has learned to come to terms with her Stage IV lung cancer. I It was at a Christmas sing-along in 2005 when I first noticed my breathing didn’t seem quite right. Later on I developed a persistent cough, so I made an appointment to see my doctor. Because I was a healthy nonsmoker in my 40s, he said it was just allergies or acid reflux and prescribed an allergy medication. But my cough didn’t go away. I saw several other general practitioners throughout the year, during which time my cough progressed to the point where I was coughing up fluid. In late 2006 I finally had a more comprehensive workup, which included a chest X-ray and a CT scan that revealed several tumors in my lower left lung. The largest was about the size of a pingpong ball. I was diagnosed with non-small cell adenocarcinoma. More specifically, my subtype was invasive adenocarcinoma (formerly called bronchioloalveolar carcinoma) – a very rare, slow-growing and difficult-to-treat lung cancer. I immediately had a lower left lobectomy, after which my surgeon told me I was cured. Unfortunately, about a year later a wedge resection verified that the cancer had returned and spread throughout my lungs. Several weeks after my surgery, I began treatment as part of a clinical trial, including eight cycles of carboplatin (Paraplatin), gemcitabine (Gemzar) and bevacizumab (Avastin). I then continued on Avastin as a maintenance therapy. In 2008, I pursued a second opinion from another thoracic oncologist, as lung cancer is an especially complex disease and treatment philosophies differ. It was the best decision I ever made. My new oncologist told me about and conducted molecular genetic testing on my tumor tissue. This panel of simultaneous tests produced a profile of my unique disease, including the chemotherapies and targeted therapies that might be effective. We discovered my cancer was resistant to the most toxic chemotherapy included in my initial treatment regimen. If we had conducted this testing panel beforehand, the combination of drugs would have been different and I might have had a greater and longer initial response. Using this information when my cancer progressed in 2009, my oncologist suggested that I participate in another clinical trial, “ “ In fighting cancer, you can’t be passive. You have to become an informed participant. Pa t ie n tResource.com Elizabeth which combined erlotinib (Tarceva) and pemetrexed (Alimta) in a way that could help short-circuit disease mutation. I’m still in the same clinical trial, now taking Tarceva as a single agent. I’m stable and no active disease is apparent on my periodic CT scans. My oncologist says I’ll be on chemotherapy for the rest of my life as I still have active disease, but my treatment regimen has been quite a success! I have some side effects, including fatigue, intestinal issues and extremely dry skin. But in the grand scheme of things, these are all minor concerns. A B12 shot helps with my fatigue, probiotics and fiber help modulate my intestinal issues, and nail conditioners and body lotions help address my skin concerns. I also now suffer from asthma and mild COPD, but I have a supportive pulmonologist who – in addition to my oncologist and general practitioner – helps optimize my overall quality of life. When I was first diagnosed, I was frightened. But by learning about my options, becoming involved with the Bonnie J. Addario Lung Cancer Foundation and participating in the Writing through Cancer program, I’ve learned to confront my fears and find peace, as there’s renewed hope for people with lung cancer. Now that I’m a veteran of this disease, I try to be for others the person I wish I’d had when I was diagnosed—a relatable and helpful resource. This is your body and your life. I firmly believe that if I hadn’t been such a strong self-advocate – both in getting my initial diagnosis and in eventually switching to an oncologist whose philosophy aligned with my own – that I might not be here today. In fighting cancer, you can’t be passive. You have to become an informed participant in choosing your treatment regimen. Don’t be afraid to ask your doctor challenging questions, and try to take it one day at a time. Focus on what you can do and make sure you’re in capable hands for the things you can’t. 31 types of cancer | breast cancer B Breast Cancer Overview and Staging Breast cancer is cancer that forms in breast tissue, usually in the milk ducts (tubes that carry milk to the nipple) or less often in the breast lobules (glands that make milk). Breast cancer is the most commonly diagnosed cancer among women. Although breast cancer can also develop in men, it is rare. Breast cancer is classified by “staging,” a process that determines how much cancer is in the body and where it is located. Staging describes the severity of the cancer, based on the original tumor and how much it has spread. Knowing this information helps your doctor plan your treatment. The managing physician does clinical staging of the cancer based on the tumor’s characteristics, which are assessed through a physical exam, X-rays and/or other imaging studies and laboratory results. A pathologist then does pathologic staging by examining tissue specimens removed during surgery or a biopsy. Breast cancer is staged according to a system developed by the American Joint Committee on Cancer (AJCC). This TNM system classifies the cancer by tumor (T), node (N) and metastasis (M) and is used as the foundation for the overall stage of breast cancer (Table 1). • The T (tumor) category describes the primary tumor. It is the same for both clinical and pathologic staging. This category describes the size and location of the tumor. • The N (node) category describes lymph node involvement – the lymph nodes that have evidence of breast cancer cells. The location of these lymph nodes is important because it shows how much the disease has spread. The pathologic N (node) category (sometimes denoted as pN) shows how many lymph nodes are involved and the amount of tumor cells actually found in the nodes. Table 1. AJCC system for classifying breast cancer Category Definition Tumor (T) Tx Cannot be assessed T0 No evidence of primary tumor Tis Tumor has not started growing into the breast tissue (known as carcinoma in situ) T1 T1mi T1a T1b T1c 2 centimeters (about ¾ inch) or less 1 millimeter or less Larger than 1 mm but not more than 5 mm (0.5 cm) Larger than 5 mm but not more than 10 mm (1 cm) Larger than 10 mm but not more than 2 cm T2 Larger than 2 cm but not more than 5 cm (almost 2 inches) T3 Larger than 5 cm T4 T4a T4b Any size Tumor extends into the chest wall Presence of edema (swelling), thickening of the skin, or ulceration (a sore, painful area where the breast skin/tissue is breaking down Signs of both T4a and T4b Inflammatory cancer (breast is red, swollen and warm) T4c T4d Nodes (N) Nx Lymph nodes cannot be evaluated N0 No metastasis or micrometastasis found in any lymph nodes N1 N1mi N1a N1b N1c N2 N2a N2b N3 N3a N3b N3c Micrometastases* Metastasis in 1 to 3 axillary lymph nodes (nodes under the arm), with at least one metastasis of more than 2 mm (0.5 cm) Metastasis in internal mammary lymph nodes (nodes on either side of the sternum [breastbone]): with micrometastases or macrometastases detected through a sentinel lymph node biopsy (but not clinically detected) Metastasis in 1 to 3 axillary lymph nodes and in internal mammary lymph nodes Metastasis in 4 to 9 axillary lymph nodes Metastasis in clinically detected internal mammary lymph nodes but no metastasis in axillary lymph nodes Metastasis in 10 or more axillary lymph nodes OR in the infraclavicular lymph nodes (nodes under the clavicle [collarbone]) Metastasis in internal mammary lymph nodes and in 1 or more axillary lymph nodes Metastasis in supraclavicular lymph nodes (nodes above the clavicle) Metastasis (M) M0 No distant metastasis (cancer has not spread to other parts of the body) M0(i+) Microscopic or molecular evidence of tumor cells in bone marrow, circulating blood or nonregional nodal tissue (but no clinical evidence of metastasis) M1 Evidence of distant metastasis (cancer has spread to other parts of the body) *Refers to a small cluster of tumor cells, no larger than 2 millimeters. 32 Pa t i e n t Re s o u r ce .co m breast cancer | types of cancer • The M (metastasis) category describes distant metastasis (spread of cancer to another part of the body), if any. Staging for the M category is mainly clinical. However, a new M subcategory is based on the presence of tumor cells that can be detected only by using a microscope or molecular testing. The most common sites of distant metastasis in breast cancer are the bones, lungs, liver and brain. Once the cancer has been classified according to this system, an overall stage is assigned. Five main stages (designated 0 to IV) are further divided to group tumors that have similar outcomes (prognoses). This grouping allows doctors to more accurately predict the outcome according to the stage (Table 2). AJCC also recommends testing for estrogen and progesterone receptors (ER and PR) and human epidermal growth factor receptor-2 (HER2). The doctor considers the stage and these other factors in selecting the most appropriate treatments. Stage IA Table 2. Stage of breast cancer according to AJCC classifications Stage TNM classifications 0 Tis, N0, M0 IA T1*, N0, M0 IB T0 or T1*, N1mi, M0 IIA T0 or T1*, N1**, M0 T2, N0, M0 IIB T2, N1, M0 T3, N0, M0 IIIA T0-T3, N2, M0 T3, N1, M0 IIIB T4, N0-N2, M0 IIIC Any T, N3, M0 IV Any T, Any N, M1 ADDITIONAL RESOURCES American Society of Clinical Oncology (patient website): www.cancer.net Breast Cancer: Staging CancerQuest (Winship Cancer Institute, Emory University): www.cancerquest.org Breast Cancer: Pathology Report and Staging *T1 includes T1mi. **T0 and T1 tumor with micrometastases in node(s) only are excluded from Stage IIA and are classified Stage IB. Tables adapted from AJCC Cancer Staging Manual, 7th edition (2010) Stage IB Subcutaneous fat tissue Tumor is 2 cm or smaller Pectoralis major muscle Patient Resource: www.PatientResource.com/ Breast_Cancer.aspx Stage IIA Lymph nodes 2nd rib OncoLink: www.oncolink.org Breast Cancer: The Basics Tumor is larger than 2 cm but smaller than 5 cm Multiple lymph node metastasis Tumor is 2 cm or smaller Nipple Micrometstases in lymph nodes Stage IIB Tumor is larger than 2 cm but smaller than 5 cm Stage IIIA Multiple lymph node metastasis Stage IIIC The tumor can be any size but has not spread to distant parts of the body Tumor is larger than 2 cm but smaller than 5 cm Stage IIIB Multiple lymph node metastasis Tumor has spread to the chest wall or caused swelling or ulceration of the breast Multiple lymph node metastasis Stage IV Multiple lymph node metastasis Tumor can be any size Multiple lymph node metastasis Metastases Brain Lung Liver Bone "Patient Resource LLC Pa t ie n tResource.com 33 types of cancer | breast cancer B Breast Cancer Treatment Options Table 1. Chemotherapy options Breast cancers can vary quite a bit, so a number of treatment options can be effective. In addition to traditional treatments – such as surgery, radiation therapy and chemotherapy – hormone therapy and targeted therapy are important for providing personalized treatment for many women with breast cancer. Drugs or combinations of drugs that may be used as adjuvant therapy to treat breast cancer: • • • • • • • • • Surgery Surgeons use two types of surgery for the primary treatment of breast cancer. A lumpectomy is a “breast-conserving treatment” that leaves the breast intact. The surgeon removes only the tumor (lump) and a small amount of healthy tissue around the lump. The surgeon may also remove some lymph nodes from under the arm. If the tumor is larger than 5 centimeters (about 2 inches), doctors usually do not recommend a lumpectomy. However, if a woman has a tumor of this size and a strong desire to save the breast, chemotherapy or hormone therapy before surgery can often shrink the tumor enough for the surgeon to remove it safely. A mastectomy is often done for larger tumors, especially those that have spread to nearby lymph nodes. Some women with a small breast cancer also choose a mastectomy to ease their worry about the tumor coming back, and some want to avoid radiation therapy. Mastectomies today are much less extensive and disfiguring than those done years ago, thanks to new and better surgical techniques. At one time, a mastectomy meant removing the whole breast as well as the muscles under the breast and all of the lymph nodes under the arm. This was known as a “radical mastectomy.” Today, a radical mastectomy is only done for tumors that are extensive or have invaded the chest wall and cannot be shrunk by other therapy. More often, surgeons perform a “total” or “complete” mastectomy, which preserves the chest wall muscles. • • • With either surgery, surgeons also remove lymph nodes under the arm. A pathologist then examines the nodes for signs of cancer cells. This step is called “lymph node staging” and helps doctors determine the stage of the breast cancer. To lessen the number of lymph nodes removed, surgeons use a procedure called “sentinel lymph node biopsy.” The number of lymph nodes removed depends on whether cancer cells are detected in the “sentinel” nodes, which are those closest to the breast cancer. After a mastectomy, women have many options for reconstructive surgery. This is usually done by a plastic surgeon, who rebuilds the breast to make it look, as much as possible, as it did before surgery. Radiation therapy Radiation therapy is almost always done after a lumpectomy to destroy any remaining cancer cells. Research shows that women with a small tumor who have breast radiation therapy after a lumpectomy live as long as women who have a mastectomy. Table 2. Hormone therapy options Menopausal status Hormone therapy options Postmenopausal • aromatase inhibitors: anastrozole (Arimidex), letrozole (Femara), exemestane (Aromasin) • selective estrogen-receptor modulator: tamoxifen (Nolvadex), toremifene (Fareston) • fulvestrant (Faslodex) • progestin: megestrol acetate (Megace) • high-dose estrogen (ethinyl estradiol) • androgen (male hormone): fluoxymesterone (Halotestin) Premenopausal • • • • • 34 tamoxifen (Nolvadex) luteinizing hormone receptor hormones (LHRHs): goserelin (Zoladex), leuprolide (Lupron) progestin: megestrol acetate (Megace) high-dose estrogen (ethinyl estradiol) androgen (male hormone): fluoxymesterone (Halotestin) • • • cyclophosphamide (Cytoxan, Neosar) docetaxel (Taxotere, Docefrez) doxorubicin (Adriamycin) epirubicin (Ellence) fluorouracil (5-FU, Adrucil) methotrexate (multiple brand names) paclitaxel (Taxol) AC (doxorubicin and cyclophosphamide) AC followed by T (doxorubicin and cyclophosphamide, followed by paclitaxel or docetaxel) CAF (cyclophosphamide, doxorubicin and 5-FU) CEF (cyclophosphamide, epirubicin and 5-FU) CMF (cyclophosphamide, methotrexate and 5-FU) EC (epirubicin and cyclophosphamide) TAC (docetaxel, doxorubicin and cyclophosphamide) TC (docetaxel and cyclophosphamide) Drugs that may be used to treat recurrent or metastatic breast cancer: • • • • • • • • • vinorelbine (Navelbine) capecitabine (Xeloda) protein-bound paclitaxel (Abraxane) pegylated liposomal doxorubicin (DOXIL, LipoDox) gemcitabine (Gemzar) carboplatin cisplatin ixabepilone (Ixempra) eribulin (Halaven) After a mastectomy, the doctor decides on the need for radiation therapy to the upper chest. The doctor mainly looks at the number of lymph nodes involved, the size of the tumor and whether cancer cells were found in the healthy tissue around the tumor. If the breast cancer has metastasized (spread), the woman may receive radiation therapy for the parts of the body to which the cancer has spread. Chemotherapy Chemotherapy may be used as the primary treatment for metastatic breast cancer. It may also be used before the primary therapy to shrink a large tumor, or after the primary therapy as an “adjuvant,” or additional, treatment. Many chemotherapy drugs are approved for treating breast cancer (Table 1). Chemotherapy is usually given as a combination of two or three drugs, sometimes given together and sometimes given after one another (sequentially). When chemotherapy is given as the primary treatment of metastatic disease, single agents given sequentially is preferred. Pa t i e n t Re s o u r ce .co m breast cancer | types of cancer Hormone therapy Adjuvant hormone therapy is used only for women with tumors that have estrogen and/or progesterone receptors (noted as ER+/PR+). Estrogen drives the growth of these tumors, so drugs that lower or block estrogen in the body can help stop the cancer from returning. Tamoxifen (Nolvadex) is the oldest, most well-known hormone therapy drug. Another drug of this type is toremifene (Fareston). Aromatase inhibitors are another type of hormone therapy and work only in postmenopausal women. Examples of these include anastrozole (Arimidex), exemestane (Aromasin) and letrozole (Femara). Another type of hormone therapy blocks the mechanism that causes the ovaries to make estrogen. This can be achieved by surgery, radiation therapy or drugs called “luteinizing hormone-releasing hormone (LHRH) analogs” such as goserelin (Zoladex). Hormone therapy drugs differ in how they work, who can use them and what side effects can result. Talk to your doctor about options available for your type of cancer (Table 2). Targeted therapy Targeted therapy agents have had a great impact on survival and quality of life for many women and are usually used in combination with other drugs (Table 3). Trastuzumab (Herceptin) was the first targeted therapy developed for any cancer. It is effective only for breast tumors with high amounts of the HER2 protein and is known as an anti-HER2 agent. Newer anti-HER2 agents include lapatinib (Tykerb) and pertuzumab (Perjeta). In 2013, the FDA also approved ado-trastuzumab emtansine (Kadcyla), which combines trastuzumab with another chemotherapy drug, and can be used to treat late-stage (metastatic) breast cancer. The many treatment choices for breast cancer can seem overwhelming, especially for women with early-stage disease. Your doctor and health care team can help you understand the risks and benefits of each treatment before deciding on a plan. Learn as much as you can about your own type of cancer and tumor. The more you know, the better able you are to work with your doctors to make informed decisions. ADDITIONAL RESOURCES Adjuvant! Online: www.adjuvantonline.com National Cancer Institute: www.cancer.gov/cancertopics/types/breast American Cancer Society: www.cancer.org/cancer/breastcancer/index National Comprehensive Cancer Network: www.nccn.com/cancer-guidelines.html American Society of Clinical Oncology (patient website): www.cancer.net Patient Resource: www.PatientResource.com/Breast_Cancer.aspx Table 3. Targeted therapy options Targeted therapy agent Type of breast cancer Approved/recommended treatment trastuzumab (Herceptin) HER2+, node-positive or node-negative • In combination with chemotherapy regimen of doxorubicin plus cyclophosphamide, followed by either paclitaxel or docetaxel • In combination with chemotherapy regimen of docetaxel and carboplatin • As a single agent following chemotherapy that includes an anthracycline (doxorubicin, epirubicin, pegylated liposomal doxorubicin) HER2+, metastatic • In combination with paclitaxel for first-line treatment • As a single agent after failure of one or more chemotherapy regimens ER+/PR+, HER2+ • In combination with letrozole HER2+, metastatic • In combination with capecitabine after failure of anthracyclines, taxanes (paclitaxel or docetaxel) and trastuzumab pertuzumab (Perjeta) HER2+, metastatic • In combination with trastuzumab ado-trastuzumab emtansine (Kadcyla) HER2+, metastatic • For patients previously treated with trastuzumab, another anti-HER2 agent and taxanes everolimus (Afinitor) Hormone receptorpositive, HER2-, metastatic • In combination with exemestane (Aromasin) lapatinib (Tykerb) Pa t ie n tResource.com 35 breast cancer patient story types of cancer | subject Survivor Fought Hard S to be Around for Her Daughters Misty Smith was just 35 years old when she was diagnosed with Stage II triple-negative breast cancer in November 2011. Despite an incorrect initial diagnosis and the development of an autoimmune lung disease, she beat her cancer and is now on the road to recovery. Misty works as a third-grade teacher and has two daughters of her own, ages 6 and 18. She enjoys taking pictures, going on walks, getting pedicures and spending time with her family. Y You know what your body should feel like, so if you think something is wrong, push your doctors to investigate further. If I hadn’t done that during my run with breast cancer, things may have turned out very differently. Back in 2011, I’d had a head cold for a couple of weeks and was having some pain around my breast. I thought I’d just pulled a muscle, but one night I decided I wanted to have it checked out anyway. While I was taking a shower the following morning, I felt a lump and knew I needed to accelerate my appointment. My family doctor got me in right away and, after a quick exam, referred me to a nearby hospital for a mammogram and an ultrasound. The test results revealed what the doctors deemed to be a fluid-filled cyst, and they immediately drained it with a needle aspiration. Three days later, the lump was back. A second ultrasound the following week confirmed that the cyst had returned and that it was already the same size as it had been before it was drained. At that point, I asked for a referral to a surgeon. He did yet another ultrasound followed by another needle aspiration. And just like the time before, the lump returned only a few days later. I’d had enough, so I told my surgeon I wanted it out. He respected my wishes and removed the cyst on Nov. 18. Four days later on Nov. 22 – a date I’ll never forget – my surgeon called me to say that what we’d thought was a cyst was actually cancer. I had Stage II triple-negative breast cancer—specifically, invasive (infiltrating) ductal carcinoma. As soon as I hung up the phone, the tears began to flow. I cried for hours, mostly because I was terrified that my daughters would have to go through life without their mom. Luckily, I’m blessed with some amazing family and friends, and within the hour I was surrounded by several of them. I don’t know how I would’ve made it through the night alone. I soon underwent surgery, including a lumpectomy and lymph node dissection in which they removed 24 lymph nodes from under my left arm. A month later, I had another surgery to have a chemotherapy port installed, and I then began eight rounds of chemotherapy. The first four treatments were with the drugs doxorubicin and cyclophosphamide (Cytoxan), and the last four treatments were with the drug paclitaxel (Taxol). The side effects were tough, and after the “ “ This journey has taught me that I’m truly blessed and that life is never guaranteed. 36 Following breast cancer, Misty Smith now spends as much time as possible with her two daughters. Misty third and fourth rounds, I was actually hospitalized for about a week due to dehydration and extreme nausea, among other things. Emotionally, I had a difficult time, too, but I knew I had to fight with everything I had to be there for my girls. Following chemotherapy, my doctors ordered a few followup scans, the results of which hit me like a ton of bricks. They showed spots in my lungs, liver and under my arms. It looked as if my cancer had spread and advanced to Stage IV. To find out exactly what was going on, my oncologist ordered a mediastinoscopy to obtain a biopsy. To everyone’s surprise, the results showed not metastasized cancer but a granulomatous inflammation. As it turned out, I had developed an autoimmune lung disease called sarcoidosis, which is what was showing up on the scans. Sarcoidosis treatment involves high doses of steroids, which I took and will need to continue to take each time the disease flares up. After confirming that I didn’t have Stage IV cancer, I underwent radiation therapy 33 times to round out my initial treatment plan. I wouldn’t have made it through all of this without my family and friends. They were with me at almost every treatment appointment and even put on a benefit in my honor. I also received a lot of support from the school district I work for and my community. This journey has taught me that I’m truly blessed and that life is never guaranteed—none of us are promised tomorrow. I spend every second I can with my children, and it meant the world to me to see my little girl start kindergarten and my oldest start college. I’m much stronger physically, mentally and emotionally than I ever thought I was, and I’m just so thankful that I had doctors who listened to me when I knew something wasn’t right. Pa t i e n t Re s o u r ce .co m prostate cancer | types of cancer A Prostate Cancer Overview and Staging After you receive a diagnosis of prostate cancer, your doctor will try to determine how far the cancer has progressed within the prostate gland and whether it has spread to nearby tissues or other parts of your body. This process is called cancer staging. Staging prostate cancer helps your doctor choose the best treatment options for you. The doctor managing your overall treatment will assign a clinical stage, which is based on the prostate-specific antigen (PSA) levels, the results of a physical exam and, often, imaging studies, such as a bone scan and computerized tomography (CT) scan and, on occasion, magnetic resonance imaging (MRI). If you have a biopsy or surgery, a pathologist will assign a pathologic stage after examining tissue specimens removed during the biopsy or surgery. The most widely used staging system was developed by the American Joint Committee on Cancer (AJCC). This system classifies the cancer by tumor (T), node (N) and metastasis (M), and together this “TNM” classification provides a description for the overall stage of cancer (Table 1). • The T (tumor) category describes the size and location of the primary tumor. • The N (node) category describes how many lymph nodes have evidence of cancer cells (known as “lymph node involvement”). Regional (or “nearby”) lymph nodes are defined in this category as involved when assessed by imaging tests or microscopic examination. • The M (metastasis) category describes distant metastasis, or how much the cancer has spread to other parts of the body. In addition to the TNM system, doctors use two other factors for staging: • A Gleason score shows the grade of the tumor, or how similar the tumor tissue Table 1. AJCC system for classifying prostate cancer Classification Definition Tumor (T) Tx Tumor cannot be evaluated (because of lack of information) T0 No evidence of primary tumor T1* Tumor is not detected during a digital rectal exam (DRE) and cannot be seen on imaging studies* T2 T2a T2b T2c Tumor can be detected during a DRE and is present in the prostate only Tumor is in half or less of one side (lobe) of the prostate Tumor is in more than half of one prostate lobe but has not invaded the other lobe Tumor is in both prostate lobes T3 T3a T3b Tumor extends outside of the prostate Tumor extends outside the prostate on one side or both sides Tumor has spread to seminal vesicles (glands on each side of the bladder) T4 Tumor has spread to tissues near the prostate other than the seminal vesicles, such as the bladder Nodes (N) Nx Nearby lymph nodes were not evaluated N0 No cancer cells are found in nearby lymph nodes N1 Cancer cells are found in nearby lymph nodes Metastasis (M) M0 M1 M1a M1b M1c Cancer has not spread beyond nearby lymph nodes Cancer is detected in tissue beyond nearby lymph nodes Cancer is detected in distant lymph nodes Cancer is detected in the bone Cancer is detected in another organ or site but not in the bone *When a tumor is found during surgery not related to prostate cancer, it is further classified as T1a (tumor cells in 5 percent or less of removed prostate tissue) or T1b (tumor cells in more than 5 percent of removed prostate tissue). A tumor is classified as T1c if found during a needle biopsy (usually done because of a high PSA level). is to normal prostate tissue. The score ranges from 2 to 10. The pathologist gives a low score when the tumor looks more like normal prostate tissue and a higher score when the cancer looks less like normal tissue. A high Gleason score means that the tumor is more aggressive, and the higher the score, the more likely it is that the tumor will spread. • The PSA level in blood is roughly correlated with how much cancer there is. Table 2. Stage of prostate cancer according to AJCC classification Stage TNM classification Gleason score Prostate-specific antigen (PSA) level I T1(a-c), N0, M0 T2a, N0, M0 6 or less 6 or less Less than 10 Less than 10 IIA T1(a-c), N0, M0 T1(a-c) or T2a, N0, M0 T2a, N0, M0 T2b, N0, M0 7 6 or less 7 7 or less Less than 20 10 or higher, but less than 20 Less than 20 Less than 20 IIB T2c, N0, M0 T1 or T2, N0, M0 T1 or T2, N0, M0 Any score Any score 8 or higher Any level 20 or higher Any level III T3(a-b), N0, M0 Any score Any level IV T4, N0, M0 Any T, N1, M0 Any T, Any N, M1 Any score Any score Any score Any level Any level Any level Pa t ie n tResource.com A low PSA level is associated with better survival outcomes. The PSA level at the time of diagnosis is used in staging and also to follow the disease after therapy. Doctors use the AJCC classification, Gleason score and PSA level at diagnosis to determine an overall stage of disease and make decisions about treatment. Five main stages (0 to IV) are further divided to group tumors that are associated with similar outcomes (Table 2). This grouping allows doctors to more accurately predict the outcome and recommend appropriate therapy. Some doctors may use the older Whitmore-Jewett staging system and assign Stage A, B, C or D to your cancer. Ask your doctor to explain the staging system used or to translate the stage into one determined by the AJCC system, which has been shown to provide more information on prognosis. ADDITIONAL RESOURCES Prostate Cancer Foundation: www.pcf.org The Prostate Net: www.prostate-online.org Us TOO International Prostate Cancer Education & Support: www.ustoo.org 37 types of cancer | prostate cancer T Prostate Cancer Treatment Options The treatment options for prostate cancer depend on the stage of the cancer and an estimate of how quickly the cancer will spread beyond the prostate gland itself. Choices are made based on a man’s age and the expected benefits of each treatment and its side effects. Watchful waiting If your cancer is limited to the prostate and expected to grow slowly, your doctor may recommend monitoring your cancer closely and beginning treatment if the cancer shows signs of progressing. This approach is very safe for low-stage, low-grade tumors and also avoids unnecessary and sometimes harmful treatments. With watchful waiting – also called “active surveillance” – your doctor will measure your prostatespecific antigen (PSA) levels and perform a digital rectal exam (DRE) regularly. If your PSA level rises sharply or your DRE results change, your doctor may need to do another biopsy of your prostate. Surgery The type of surgery your doctor recommends depends on the stage of the disease and your general health (Table 2, page 37). A radical prostatectomy is the most common surgery for prostate cancer. In this procedure, the prostate and some surrounding tissue are removed. The procedure may be done either as an open procedure through an incision in the body or laparoscopically, or with a robotic surgical system. Laparoscopic surgeries require only small, keyholesize incisions in the body, so they are much less invasive than an open procedure. Cryosurgery is another minimally invasive approach that freezes and destroys cancer tissue. Also called “cryotherapy” or “cryoablation,” this procedure is done with very thin needles inserted through a small incision between the scrotum and rectum. Radiation therapy Prostate cancer treatment often uses externalbeam radiation therapy (EBRT) using a technique called “intensity-modulated radiation therapy” (IMRT). This allows delivery of high doses of radiation to the prostate while sparing the normal tissues around the prostate as much as possible. To accomplish this, many medical centers also use three-dimensional conformal radiation therapy (3-D CRT) to find the exact location and shape of the tumor. Proton therapy, another form of EBRT, uses beams of protons (atomic particles) to precisely target and destroy tumor cells in the prostate. Radiation oncologists will also use computerized tomography (CT), 38 magnetic resonance imaging (MRI) and other imaging technologies during radiation therapy to improve the accuracy and precision of the therapy. This is called “imageguided radiation therapy” (IGRT). Brachytherapy is another technique in which radioactive seeds are placed in and around the tumor. These seeds give off continuous low doses of radiation to the tumor and are left in the prostate permanently. ADT Androgen deprivation therapy (ADT) reduces the supply of male hormones (such as testosterone) to keep prostate cancer cells from growing. This therapy may be combined with surgery or radiation therapy to treat prostate tumors at high risk of spreading or returning after treatment. ADT is also the main treatment for tumors that have already recurred or spread. Known as medical castration, ADT reduces the levels of male hormones, which are produced in the testicles. (Surgical removal of the testicles may also be done.) ADT usually consists of any of the following drugs: • LHRH (luteinizing hormone-releasing hormone) analogs – These include drugs such as leuprolide (Eligard, Lupron), goserelin (Zoladex) or triptorelin pamoate (Trelstar Depot), which are known as agonists, or degarelix (Firmagon), an antagonist. Antagonists are usually used only in men in whom prostate cancer has spread to lymph nodes or bones. • Anti-androgen drugs – These drugs block the action of androgens. Examples are flutamide, enzalutamide (Xtandi) and bicalutamide (Casodex). • Drugs that prevent adrenal glands, fatty tissue and prostate cancer cells from making androgen – Examples include abiraterone (Zytiga) and ketoconazole (Nizoral). • The female hormone estrogen • Combinations of LHRH analogs and anti-androgen drugs (primarily flutamide or bicalutamide) • Abiraterone, enzalutamide and ketoconazole are currently used only when other ADT drugs have stopped being effective. Chemotherapy Chemotherapy is used primarily for prostate cancer no longer responding to ADT, known as castration-resistant (or hormone-refractory) disease. Drugs used for this type are docetaxel (Taxotere), which is used as firstline (initial) treatment and has been shown to improve survival, and cabazitaxel (Jevtana), which is used when treatment with docetaxel has failed. Mitoxantrone (Novantrone) may also be prescribed but is almost always used when docetaxel and cabazitaxel are no longer effective. These drugs are all given in combination with prednisone, a type of steroid. Biologic therapy (immunotherapy) Biologic therapy drugs work with the immune system, the body’s natural defense against disease. Sipuleucel-T (Provenge) is an immunotherapy drug that fights prostate cancer by boosting the immune system. It’s FDAapproved for treating metastatic, castrationresistant prostate cancer in men who have few or no symptoms. Before treatment, the patient’s white blood cells are removed through a process called leukapheresis. The immune cells in the blood are then separated out, modified in a laboratory and injected back into the patient. These enhanced cells stimulate other immune cells to kill prostate cancer cells. Radiopharmaceuticals Radiopharmaceuticals are drugs that contain a radioactive substance. One radiopharmaceutical used to treat advanced prostate cancer that has spread to bone is radium Ra-223 dichloride (Xofigo). This drug carries the radioactive substance directly to the bones to kill cancer cells. Radium Ra-223 can be used only when prostate cancer has spread to bones but no other organs. Targeted therapies Targeted therapies are designed to block the action of newly recognized genes and proteins thought to enhance cancer growth. Under study is a type of drug called a “c-Met inhibitor,” which targets a protein needed for prostate cancer to grow. Monoclonal antibodies are also being studied for castrationresistant prostate cancer. These antibodies are made in a lab and block the activity of a specific target on the surface of a cancer cell. Other treatments Several treatments are available for bone complications, such as pain and fractures, that may accompany metastatic disease: • Denosumab (Prolia) is an osteoporosis drug used in men with prostate cancer who are receiving ADT and are at high risk of bone fractures. It’s also approved for men with bone metastases. • Strontium and samarium are radioactive agents that may be injected into the veins to reduce bone pain due to metastatic cancer. • Zoledronic acid (Zometa) blocks the breakdown of bone and is used to reduce bone complications due to metastatic prostate cancer. Pa t i e n t Re s o u r ce .co m NOVEL TARGETED THERAPIES FOR CANCER PATIENTS www.algeta.com prostate cancer patient story Super Bowl MVP Len Dawson was an NFL quarterback for 19 years. And in 1970, No. 16 led the Kansas City Chiefs to a victory over the Minnesota Vikings in Super Bowl IV and was named the Most Valuable Player of the game. Len retired from the NFL in 1976 as one of the best forward passers of all time and in 1987 was inducted into the Professional Football Hall of Fame. After his playing days, Len began an impressive career in sports broadcasting and currently serves as the sports director at KMBC-TV in Kansas City and the color analyst for the Chiefs Radio Network. He also hosted HBO’s “Inside the NFL” from 1977 to 2001 and worked as an analyst for NBC’s AFC coverage from 1977 to 1982. Then in 1991 at the age of 56, Len was diagnosed with earlystage prostate cancer. He put to use the tools he learned as a quarterback to analyze the situation and beat his newest opponent. He has now been cancer-free for more than two decades. L Len is no stranger ger to adversity. “As a quarterback things didn’t always go o my way, so I learned to make adjustments,” he explained. ained. “When my doctor said, ‘You have cancer,’ I knew I just needed to make some adjustments and deal with it.” Len owes the early discovery of his prostate cancer to his wife, Linda. He was in New York taping “Inside the NFL” for or HBO when she read an article in the newspaper spaper about Sen. Bob Dole’s prostate cancer. She also saw an advertisement in that same me paper for free prostate cancer c screenings at a local hospital that that Friday. Linda knew her husband was w busy, so she called and made an appointment for him at 9 a.m. When a Len L returned home to Kansas City on Thursday T night, she told him about it. “Like a typical man, my first reaction was w to say I wasn’t going,” he said. “I didn’t d think I needed to because I didn’t have any a symptoms of prostate cancer. She held her h ground, though, and said if I didn’t want w to go I had to call and cancel myself. m I decided that this was a battle b I wasn’t going to win, so I kept the appointment.” k The doctor performed a prostate specific antigen p (PSA) ( PSA) blood test and a digital rectal examinad tion tion (DRE). He found an abnormality, a so s he told Len to schedule an uls trasound trasound and a Len Dawson biopsy. Sure b during his 1970 enough, e the Super Bowl MVP season results of results 4 40 L en Was Victorious On and Off the Field tests revealed early-stage prosthose follow-up follow tate can cancer. ncer. Fortunately it was caught early, so it was sstill confined to the prostate gland and hadn’t yyet spread throughout his body. Len rece received a second opinion from a doctor in N New ew York, who confirmed the original diagnosis. agnos sis. After carefully considering all of his treatment trea tme options, he ultimately decided have a radical prostatectomy to get to o ha the cancer out of his body. The surgeon used a nerve-saving technique, ge which left him with no lasting side efwh fects. Len stayed in the hospital for fec two days after his surgery, and it took tw him about six months before he was back to normal. He has been cancerbac ffree ever since. “As a quarterback and a broadcaster, I “A on the fast track for a long time,” he was o w explained. “I’ve slowed down with age, ex plain really enjoy putting my feet up and and I re relaxing. relaxi ing. But I know my health is important so I’m still very active with what I can do. The difference differe nce is that now my workouts consist of golf instead of training camps.” rounds of g Len cconsiders that initial screening appointons the luckiest thing that has ever hapment to b be th “As the seventh son of a seventh pened to him. h supposed son, I am sup ppos to have good luck,” he explained. “I am very lucky that my wife made that appointment y th never would have done it myself.” for me because I neve er wo Len now recommendss that th all men over the age of 50 get they have any symptoms. “Even the screened whether or nott the toughest guys need to ttake ake care of their health,” he said. “If to find out about it as quickly as there’s a problem, you want w deal with it. In sports and in life, you’ll possible so you can dea al w face adversity. It’s up to o you yo to make adjustments and make things right.” Pa t i e n t Re s o u r ce .co m LOOK FOR THIS SEAL OF APPROVAL ACCREDITATION FROM THE AMERICAN COLLEGE OF SURGEONS COMMISSION ON CANCER (CoC) IS T H E H A L LM A R K O F E XC E L L E N C E By receiving cancer care at a CoC-accredited center you can be confident that your cancer care team includes health care professionals from a variety of disciplines who are committed to working together to provide you with quality care. When looking for quality cancer care, look for the CoC logo. A list of accredited cancer care programs can be found on the CoC Hospital Locator at facs.org/cancerprogram/index.html. types of cancer | colorectal cancer C Colorectal Cancer Overview and Staging Colorectal cancer is the third most common cancer in men and women. It begins in the lining of the colon or the rectum, which are parts of the large bowel or large intestine. The colon is about 6 feet long, and the rectum and anal canal make up the last 6 to 12 inches of the large intestine. Colorectal cancer is classified by a process called staging. This classification is based on how deeply the tumor has grown into the lining of the intestine and whether or not it has spread beyond the colon or rectum. Determining the stage of colorectal cancer is important because it helps your doctor choose the best treatment options for you as well as make a prognosis (predict the outcome). The doctor managing your care will assign a clinical stage, which is based on the results of a physical exam, X-rays and/or other imaging studies and laboratory results. A pathologist then classifies the tumor according to a pathologic stage, which is based on examination of tissue specimens removed during surgery or a biopsy. Colorectal cancer is staged according to a system developed by the American Joint Committee on Cancer (AJCC), and this “TNM” system classifies the cancer by tumor (T), node (N) and metastasis (M) (Table 1): • The T (tumor) category describes the primary tumor, including how deeply the tumor has grown into the layers of tissue that line the inside of the colon or rectum. • The N (node) category describes lymph node involvement, or whether cancer cells are found in nearby lymph nodes. The location of involved lymph nodes is important because it shows how much the disease has spread. • The M (metastasis) category describes distant metastasis, or how much the cancer has spread to other parts of the body. Once the cancer has been classified according to this system, an overall stage is assigned. Five main stages (0 to IV) are further divided to group tumors that have similar Table 1. AJCC system for classifying colorectal cancer Classification Definition prognoses. This grouping allows doctors to more accurately predict the outcome according to the stage (Table 2) and select the most appropriate treatments. Table 2. Stage of colorectal cancer according to AJCC classification Tumor (T) Stage TNM classification Tx Tumor cannot be evaluated (because of lack of information) 0 Tis, N0, M0 T0 No evidence of primary tumor I T1 or T2, N0, M0 Tis Carcinoma in situ; cancer cells are found only in the mucosa, the first layer of the lining of the colon or rectum IIA T3, N0, M0 IIB T4a, N0, M0 T1 Tumor has grown into the submucosa, the second layer of the lining IIC T4b, N0, M0 T2 Tumor has grown into the muscularis propria, the third layer of the lining IIIA T3 Tumor has grown into the subserosa, the deepest layer of the lining, or into tissues surrounding the colon or rectum T1 or T2, N1(a-c), M0 T1, N2a, M0 IIIB T4a T4b Tumor has grown to the wall of the colon or rectum The tumor has grown through the wall of the colon or rectum and invaded or attached to nearby tissues or organs T3 or T4a, N1(a-c), M0 T2 or T3, N2a, M0 T1 or T2, N2b, M0 IIIC T4a, N2a, M0 T3 or T4a, N2b, M0 T4b, N1(a-c) or N2, M0 IVA IVB Any T, Any N, M1a Any T, Any N, M1b Nodes (N) Nx Nearby lymph nodes cannot be evaluated N0 No cancer cells are found in nearby lymph nodes N1a N1b N1c Cancer cells are found in one nearby lymph node Cancer cells are found in two or three nearby lymph nodes Cancer cells are found in the subserosa, mesentery (the fatty tissue that contains the lymph nodes and blood vessels) or tissues around the colon or rectum but not in nearby lymph nodes N2a N2b Cancer cells are found in four, five or six nearby lymph nodes Cancer cells are found in seven or more nearby lymph nodes Metastasis (M) M0 Cancer has not spread beyond nearby lymph nodes M1a Cancer has spread to one organ or site (for example, the liver, lung, ovary or distant lymph node) Cancer has spread to more than one organ or site or to the lining of the abdominal cavity (peritoneum) M1b 42 ADDITIONAL RESOURCES American Cancer Society: www.cancer.org How is Colorectal Cancer Staged? American Society of Clinical Oncology (patient website): www.cancer.net Colorectal Cancer: Staging, with Illustrations CancerQuest: www.cancerquest.org Colon and Rectal Cancer: Pathology Report and Staging OncoLink: www.oncolink.org Colon Cancer: The Basics Pa t i e n t Re s o u r ce .co m colorectal cancer | types of cancer T Colorectal Cancer Treatment Options Treatment of colorectal cancer depends on the stage of the disease, just as with other types of cancer, and early diagnosis can lead to a complete cure, which is why screening is so important. Ongoing research is also leading to personalized treatments for some types of colorectal cancer. Surgery Surgery is the most common treatment for colorectal cancer and is usually the primary treatment for all stages of the disease. If the cancer is localized to a single polyp – simply a mass of overgrown tissue – or is at a very early stage, your doctor may be able to remove it during a colonoscopy. If cancer cells are located where the polyp attaches to the wall of the colon, your doctor may need to remove that part of the colon to ensure all cancer cells are removed. For later-stage colorectal cancer (Stages II and III), the surgeon also removes nearby lymph nodes. A pathologist can then check the lymph nodes for cancer cells and determine the stage of the cancer. Two main types of surgery can be done to treat colon cancer: • Open surgery – In this traditional surgery, the surgeon makes a large incision in the abdomen. • Laparoscopic surgery – With this type of surgery, the surgeon passes special instruments through a few small incisions. One of these instruments is a laparoscope, which has a small video camera on the end. This allows the surgeon to see inside your abdomen. Most patients recover faster and have less pain after a laparoscopic procedure compared with open surgery. For some rectal cancers, robotic-assisted surgery can be done with a laparoscopic procedure. With this type of surgery, the surgeon uses special instruments that can reach areas that may be difficult to manage with traditional instruments. Laparoscopic and robotic-assisted surgeries are less invasive, and recovery time is shorter. However, you and your doctor should consider many factors before choosing either of these procedures. The surgeon’s experience in using these techniques is very important. When a section of the colon is removed, the surgeon can usually attach the healthy ends together during the same surgery. However, sometimes the colon needs to heal before this can be done. If so, the surgeon will make an opening, or stoma, in the abdomen and attach one end of the intestine to the opening. This procedure is called a colostomy and provides a new pathway for the body to eliminate waste. A pouch attached to the skin around the stoma collects the waste. Most often, a colostomy is temporary. However, if the surgeon needs to remove the anal sphincter muscles, which control bowel movements, the colostomy will become permanent. When treating rectal cancers, the goal is to preserve the anal sphincter to keep as much normal bowel function as possible. Chemotherapy Chemotherapy for colorectal cancer usually involves two or more drugs. Several effective regimens are available for initial (first-line) and later treatments. The most commonly used drugs for colorectal cancer are fluorouracil (5-FU), irinotecan (Camptosar), oxaliplatin (Eloxatin) and capecitabine (Xeloda). The drug leucovorin (folinic acid) or levoleucovorin is often given with fluorouracil to make that drug more effective. When cancer has spread to nearby lymph nodes (Stage III), the doctor may give adjuvant, or additional, chemotherapy after surgery to lower the risk of the cancer coming back. Adjuvant chemotherapy is not recommended for treating Stage I disease, and it’s used for Stage II disease only when there is a high risk of the cancer returning. Chemotherapy may also be the main treatment for advanced (metastatic) colorectal cancer. In these cases, the treatment goal is to increase survival time rather than cure the disease. Chemotherapy is also often combined with radiation therapy for the treatment of rectal cancer. Targeted therapy Targeted therapy involves the use of drugs or other substances to stop cancer cell growth by interfering with the way cells communicate. For colorectal cancer, targeted therapy has mainly involved the use of epidermal growth factor receptor (EGFR) inhibitors and antiangiogenic agents. These drugs are usually given along with chemotherapy for metastatic disease. EGFR inhibitors include cetuximab (Erbitux) and panitumumab (Vectibix). These Pa t ie n tResource.com are effective for treatment of people with metastatic colorectal cancer, but only if their tumors do not have changes (“mutations”) in the KRAS gene. Therefore, experts recommend that all people with metastatic colorectal cancer have genetic testing on the tumor to see if KRAS mutations are present. If a patient has a tumor with the KRAS mutation, other types of treatment, such as standard chemotherapy, are available. Two new drugs are available for metastatic colorectal cancer that has not responded to previous treatment. Regorafenib (Stivarga) is used for colorectal cancer that has not responded to chemotherapy or an EGFR inhibitor, and ziv-aflibercept (Zaltrap) is used for metastatic colorectal cancer that has not responded to treatment with an oxaliplatinbased chemotherapy regimen. Another type of targeted therapy for metastatic colorectal cancer is bevacizumab (Avastin). Known as an antiangiogenic agent, it stops the growth of blood vessels to the tumor. Without a blood supply, tumor cells dies. Bevacizumab is most often given with chemotherapy. Radiation therapy Radiation therapy is often used for patients with rectal cancers or with colon cancers that have attached to an internal organ or wall of the abdomen. It’s also used to treat colorectal cancer that has spread to another organ, such as the brain or bones. Radiation therapy is mostly used along with chemotherapy for rectal cancers because these tumors tend to recur near where they originally started. This combination, known as chemoradiation therapy, may be given after surgery (adjuvant therapy) to help reduce the risk of the cancer coming back. Chemoradiation therapy can also be given before surgery (neoadjuvant therapy) – a common treatment for rectal cancers – to shrink the tumor and make it easier to remove. ADDITIONAL RESOURCES American Cancer Society: www.cancer.org Colon/Rectum Cancer American Society of Colon & Rectal Surgeons: www.fascrs.org Laparoscopic Surgery – What is It? College of American Pathologists: www.cap.org KRAS Mutation Testing for Colorectal Cancer Fight Colorectal Cancer: www.fightcolorectalcancer.org Is KRAS Testing Right for You? National Cancer Institute: www.cancer.gov Colon and Rectal Cancer National Comprehensive Cancer Network: www.nccn.com 43 colon cancer patient story Survivor’s Family History S Mary Ellen Fleming-Jones overcame a long family history when she beat colon cancer 20 years ago. She is a retired U.S. Food and Drug Administration chemist and has two adult daughters. When she’s not driving patients to their cancer treatments through Cancer Action or talking to people over the phone through the R.A. Bloch Cancer Foundation’s Hotline, Mary Ellen enjoys feeding birds and attending live theater shows, movies and concerts as well as fishing, reading and playing brain games. I I come from a “cancer family.” I have had grandparents, aunts, uncles and cousins on both sides who have battled various types of cancer. My father was diagnosed with colon cancer in 1978 and lymphoma in 1980. Two years later, my mother also was diagnosed with colon cancer, and then in 1988 my brother found out he had melanoma. Many of them lost their fights. When I was diagnosed with Stage III colon cancer in March 1993 at the age of 52, I was determined to work toward a different result. That determination paid off. I survived and began a new, more optimistic chapter in my family’s history. My sister and her daughter have since beaten breast cancer and two of my cousins have conquered melanoma. While we may still be a cancer family, we are now also a family of survivors. A gastroenterologist first discovered my cancer during a colonoscopy and endoscopy. I went in for the procedures because of frequent stomach pain, which I originally suspected to be from an ulcer. When I found out the true cause, I reacted rather nonchalantly because the doctor said the mass was very small. A couple of weeks later – at the urging of my youngest daughter – I made an appointment with a surgeon to have it removed. After my surgery, the surgeon told me the tumor actually was the size of his fist—much larger than originally thought. He also told me that the tumor had broken through my bowel wall, that my appendix was malignant and that 23 of the 27 lymph nodes he tested were positive for cancer. At that point, my family history flashed before me and it felt like my world was crashing down. An oncologist came to my hospital room soon after to set up a consultation for six weeks later. At that appointment she helped me enroll in a clinical trial. I soon found out that I was chosen to be in the control group of the trial rather than in the study group, so I didn’t receive the newest medication. Instead, I received 30 cycles of the chemotherapy drugs leucovorin (Wellcovorin) and fluorouracil (5-FU). I was disappointed at first, but ultimately the treatment worked and that’s all that really matters in the end. Physically, my therapy was a breeze compared to what I’ve seen others experience. I did feel fatigued and I lost 46 pounds “ “ While we may still be a cancer family, we are now also a family of survivors. 44 Mary Ellen Didn’t Define Her Fight due to a combination of diarrhea and loss of appetite, but overall the physical effects were minimal. Emotionally, I still have to work at not making every health issue I have a symptom of my cancer. Luckily, I’m not alone in that struggle. I believe that no one should have to carry a burden alone. Thankfully, my friends and family members do, too, so they all were a great source of support for me during my treatment and for a long time after. I also attended support group sessions, which were incredibly important to my recovery. Now that I’m a long-term survivor, I do what I can to help others. I volunteer with the Bloch Cancer Hotline and Cancer Action, talking to current cancer patients over the phone and while driving them to their appointments. I think it helps them to hear advice and receive support from a cancer survivor like me, but I also get a lot of continued support from them by observing how they cope and thrive. I truly believe that I’m actually getting more than I’m giving through my involvement with these organizations. My best advice for those newly diagnosed is to find a doctor who specializes in your particular type of cancer with whom you can communicate freely and trust. If you don’t feel a connection with the first doctor, seek out a second opinion. This philosophy wasn’t as prevalent when I was diagnosed, but through my volunteer efforts, I find myself encouraging people who are having difficulty communicating with their doctors or accepting a diagnosis or treatment scheme to search for a second opinion. A doctor’s attitude can greatly influence a patient’s handling of side effects and, ultimately, the outcome of the treatment. Pa t i e n t Re s o u r ce .co m leukemias and multiple myeloma | types of cancer C Leukemias and Multiple Myeloma Cancers fall into two general categories: solid and hematological (blood). When most people think of cancer, they think of solid cancer, which involves a tumor that grows and sometimes spreads to other places in the body. In contrast, blood cancers affect the blood, bone marrow and lymph nodes and may not create an actual tumor. Leukemias and multiple myeloma are both blood cancers that develop when normal blood or plasma cells transform and grow uncontrollably. These abnormal cells don’t mature or function properly and may crowd out normal cells, making it hard for them to do their work. About bone marrow and white blood cells To understand leukemias and multiple myeloma, it’s important to first gain a general understanding of bone marrow and white blood cells, which both play a major role in these two diseases. • Bone marrow is the soft, spongy center of some bones that contains immature blood stem cells, more mature bloodforming cells, fat cells and tissues that support cell growth. • White blood cells (leukocytes) are a component of blood that help the body defend against infection. Granulocytes and lymphocytes are two of the main types of white blood cells: ! Granulocytes are cells with enzymecontaining granules visible under a microscope. They develop from myeloblasts (immature cells found in bone marrow) into mature, infection-fighting cells. Subtypes of these cells include basophils, eosinophils and neutrophils. ! Lymphocytes are the primary cells in lymphoid tissue, which is a major part of the immune system. They develop from lymphoblasts (immature cells found in bone marrow) into mature, infection-fighting cells. Subtypes of these cells include B lymphocytes and T lymphocytes. Plasma cells develop from B lymphocytes. They produce antibodies to help fight infection and are mainly found in the bone marrow. Leukemias Leukemias start in the blood and bone marrow and occur when large numbers of white blood cells do not function properly. The two major types of leukemia are acute and chronic: • Acute leukemia grows quickly and occurs when immature white blood cells Pa t ie n tResource.com properly and interfere with the production of healthy cells. Like CLL, CML develops slowly and may not produce symptoms in the early stages. When symptoms do occur, they often include easy bruising or bleeding, unexplained weight loss, fever, fatigue, shortness of breath, pain in the bones and night sweats. Multiple myeloma increase rapidly, preventing bone marrow from making normal blood cells. Treatment should be immediate because these fast-growing cells can quickly become life-threatening. • Chronic leukemia grows more slowly and occurs when white blood cells mature partly but not completely. These abnormal cells don’t fight infection as well as normal cells, and because they survive longer, they accumulate and crowd out normal cells. Progression tends to take months or years, and treatment may move more slowly than it does for acute leukemia. Leukemias are further subdivided based on whether they affect lymphoid or myeloid cells. Some of the main subtypes include: • Acute lymphocytic leukemia (ALL): Too many stem cells develop into abnormal lymphocytes, which don’t fight infections well. Symptoms include anemia, frequent infections, swollen lymph nodes, abdominal pain, fever, night sweats, appetite loss and weight loss. ALL progresses very quickly if not treated. • Acute myeloid leukemia (AML): Too many stem cells develop into abnormal granulocytes, which don’t function properly and interfere with the production of healthy cells. This causes the same symptoms as ALL, and AML also progresses rapidly if not treated. • Chronic lymphocytic leukemia (CLL): Too many stem cells develop into abnormal lymphocytes, which don’t fight infections well. CLL develops slowly, and patients may have no symptoms in the early stages and little change in their health for many years. In time, symptoms may include fatigue, shortness of breath, swollen lymph nodes or spleen, and frequent infections. CLL is the most common type of leukemia in adults. • Chronic myeloid leukemia (CML): Too many stem cells develop into abnormal granulocytes, which don’t function Multiple myeloma starts in plasma cells inside bone marrow and occurs when normal plasma cells transform into abnormal myeloma cells and grow uncontrollably. As these abnormal cells multiply, they prevent the growth of healthy cells in the bone marrow. They may also damage the bone itself as well as other organs, such as the kidneys. Multiple myeloma may not cause any symptoms. However, the symptoms that can develop include bone pain (especially in the back or ribs), bones that break easily, fever, frequent infections, easy bruising or bleeding, difficulty breathing, kidney problems, weakness of the arms or legs, and feeling very tired. Treating leukemias and multiple myeloma The choice of treatment is dependent on the type and subtype of the cancer and the stage of the disease, as well as other factors, including the patient’s age and gender. Leukemia treatment options include chemotherapy, targeted therapy, immunotherapy (also called biological therapy), radiation therapy and stem cell transplantation. Multiple myeloma treatment options include chemotherapy, targeted therapy, radiation therapy and stem cell transplantation, as well as steroids and supportive therapies to relieve symptoms such as infections or bone damage. Treatment plans for multiple myeloma most often recommend more than one type of therapy. Another treatment option for both leukemias and multiple myeloma is watchful waiting. Some early-stage diseases grow slowly, so it’s better to wait until the cancer has progressed before giving other treatment. ADDITIONAL RESOURCES American Cancer Society: www.cancer.org Leukemia & Lymphoma Society: www.lls.org The Multiple Myeloma Research Foundation: www.themmrf.org National Cancer Institute: www.cancer.gov Patient Resource: www.PatientResource.com 45 CML patient story The Kareem Abdul-Jabbar bounces back from CML battle and works to help others with the disease a akim lowers his arms and slowly rises from the ffloor, extending to his full 7 feet, 2 inches, and calmly looks at the much smaller man, poised in a fighting stance before him. Billy-Lo, who has faked his death to find the people trying to kill him, has battled to this level of the pagoda to eliminate Hakim in whichever fighting style seems to be effective. Unfazed, Hakim stares down at his visitor through dark sunglasses, confident and relaxed. “You little runt. What do you think you’re trying to prove?” Of course, Bruce Lee’s character would soon overcome the sizeable odds and beat down the imposing Hakim, embodied by Kareem Abdul-Jabbar in 1978’s “The Game of Death.” But looking at that sheer volume of space absorbed by Hakim, the cool confidence of a seasoned athlete? For a few minutes, the fight doesn’t seem fair—like maybe the film’s famous star and protagonist doesn’t save the day after all. Kareem is used to being larger than life. His study of martial arts under Bruce Lee came in the middle of an NBA career that has yet to see its equal, setting NBA records for points (38,387), minutes (57,446), career field goals (15,837) and All-Star honors (19). A member of the Naismith Memorial Basketball Hall of Fame with six NBA championship rings, a statue of his likeness was recently unveiled in front of the Staples Center in Los Angeles. Former Lakers coach Pat Riley summarized Kareem’s 20-year NBA career: 46 “Why judge anymore? Let’s toast him as the greatest player ever.” Now long retired from basketball, and 30 years after Billy-Lo, the next “runt” in Kareem’s path came at the cellular level: Philadelphia chromosome-positive chronic myeloid leukemia (CML), diagnosed in 2008. “My reaction was that I was in a fight for my life,” he said. “I kind of saw it as a challenge to my existence.” It wasn’t his first run-in with cancer. Kareem carries the genetic risk for colorectal cancer and watched as it claimed the lives of both his grandfather and uncle. His father nearly died himself from the disease, which eventually took a large section of his intestine. Kareem was briefly involved with a colorectal cancer educational campaign from 2006 to 2007 to help raise awareness of the risk. So when he began experiencing symptoms of his CML, he took notice. Always in tremendous shape between a lifetime of competitive basketball and an advanced yoga habit he credits for his career longevity, he was perplexed about the night sweats that occurred two to three times a month. “I’d wake up and just be soaking wet, and I didn’t understand what was going on,” he said. “I initially just attributed it to the fact that I was getting older, but it was a lot more serious than that.” Kareem’s doctor ordered some blood work, which showed a sky-high white blood cell count. That was the first indication, he said, that something was awry. “I figured I wasn’t a candidate for anything that would be life-threatening,” he said. “It took me entirely by surprise, and it was a very frightening moment to have somebody tell you that you probably have leukemia.” His first call was to his son – in medical school at the time – who deciphered the medical jargon and assured him that leukemia isn’t always life-threatening, that many drugs have been developed in the past decade that are quite effective for many people. The first drug Kareem tried proved useful at first, in spite of side effects such Pa t i e n t Re s o u r ce .co m as severe hand cramping and fatigue. But after the drug’s effectiveness began to level off, Kareem switched to nilotinib (Tasigna), which not only helped Kareem achieve the molecular response he was looking for but also eliminate any lifeintruding side effects. “I’m able to do everything that I was doing before I was diagnosed,” he said. With his leukemia under the control of his medication, Kareem has focused on several new ventures, including filmmaking – the documentary “On the Shoulder of Giants” was released in 2011 – as well as writing. In addition to an autobiography and memoir, he recently published a children’s book about the history of African-American inventors and is planning a trilogy of books for kids learning about basketball and life. The first installment – called “Sasquatch in the Paint” and loosely based on his life – hit bookshelves September 2013. His advocacy efforts have also reached across borders. Named a cultural ambassador for the United States in 2012, he’s traveled to Brazil in a partnership with that country to upgrade its educational system, particularly in the areas of science and math. Among the many responsibilities involved with these creative efforts, he’s also in the middle of a nationwide educational campaign, appearing at summits across the country, meeting with CML patients in various stages of their cancer journeys. “I’ve found that I’ve been able to do a lot of good just sharing my story with people and letting them know that they’re not alone and that they have the opportunity to treat this disease,” he said. “So many people think that once they’re diagnosed, that’s it, and it’s just going to be a slow descent into a bad end, and it doesn’t have to be that way.” So while his schedule stays full – he Pa t ie n tResource.com hopes to eventually get back into his piano practice if he’s ever home long enough – Kareem remains ever grateful for the advances that have led to his successful treatment and the opportunity to share his story with others. “Using my celebrity just to raise awareness really helps because research is the key to the ongoing elimination of threats like this,” he said. “So every time we figure out a way to treat a different aspect of the various blood cancers, we’re saving lives and making it possible for further discoveries. So all of these things work together to make for progress, and there’s been great progress in the past 10 to 12 years.” Kareem and his doctors now simply keep a close eye on his blood levels with checkups and blood work appointments every 90 days. He also stresses the importance of a healthy lifestyle – exercise, plenty of sleep, good nutrition – especially when you’re battling cancer. That combination, along with his treatment plan, allows him to keep the enemy in front of him at arms’ length. “I kind of relied on my martial arts training,” he said. “Sometimes you have to eliminate everything except the thing you have to defeat, or it’s going to get you.” 47 When I asked about medication options, my doctor said TASIGNA. TASIGNA® (nilotinib) is a prescription medicine used to treat adults with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The efficacy of TASIGNA is based on major molecular response and cytogenetic response rates. The study is on-going and more data will be needed to determine long-term outcomes. TASIGNA is also used to treat chronic phase or accelerated phase Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in adults who are no longer benefiting from previous other treatments, including imatinib (GLEEVEC®), or have taken other treatments, including imatinib (GLEEVEC) but cannot tolerate them. The efficacy of TASIGNA is based on hematologic response and cytogenetic response rates. Visit www.tasigna.com to learn more about the response data and the safety risks observed in clinical trials for TASIGNA. Patients should tell their healthcare provider if they experience any side effect that bothers them or does not go away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (FDA Medwatch). Patients, caregivers, friends, family, and healthcare professionals in the United States can contact Novartis Corporation with questions by calling 1-888-NOW-NOVA (1-888-669-6682), Monday - Friday, 8:30AM - 5:00PM EST. For additional safety information, please see the Important Safety Information on the next page. Please see Important Safety Information, including Boxed WARNING for TASIGNA, on the next page. Learn more at www.tasigna.com and ask your doctor if TASIGNA is a treatment option for you. IMPORTANT SAFETY INFORMATION IMPORTANT SAFETY INFORMATION ABOUT TASIGNA® (nilotinib) What is the most important information to know about prescription TASIGNA? TASIGNA can cause a possible life-threatening heart problem called QT prolongation. QT prolongation causes an irregular heartbeat, which may lead to sudden death. Your doctor should check your heart with a test called an electrocardiogram (ECG): • Before starting TASIGNA • 7 days after starting TASIGNA • With any dose changes • Regularly during TASIGNA treatment You may lower your chances for having QT prolongation with TASIGNA if you: • Take TASIGNA on an empty stomach • DO NOT TAKE TASIGNA WITH FOOD ° Food can affect the levels of TASIGNA in your body, which can lead to serious side effects ° Taking TASIGNA on an empty stomach may lower your chances of having a possibly life-threatening heart problem called QT prolongation ° QT prolongation causes an irregular heartbeat, which may lead to sudden death Who should not take TASIGNA? Do not take if you have: • Low levels of potassium or magnesium in your blood • Long QTc syndrome Taking TASIGNA: • TASIGNA should be taken exactly as instructed by your doctor. Do not change the dose or stop taking TASIGNA unless instructed to by your doctor. • Take TASIGNA at least 2 hours after eating any food • After taking TASIGNA, wait at least 1 hour before eating any food • Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking TASIGNA. Food and grapefruit products increase the amount of TASIGNA in your body ° Avoid taking other medicines or other supplements with TASIGNA that can also cause QT prolongation ° Swallow TASIGNA capsules whole with water. If you cannot swallow TASIGNA capsules whole, tell your doctor • If you cannot swallow TASIGNA capsules whole: ° Open the TASIGNA capsules and sprinkle the contents in 1 teaspoon of applesauce (puréed apple) - Do not use more than 1 teaspoon of applesauce - Only use applesauce. Do not sprinkle TASIGNA onto other foods ° Swallow the mixture right away (within 15 minutes) • Do not drink grapefruit juice, eat grapefruit, or take supplements containing grapefruit extract. It may affect the levels of TASIGNA in the blood • If you miss a dose, take your next dose as scheduled. Do not take a double dose to make up for a missed dose Before taking TASIGNA Talk to your doctor or pharmacist about all other medication(s) you may be taking, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements, since they may affect how TASIGNA works and increase your chance of serious and lifethreatening side effects. Tell your doctor if: • You have a heart disorder or are taking medication for the heart • You have an irregular heartbeat • You have QT prolongation or a family history of it • You have liver problems Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 ©2012 Novartis • You know that you suffer from low blood levels of electrolytes, such as potassium, magnesium, or calcium • You have a pancreas disorder • You have had a surgical procedure involving the removal of the entire stomach (total gastrectomy) Also tell your doctor if you are pregnant, breast-feeding, or lactoseintolerant. The TASIGNA capsules contain lactose. Most patients who have mild or moderate lactose intolerance can take TASIGNA. Serious side effects TASIGNA may cause serious side effects including: • QT prolongation. Call your doctor right away if you feel lightheaded, faint or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QT prolongation, a possible life-threatening heart problem • Low blood counts. Low blood counts are common with TASIGNA. Your doctor will check your blood counts regularly during treatment with TASIGNA. Symptoms of low blood counts include: ° Unexplained bleeding or bruising ° Blood in urine or stool ° Unexplained weakness ° Shortness of breath • Liver damage. Symptoms include yellow skin and eyes • Pancreas inflammation (pancreatitis). Symptoms include sudden stomach area pain with nausea and vomiting • Bleeding in the brain. Symptoms include sudden headache, changes in your eyesight, not being aware of what is going on around you and becoming unconscious • Tumor Lysis Syndrome (TLS). TLS is caused by a fast breakdown of cancer cells. TLS can cause you to have: ° kidney failure and the need for dialysis treatment ° an abnormal heart beat Your doctor may do blood tests to check you for TLS Call your doctor immediately if you experience any of these symptoms. Your doctor may change your dose. Your doctor may have you stop TASIGNA for some time or lower your dose if you have side effects with it. Common side effects Most patients experience side effects at some time. Some common side effects you may experience include: • Low blood count • Rash • Nausea • Fever • Stomach (abdominal) pain • Headache • Itching • Muscle and joint pain • Tiredness • Diarrhea • Constipation • Back pain • Muscle spasms • Weakness • Hair loss • Cough • Runny or stuffy nose, sneezing, sore throat Be sure to tell your doctor or pharmacist if you have any side effects during treatment with TASIGNA. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. It is not known if TASIGNA is safe or effective in children. Tell your doctor if you are pregnant or planning to become pregnant. TASIGNA may harm your unborn baby. If you are able to become pregnant, you should use effective birth control during treatment with TASIGNA. Talk to your doctor about the best birth control methods to prevent pregnancy while you are taking TASIGNA. Tell your doctor if you are breast-feeding or plan to breast-feed. It is not known if TASIGNA passes into your breast milk. You and your doctor should decide if you will take TASIGNA or breast-feed. You should not do both. If you take too much TASIGNA, call your doctor or poison control center right away. Your doctor will check your heart, do regular blood tests, and take bone marrow samples during treatment with TASIGNA. These are done to check for side effects with TASIGNA and to see how well TASIGNA is working for you. Your doctor should check your blood to monitor the amount of blood cells (white blood cells, red blood cells, and platelets) during treatment. These should be checked every 2 weeks for the first 2 months and then monthly thereafter, or as considered necessary by your doctor. Please see the full prescribing information, including the Boxed WARNING, and the TASIGNA Medication Guide. Printed in USA 3/12 AM7-1036536 Consumer Brief Summary for TASIGNA® (nilotinib) Capsules Read the Medication Guide that comes with TASIGNA before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment. What is the most important information I should know about TASIGNA? TASIGNA can cause a possible life-threatening heart problem called QTc prolongation. QTc prolongation causes an irregular heartbeat, which may lead to sudden death. Your doctor should check the electrical activity of your heart with a test called an electrocardiogram (ECG): • before starting TASIGNA • 7 days after starting TASIGNA • with any dose changes • regularly during TASIGNA treatment You may lower your chances for having QTc prolongation with TASIGNA if you: • Take TASIGNA: ° on an empty stomach. Do not take TASIGNA with food. ° at least 2 hours after eating any food, and ° at least 1 hour before eating any food • Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking TASIGNA. Food and grapefruit products increase the amount of TASIGNA in your body • Avoid taking other medicines or supplements with TASIGNA that can also cause QTc prolongation • TASIGNA can interact with many medicines and supplements and increase your chance for serious and life-threatening side effects • Do not take any other medicine while taking TASIGNA unless your doctor tells you it is okay to do so • If you cannot swallow TASIGNA capsules whole, you may open the TASIGNA capsule and sprinkle the contents of each capsule in 1 teaspoon of applesauce (puréed apple). Swallow the mixture right away (within 15 minutes). For more information, see “How should I take TASIGNA?” Call your doctor right away if you feel lightheaded, faint or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QTc prolongation. What is TASIGNA? TASIGNA is a prescription medicine used to treat a type of leukemia called Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in adults who: • are newly diagnosed, or • are no longer benefiting from previous other treatments, including treatment with imatinib (GLEEVEC®), or • have taken other treatments, including imatinib (GLEEVEC), and cannot tolerate them It is not known if TASIGNA is safe or effective in children. Who should not take TASIGNA? Do not take if you have: • low levels of potassium or magnesium in your blood • long QTc syndrome What should I tell my doctor before starting TASIGNA? TASIGNA may not be right for you. Before taking TASIGNA, tell your doctor about all of your medical conditions, including if you have: • heart problems • irregular heartbeat • QTc prolongation or a family history of it • liver problems • had pancreatitis • low blood levels of potassium or magnesium in your blood • a severe problem with lactose (milk sugar) or other sugars. The TASIGNA capsules contain lactose. Most patients who have mild or moderate lactose intolerance can take TASIGNA • had a surgical procedure involving the removal of the entire stomach (total gastrectomy) • are pregnant or plan to become pregnant. TASIGNA may harm your unborn baby. If you are able to become pregnant, you should use effective birth control during treatment with TASIGNA. Talk to your doctor about the best birth control methods to prevent pregnancy while you are taking TASIGNA • are breastfeeding or plan to breastfeed. It is not known if TASIGNA passes into your breast milk. You and your doctor should decide if you will take TASIGNA or breastfeed. You should not do both What are the possible side effects of TASIGNA? TASIGNA may cause serious side effects including: • See “What is the most important information I should know about TASIGNA?” • Low blood counts. Low blood counts are common with TASIGNA. Your doctor will check your blood counts regularly during treatment with TASIGNA. Symptoms of low blood counts include: ° unexplained bleeding or bruising ° blood in urine or stool ° unexplained weakness • Liver damage. Symptoms include yellow skin and eyes • Pancreas inflammation (pancreatitis). Symptoms include sudden stomach area pain with nausea and vomiting • Bleeding in the brain. Symptoms include sudden headache, changes in your eyesight, not being aware of what is going on around you and becoming unconscious • Tumor Lysis Syndrome (TLS). TLS is caused by a fast breakdown of cancer cells. TLS can Tell your doctor about all the medicines you cause you to have: take, including prescription and nonprescription ° kidney failure and the need for medicines, vitamins and herbal supplements. dialysis treatment TASIGNA can interact with many medicines and ° an abnormal heart beat Your doctor may do blood tests to check supplements and increase your chance for serious you for TLS. and life-threatening side effects. See “What is the most important information I should know The most common side effects of TASIGNA about TASIGNA?” include: Know the medicines you take. Keep a list of them • low blood count • rash • nausea • fever and show it to your doctor and pharmacist when • headache • itching you get a new medicine. • tiredness • stomach (abdominal) pain How should I take TASIGNA? • constipation • muscle and joint pain • Take TASIGNA exactly as your doctor tells you • back pain • muscle spasms to take it. Do not change your dose or stop • weakness • hair loss taking TASIGNA unless your doctor tells you • diarrhea • runny or stuffy nose, • TASIGNA is a long-term treatment • cough sneezing, sore throat • Your doctor will tell you how many TASIGNA Tell your doctor if you have any side effect that capsules to take and when to take them • Do not take TASIGNA with food. Take TASIGNA bothers you or does not go away. at least 2 hours after you eat and at least These are not all of the possible side effects of 1 hour before you eat TASIGNA. For more information, ask your doctor • Swallow TASIGNA capsules whole with water. or pharmacist. If you cannot swallow TASIGNA capsules whole, tell your doctor Call your doctor for medical advice about side • If you cannot swallow TASIGNA effects. You may report side effects to FDA at capsules whole: 1-800-FDA-1088. ° Open the TASIGNA capsules and sprinkle • Keep TASIGNA and all medicines out of the the contents in 1 teaspoon of applesauce reach of children. (puréed apple) - Do not use more than 1 teaspoon General information about TASIGNA of applesauce Medicines are sometimes prescribed for purposes - Only use applesauce. Do not sprinkle other than those listed in a Medication Guide. Do TASIGNA onto other foods not use TASIGNA for a condition for which it was ° Swallow the mixture right away not prescribed. Do not give TASIGNA to other (within 15 minutes) people, even if they have the same problem you • Do not drink grapefruit juice, eat grapefruit, or take supplements containing grapefruit extract have. It may harm them. at any time during treatment. See “What is the This brief summary summarizes the most most important information I should know important information about TASIGNA. If you about TASIGNA?” would like more information, talk with your • If you miss a dose, just take your next dose as doctor. You can ask your doctor or pharmacist scheduled. Do not make up for a missed dose for information about TASIGNA that is written for • If you take too much TASIGNA, call your doctor healthcare professionals. or poison control center right away. Symptoms For more information, go to www.us.TASIGNA.com may include vomiting and drowsiness. During or call 1-866-411-8274. treatment with TASIGNA, your doctor will do tests to check for side effects and to see how Manufactured by: well TASIGNA is working for you. The tests Novartis Pharma Stein AG will check your: Stein, Switzerland ° heart Distributed by: ° blood cells (white blood cells, red blood Novartis Pharmaceuticals Corporation cells, and platelets). Your blood cells East Hanover, New Jersey 07936 should be checked every 2 weeks for the first 2 months and then monthly AM7-1036536 ° electrolytes (potassium, magnesium) pancreas and liver function ° ° bone marrow samples • Your doctor may change your dose. Your doctor may have you stop TASIGNA for some time or lower your dose if you have side effects with it gynecologic cancers | types of cancer Gynecologic Cancers G Overview and Treatment Options Gynecologic cancers are found in a woman’s reproductive organs, most commonly in the uterus, ovaries or cervix. Less common forms of the disease can also be found in the fallopian tubes, vagina and vulva. Each subtype of the disease has its own unique signs, symptoms and risk factors as well as treatment strategies. Uterine cancer Uterine cancer is the most common type of gynecologic cancer and is classified as adenocarcinoma or sarcoma. Adenocarcinomas account for more than 95 percent of uterine cancers. This type of cancer begins in the cells of the endometrium – the inner lining of the uterus – and therefore is often referred to as endometrial cancer. Sarcomas account for the remaining uterine cancers and begin in the myometrium, the outer muscle layer of the uterus. The good news is that the cure rate for endometrial cancer is high. Surgery is the most common treatment option and typically begins with a total hysterectomy (removal of the uterus and cervix) and usually some lymph glands to evaluate for cancer spread. Depending on the stage of the cancer, the surgeon may instead choose to perform a radical hysterectomy, in which the uterus, cervix and a small part of the vagina are removed. The ovaries, fallopian tubes and nearby lymph nodes are generally removed as well. The degree of endometrial cancer is measured in stages, from Stage I, which indicates that the cancer is contained in the uterus, to Stage IV, which indicates that the cancer has spread beyond the uterus to the rectum, bladder and other organs. The earlier the cancer is detected, the greater the chance for cure. If some cancer cells are still present after surgery, other treatment options, such as radiation therapy, hormone therapy and chemotherapy, are available and can be used alone or as combination therapies. They also can be used instead of surgery if that is not the best option. Ovarian cancer Of the women diagnosed with ovarian cancer, more than half are older than age 60, and the disease is more common in white women than in African-American women. The disease is also more common in women with a family history of ovarian cancer, and research indicates that inherited gene mutations cause some ovarian cancers. Pa t ie n tResource.com Ovarian cancer usually forms in the tissues of the ovaries, which produce eggs and are the main source of the female hormones estrogen and progesterone. Most ovarian cancers are epithelial carcinomas, which begin in the cells on the surface of the ovary. However, some malignant germ cell tumors begin in the cells that produce the eggs or arise from the tissue that holds the ovary together. As part of the treatment regimen, women with an increased risk of ovarian cancer sometimes have preventive surgery, called a prophylactic oophorectomy, in which one or both ovaries are removed. Tests examining the ovaries, pelvic area, blood and ovarian tissue are used to detect ovarian cancer, and roughly 20 percent of ovarian cancers are found in the early stages. Surgery, chemotherapy and radiation therapy are the main treatments for ovarian cancer and can be used alone or in combination. New types of treatments, such as biologic therapy and targeted therapies, are currently being tested in clinical trials. Biologic therapies – also called immunotherapies – use a patient’s own immune system to fight the cancer. Other targeted therapies use drugs or other substances to identify and attack specific cancer cells without harming normal cells. Cervical cancer Cervical cancer develops in the cervix, which is the lower, narrow end of the uterus leading to the vagina. It is a slow-growing cancer that may or may not cause symptoms, but it can be found with regular Pap tests. Cervical cancer most often affects women between the ages of 20 and 50 and is predominately caused by a human papillomavirus (HPV) infection, for which a vaccine is now available. As with all types of cancer, the treatment options for cervical cancer depend on the stage in which the disease is discovered, but surgery, radiation and chemotherapy – alone or in combination – are the traditional methods. Early-stage (Stage I) disease confined to the cervix is most often treated by a radical hysterectomy and removal of the lymph nodes. Women who want to preserve the ability to bear children can instead opt for a radical trachelectomy, in which the cervix, the top part of the vagina and the pelvic lymph nodes are removed, but not the uterus. Cervical cancers that have progressed to Stages II through IV are most often treated with a combination of radiation therapy and chemotherapy, known as concurrent chemoradiation therapy. ADDITIONAL RESOURCES American Society of Clinical Oncology (patient website): www.cancer.net Foundation for Women’s Cancer: www.foundationforwomenscancer.org National Cervical Cancer Coalition: www.nccc-online.org National Ovarian Cancer Coalition: www.ovarian.org Ovarian Cancer Network Alliance: www.ovariancancer.org Society of Gynecologic Oncology: www.sgo.org Women’s Cancer Network: www.wcn.org 51 cervical cancer patient story Survivor Beat Cervical Cancer S Diagnosed on Her Birthday Anissa Norris, a 42-year-old business operations manager, had never had an abnormal Pap test when she was diagnosed with Stage II cervical cancer at the age of 36. Relying on the strength and support of her family and friends, she beat the disease and has been cancer-free for nearly eight years. Anissa and her husband of 19 years have three children who are now ages 11, 14 and 17, and their family also includes two dogs and one cat. When Anissa isn’t spending time with her family, she can likely be found cozied up with a good book. G Generally, birthdays come with gifts. My 36th birthday, however, came with quite the opposite. It was on that day that I was diagnosed with Stage II cervical cancer. About six months earlier, I’d begun experiencing heavy menstrual bleeding that continued to get worse. My gynecologist determined that it was likely a cervical fibroid and scheduled a surgery to remove it. During the procedure, my specimen was sent to a pathologist who immediately identified it as cancerous. When I woke up from the anesthesia, my doctor broke the news. I was shocked. I’d never had an abnormal Pap test, which is generally the first indication of cancer. In fact, the test I’d had just five months prior to my diagnosis was completely normal. My gynecologist later told me that the area where the cancer was present had likely just not been swabbed. She explained that the tool used for the test is similar to a mascara wand and that, depending on an individual’s anatomy, it may not reach all areas. My gynecologist referred me to a gynecological oncologist at a nearby hospital, and about a month after my diagnosis, I underwent a radical hysterectomy with total lymph node dissection. During the surgery, my doctor also lifted my small intestine out of my pelvic region with an omental sling and moved my ovaries under my hipbones to protect them from future radiation. Even though my gynecological oncologist believed all of the malignant tissue had been removed, she still felt that chemotherapy and radiation therapy were necessary to be absolutely sure nothing was left behind. So two months after my surgery, I began concurrent chemotherapy and radiation therapy. For five weeks I took the chemotherapy drug cisplatin on Mondays and received radiation therapy treatments every weekday. While my treatment time was relatively short, it still came with side effects. In addition to fatigue and nausea, I developed a small bowel obstruction, which my doctor attributed to radiation damage and/or scar tissue from surgery. So a year after my initial surgery, I had a second surgery in which a foot of my small intestine was removed. Abdominal pain due to partial and full blockages in my small intestine continued to plague me, and I eventually had a third surgery to remove scar tissue and clean up my abdominal cavity. During that same time I was also diagnosed with celiac disease, which my doctor thinks was triggered by the physical stress caused by cancer and its treatment. While my side effects admittedly have been tough, I remind myself that surviving with side effects is better than not surviving at all. 52 Anissa Anissa relied on the strength and support of her family, friends and husband, Doug, during her battle with cervical cancer. Through everything, my husband was my rock. He was amazing. I also had family and friends who went over the top to help with meals, visits and house cleaning as well as child care and constant love. As a mom, it was incredibly reassuring to know that my children, who were 4, 7 and 10 at the time, were being cared for by loved ones. I simply could not have done it all without the love and support from those around me. As time continues to pass, I continue to do better. I’ve been cancer-free for nearly eight years, so the likelihood of recurrence is low. I’ve also become a big advocate for the HPV immunization. Several doctors believe that cervical cancer would be largely eradicated if young people got the series of HPV shots. Although it was obviously too late for me, both of our teenage children – our son and daughter – have been immunized, and I encourage others to do the same. It’s amazing to me that if I’d received the immunization, I likely could have avoided all of this—my diagnosis, treatment and years of side effects. My best advice is to always listen to your body and to be a strong self-advocate. Ask questions, and make sure that doctors hear what you’re saying and have a vested interest in your life. Above all, have faith. You really are stronger than you think. Pa t i e n t Re s o u r ce .co m melanoma | types of cancer M Melanoma Overview and Treatment Options Melanoma is an aggressive type of skin cancer that begins in melanocytes (cells that make the pigment melanin) and usually appears as a changing mole on the skin. In rare cases, it can also be found in other pigmented tissues, such as the mouth or the eye. Even though most skin moles are benign (not cancerous), you should tell your doctor about any mole you find on your skin so it can be evaluated, especially when you notice a change in the mole. When melanoma is treated at an early stage, the probability for cure is high. Treatment of melanoma The types of treatment used for melanoma include surgery, biologic therapy, chemotherapy and radiation therapy. As with other types of cancer, the treatment of melanoma depends on the stage of disease. Most melanomas are treated with surgery, with removal of the cancerous tissue along with a margin of healthy tissue from around the tumor. This surgery is known as wide excision. Depending on the thickness of the melanoma, it may be necessary to surgically remove a half-inch to a full inch of skin and fatty tissue around the primary melanoma or biopsy site. The affected area can usually be closed with a plastic surgery procedure, although in some circumstances, skin grafting may be necessary to cover the wound. When melanoma is diagnosed at an early stage (Stage I or II), surgery alone is usually adequate. Precise tools can now predict the risk of microscopic spread of melanoma to the patient’s regional lymph nodes or beyond. Your doctor will plan treatment and predict survival according to many features of the melanoma, including the tumor’s thickness, presence or absence of ulceration (a sore) on Pa t ie n tResource.com the tumor surface, and mitotic rate (how fast the melanoma is growing). To determine whether the lymph nodes are free from cancer, a staging procedure known as a sentinel lymph node biopsy is usually recommended for melanomas more than 1 millimeter thick. (The likelihood that a thinner melanoma has spread to lymph nodes is very low, but thin melanomas that display aggressive features may still be candidates for this staging procedure.) If no cancer cells are found in the sentinel node (the node nearest to the cancer), it is unlikely that they have spread to farther lymph nodes, and no additional surgery is needed. However, if the sentinel node shows cancer cells, the removal of nearby lymph nodes is usually necessary because they might also contain microscopic tumor cells. Talk to your doctor about whether a sentinel lymph node biopsy is right for you. Melanoma is classified into four stages, and treatment depends on the stage. Stage I – Stage I melanomas are subdivided into Stage IA (less than 1 millimeter thick [about the size of a pencil point] and not ulcerated) and Stage IB (less than 1 millimeter thick and ulcerated or 1 to 2 millimeters thick and not ulcerated). For both of these stages, there is no evidence that the cancer has spread to lymph nodes or other organs. Wide excision with sentinel lymph node biopsy is usually done for Stage IA and IB. Stage II – These melanomas are thicker and are classified as Stage IIA, IIB or IIC, according to how thick they are and whether they are ulcerated. The melanoma has not spread to nearby lymph nodes, but thicker melanomas (especially those that are ulcerated) are more aggressive, which means they are more likely to spread. Wide excision with sentinel lymph node biopsy is usually done for Stage IIA, IIB and IIC melanoma. In addition, treatment with interferon alfa is sometimes given after surgery for Stage IIC melanoma. Two approved forms of the drug are available to treat melanoma: 1) a highdose regimen, interferon alfa-2b (Intron A), that requires a daily infusion for a month and then injections under the skin every three weeks for a year, and 2) a lower-dose injection of a slow-release form, peginterferon alfa-2b (Sylatron), that is administered by injection under the skin weekly for up to five years. Stage III – Stage III melanomas have spread to the regional lymph nodes or to some lymph vessels (thin tubes that carry fluid and white blood cells through your body) in the fatty tissue between the original tumor and the regional lymph nodes. Treatment with either form of interferon alfa is usually given after surgery for this stage of disease. Stage IV – Stage IV (metastatic) melanomas have spread beyond the regional lymph nodes to other organs in the body. If the amount of tumor is limited and accessible, the tumor may be surgically removed. In other circumstances, radiation therapy may be given to relieve symptoms, such as growing tumors in the bones or brain. With Stage IV disease, treatment is given to attack the melanoma cells that have traveled to distant parts of the body. Until recently, only one drug was approved for the treatment of metastatic melanoma: the chemotherapy drug dacarbazine (DTIC). Now, a targeted therapy drug, vemurafenib (Zelboraf), is available for people with Stage IV melanoma that has tested positively for the BRAF gene mutation. Studies have shown that melanomas with this gene mutation respond to vemurafenib; in fact, the rate of response and overall survival have been better than that for dacarbazine. Two other targeted therapy drugs for Stage IV melanoma that have tested positively for specific BRAF gene mutations are trametinib (Mekinist) and dabrafenib (Tafinlar). Both of these drugs have been shown to prolong the time until disease progresses. Another new treatment is a biologic drug, ipilimumab (Yervoy). This drug is given as an intravenous infusion and has improved overall survival for people with metastatic melanoma. For people with metastatic melanoma confined to an arm or a leg, a special kind of regional chemotherapy may be given. Delivered in an operating room, the treatment is called hyperthermic isolated limb perfusion (HILP). A chemotherapy drug (usually melphalan) is given directly into the arm or leg without exposing the rest of the body to chemotherapy. ADDITIONAL RESOURCES Aim at Melanoma: www.aimatmelanoma.org Joanna M. Nicolay Melanoma Foundation: www.melanomaresource.org Melanoma International Foundation: www.melanomainternational.org Melanoma Research Foundation: www.melanoma.org Patient Resource: www.PatientResource.com/Melanoma_ Overview.aspx The Skin Cancer Foundation: www.skincancer.org 53 melanoma patient story Survivor Turns Melanoma Diagnosis to Just a ‘Bump in the Road” LeAnn Hankel didn’t even know she was at a higher risk for skin cancer. So when she was diagnosed with melanoma at age 28, this married mother of two could barely believe the news. She quickly took action, however, relying on the love and support of her family to get her through treatment. Now realizing the power of early detection, she encourages others to get checked early and often. E Even though I had never paid much attention to changes in my skin, I was a little worried about a spot I noticed on my shoulder. Turns out I should have been paying more attention to my back. At a routine gynecology appointment, I mentioned the suspicious spot to my doctor. When he found out I had never been to a dermatologist, he encouraged me to make an appointment. Once there, I learned that my shoulder wasn’t the problem. The dermatoloAfter briefly sidelined by melanoma, LeAnn Hankel is now gist completed a full-body exam and found back to plenty of family time. two moles on my back he considered abnormal—larger than the head of a pencil eraser bump in the road—and and a little discolored. He promptly removed them both and sent quite the learning experithem to the lab. ence. Our children were When the news came, I did not react well. After all, no one very young at the time, so likes to hear, “I’m sorry, but your lab results have come back they didn’t really underpositive for cancer.” One of the two moles tested positive for stand what was happenearly-stage melanoma. I was almost in a complete state of deing, which was how we nial. Aren’t I too young for cancer? What about my kids? This preferred it. And because we knew the melanoma was treatable, can’t really be happening to me! we wanted to keep our home routine as normal as possible. At the time, I didn’t want to answer a bunch of questions from My doctor explained to me that early detection saved my people – plus I was still pretty emotional about the news – so I life—that if it had not been spotted, the melanoma would have kept the diagnosis to myself, aside from my close family memquickly spread to other parts of my body. This whole experience bers, who provided a great deal of love and support. has definitely changed my daily routine as well as our whole Once I calmed down and was able to speak with my doctor, I family’s routine! Before I was diagnosed, I didn’t pay much atquickly realized that I was lucky, that the melanoma was caught tention to my skin or my daily habits, but now we are all much early and was curable. We discussed my options, and because more sun-safe. We still spend plenty of time outdoors, but we the cancer was still localized and hadn’t yet spread to any lymph make sure we include plenty of sunblock and lip balm. Plus, I nodes, surgery was my best treatment option. now wear sunglasses, a hat and additional clothing to cover as The incision in my back was 3 inches wide, 8 inches long and 3 much skin as I can when we’re out in the sun. I also make sure millimeters deep, but the surgeon was able to remove the melato keep a close eye on my skin between doctor visits to look for noma as well as plenty of healthy skin surrounding it. My surgical anything suspicious. margins came back clear (no cancer detected) and the melanoma It turns out that my complexion and family history – along with had not spread, so no chemotherapy or radiation was needed. regular sun exposure and plenty of other moles – had increased I did suffer some nerve damage once the wound healed, and my skin cancer risk without even knowing it. So it was very imI wasn’t able to bend over or lift anything for quite a while after portant to me to educate my family about melanoma and skin the surgery—a pretty mild side effect but extremely difficult cancer and encourage them to get checked. In fact, not long afwhen you have a 4-month-old baby at home. Thankfully, I had ter my surgery, my sister found a mole that tested for Stage 0 plenty of help from my husband as well as my mom, who came melanoma. When I heard the news, my heart sunk, but I knew to stay with us and help out with the kids while I healed. Once that my experience, while not anything I wanted, helped her. And I got through that, I haven’t had any permanent side effects. that’s made it all worth it. I’m so thankful for the support we got from my family, espeAfter all, life isn’t always fair, but it’s up to us to make the very cially my husband, who was my biggest cheerleader. Because best out of what we have! of my family, I was able to chalk up my diagnosis to just a slight 54 Pa t i e n t Re s o u r ce .co m