Prostate - the European Oncology Nursing Society

N U R S I N G
A T
T H E
H E A R T
O F
P A T I E N T
C A R E
Winter 2009
Theme:
Prostate
Cancer
President Sultan Kav speaks out
Screening: PSA test is not the answer
Surviving Cancer, Living Life:
Interview by: Jim Boumelha
by: Mark R. Haythorn and Richard J. Ablin
a nurse-led telephone service
by: Jannike Nordlund and Jan Hanson
Editorial
Contents
Guest Editorial
Wi nter 2009
The Big C in Prostate Cancer:
Controversy
EDITORIAL
3
Editor-in-Chief:
Production Editor:
4
EONS General Meeting: from strength to strength
6
Multidisciplinary congress strengthens oncopolicy
Jim Boumelha
Editorial Assistant:
The big C in prostate cancer – Controversy
LATEST NEWS
Clair Watts
Daniel Kelly
Catherine Miller
VIEWPOINTS
Art Editor:
Jason Harris
EONS Secretariat:
Avenue Mounier 83, 1200 Brussels, Belgium
10
President Sultan Kav speaks out
11
The plight of the cowgirl
12
Luca Incrocci – sexual healer willing to listen
Phone: +32 (0)2 779 99 23
Fax: +32 (0)2 779 99 37
e-mail: [email protected]
Website: www.cancernurse.eu
FEATURES
14
Nursing patients with localised prostate cancer
16
Screening: PSA test is not the answer
18
Surviving cancer, living life
to 24000 EONS members
20
Promoting bone health in men with prostate cancer
Design and production:
24
On-line surveys pave the way for educational solutions
EONS acknowledges AMGEN (Europe) GmbH,
AstraZeneca, Merck KGaA, Novartis, HoffmannLa Roche, Sanofi-Aventis Groupe, Wyeth Europa,
Psizer, GSK and Topotarget for their continued
support of the Society as sustaining members.
Print run: 5000 copies
Electronic version accessible
© 2010 HarrisDPI. www.harrisdpi.co.uk
PROFILE
Cover Photo:
26
Hampered by hormones?
28
Gathering user information to improve prostate care services
30
Supporting practitioners in setting quality standards
Getty Images
Disclaimer
The views expressed herein are those of the
authors and do not necessarily reflect the views of
the European Oncology Nursing Society. The
agency/company represented in advertisements is
solely responsible for the accuracy of information
presented in that advertisement.
The European Oncology Nursing Society (EONS)
does not accept responsibility for the accuracy of
The aim of the EONS Newsletter is to provide a written resource for European nurses working
in cancer settings. The content of the articles is intended to contribute to the growing body
of knowledge concerning cancer care.
his issue of the EONS Newsletter focuses on
prostate cancer – a cancer marked by being the
most commonly diagnosed in men in many countries,
but also one of the most controversial. This debate continues, despite recent large-scale clinical trials that set out
to provide clear evidence of whether men should be offered
routine screening, and if they are, what should this entail,
how often should it happen and for what degree of benefit?
Haythorn and Ablin make the point in this newsletter
that PSA, a method commonly used to screen men for
prostate cancer, is too imprecise for this purpose. It may
best be saved for situations where high levels are detected
indicating aggressive disease, or for detecting disease recurrence or progression.
Fifteen years ago when I started out on my doctorate
on the impact of prostate cancer on a group of men, a
memorable quote from experts at the time opened my thesis: “There are few areas in clinical cancer management
today where such diversity of opinion exists, even
amongst experts.”
Writing this some years later, it is clear that prostate
cancer treatments have advanced significantly with the
availability of more accurate forms of localised radiotherapy, less damaging surgery and new agents that prevent
bone weakening or help control metastatic disease. However, much still remains unknown about the benefit of
screening or the relative efficacy of different treatments.
Men are more aware about prostate cancer − particularly those who have been diagnosed and have faced the
realities of treatment. In my own country, the United
T
Kingdom, prostate cancer is now a problem that is growing exponentially and is likely to continue to evoke controversy about when, whether and how it should be treated.
Recently, two large-scale screening studies have been
published, intending to offer some direction – the Prostate,
Lung, Colorectal and Ovarian (PLCO) trial from the United
States and the European Randomized Study of Screening
for Prostate Cancer (ERSPC) trial. However they failed to
offer definitive evidence.
The controversy surrounding prostate cancer may mask
the need for greater awareness about the impact of this
disease and its treatment. If men are told they should be
screened regularly by one group of professionals, only to
be told by others, “No, it’s best to wait for symptoms”,
whom should they believe? This is certainly not helpful to
men who are being encouraged to be more aware of their
risk. Across Europe, there is also huge variation in support.
EONS is making its own contribution by conducting the
PSA study, described in this issue by Jane Cockle-Hearne.
This survey explores the training needs of nurses to support men with prostate cancer and will compare these
with the needs of junior doctors. We aim to compare both
sets of findings with what patients themselves think we
should know.
Due to the lack of attention paid to the disease in the
past, prostate cancer will continue to attract controversy
for some time. Nurses, therefore, will have a key role to
play in educating men about their choices and ensuring
that, despite uncertainty, they are offered appropriate support to cope with the daily demands of this unique cancer.
any translated materials contained within this
edition of the EONS Newsletter.
All correspondence should be addressed to the Editor-in-Chief at: [email protected]
Daniel Kelly has been involved in cancer nursing in the UK for more than 25 years as a clinician, manager, educator and
researcher. His current interests include supportive care and patient experiences in prostate and young adult cancer.
2
3
LATEST NEWS
A Message from the Board
We are pleased to welcome two new
Board members, Mary Wells and
Dimitrios Papageorgiou, who have joined
us since the annual General Meeting in
Berlin last September. But new members
also means that we had to bid farewell to
departing Board members Yvonne
Wengström from Sweden and Rolf Bäumer
from Germany. Although they will be
missed, we expect to continue collaborating
with them.
During the autumn, the EONS Board took
a key role in the EONS nursing programme
at the ECCO15-ESMO34 congress in Berlin.
It was easy to get lost in such a vast venue
but in the end, it was a massive success,
with 784 nurses in attendance. We would
like to thank everyone who participated as a
speaker, session chair or delegate, as well as
the KOK and all members of the scientific
committee who delivered a truly exceptional
programme. As we left Berlin, the planning
for ECCO16-ESMO 36, taking place in
Sweden in 2011, is already in full swing
with the appointment of a Scientific Nursing
Committee. The Swedish Oncology Nursing
Society has agreed to join us in this work.
At the Berlin congress, we launched two
specialist training curricula: the “lung
cancer curriculum” and the “breast cancer
curriculum”. If you want a copy, please ask
the EONS secretariat.
Nurses – a Leading
and Dynamic Force in Urology
For other updates on our projects, please
visit our redesigned website
http://www.cancernurse.eu/. By the way,
what do you think of the new look
newsletter? We decided to continue
publishing it four times a year, but only in
hard copy to coincide with EONS
conferences. We always welcome your
views and suggestions.
Finally, the Board wants to remind you of
the 2010 EONS Spring Convention that will
be held on 15-16 April 2010 in The Hague,
The Netherlands, on the theme “Advancing
Cancer Nursing”.
We hope to see you there
Ulrika Östlund, EONS Board Secretary
EONS General Meeting:
tockholm played host
to the tenth congress
of the European Association
of Urology Nursing (EAUN),
held in conjunction with the
24th EAU congress
on 18-20th March.
Two major workshops
launched an outstanding programme. The first was about
nocturia – its causes, treatment and reasons for treating. The second dealt with
superficial bladder cancer and the use of Hexvix
fluorescence cystoscopy in the detection of bladder
cancer, giving nurses an opportunity to enhance
their skills in the diagnosis and treatment. Following
this, the latest booklet on “Good practices in health
care” was presented with guidelines on urostomas.
The winning poster was systematic standardisation of urological catheters: practical feasibility
and clinical implication. The aim was to design a
practical guideline for the use of these catheters
S
by the nursing staff in the urology operation room
and also in the wards, in order to facilitate their
use and improve their efficiency.
Two other highlights included presentations of
the result of the first trials by Amgen of the new target therapy against bone metastases Denosumab
and the PSA joint project between EONS and EAUN.
The meeting ended with EAUN’s Annual
General Assembly.
Françoise Charnay-Sonnek
From Strength to Strength
ONS held its General Meeting during the
ECCO-ESMO congress in Berlin. It started
with changes to the Board – welcoming new
members Mary Wells, Senior Lecturer at Dundee
University in Scotland and Dimitrios Papageorgiou,
Head Nurse of the Oncology Deopartment at
Euroclinic Athens, Greece, and bidding farewell to
Yvonne Wengström who completed her term as
Past-President and Rolf Bäumer, former Treasurer.
The meeting thanked them for their excellent
contribution.
The EONS Excellence in Education Award
was awarded to Corien Eeltlink who teamed up
with Daniela Hahn to produce a patient information booklet “A question and answer approach about cancer and sexuality.” The EONS
Major Research Award was presented to Lena
Sharp for her project “Randomised blinded trial
of Calendula officialis compared with aqueous
cream for the prevention of acute skin reactions
in relation to radiotherapy for breast cancer”.
E
4
The meeting also dealt
with proposals for
changes to the EONS
constitution and
byelaws to allow a
limited degree of flexibility to the elected
Board during the
process of appointing
future President-elects.
The amendment, advised by the EONS legal team, was carried by
a large majority – 47 votes for the change,
6 against, and 1 abstention. Further clarifications to the constitution and byelaws are likely
to be submitted to the next General Meeting in
Spring 2010.
Daniel Kelly moved the financial report,
stressing the need in the present financial climate to use the funds carefully and increase
reserves. The effort to further raise the profile
Memorandum of Agreement with ONS
of EONS in the redesigned website
and newsletter was noted, as well as an
update on current EONS projects (including
PSA, and the newly launched Breast and
Lung Cancer curricula).
Finally, it was the turn of Sultan Kav to take
over the presidency of EONS from Sara Faithfull.
Sara was thanked for all her hard work and
presented with a gift.
Daniel Kelly
A team from EONS, visiting the congress of
the US Oncology Nursing Society (ONS) from
April 30th to May 3rd in San Antonio, met
with its leaders to sign a formal agreement
setting out closer links. EONS President
Sultan Kav and Past-President Sara Faithfull
joined their American counterparts, ONS
President Brenda Nevidjon (top left) and CEO
Paula Trahan Reiger (bottom left), to sign the
memorandum. Among joint initiatives will be
the translation of EONS “Putting Evidence into
Practice” (PEP) for European nurses, an
outstanding compilation of evidence based
reviews to assist in making local policies,
improving standards, education and training
and identifying nursing outcomes in 12 key
areas of nursing activity and symptom
management. The two sides also agreed to
organise a joint clinical leadership workshop
at the next EONS spring convention in 2010
in the Netherlands. Sara Faithfull
NEWS SCAN
target 2009: Updated
Course in German
Sixteen nurses came to Salzburg from
all over Austria to attend on October 16
and 17 the first “new” target course
held in German and the second course
organised by the AHOP (Arbeitsgemeinschaft hämatologischer onkologischer Pflegepersonen in Österreich).
On the first day, Professor Bauernhofer
unravelled the complexities of the
molecular biology of cancer, while Dr
Pall talked about how these therapies
are used in clinical practice. On the
second day Anita Margulies talked
about considerations when caring for
patients on targeted therapies, and
Bernhard Glawogger about supporting
the needs of the patients and their
carers. The participants praised the
organisation of the course and
acknowledged the important impact it
will have on their daily work in the
hospital. All are looking forward to the
next course in the summer of 2010.
Bernhard Glawogger
EJON is Making an Impact
The European Journal of Oncology
Nursing received its first Impact Factor of
0.976, ranking 30th out of 62 journals in
the “nursing” category of the Journal
Citation Reports published by Thomson
Reuters. “This success could not have
been achieved without the commitment
of the journal’s Editorial Committee,
International Advisory Board, authors,
reviewers and members of EONS.”said
Editor in Chief Professor Alex Molassiotis.
EJON offers on-line submission and
peer-review system, rapid publication,
global visibility through ScienceDirect,
giving on-line access to more than 3500
institutions, and a wide ranging index and
abstract service including PubMed/
MEDLINE. For further information, please
visit www.elsevier.com/ejon.
Alexander Molassiotis
5
BRIEFING
Multidisciplinary Congress
Strengthens Oncopolicy
SPECIAL GROUPS
More than 15,000 participants, including 800 nurses, packed the Internationale
Congress Centrum in Berlin to take part in the first congress since the European
CanCer Organisation and the European Society for Medical Oncology joined
forces. The Scientific Programme, incorporating a record number of 26 different
tracks devised by over 100 leading experts, gave a distinct track to EONS oncology
nurses incorporating 103 nursing abstracts – 75 posters and 28 oral presentations.
Barry Quinn, UK, described a successful
collaborative project between acute hospital
and community settings regarding care of
patients with oral chemotherapy, following a
national safety alert in 2008, which
highlighted the risks involved with oral
chemotherapy.
Sultan Kav, Ulrika Östlund, Petra Riemer Hommel, Lena Sharp and Anita Margulies
The variety of topics presented was
outstanding, bursting with new
ideas for future directions aimed at
improving cancer across Europe and with a
wide range of data from early clinical trials
to multicentre Phase III trials.
At the EONS session, Distinguished Merit
Award recipient Jan Foubert presented his
honorary lecture “From baby to granny: why
do we consider older persons living with
cancer different?” and pointed out the
inadequacies in care and treatment, limited
research and lack of awareness of the needs
of this patient group. A randomised
controlled trial of a symptom-oriented home
care nursing programme for patients
6
receiving oral chemotherapy, presented by
Alex Molassiotis, concluded that home care
programme was able to assist patients
managing toxicities and support. This
session ended with a presentation on
reimbursement opportunities and on the
shortcomings for supportive care and
nursing role in the German health system.
‘SPIRIT’ OF THE NURSING TRACK
Three sessions in the nursing track attracted
a keen audience despite the early start.
Roma Maguire, UK, established the ‘spirit’ of
the nursing track by emphasising patientcentred care. Emma Ream, UK, and
Christine Miaskowski, USA, presented a
joint session on ‘linking symptom
science to practice’ using case
studies to demonstrate the
complexity of symptom clusters.
Finally, in a session on ‘Using
evidence-based cancer nursing
practice’, Michael Traynor, UK and
Meinir Krishnasamy, Australia,
talked about factors for successful
evidence implementation, mainly
from the managers’ perspective,
emphasising the importance of
organisational changes.
EXPERIENCE OF CARE
CANCER NURSING ROLES
A teaching lecture on "The value of quality
indicators for cancer services", by Ulrich
Wagner, provided an interesting metaperspective on the evolution of quality
indicators in general and how they apply in
nursing practice.
The scientific symposium was equally
well-structured allowing a lively discussion
on the gap between the UK, Canada and the
rest of the world, following a presentation
on "Divergence within cancer nursing roles,"
where Miranda Laurant, Diane Doran,
Catriona Kennedy and Paul Trevatt each
offered interesting perspectives on cancer
nursing roles – in particular the potential for
community nursing and the challenges of
workforce planning.
Oral chemotherapy was one of the scores
of topical issues discussed at the congress.
Among the proffered papers, “Experience of
care” turned out to be an exceptionally wellbalanced mix of talks from childhood,
disadvantaged groups and elderly patients,
ending with a discussion about euthanasia.
The session was opened by Susie Pearce,
who discussed a study “The experiences of
young people from first symptoms to the
diagnosis of cancer”, highlighting the
difficulties in prompt diagnosis, referral and
treatment of cancer in young people.
Nuka Hove presented an educational
film, offering a new opportunity to reach
teenagers and young adults with cancer.
A group Aarhus Sygehus at the
Department of Oncology of
Aarhus hospital, Denmark,
initiated a program by creating
an oncology Youth Ward caring for
cancer patients aged 15-22. Along the
same lines, Pia Riis Olsen, also from the
same hospital, discussed “Creating a space –
teenagers and young adults with cancer and
network-focused nursing”.
Two talks from Emma Blows and Neneh
Rowa-Dewar bridged the age group from the
childhood/adolescence cancers to that of a
special adult population.
A study carried out in three
disadvantaged communities in Glasgow
characterised by higher cancer morbidity
and mortality, showed that “participants
do not receive healthy lifestyle messages
passively, but actively construct cancer
related health beliefs, including both
scientific knowledge and elements of
personal, social and area histories.” The
question was how to close the gap and
promote healthy lifestyles.
“Information and support for Asian
and African Caribbean women
affected by breast cancer:
role of voluntary
organisations in meeting
needs,” presented by
Emma Blows, added to
the awareness of
support for special
groups of patients.
Petra Stolz contributed a
presentation on “Care needs
of the elderly cancer patient
and their informal care givers”,
demonstrating through a review of the
literature that little is known about the
specific care needs of elderly cancer
patients and their informal carers.
Marc Karim Bendiane closed the session
with his presentation, “Agreement of French
nurses with euthanasia for end-of life cancer
patients: focus on haematology and
oncology hospital nurses”. This very
emotional and delicate
subject was investigated,
based on a telephone
survey which was carried
out among a national
random sample of French
home and hospital nurses.
One of the most
important innovations of
this congress was the
involvement, for the first
time, of patient groups and clinicians, not
only to tell their stories, but as speakers in
seminars and debates, as well as organisers
and chairpersons. This gave a new
perspective and showed that EONS is
taking a great step towards viewing
patients as partners in cancer care.
7
7th EONS Spring Convention in partnership with V&VN
Dear Colleagues,
On behalf of European Oncology Nursing Society
(EONS) in partnership with V&VN - the Dutch
Oncology Nursing Society, we cordially invite you to
the 7th biennial EONS Spring Convention that will be
held in The Hague, The Netherlands, 15-16 April 2010.
The general theme for the 2010 Spring Convention is
‘Advancing Cancer Nursing’. The conference format
is specifically designed to meet the needs of nurses
working in the field of cancer care, education and
research. This is the ideal connective platform to
exchange and debate the very latest in patient
treatment and care as well as novel approaches to
managing cancer care in a rapidly changing health
care environment.
Incorporating all the essential elements common to
past Spring Convention programmes – striking an
essential balance of instructional methods, plenary
lectures and selected proffered papers, we also
hope to heighten quality, attendance and exposure
through the addition of yet more educational and
interactive sessions as well as varied clinical update
symposia.
A first class panel of speakers presenting on the very
latest trends and developments within the field, will
tackle a broad range of timely topics including EU
policy across the borders, the value of cancer
clinical nurse specialists, survivorship and late effects,
neurological complications, symptom science,
rehabilitation, ethical issues in cancer care,
psychosocial issues, leadership, updates surrounding
breast, lung, prostate, and GI cancers, as well as
cutting edge developments in targeted therapy,
radiotherapy and genetics.
The intensive two-day programme incorporating
discussion forums, workshops and an exclusive
opportunity to visit the only dedicated cancer centre
in The Netherlands combining treatment and
research will guarantee an essential educational
and interactive approach throughout the
convention.
Simultaneous translation will also be especially
arranged for National nursing organisations and
societies that can guarantee an attendance of at
least 75 nurses from their respective memberships.
We are looking forward to welcoming you all to The
Netherlands in April 2010 for what promises to be our
most exciting and innovative convention yet!
Sultan Kav
Organising Committee Chair
To view the Advance Programme, register early before 29 January 2010 and bookmark the Abstract Submission pages visit:
www.ecco-org.eu (select ‘Congresses and conferences’ > EONS 7).
Should you require any additional information please do not hesitate in contacting the EONS 7 Secretariat directly: Tel: +32 2 775
02 01, Email: [email protected].
B
eing in the driving seat at EONS is a
lengthy affair. You will have been a
Board member for two years, Presidentelect for another two years, then you
take on the Presidency for a further two years, after
which you become Past President. Eight years in total.
But Sultan remains unfased. Having started her nursing
career after graduating nursing high school, she was
appointed to work in oncology in a patients’ unit at
one of the biggest university hospitals in Turkey. At
that time she was also studying in nursing college for
a BSN degree.
“I had very limited knowledge and skills about
oncology and learned in a hands-on practice,
supplemented with further education. I worked
nights or in evening shifts while studying during the
day”, she reminisced.
It was hard, it was demanding and in the end it was
frustrating, says Kav. But she stuck with it, showing grit,
determination and compassion. Remembering with a
tinge of nostalgia her first days, she recalled that, “It was
a huge unit with 50-bed capacity and we had a very
mixed patient population. We had bone marrow
transplant patients, radiation oncology patients, all kinds
of haematology/oncology patients, as well as patients
with other diseases such as renal and liver failure. I was
19 years old and it was very hard for me to handle these
kinds of patients. I really felt I needed someone to help
me to get the necessary knowledge and skills. But I
stayed in that area, and I aimed to be an oncology nurse
educator to pass on my knowledge to the new graduates
and those who started to work in this area.”
DEDICATING HER LIFE TO CANCER PATIENTS
Few of the young nurses working alongside her stayed
in oncology. “People stayed only a couple of months
then moved to other places. It was considered like a
President Sultan Kav speaks out
Internationalism can offer a litmus test to gauge how effectively a professional society represents
all its members. Cultural and language barriers can be hard to bridge, but EONS President-elect,
Dr Sultan Kav, is determined to do it. Taking over at the Berlin Annual General Meeting, she
came armed with years of experience and is poised to give the organisation a new impetus.
Jim Boumelha asks her about her plans and ambitions.
10
INTERVIEW
school to learn from, then they went to another place,”
she recollects. There were times when she was
tempted to do the same. “Almost every day I was faced
with losing a patient, and at that time I felt we were
not helping the patients and their families. We were
just helping them to pass away quicker than they were
supposed to. But that feeling and that experience with
patients made me stay, because they really needed
well-educated people and people who knew what they
were doing.” she said.
Having decided to dedicate her life to nursing cancer
patients, Kav joined the National Oncology Nursing
Association in 1995, which gave new impetus to her
career. She was elected to the post of General Secretary,
and this is when she stumbled upon EONS. “I was in
email correspondence with Rudi Briké, from the EONS
secretariat, not knowing for a long time whether it was a
he or a she,” she laughs. But she was very serious in
attending EONS educational programmes, which she
found helped her considerably in her career. Her first
course, which she attended in 1996, explored learning
to live with cancer. “This was my first international
experience,” she recalls with warmth. “I felt that I was
in the right place with the right people”.
BUILDING A STRONGER VOICE IN BRUSSELS
A few years later she was firmly implanted at the
heart of various societies – joining the Board of the
International Society for Nurses in Cancer Care in
2000, then later the Multinational Association of
Supportive Care in Cancer, and then the Board of
EONS “My career developed through my involvement
in the professional organisations, both through the
national organisation and most importantly EONS.”
Such a long and serious apprenticeship may have just
been the ticket to prepare her for leadership role, but
she does not take her new post for granted. “Personally
it’s really a big honour and also a big responsibility and
I feel privileged to be awarded this task.”
Having herself been a keen practitioner for nearly
two decades, Sultan has a strong sense of what nurses
wish to get out of EONS. “I think they want support
for what they are doing at all levels, training,
networking, attending conferences, and support for
their research and dissemination of their projects.
There are many EONS activities such as the Spring
convention, educational conferences and curricula
that they can get involved in.”
Above all, she can’t wait to get stuck in on the main
priorities that EONS has already mapped out.
Building a stronger voice in Brussels remains the
cornerstone to any attempt to influence EU policy.
This can be achieved much quicker if EONS can
strengthen its profile and improve its partnership
with other European professional cancer
organisations. “We should advertise what we are
doing. We should be lobbying and partnering with
other organisations and doing more projects together.”
Implementing and disseminating EONS curricula
such as the older persons with cancer, breast cancer
and lung cancer curricula and keeping them updated,
will be crucial in promoting convergence between the
organisations of cancer nurses across Europe. Bearing
in mind that EONS covers countries with so many
different levels and concepts of cancer nursing, she
sees cultural differences and language barriers as
limitations but not real obstacles. Equally important
are economic barriers – the current economic crisis,
for instance, is making it harder for nurses to obtain
funding to travel and attend courses. But she also sees
a strength in diversity, which brings many different
perspectives to a shared experience. “We share
common issues and problems for cancer. Nurses and
patients are natural allies.”
Sultan is confident that the current EONS leadership
is well equipped to bridge any gaps that may arise. She
is keen, however, to push through a programme of
modernisation that will make the organisation more
effective. And she is determined to keep her eye on the
ball – staying focused on members’ best interests,
helping nurses to improve the patient experience and
serve the common good, and mentoring new people so
they can work with and for EONS.
If there was one thing she could change during
her time in the Presidency? “I would like to make
nurses believe in themselves, believe in what they
are doing now and what they can do in the future.”
Now firmly at
the helm, Sultan
leads her first
board meeting
with support
from Past President
Sara Faithfull.
11
VIEWPOINT
I
The Plight of the Cowgirl
A reflection on healthcare inequality
Sara Faithfull,
Past President, EONS
12
have always taken
health care for granted,
especially working within
a government single payer,
the UK National Health Service.
We talk about health inequalities
in terms of access for minority or
vulnerable groups for example;
however, I had never appreciated
what it means not to have health
care. Visiting the congress of
American Oncology Nurses was
an eye opener on how different
systems are funded and their
impact on cancer care provision.
Cancer care in the USA is
characterised on the one hand by
generous spending on
biochemical and clinical research,
with “cutting edge” treatments for some patients, and
on the other, large inequalities, rising costs and
inadequate quality. From 1999 to 2008, average health
insurance premiums and individual contributions for
family coverage have increased by approximately 120%.
Health care spending, both public and private, is
expected to exceed the US defence budget, and is one of
the highest per capita in the world. The debate over the
Health Reform Bill has been particularly vigorous and,
on December 24th, it was passed on a 60-39 party line
vote by the US Senate. The $871 billion bill is expected
to be merged with similar legislation passed by the
House of Representative to reach the President’s desk by
mid-February. Its sweeping provisions are likely to be the
largest extension to health care since Medicare
legislation in 1965 which provided coverage for the over
65s. This bill will provide health insurance for about 36
of the 46 million currently uninsured Americans.
I saw first-hand the reality of not having health care
when, on a day off from the conference, I visited a
cowboy ranch to ride American style. I noticed my
guide having difficulty getting on her horse and in
obvious pain. Being a nurse never stops and, as I
quizzed her, she told me that she fell from a horse and
may have broken a bone. I naturally assumed she
would see a doctor, but she told me that she could not
afford health insurance and farms could not afford
workers’ insurance, so her injuries were self-treated. I
learned from her that most of her friends and family
were not covered by health care and that only
children, the over 65s or those who had been in the
military were covered outside of personal or work
insurance. She was largely unaware of the debate on
health reforms. Until then, I had not realised the scale
of the problems faced by low-income workers, and this
shocked me. Back at the conference I asked nurses
about their experiences, and they told me about their
inability to give some people cancer medications or
pain relief for palliation, and described the inequalities
between social groups, especially in the current
economic difficulties.
The cowgirl’s plight was clearly not an isolated case.
In the USA, despite being one of the world’s wealthiest
countries, 15% of the population do not have health
care cover – ranking 37th in the world. As health costs
increase, the American system costs more per head
than anywhere in the world and is increasing faster
than inflation. This may be due to over treatment, high
cost of therapies and a litigation culture. In Europe we
are also facing rising costs in health care, including
the cost of providing expensive cancer drugs. This
has forced some countries to review the costeffectiveness of new medications. However, we
provide health care in a variety of ways through
social systems as well as through insurance.
Discussion of health care reform is in many political
debates at EU level, but do we have such
inequalities? Most probably not. However, perhaps
we assume too much about the benefits of our own
systems and need to reflect on those who face
inequalities. Oncology nurses in the US face difficult
times ahead and it made me realise that nurses in
Europe will also be facing reform in the future.
As economic pressures, increased ageing and
workforce shortages grow, this will increasingly
influence health service provisions and we
should be prepared for changes ahead.
Luca Incrocci
Sexual Healer Willing to Listen
Interview by Sara Faithfull
An active member of the International Society for Sexual Medicine
(ISSM), Luca Incrocci has worked closely
with psychologists, sexual therapists and
nurses to develop interventions for men
suffering sexual problems following radiotherapy. In this interview he talked to
EONS Past-President Sara Faithfull about
his involvement in sexual health medicine
and the experience and research he
brought to the field of oncology.
SF: Do you think that sexual
dysfunction in men with prostate cancer is
not well represented in clinical practice?
LI: Urologists often do not have enough
time to properly address the problem, and
in most cases they focus on erectile
dysfunction only and not on other sexual
dysfunctions, for example problems with
ejaculation, libido, intimacy and partner
sexual relationship.
SF: How did you first develop an interest
in the sexual aspects of oncology?
LI: I am not a urologist but an oncologist
specialised in urological cancer. My
training taught me to spend more time in
listening as well as talking to my patients
about their issues; I am therefore used to
spending more time in communicating
about sexual dysfunction related to cancer
diagnosis and treatment. I started in 1992
doing research on sexual dysfunction after
prostate cancer surgery, then became
interested in the influence of different
oncological treatments, including
radiotherapy and also chemotherapy on
sexual functioning. In those years this was
seen as extremely daring.
SF: Do you think most clinicians have an
understanding of sexual counselling?
LI: Not yet. Fortunately today’s training
for doctors is changing and students are
taught to communicate more with patients.
In earlier days, urologists considered
operating theatres as more important.
SF: Most prominent sexologists and
researchers working in this area are based
in the Netherlands. Is this a reflection of a
more open society or culture?
LI: It is true that Dutch people are
open-minded, but even in the US there
are some active researchers within the
oncology world, for example radiotherapists
and nurses.
SF: What do you think has been the
biggest breakthrough in this area in the
support for men?
LI: The introduction of oral medications
to treat erectile dysfunction has certainly
made a difference. Before Sildenafil
(Viagra) was introduced in 1998, male
cancer patients did not talk about their
sexual problems because they knew that
there was no treatment. Following the
publication of studies on the efficacy of
Viagra after surgery and radiotherapy for
prostate cancer, and even after colorectal
cancer and haematological malignancies,
more men are now keen to consult a
physician for their sexual problems.
SF: What are the barriers in clinical
practice to good communication and
support for men with sexual issues
following prostate cancer?
LI: The main problem is the training of
the oncologists, as they are not used to
talking to patients about sexual problems.
Furthermore, the limited time available in
clinical practice is a real problem. Sexual
difficulties cannot be addressed in the
10 minutes before the next patient enters
the room. In such limited time, sexual
problems are usually treated by
prescribing a pill, and this is not the best
way to go. Many patients need to be
counselled on sexuality, and not only
have a functional penis restored.
SF: What is the commonest problem
you had to deal with?
LI: Questions about erectile
dysfunction and a decrease in libido
and solutions for those.
SF: How do you see the oncology
nurses’ role within the urology team?
LI: Nurses are very important in such a
team. In the Netherlands, there has been a
switch from specialist to advanced practice
nurses in the follow-up of cancer patients
and also for the preparation of treatments.
Nurses have more time to spend with the
patient (and their partner) and patients often
find it easier to talk about their sexual
problems with a nurse than with a busy
physician who is going to see the next
patient in a few minutes. But for nurses, the
question arises: do they have enough
knowledge on how to deal with sexuality?
13
F E AT U R E
Nursing Patients with
Localised Prostate Cancer
Team working between specialist
cancer nurses at the Centre Paul
Strauss is the norm
In today’s multidisciplinary teams, everybody collaborates
to ensure the best care of patients. The quality of care
depends more and more on the cohesiveness of this
partnership, where cancer nurses have become an
irreplaceable and dynamic element.
Françoise Charney-Sonnek
Nursing a cancer patient in France
is a big challenge. Until recently,
there was no recognised specialisation for
nurses working in cancer care, and health
authorities were slow in accepting this
professional group. However, since the
publication of the Cancer Plan in 2003, the
role of the nurse started gaining value.
Chapter 40 of the Plan was unequivocal in
giving nurses an interesting and important
role to play in counselling patients after the
initial diagnosis of cancer, thus formally
recognising the proper role of nursing.
Other initiatives strengthened this role. In
education, the School of European Training
in Oncology (Ecole de Formation Européenne
en Cancérologie, EFEC) and the departments
of continuous medical education in hospitals
and cancer centres have started offering
appropriate courses in cancer care for nurses.
More recently, the annual congress of the
French Association of Nurses in Cancer Care
(AFIC), held in March 2009, set out a forum
for the training and networking of nurses.
Finally, the establishment of the “French
Order of Nurses” presented a new challenge
for the profession by formally establishing
the nurses’ position in the medical arena
and in society.
14
OTHER THERAPIES
HIFU
VITAL ROLE
Since this breakthrough, cancer nurses
have become an integral component of the
cancer care team, earning the respect of
physicians, other health care professionals,
and, most importantly, patients and their
families. In the field of the treatment of
localised prostate cancer, for example, you
will find oncology nurses engaged in a
collaborative practice with all members of
the care team to provide optimal
management of patients with cancer.
Cancer nurses play a vital role in
coordinating the multiple and complex
technologies now commonly employed in
cancer diagnosis and treatment. They are
involved directly in therapy and symptom
management, in educating both the patient
and the family, and in counselling throughout diagnosis, therapy and follow up.
If you take the surgical urological
department at the Centre Paul Strauss, in
Strasbourg, cancer nurses practice in a
variety of settings, including surveillance,
hormonal therapy, open, laparoscopic or
robotic radical prostatectomy and high
intensity focussed ultrasound (HIFU).
Other treatment options performed in the
centre include brachytherapy as well as 3D
the surgeon. Most importantly, they outline
what to expect on the day of the surgery,
arrival time to the hospital and the
preparation for surgery. They also liaise
with the anaesthetist who will prescribe
pre-operative screening tests. This preoperative care includes documenting baseline information such as temperature, blood
pressure, and heart rate. The patients are
usually admitted the day before surgery.
Post-operatively, the nurse is also there
to provide physical and psychological
comfort. As the patient progresses from the
recovery room to the unit, he is
continuously assessed and treated if
necessary. The urinary catheter can be
painful and should be actively managed.
The nurse is responsible for monitoring
urine output for bleeding, clots, sludges, or
smell. Symptoms such as fever and
increasing abdominal or flank pain should
be reported to the surgeon.
High intensity focused ultrasound is a
therapy that destroys tissue with rapid
Brachytherapy team Cancer
Centre Paul Strauss
conformal radiotherapy and IMRT
(Intensity Modulated Radiation Therapy).
A patient suspected of prostate cancer
will first undergo various investigations
(prostate biopsy, PSA test, bone scan, MRI).
The case is then discussed in the urooncology multidisciplinary fortnightly
meeting between surgeons, oncologists,
radiation oncologists, radiologists and
pathologists. After a treatment plan is
agreed, the patient is counselled by the
urologist who presents the different
treatment strategies including a risk/benefit
assessment – surgery, hormonal therapy,
radiotherapy, brachytherapy as well as the
option of surveillance. The patient can
then choose the treatment.
RADICAL PROSTATECTOMY
If surgery has been chosen, the surgeon will
discuss with the patient common risks
including infection, bleeding, erectile
dysfunction and urinary incontinence. It is
at this stage that pre-admission nurses play
a crucial role in explaining to the patient
what he has to do prior to admission for
surgery. They assess the patient’s
understanding of the procedure and, if
necessary, arrange further follow up with
heat elevation that essentially “cooks” the
tissue. In this therapy the post-operative
role of cancer nurses is fundamental in
assessing the patient’s understanding of
the treatment and ensuring compliance.
The main patient’s concerns are
incontinence and sexual dysfunction after
the treatment. Incontinence after removal
of the catheter is due to the intra-operative
alteration of the sphincter. It is then very
important to be able to listen to the patient
to assess his needs in order to give tailored
advice; for example pelvic floor training.
Pelvic floor electrical stimulation or
pharmacologic intervention are other ways
of managing these side effects.
Brachytherapy
Brachytherapy is an ultrasound-guided
transperineal implantation of radioactive
seeds into the prostate. It is a minimally
invasive procedure but does require
general anaesthesia. Patients are selected
according to specific criteria such as the
size of the tumour, the volume of the
prostate, the IPSS (International Prostate
Score Symptom) and the result of the
mictiometry. Weeks before the
intervention, the patient is counselled by
the radiation oncologist and the
radiotherapist assistant and receives an
information sheet with information and
explanation of the procedure.
Pre-operatively the patient is advised on
the physical implant procedure, as well as
its associated symptom management and
radiation safety precautions. But is the
cancer nurse who leads the post-operative
care, in particular anaesthesia recovery,
monitoring of urinary status, catheter care,
medication administrations, and comfort
measures such as icepacks. Advice on how
to filter the urine is crucial and, the day
after the intervention, the urinary catheter
is removed. Throughout it is very important
to listen to the patient and to answer any
outstanding questions before he is
discharged. And it is the cancer nurse who
is better equipped than any other member
of the health care team for this role.
Cancer nurses practice in a variety of
settings, working with several oncologic
disciplines which prepare them to assist
patients to cope with their diagnosis and
symptoms, and make long-term adjustments.
Nurses will continue to develop as a
dynamic element within the health care
delivery system as their number rises and
their levels of knowledge, experience,
and expertise advance.
Françoise Charney-Sonnek is head nurse of
the Cancer Centre Paul Strauss and is an
EONS Board member.
15
F E AT U R E
Screening:
PSA test is not the answer
More men die with prostate cancer than from it. However, the PSA test that we currently rely on
cannot distinguish between cancers that are aggressive and life-threatening and those that will
never become symptomatic. New screening methods are needed to avoid unnecessary treatment.
D
Mark R. Haythorn and Richard J. Ablin
iscovered in 1970,1,2 prostate specific
antigen (PSA) has become the gold
standard screening test for prostate
cancer. And yet PSA is not cancerspecific. Rather, it is present in the normal, benign, and
malignant prostate.3 The normal level of PSA is often
cited by the medical community as between 0-4.0
ng/ml, but studies have shown that there is no level of
PSA that is diagnostic for cancer. An elevation of PSA
may signify a problem with the prostate – but this
elevation may be due to prostatitis, benign prostatic
hypertrophy, size of the prostate, recent
physical/sexual activity, cancer, or simply aging. Men
with PSA levels less than 4.0 ng/ml cannot be assured
to be cancer-free, while men with elevated PSA values
of greater than 4.0 ng/ml cannot be given a diagnosis of
prostate cancer based on this absolute value of PSA.
The concept of ‘screening’ pertains to the use of a
single PSA test to identify preclinical and
asymptomatic cases of prostate cancer in a
population at risk, as opposed to making a diagnosis
of cancer based on a patient’s presentation with
symptoms and disease.
Knowing that PSA is not cancer-specific and that no
value of PSA is diagnostic for prostate cancer, it should
be no surprise that screening for prostate cancer using
PSA cannot work. This was further exemplified by two
recently published studies. The Prostate, Lung,
Colorectal and Ovarian (PLCO) trial4 started in 1993 in
16
Getty
SCREENING WITH PSA
the United States, and the European Randomized
Study of Screening for Prostate Cancer (ERSPC)5
started in 1994, respectively enrolled nearly 77,000
and 182,000 men randomly assigned to receive
screening or not. The PLCO trial found no difference
in mortality from combined screening with the PSA
test and digital rectal examination (DRE) over 10 years;
the ERSPC trial reported that PSA screening without
DRE was associated, over 9 years of the study, with a
20% reduction in mortality from prostate cancer, or a
reduction of 7 deaths per 10,000 men screened,
although the trial was designed to show a 25%
reduction in mortality.6 With due consideration to the
stated 20% reduction in mortality in the ERSPC study,
it is noted that 1410 men needed to be screened and 48
men treated to prevent one cancer death, thus
overtreating 47 men. Of
the men who underwent
biopsy following a
‘positive’ PSA test, 76%
were found to have a
false-positive PSA test.
ERPSC contained
inconsistencies in
methodology; in some
countries the PSA cutoff
was 4.0 ng/ml, while other
countries used 3.0 ng/ml.
Denmark and Belgium
combined PSA testing with
DRE, while other countries
used only PSA
measurements. Screening
was performed every four
years (as opposed to annual
screening in PLCO), but
Sweden screened every two
years, while in Belgium the
interval between the first
and second screening was
seven years. The core age
group of men in ERSPC
was age 55-69, although
Sweden included men
aged 50-54, while the
Netherlands, Italy, and
Spain included men up
to age 74. Finland
enrolled men at age 55,
59, 63, and 67.
Given that 45-80% of men
were between the ages of
50 and 75, the age-range
of the men in the PLCO and ERSPC trials, possessing
indolent or clinically insignificant cancers,7 the
detection of prostate cancer via the PSA test, given the
absence of cancer-specificity, was likely a
serendipitous observation.
OVERDIAGNOSIS
The rate of overdiagnosis (defined as the percentage
of men diagnosed via screening who will never
develop clinically-significant prostate cancer in their
lifetime), based on the ERSPC trial estimates is
approximately 50% – the same chance as flipping a
coin. Other studies put the rate of overdiagnosis via
screening at 56%. A recent study8 estimates that over
1 million excess men (in the United States) have been
diagnosed with prostate cancer due to screening, and
that “for each man who experienced the presumed
benefit, more than 20 had to be diagnosed with
prostate cancer.”
PSA testing is not without merit – extremely high
levels of PSA indicates that something is wrong and
warrants further exploration, and the rate of change of
PSA over time, or PSA kinetics, provides valuable early
warning for disease recurrence or progression.
However, the use of PSA testing for screening all men –
not just those with symptoms or a family history of
prostate cancer – has not resulted in increased cancer
survival. This lack of survival benefit has cost
enormous amounts of emotional distress,
overtreatment resulting in impotence, incontinence, or
other adverse effects, and a significant financial burden
of billions of euros on the health care system.
INSUFFICIENT EVIDENCE
The inability of the PSA test to do what it is purported
to do, its lack of cancer-specificity along with the
recently reported mortality data from the PLCO and
ERSPC trials, interim as they are, leave little doubt that
there is insufficient evidence to support population
screening for prostate cancer with the PSA test.
Why do we continue to study the use of PSA as a
screening tool for prostate cancer? How many more
studies need to be run? How many more papers need
to be written? How many more excessive biopsies
need to be taken? How many more men need to suffer
through overtreatment for prostate cancer before the
medical community finally understands what one of
us (RJA) has explained for more than 35 years - that
the PSA test as currently used for screening could not
and cannot work?
A serendipitous
observation?
“Serial PSA screening
has at best a modest
effect on prostate
cancer mortality
during the first decade
of follow up.
This benefit comes at
the cost of substantial
overdiagnosis and
overtreatment.”
An important next step
is for a neutral body,
such as the US
Preventive Services
Task Force, to update
its analysis of prostate
cancer screening,
given these new data.
Healthcare policy
makers also need to
ask boldly whether the
PSA screening juggernaut -- with all the
time, energy and
resources consumed
by screening and its
sequelae -- is appropriate in an era of
unsustainable growth
in healthcare spending.
Published in Journal
Watch General Medicine, March 18, 2009
Details of the references cited in this article can be accessed at
www.cancernurse.eu/communication/eons_newsletter.html
17
F E AT U R E
Surviving Cancer,
Living Life: A Nurse-led
Telephone Service
Figure 2
Building the confidence and skills to cope with the anxiety
of living life after a cancer diagnosis remains among the
most difficult challenges for survivors. A telephone-based
support programme could be the answer to help ease
the transition from patient to survivor.
Jannike Nordlund and Jan Hanson
In the UK, approximately 2 million
people are currently living with or
beyond cancer and the number is rising
by circa 3% per year.1 The Cancer Reform
Strategy2 highlighted that survivors of cancer have a range of physical, psychological,
spiritual, financial and informational needs
which are not always met. A study by Ream
et al.3 reported that men living with prostate
cancer in England have specific and significant unmet supportive care needs, with the
greatest need being related to psychological
distress, sexual issues and management of
enduring lower urinary tract symptoms.
HOLISTIC SUPPORT
Following the publication of the Cancer Reform Strategy, the National Cancer Survivorship Initiative (NCSI) was launched in the UK.
This programme is considering a range of approaches to support cancer survivors and to
ensure that care and support are tailored to
meet individual patient needs.
In 2006, Birmingham North and Birmingham East Primary Care Trusts, in partnership
with Pfizer Health Solutions and NHS Direct,
commissioned a telephone-based model
(OwnHealth) for supporting individuals with
18
long-term conditions such as diabetes, cardiovascular disease and chronic obstructive
pulmonary disease (COPD). Specially trained
nurses, known as Care Managers, were used
to deliver holistic support and motivation, enabling individuals to become competent selfcarers (Figure 1). This resulted in improving
health-related behaviours that affect their
Figure 1
condition and also had a
positive impact on clinical indicators and service
utilisation. Results obtained in the first year
showed that the service
was delivering significant changes, and in
2008 it was extended for
a further three years.
During this time, cancer was increasingly
being described as a longterm condition and, in
2007, Pfizer Health Solutions approached Guy’s
and St Thomas’ NHS
Foundation Trust to explore the possibility of
applying the OwnHealth concept to people
suffering from cancer. It was subsequently decided that the initial pilot would focus on people living with and beyond cancer, and that it
would initially be offered to breast and
prostate cancer patients. As a result the ‘Surviving Cancer, Living Life’ pilot service, devel-
oped from the OwnHealth model, was
launched in May 2008 for survivors of breast
and prostate cancer. The pilot is funded by
Guy’s and St. Thomas’ Charity and Pfizer
Health Solutions.
SURVIVING CANCER, LIVING LIFE
The Surviving Cancer, Living Life service is
a telephone-based support programme delivered by Care Managers who are employed by Guy’s and St Thomas’, and based
at Guy’s Hospital. It is a holistic service and
uses the concepts of motivational support
and health coaching to help people to:
● Better understand the factors that affect
their health
● Build the confidence and the skills to
cope with, and overcome, the anxiety of
living life after cancer
● Acquire the skills, knowledge and
habits to remain fit and healthy
● Follow their treatment correctly
● Understand how to engage with, and
use, local NHS, social and voluntary
services more effectively.
Patients are invited to join the service shortly
after they reach the end of their ‘active
treatment’ (surgery, chemotherapy, radiotherapy). Each person eligible is allocated a
dedicated Care Manager who calls at prearranged times to provide advice, support
and encouragement on specific aspects of
their treatment programme and any other
health-related issues. Once enrolled by the
Care Manager, a detailed initial assessment
is undertaken, which provides the necessary
information to help the patient achieve the
best quality of life for themselves and their
families and carers. Assessment is undertaken using the ‘Basic Eight’ priorities for
self-care (Figure 2).
Following assessment, the Care Manager
and the patient identify priorities and together agree and develop an individual
care plan, focusing on the areas of greatest
need. The decision of where to start and
the subsequent interventions are decided
with the patient, and future telephone calls
are planned according to the needs of the
patient, initially at fortnightly intervals, before moving to monthly. Patients will be
graduated from the service after approximately 9 months.
POSITIVE EVALUATION
Evaluation of the service is being undertaken by Pfizer Health Solutions and Florence Nightingale School of Nursing and
Midwifery at King’s College London to determine the impact of the service on patients’ quality of life, psychosocial and
informational unmet needs, return to work
and utilisation of health care services. The
evaluation also aims to assess the feasibility
of a telephone-based support service and its
acceptability in terms of patient
satisfaction and also satisfaction
of carers, providers and commissioners.
Initial qualitative research was
carried out using telephone interviews of up to an hour with a sample of prostate patients enrolled in
the service.4 The results were extremely positive and patients felt
that the service answered a need
for support at a time when they
felt particularly vulnerable. They
were impressed by the holistic approach of the Care Manager to
care, and felt confident of the advice and
guidance they received, both in relation to
cancer and to any co-morbidities. The programme helped them to understand better
their illness and its treatment, to improve
their morale and face life with new confidence, often to adopt necessary changes in
lifestyle and in some cases to develop better
relationships with their families and an increase in personal confidence when dealing
with other professionals.
FROM PATIENT TO SURVIVOR
This small-scale qualitative evaluation suggests that the Surviving Cancer, Living Life
programme is beneficial to prostate patients. The service is able to respond to a
range of previously unmet needs, providing
continuity of care and easing the transition
from patient to survivor.
Results from a quantitative evaluation
will indicate whether these promising findings are replicated in the evaluation group
as a whole, by comparing them with a
group of prostate cancer survivors who
were not exposed to the Surviving Cancer,
Living Life programme.
The focus in the immediate future is
how best to integrate Surviving Cancer,
Living Life with mainstream cancer services in order to ensure effective working
relationships and to maximise the potential to enhance patient care in the period
following treatment.
Details of the references cited in this article can
be accessed at www.cancernurse.eu/
communication/eons_newsletter.html
19
F E AT U R E
Bone health poses a challenge for men with prostate cancer who are being
treated with hormonal therapy. Nurses have a significant role in increasing
men’s awareness of bone health issues and educating them on diet and lifestyle
interventions, prevention of falls and medication management.
P
Kay Leonard
Amgen/Bone Health
rostate cancer is a major public health
problem as it is the commonest cancer in
men in Europe and the USA. Many men
with prostate cancer receive androgen
deprivation therapy (ADT) at some point during the
treatment, as adjuvant therapy combined with
radiotherapy or surgery in locally advanced disease; or
to treat biochemical progression following radical
treatment; or to treat metastatic disease. Androgen
deprivation can be achieved by surgical castration or
administration of a gonadotropin-releasing hormone
(GnRH) or luteinising hormone-releasing hormone
(LHRH) agonist with or without an anti-androgen.
Hormone therapy and other therapies such as
chemotherapy, radiotherapy and surgical castration can
directly or indirectly damage bone, resulting in the loss
of bone density, i.e. osteopenia and osteoporosis,1 and
significantly increase the risk of fractures2 primarily of
the hip and spine.3 Because survival in men with
nonmetastatic prostate cancer treated with hormone
therapy is long (median survival time >7 years) bone
health is a particularly significant issue.4
Cancer-treatment-induced bone loss (CTIBL) is a wellrecognised long-term toxicity that occurs in many
patients with cancer. Despite this, many of our patients
are not aware of the risks of osteoporosis caused by
their treatment and they are not receiving any tertiary
care for it.3 Pathological fractures in men on ADT have
been correlated with decreased overall survival.3 Nurses
20
CAUSES OF BONE LOSS
The primary cause of cancer-treatment induced bone
loss (CTIBL) is hypogonadism induced by
chemotherapy, hormone therapy, surgical castration or
radiotherapy1,5 bone metastases, inactivity and
inadequate intake of calcium and vitamin D.1 LHRH
analogues +/- anti-androgen therapy reduce the level of
circulating testosterone and oestrogen and induce
hypogonadism causing significant decreases in bone
mineral density. Therefore, men who are receiving ADT
for prostate cancer are at risk of developing CTIBL.
Pathophysiology
Bone is living tissue and is therefore constantly changing.
Normally, bone undergoes a continual process of loss and
formation called remodelling, to maintain its structure
and mineral integrity.1,5 Due to the natural aging process
and reduction of hormone production, bone loss
outweighs bone formation, resulting in an overall loss of
bone and increasing the risk of fractures.5 Testosterone
plays a fundamental role in maintaining bone mass by
directly or indirectly suppressing bone resorption. During
ADT, circulating levels of testosterone and oestrogen are
significantly decreased, inducing hypogonadism1
decreases in the levels of these hormones, resulting in
accelerated bone loss. Unless bone formation rates
increase, continual loss of bone will occur, leading to
osteopenia and eventually osteoporosis.5 Although bone
loss occurs more rapidly and tends to be more severe in
patients with CTIBL, the clinical consequences of
developing it are similar to osteoporosis.1,5 CTIBL
increases bone fragility, and fractures may occur even
when the bone is subjected to mild trauma. Some of the
other clinical consequences are acute pain, chronic pain,
decreased functional capacity, height loss, increased
mortality rate and kyphosis.5
BONE HEALTH
Although men usually have a higher bone mass than
women, both lose bone mass over time and can
develop osteopenia and osteoporosis. Approximately,
10 million Americans have osteoporosis and, of those,
2 million are men.3 In addition, approximately
Amgen/Bone Health
Promoting Bone Health
in Men with Prostate Cancer
who administer hormone therapies have a significant
role to play in the early identification of those at risk of
developing ADT-associated bone loss, educating patients
about bone health and promoting preventative measures
to reduce bone loss.5,6 It is therefore crucial that nurse’s
awareness of bone health issues for men with prostate
cancer increases so they can identify risk factors and be
involved in setting up strategies for the prevention and
management of CTIBL.
34 million people are estimated to have osteopenia
placing them at risk for developing osteoporosis.5
Risk Factors
Men on long-term ADT have a five-fold increase in
the development of osteoporosis-related fractures
compared to their healthy male counterparts.3 Men
who are receiving LHRH analogues with or without
an anti-androgen for treatment of non-metastatic
prostate cancer experience spine or femoral neck
bone density loss of 2-10% within nine months to a
year of initiating ADT. Furthermore, bone mineral
density tends to progressively decrease and the risk of
fractures increases the longer the duration of ADT.5
However, it must be stressed that not all men will
21
F E AT U R E
Organisation issued
guidelines for
diagnosing
osteopenia and
osteoporosis. They
have identified four
categories: normal
bone mineral
density, osteopenia,
develop osteoporosis during longterm ADT as it depends on their pretreatment bone mineral density,
which is variable according to the
patients risk factors.7
A variety of other risk factors, such
as age, family history, Caucasian race,
smoking, excessive alcohol use, low
calcium intake, inadequate physical
exercise, low levels of testosterone,
low body mass index, medications
such as prolonged use of steroids,
some cancer therapies and
anticonvulsants and chronic diseases
of the kidneys, lungs and
gastrointestinal tract can increase the
risk of ADT-associated bone loss and
subsequent bone fracture.6,7
Assessment
Currently, there are no guidelines for
the prevention and management of
CTIBL in men with prostate cancer,
but a consensus group of oncologists
has recommended that every patient
receiving ADT should have a baseline
bone mineral density measurement and receive
adequate calcium and Vitamin D intake.5 Although
there are other techniques available, dual-energy Xray absorbiometry (DEXA) is the gold standard
technique for measuring bone mineral density in
people at risk of bone loss. This technique uses a low
dose of radiation to measure bone mineral density in
the spine, proximal femur and total body.6
Results of the DEXA are reported as T-score or Zscore. The T-score reflects the number of standard
deviations by which the patient’s bone mass differs
from the mean bone mineral density of a healthy
young person.
The World Health Organization issued guidelines for
diagnosing osteopenia and osteoporosis, and these are
osteoporosis and
severe osteoporosis.
WHO categories of osteopenia and osteoporosis
DIAGNOSTIC CATEGORY
Normal bone mineral density
Osteopenia
Osteoporosis
Severe osteoporosis
Information from Maxwell5
22
T-SCORE
>/= -1.0
-1.0 to –2.5
</= -2.5
</= -2.5 with fractures
used widely to diagnose bone loss. They have
identified four categories: normal bone mineral density,
osteopenia, osteoporosis and severe osteoporosis.5 The
T-scores for these categories are outlined in the table
below. Some authors5 advocate that men who receive
ADT should be screened for bone loss at yearly
intervals; others argue that bone mineral density
measurement is not readily available, is costly and may
not change management in at-risk patients.
MANAGEMENT OF CTIBL
Although there are no clinical trials to evaluate diet
and lifestyle interventions for patients with CTIBL,
there are clinical trials evaluating these interventions
in others at risk of bone loss, e.g. post-menopausal
women with cancer These recommendations have
been extrapolated to this patient group.8 A multidisciplinary approach is necessary for optimal
management of CTIBL, as good nutrition, exercise
and other lifestyle changes promote bone health and
may lead to increased bone mineral density and
improved bone strength.6-8 The goal of CTIBL
management is to optimise bone mass and prevent
osteoporosis. In patients who already have bone loss,
the goal is to prevent further bone loss, fractures and
subsequent clinical sequelae, e.g. pain and decreased
functional capacity.8 Nurses play an important role in
the early identification and education of at-risk
patients, as bone loss therapies are more effective in
the early stages of bone loss, so early diagnosis before
the occurrence of a first fracture is imperative.5
Nurses should advise men who are already on or are
due to start ADT of the potential risk of developing
bone health problems and should discuss
interventions such as, diet and lifestyle modifications
that may help to promote bone health.
Diet
Calcium and vitamin D are essential for bone health.
Dietary modification is a simple but effective way of
raising levels of calcium and vitamin D to reduce bone
loss and improve bone density.6 Men on ADT need to
have a daily intake of 1000-1500 mg of calcium and
400-800 iu of Vitamin D.6-8 Sources of calcium include
dairy products, green leafy vegetables, nuts and
calcium supplements, while sources of vitamin D are
exposure to direct sunlight, dietary supplements and
foods including fortified milk, liver, fatty fish and
oils.6,7 Some men may require higher levels of
calcium and vitamin D depending on their BMD
scores.6,7 A daily supplement of both calcium and
vitamin D is recommended for all adults with or at
risk of osteoporosis.8,9
Exercise
Exercise produces increased bone
and muscle strength and thus
reduces the risk of falls and
fractures. Weight-bearing exercise,
such as walking or climbing
stairs, and resistance exercise
such as weight lifting for 30
minutes once or twice a week can
decrease the risk of CTIBL5,6 and
increase BMD.8 However, other
studies7 have shown no increase
in BMD but have demonstrated
improvements in quality of life
measures such as fatigue, and in
muscle strength, balance, mobility
and reduced body fat.7,8 Exercise
programmes need to be
individualised and developed
under medical supervision.6,8
Amgen/Bone Health
The World Health
Lifestyle Modification
Smoking and high alcohol and
caffeine consumption have a
detrimental effect on BMD and
increase the risk of fractures. Lifestyle modifications
such as smoking cessation, and moderation of
alcohol and caffeine consumption should therefore
be encouraged.5-7
Pharmacological Interventions
Currently, the US FDA has approved no drugs
specifically for the prevention or treatment of CTIBL.
However, numerous drugs are approved for
preventing or treating men and women with
osteoporosis, and it is likely that they are also
effective in CTIBL.5,9 Bisphosphonates are standard
treatment for osteoporosis and have been shown to
reduce cancer-related bone complications and have a
potential role in the prevention of CTIBL in prostate
cancer.4 They have also been used to treat bone loss
caused by ADT.6 Bisphosphonates work by binding to
bone undergoing remodelling and slow down both
the rate of growth and dissolution thereby reducing
the rate of bone turnover. Bisphosphonates can be
given orally or intravenously and their benefits
include halting bone loss caused by ADT and other
cancer therapies, reducing the occurrence of
fractures, decreasing bone pain from metastases,
reducing or preventing skeletal-related events (SREs).
SREs may include pathological fractures that may
require radiation/surgery to the bone, spinal cord
compression or hypercalcaemia.6
The gastrointestinal tract poorly absorbs oral
bisphosphonates and uptake can be further reduced
by food and coffee. Therefore, high doses must be
administered, which can cause significant
gastrointestinal toxicity. In order to minimise this
they must be taken on an empty stomach with a large
glass of water. Bisphosphonates administered
intravenously are usually well tolerated, but
precautions need to be taken to check renal function,
and patients may develop flu-like symptoms, muscle
and joint pain, low-grade fever and nausea within
hours of the injection which may last a couple of
days.6 Osteonecrosis of jaw (ONJ) has been reported
in patients treated with bisphosphonates. Therefore,
it is recommended that patients should have a dental
check-up prior to commencing bisphosphonates and
delay dental procedures while on therapy.6,7 Nurses
have a role in reinforcing this information and
teaching patients the principles and importance of
good oral hygiene.
New therapies for the prevention and management
of CTIBL are currently being developed. EONS is
part of a working group which is developing
education materials for nurses to improve
knowledge of bone health.
Details of the references cited in this article can be accessed at
www.cancernurse.eu/communication/eons_newsletter.html
23
Corbis
F E AT U R E
On-line Surveys Pave the Way
for Educational Solutions
Jane Cockle-Hearne
EONS has teamed up with EAUN, ECCO and Amgen to
develop a project addressing the training needs of nurses
There are currently more than
two million men living with
prostate cancer in Europe. A man has a
1 in 12-lifetime risk of being diagnosed
with the disease in response to clinical
symptoms, signs or PSA testing. Despite
guidelines issued in 2001 by the
European Association of Urology on the
medical management of prostate cancer
(www.uroweb.org/nc/professionalresources/guidelines/online), there is still
no consensus statement for the health
care management of men’s supportive
care needs across Europe. In addition,
24
and doctors working in prostate cancer across Europe.
there is a dearth of understanding about
the roles and training needs of nurses
and young oncologists and, furthermore,
what patients feel their health care
professionals should know about their
supportive care needs.
This project has been set up to remedy
this lack of information and to provide
educational solutions. The first research
phase is to survey the working practices,
skills, knowledge and training needs of
nurses and young oncologists, and to
compare and collate these with patient
reports of what support they feel they
need and how this is being met by their
health care teams. In the final
development stage, a comprehensive
and tailored education package for nurses
and young oncologists working
in prostate cancer will be produced
for dissemination across European
countries.
A project team of representatives from
the partner organisations, including
Daniel Kelly (Project Lead), Francoise
Charnay-Sonnek, Sara Faithfull, Kay
Leonard, Bente Thoft Jensen and Louis
Denis has been assembled and will steer
the project through all its phases. Initial
work started in October 2008 and is
planned to be complete by the end of
2010. Middlesex University and the
University of Surrey in the UK are
undertaking the research stage jointly,
and Virtual Surveys Limited, an
independent market research company,
has been managing the questionnaire
and data entry. The resulting education
package, based on the research data,
will be created by the project team and
other collaborator representatives.
ON-LINE SURVEYS
For the initial stage, cancer nurses,
young oncologists and patients across
seven European countries are
questioned separately via on-line
surveys individually designed for each
group. The nurses’ survey was posted
on-line in June 2009 and the response
rate was excellent. Surveys of
this nature can present a
significant challenge in terms
of achieving response rates
large enough for meaningful
analysis, and the success
achieved was due largely to
the efforts and encouragement
of many collaborators across
the cancer nursing societies
and networks in each country.
Waves of e-mails were
circulated to members via
national societies and contacts
in each country, announcing
the launch of the survey and
inviting nurses to visit the
EONS website to complete
and submit the survey on-line.
During the course of the
survey, two further reminders
and announcements were
sent. This strategy paid off
and the response rate
achieved was excellent. The
researchers anticipated around 50
completed questionnaires in each
country, but in the end some 472
responses in total were received: 60
from Denmark; 51 from France; 57
from Ireland; 58 from The Netherlands;
55 from Spain; 52 from Turkey; 112
from the UK and 27 from a variety of
other countries.
Producing the research instruments
presented a challenge, but again this
was accomplished successfully. The
questionnaire was developed in close
consultation with the project team, and
several volunteer nurses and urologists
across Europe took part in piloting and
helping to refine the final version. All
the advertisements about the survey and
the questionnaires were translated and
presented in each country’s native
language and the responses were then
translated back so that the analysis
could take place in English. These data
are now being analysed and top-line
results are providing useful guidance for
developing two further on-line surveys.
The first, involving junior oncologists
and urologists across the same seven
countries, is running in January and
February 2010. The data from this stage,
together with the nurse data, will be
used to develop the third and final stage,
which will involve a patient survey.
This is set to take place later in 2010,
again across the same countries.
The findings from the nurses’ survey
will be available in an edited form on
the EONS website and in the EONS
Newsletter later in the year. Papers
based on data from all the stages will
also be published in peer-reviewed
journals and the findings presented at
conferences. Most importantly, the aim
is to produce an educational
programme, aimed at the needs of
oncology nurses and young oncologists
working with prostate cancer patients,
which can be incorporated into training
across all European countries.
Responses received from each participating country
Denmark
France
Ireland
Netherlands
Spain
Turkey
UK
Other
0
20
40
60
80
100
120
Seven European countries
were targeted in this
project. The survey was
provided in the local
language and the
responses were translated
by expert medical
translators into English
before analysis.
25
PROFILE
Hampered by Hormones?
The Prostate Cancer Charity calls
for better information and support
Men with prostate cancer continue missing out on vital information and support to help them
live with the impact of the disease and of its treatment. Research by The Prostate Cancer Charity
makes for uncomfortable reading.
John Neate
The Prostate Cancer Charity’s campaign “Hampered by Hormones?”
aims to highlight the needs of men on hormone therapy and their partners and to ensure that they receive the high standard of
care and support they deserve and are entitled to. This includes access to appropriate information, the assessment of side
26
effects and associated support needs and
the provision of appropriate interventions
and support to men (and their partners) to
help them cope with and manage these
side effects.
MISSING OUT ON VITAL INFORMATION
In the United Kingdom, 35,000 men are diagnosed every year and one man dies from
the disease every hour. Yet, despite the incidence and impact of this condition, men
with prostate cancer have consistently reported worse experiences of care within the
National Health Service (NHS) than patients with other common cancers.
New research undertaken by The
Prostate Cancer Charity on the experiences
of men receiving hormone therapy, a common treatment for prostate cancer, suggests
that this legacy continues – with many men
missing out on vital information and support to help them live with the impact of
prostate cancer and of this treatment on
their lives. Feedback from the men who
took part in this research makes for uncomfortable reading:
● Seven out of ten men who took part in
Charity’s survey experianced fatigue;
● One in four men who experienced
fatigue side effects found the impact it
had on their lives difficult to cope
with.
● One in four respondents said that
hormone therapy affected their ability
to work.
● Eight out of 10 said that they
experienced erectile dysfunction as a
result of their treatment – with a
quarter of these men reporting that
they found it difficult to cope with the
impact this had on their lives.
● One in every two men reported serious
issues related to their mental
wellbeing, for example, feelings of
depression, loss of confidence and
cognitive problems.
Despite these experiences, over half of the
men who responded to the survey said
that they received “too little” information
before they began hormone therapy, and
“too little” support whilst they were on the
treatment. Many did not receive verbal or
written information on the potential side
effects of hormone therapy before they
began treatment – nor were they asked by
the health care professionals involved in
their care about their experiences of side
effects, or their support needs.
The Prostate Cancer Charity believes that
the failure to provide information and to
talk to men about the effects of this treatment means that too many are left unaware
that there are practical medical interventions and support services available that
could help them better manage and cope
with the impact of the treatment.
The research also found evidence of serious shortcomings in the information and
support provided to the partners of men
who receive hormone therapy. When surveyed, significant numbers reported that
they found the side effects experienced by
the partner undergoing hormone therapy
difficult to cope with, but nearly two-thirds
said that they had not received appropriate
support from healthcare professionals to
help them cope with the impact of these
side effects on their lives.
These findings highlight serious inadequacies in how well the information and
support needs of men living with the effects
of hormone therapy – and their partners –
are understood and provided for. They also
suggest that existing guidance from the National Institute for Health and Clinical Excellence (NICE) in England and Wales and
NHS Quality Improvement Scotland (NHS
QIS), on the standards of care that should
be in place for men with prostate cancer,
have not been implemented.
current guidelines on the care of men with
prostate cancer, to address the unacceptable
gaps in care. The Prostate Cancer Charity
has also set out a number of recommendations within this report to improve the information, support and care provided by
the NHS to men receiving hormone therapy,
and their partners. The Charity is calling on
Government Health Departments across the
UK, the National Cancer Survivorship Initiative in England and the Scottish Cancer
Taskforce to take action in accordance with
the Charity’s recommendations.
For more information please contact The Policy
and Campaigns team via email at: policy@
GAPS IN CARE
Through this campaign, the Charity is calling for the urgent full implementation of
prostate-cancer.org.uk, or by calling the Charity’s
helpline on: +44 (0)800 074 8383. Website:
www.prostate-cancer.org.uk
Recommendations for improved care
The Prostate Cancer Charity has made nine recommendations for improved
care and support arising from its research:
● All men considering hormone
●
●
●
●
therapy for prostate cancer should
be informed about the potential side
effects of the treatment by a health
care professional.
All men receiving hormone therapy
should be given verbal and written
information about how they can
manage the side effects of the
treatment and where to go to
receive support.
All men receiving hormone therapy
should be regularly assessed by a
health care professional for the side
effects of the treatment and
associated support needs.
Appropriate medical interventions
and support services that can help
men manage the side effects of
hormone therapy should be
available to men across the UK.
Further research should be
conducted into the impact of
hormone therapy on the lives of
men (and their partners) who
receive the treatment and
●
●
●
●
interventions to help them cope
with, or manage these side effects.
The National Cancer Survivorship
Initiative in England and the Living
with Cancer Group of the Scottish
Cancer Taskforce should consider
the action they can take to improve
the support and information
provided to men receiving hormone
therapy.
NHS Quality Improvement Scotland
should develop Standards for
Cancer Services for prostate cancer
to ensure men receiving hormone
therapy receive high quality care.
The partners of men receiving
hormone therapy should be
informed about the side effects of
the treatment and signposted to
support services, by health care
professionals involved in their
partner’s care.
National guidance related to the
effective treatment and care of men
with prostate cancer must be fully
implemented.
27
PROFILE
Gathering user information
to improve prostate
care services
Using the web to research what their next steps should
be is normal for many men.
This second on-line
project invites men
to ask questions
It is often believed that health
about premature
ejaculation,
differences between the sexes are
erectile dysfunction
mostly the result of biology and therefore
and other topics
they are reluctant
inevitable. But men and women react
to discuss with
their doctors.
differently to their health needs and
(www.malehealth
services must be designed in a way to
S
questions.eu)
enhance good health for all.
Erick Savoye
ocio-economic
groupings and
ethnicity have long
been accepted as
important factors in determining
a person’s state of health. But
gender, on the other hand,
continues to be viewed as
peripheral. It is often believed to
be an issue for women but not
for men, based on the inaccurate
perception that the huge
changes in women's lives over
the past 30 years have made
gender irrelevant. In fact,
gender is one of the key
determinants of health.
Although standards of health are
gradually improving across Europe, gender
persists as a key determinant of health
outcomes and one that we are a long way
off understanding fully. Men and women
28
This first on-line project involving data
collection of Q&A about prostate ended just
before Christmas. The results will be available
in February. They will be presented at the
European Association of Urology annual
congress in April.
react differently to their health
needs, yet services are often still
designed in a way that seems
blind to this.
The European Men's Health
Forum (EMHF) is an
independent, nongovernmental, non-profit
making organisation established
to raise male health awareness
across Europe. It aims to
promote collaboration between
interested individuals and
organisations on the
development and application
of health policies, research,
education and prevention programmes.
EMHF provides a unique platform for
non-discriminatory co-operation and
information exchange within Europe and
with other countries worldwide.
With a view to contributing to more
gender-aware health service delivery,
EMHF has among its key objectives to:
● improve the delivery of health services
to men, including primary care and
health promotion information;
● increase the awareness among health
professionals of men’s health issues and
improve their ability to work effectively
with male patients and men generally.
Obviously, improvements in health
cannot be achieved through the
development of services alone, so EMHF
also works to:
● increase men’s awareness of their own
health and their treatment options; and
● foster improvements in men’s healthrelated behaviour, not least in terms of
increasing their willingness to access
health care and reducing the risks they
take with their health.
EMHF is currently running a project
designed to meet both sets of
objectives – encouraging men to
seek advice and information on
two areas of health that are often
seen as difficult to discuss: prostate
health and sexual dysfunction. In this
way the current concerns of men in these
health areas can be assessed, and this
information will be used to influence the
decision-making processes of service
providers and policy makers. It will also
be used to develop a publication for men
on sexual dysfunction.
This is a web-based initiative using two
sites where men, or their partners, can
seek confidential advice from specialist
health professionals. Using the web to
research what their next steps should be in
a given situation is normal for many men.
When men feel comfortable they will
discuss their health openly.
At www.yourprostate.eu, men can ask
anything they want about issues to do with
the prostate. EMHF is keen to learn at what
point men begin to feel things have
reached the stage that they have to seek
support or diagnosis.
The second website, www.malehealth
questions.eu, offers men the opportunity
to ask questions about erectile
dysfunction and premature ejaculation in
total confidence. Specialist urologists with
experience of dealing with these issues
are available to answer questions in
twelve European languages.
This project is not designed to duplicate
or replace any of the great work being
done in men’s health by organisations
across Europe, but as a complementary
piece of research. Where appropriate
visitors to the website will be referred to
specialist services should that be a
suitable option for their particular
circumstances.
With this initiative, EMHF is working on
the principles that improvements in
service delivery must be driven by the
experience of those who use them, and
that men should be offered support to help
them take responsibility for their heath.
If you would like more information
on these projects, or on any other aspect
of EMHF please visit www.emhf.org
or email [email protected].
29
Supporting Practitioners
in Setting Quality
Standards
Putting the improvement of standards in urological
nursing as top of its agenda, the European
Association of Urology Nurses believes that
excellent health care goes beyond geographical
boundaries and a European urology nursing
alliance is essential to promote excellence.
Bente Thoft Jensen
The European Association of Urology Nurses (EAUN) has grown as
an organisation since its inception in 2000
and aims to bring urology nursing in Europe to a higher professional level. With
members in more than 20 countries, and
the numbers steadily growing in recent
years, EAUN aims to create a dynamic and
open forum for the exchange of ideas and
knowledge, which will hopefully continue
to strengthen and improve urological nursing care locally and throughout Europe.
EAUN also aims to bridge the diversity in
approach brought about by the differences
in our daily working environments, backgrounds and health care systems.
EXCELLENCE IN UROLOGY NURSING
EAUN has scientific and not-for-profit objectives and is characterised as a general
urology nurses association. In seeking to foster a European urology nursing alliance to
provide and promote excellence in urological nursing, it has set out as its main ambition the sharing of knowledge and the setting
of standards for quality urological nursing
practice, research and education. Nursing is
obviously the backbone in any health care
30
system around Europe and EAUN strives to
act as the representative body of the European urological nurses, with the purpose of
facilitating the continued development of urological nursing in all its aspects.
GUIDELINES ON BEST CLINICAL
PRACTICE
With administrative, financial and advisory
support from the European Association of
Urology (EAU), EAUN aspires to develop European standards for education and accreditation of urology nurses. Publications like
the Good Practice in Health Care series, a
comprehensive compilation of theoretical
knowledge and practical guidelines on incontinent urostomy, have been essential in
fulfilling this goal. Based on a consensus
process, the guidelines are supplemented by
clear illustrations, case report summaries,
extensive references and annotated procedures to help nurses to identify potential
problem areas and efficiently carry out possible options for effective patient care. The
guideline has just been approved by the
American Clearing House. The full text
can be accessed at www.uroweb.org/professional-resources/guidelines/
MULTIDISCIPLINARY
RESEARCH AND DEVELOPMENT
One of the goals in EAUN’s long-term strategy is to liaise and collaborate with other
organisations in the field of urology and
uro-oncology. This includes co-operating
with EONS in projects of mutual interest.
Today, perhaps more than ever before, European health care associations are being
forced to join forces due to economic factors as well as the desire to promote multidisciplinary research and development. A
major initiative has been the decision by
EAUN to extend its boundaries and accept
the invitation by EONS to take part in the
PSA-project described elsewhere in this
Newsletter (p.24). Both organisations see
this first step as the beginning of a fruitful
partnership and many other future projects
addressing the care of patients with cancers
and associated urological conditions.
EONS members are invited to the 11th
Annual Meeting of EAUN taking place in
Barcelona from 17th till 19th April 2010 and held
in conjunction with the Annual EAU Congress.
Further information can be found at:
www.eaun.uroweb.org
OUR FIRST
IMPACT FACTOR!
European Journal of Oncology Nursing has just received
its FIRST IMPACT FACTOR of 0.976.*
We are delighted with this result, and hope
that you share our confidence that this new
Impact Factor will add to EJON’s excellent
reputation
The European Journal of Oncology Nursing is an
international journal which publishes research of direct
relevance to patient care, nurse education,
management and policy development.
Abstracting and Indexing includes:
BDLIC; British Nursing Index; CINAHL; EMBASE;
PubMed/MEDLINE; Scopus; VINITI
Editor-in-Chief:
Professor A. Molassiotis
Submit online via http://ees.elsevier.com/yejon/
EJON is proud to be the official journal of the European Oncology Nursing Society.
For more information on the journal and links to online submission visit:
www.elsevier.com/ejon
Now in your hands for mCRC* patients with nonmutated (wild-type) KRAS **1
Targeted Power.
Confident Choice.
Because Every Day
Counts.
*mCRC: metastatic colorectal cancer
**Vectibix® is indicated as monotherapy for the treatment of patients
with EGFR-expressing, metastatic colorectal carcinoma with
nonmutated (wild type) KRAS after failure of fluoropyrimidine-,
oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Reference: 1.Vectibix® Summary of Product Characteristics 2008.
VECTIBIX® (panitumumab)
ABBREVIATED PRESCRIBING INFORMATION
Please refer to the Summary of Product Characteristics before
prescribing Vectibix® (panitumumab).
PHARMACEUTICAL FORM: Vectibix® 20 mg/ml concentrate
for solution for infusion. Each vial contains 100 mg of
panitumumab in 5 ml or 400 mg of panitumumab in a 20 ml
vial. Excipients: sodium chloride, sodium acetate trihydrate,
acetic acid (glacial [for pH adjustment]), water for injection.
INDICATION: Vectibix® is indicated as monotherapy for
the treatment of patients with EGFR-expressing, metastatic
colorectal carcinoma (mCRC) with nonmutated (wildtype)
KRAS after failure of fluoropyrimidine-, oxaliplatin-, and
irinotecan-containing chemotherapy regimens.
DOSAGE AND ADMINISTRATION: The recommended dose of
Vectibix® is 6 mg/kg of bodyweight given once every two
weeks. The recommended infusion time is approximately 60
minutes. Doses higher than 1000 mg should be infused over
approximately 90 minutes.
CONTRAINDICATIONS: Hypersensitivity to the active
substance or to any of the excipients; interstitial pneumonitis
or pulmonary fibrosis.
SPECIAL WARNINGS AND PRECAUTIONS: Dermatologic
reactions: Dermatologic reactions are experienced with nearly
all patients (approximately 90%) treated with Vectibix®; the
majority are mild to moderate in nature. If a patient develops
dermatologic reactions that are grade 3 (NCI-CTC/CTCAE)
or higher or considered intolerable, temporarily withhold
Vectibix® until the reactions have improved to ≤grade 2. Once
improved to ≤grade 2, reinstate administration at 50% of
the original dose. If reactions do not recur, escalate the dose
by 25% increments until the recommended dose is reached.
If reactions do not resolve (to ≤grade 2) or if reactions recur
or become intolerable at 50% of the original dose, the
use of Vectibix® should be permanently discontinued.
Pulmonary complications: If pneumonitis or lung infiltrates are
diagnosed, Vectibix® should be discontinued and the patient
should be treated appropriately. Electrolyte disturbances:
Progressively decreasing serum magnesium levels leading
to severe (grade 4) hypomagnesaemia have been observed in
some patients. Patients should be periodically monitored for
hypomagnesaemia and accompanying hypocalcaemia prior to
initiating Vectibix® treatment, and periodically thereafter for
up to 8 weeks after the completion of treatment. Magnesium
repletion is recommended, as appropriate. Other electrolyte
disturbances, including hypokalaemia, have also been
observed. Repletion of these electrolytes is also recommended,
as appropriate. Infusion-related reactions: Across all clinical
studies, infusion-related reactions (occurring within 24 hours
of any infusion), were reported in 3% of Vectibix®-treated
patients, of which <1% were severe (NCI-CTC grade 3–4).
Severe infusion reactions included anaphylactic reactions,
bronchospasm, and hypotension. Stop infusion if a severe
infusion reaction occurs, and permanently discontinue
treatment if it occurs at any time post-infusion. Other
hypersensitivity reactions: Hypersensitivity reactions have
been reported, including a fatal case of angioedema that
occurred more than 24 hours after the infusion. Vectibix®
should be permanently discontinued if a severe reaction
occurs at any time post-infusion. Patients should be
instructed to report symptoms of a late-onset reaction to
their physician. Acute renal failure: There have been reports
of acute renal failure in patients who develop diarrhoea
and dehydration
INTERACTIONS: Vectibix® should not be administered in
combination with IFL chemotherapy or with bevacizumabcontaining chemotherapy. A high incidence of severe diarrhoea
was observed when panitumumab was administered in
combination with IFL, and increased toxicity and deaths were
seen when panitumumab was combined with bevacizumab
and chemotherapy.
UNDESIRABLE EFFECTS: Very common (≥1/10): Rash,
dermatitis acneiform, erythaema, skin exfoliation, pruritus,
dry skin, skin fissures, paronychia, diarrhoea, fatigue.
Common (≥1/100 to <1/10): Infusion reactions (pyrexia,
chills), hypomagnesaemia, hypocalcaemia, hypokalaemia,
dehydration, nausea, vomiting, dyspnoea, cough, headache,
conjunctivitis, growth of eyelashes, increased lacrimation,
ocular hyperaemia, dry eye, eye pruritus, stomatitis, mucosal
inflammation, onycholysis, hypertrichosis, alopecia, nasal
dryness, dry mouth, pulmonary embolism.
The safety profile of panitumumab in patients whose tumour
express KRAS wild-type was generally consistent with overall
mCRC monotherapy set described above. The only differences
were that nausea, vomiting, dyspnoea and cough were
reported as very common (≥1/10) in the KRAS wild type
arm whereas these adverse drug reactions were reported as
common (≥1/100 to <1/10) in the overall mCRC monotherapy
population.
STABILITY AND STORAGE: Store vials in the original
carton under refrigeration at 2°C to 8°C until time of use.
Protect from light. DO NOT FREEZE. Do not shake vigorously
oragitatethevial. SinceVectibix® doesnotcontainpreservatives,
any unused portion remaining in the vial should be discarded.
Use of Vectibix® should normally be within 24 hours of dilution
if stored at 2°C to 8°C.
LEGAL CLASSIFICATION: Medicinal product subject to
restricted medical prescription.
MARKETING AUTHORISATION HOLDER: Amgen Europe B.V.,
Minervum 7061, NL-4817 ZK Breda, The Netherlands. Further
information is available from Amgen (Europe) GmbH,
Dammstrasse 23, PO Box 1557, Zug, Switzerland, CH-6301.
Additional information may be obtained from your local
Amgen office.
Marketing Authorisation Number 100 mg
EU/1/07/423/001; 400 mg vial: EU/1/07/423/003
vial:
© 2008 Amgen. All rights reserved. PMO-AMG-462-2008
Amgen_Ad_Adapted_150509.indd 2
15.05.09 14:49
Advancing nursing management
approaches with new targeted
therapies for ErbB2-positive metastatic
breast cancer
EONS APPROVED
Prior to the ECCO 15 – ESMO 34 Conference, an educational workshop for cancer nurses was held on Sunday
20th September 2009 in Berlin, Germany. The meeting was accredited by EONS with sponsorship provided
by GSK. The purpose of the workshop was to discuss current knowledge behind clinical therapies in ErbB2positive breast cancer, common side effects associated with these interventions and step-by-step proactive
nursing management. Fifty four nurses from 12 countries across Europe attended the event and took part in
interactive sessions with the various speakers.
Epidemiology and pathology of
breast cancer
Annie Young, Nurse Director, 3-Counties Cancer Network
(Gloucestershire, Herefordshire and South Worcestershire, UK).
Past-president UK Oncology Nursing Society.
Despite many recent advances in diagnostic investigation technology
and improvements in treatment and supportive care, breast cancer
remains the leading cause of cancer-related mortality in European
women1. Evidence-based public health measures exist in many
European countries to reduce mortality from breast cancer. National
screening programmes that detect early invasive cancers have
greatly improved early detection and hence survival rates1. In
Europe; Belgium, France and Sweden recorded the highest incidence
(probably due to the presence of screening programmes), while the
lowest incidence is to be found in countries, such as Cyprus, Belarus
and the Ukraine1.
Recent research has suggested patterns of gene expression may
better predict prognosis and response to different types of cancer
treatment2. This research implies that there are four basic subtypes
of breast cancer. The gene expression patterns of these cancers are
comparable to the normal cells that line the lumen of breast ducts
and glands2. Luminal A and B cancer subtypes are both oestrogen
receptor positive and are the most common2. Luminal A cancers are
associated with the best prognosis. Luminal B cells have a higher
expression of proliferative genes such as ErbB2. They therefore
grow more rapidly and are associated with a poorer prognosis3.
Amplification and over-expression of ErbB2 has been found to be
associated with a median survival of 3 years3.
ErbB2- (or HER2)-positive, oestrogen receptor negative breast cancers
are less common but are also linked to a poor prognosis3. Basal
type cancers are principally triple negative phenotype – that is to
say they lack oestrogen and progesterone receptors and have low
expression of ErbB2. The gene expression of these cells is akin to cells
in the deeper basal layers of the breast ducts and glands. Basal type
cancers tend to be high grade tumours that grow quickly and have a
poor prognosis2.
Growth factors and receptors
Growth factors (or ligands) may be characterised as protein “signals”
circulating in the blood or near to the cells that secrete them and are
typically present in low concentrations. They initiate various cellular
activities by first binding with their associated receptor on the cell’s
surface. There are about 58 tyrosine kinases which act as growth
factor receptors4. When bound to the growth factor, the receptor
triggers various processes within the cell such as cell division,
development of blood vessels, blood vessel formation and embryonic
development. The process of message transfer to initiate these
intracellular activities is known as signal transduction – a complex
and tightly regulated network of signal pathways, with many starting
points and alternative routes for message transfer.
The ErbB family of receptors are major regulators of cellular processes
such as cell division, growth, differentiation, migration and survival.
The family comprises four related transmembrane receptor tyronsine
kinases (RTK’s) that bind to members of the epidermal growth factor
This article was supported by an unrestricted educational grant from GSK Oncology.
EONS New insight 09.indd 3
25/1/10 17:22:46
(EGF) family to trigger these processes5. Malignant tumours,
including breast cancer, may be a consequence of unregulated
or dysregulated control of the ErbB signaling pathway by
other genes5.
Approximately 20-30% of invasive breast carcinomas have
ErbB2 over-expression or gene amplification3. This overexpression is associated with aggressive disease, poorer
response to conventional cytotoxic chemotherapy and hormonal
therapy resulting in a reduced survival time.
Strategies to inhibit ErbB2
A number of strategies have been developed to target the ErbB2
signalling pathway. However so far only monoclonal antibodies
(mAbs) and small-molecule tyrosine kinase inhibitors (TKIs)
have been developed to the greatest extent in a clinical setting.
Trastuzumab (Herceptin®) is the only mAb currently licensed
for use in ErbB2-positive breast cancer. Other mAbs under
investigation for this indication include pertuzumab (Omnitarg®),
Targeted therapies for ErbB2-positive
breast cancer
Thomas Bogenrieder, GSK Clinical Director Oncology,
Oncology Center of Excellence, Europe, Asia-Pacific, Japan
& Emerging Markets
Trastuzumab (Herceptin®) was the first humanised monoclonal
antibody to be developed to treat breast cancer. Compelling
clinical trial evidence in metastatic and adjuvant settings has
resulted in trastuzumab becoming a crucial component of
therapy for ErbB2-positive breast cancer as both monotherapy
and in combination with other cytotoxic agents.
Safety Considerations and Side
Effect Management with Lapatinib
(Tyverb®) and capecitabine.
Annie Young, Nurse Director, 3-Counties Cancer Network
(Gloucestershire, Herefordshire and South Worcestershire, UK).
Past-president UK Oncology Nursing Society.
Paz Fernandez, Institut Català Oncologia ICO, Barcelona, Spain
Empowerment is a primary objective of patient education,
which is the cornerstone of the safe administration of oral
anti-cancer drugs. Topics that the patient needs to be educated
upon on include potential and anticipated side effects; how to
monitor them as and when they occur, what to do and who to
call in the case of their happening. Nurses therefore need to be
EONS New insight 09.indd 4
bevacizumab (Avastin®) and T-DM1. Trastuzumab binds to the
extra cellular domain of the ErbB2 receptor, thereby preventing
activation of the receptor. mAbs have limits to their activity in
that they are specific to only one receptor (e.g. ErbB2)6 and they
can only act outside the cell. Therefore, if a receptor does not
have an extracellular domain, a monoclonal antibody might not
be effective.
TKIs are small enough to enter the cell and block the activation
of downstream signaling pathways. The TKI lapatinib (Tyverb®)
is the only TKI currently licensed fro use in ErbB2-positive breast
cancer. Lapatinib binds with the intracellular tyrosine kinase
domain of the ErbB2 receptor to block its activation and prevent
signal transduction inside the cell. The same tyrosine kinase
domain may be present on more than one type of receptor (e.g.
ErbB1 and ErbB2). Therefore TKIs have the potential to be active
against multiple receptors7. That TKIs can enter the cell and be
active is significant in instances where no extracellular domain
is present.8
Lapatinib (Tyverb®), an oral tyrosine kinase inhibitor (TKI), acts
inside the cell to block growth and survival of breast cancer
cells and may therefore also be active in cells which do not
have an extracellular ErbB2 domain.8 Pre-clinical investigation
of lapatinib has shown that it is a potent inhiibitor of both
the EGFR and ErbB2 receptors7. Dual receptor inhibition is
a hopeful therapeutic strategy as it may potentially block
multiple signalling pathways7. Lapatinib, in combination
with capecitabine, is indicated for the treatment of patients
with advanced or metastatic breast cancer whose tumours
overexpress ErbB2. Patients should have progressive disease
following previous therapy, which must include anthracyclines,
taxanes and therapy with trastuzumab in the metastatic setting.
able to confidently and competently explain how the prescribed
drug works, discuss the benefits of the treatment; how the drug
should be taken; the drug schedule; do’s & don’ts associated
with the regimen including what to do if tablets are missed, or
inadvertently overdosed.
Questions you may be asked about lapatinib and
capecitabine:
What should I do if forget to take my tablets?
If it is still the same day, take your lapatinib tablets as soon
as you remember. Do NOT double the dose the next day. If
capecitabine dose is missed (e.g. morning dose), take next
dose as usual (do not double up). Remember to inform the
cancer unit.
25/1/10 17:22:48
What if I missed a whole day?
Take the usual dose of lapatinib (or capecitabine) on the day
after the missed day at the usual time(s). Remember to inform
the cancer unit.
What if I am sick after taking my tablets?
Do not take a second dose to make up for the vomited dose.
Take next dose as normal when due. If vomiting continues,
contact the cancer unit.
What should I do if I get diarrhoea while taking lapatinib?
If diarrhoea occurs it usually happens during the first week
or so but can happen at any time during treatment. It is
usually mild or moderate, but can be severe in some cases.
Most people with diarrhoea should be able to continue their
treatment with appropriate management. If experiencing
diarrhoea or a change in your normal bowel pattern, inform
the cancer unit.
The patient’s usual bowel routine should be assessed in order to
understand what their normal state is and record the baseline
measure. Subsequent grading can be monitored against readily
available and utilised Common Toxicity Criteria, such as the
North American NCI Common Terminology Criteria for Adverse
Events v3.0 (CTCAE).
Grade
Measure
1
< 4 stools per day more than baseline
2
4-6 stools per day more than baseline. Not interfering with
daily routine.
3
> 7 stools per day. IV fluids. Needs health professional
support. Requires hospitalization for complications.
4
Life threatening consequences e.g. haemodynamic
collapse. Potential for electrolyte imbalance or similar.
Requires immediate attention.
5
Death – extremely rare
What should I do if I get a rash while taking lapatinib?
Rash is a very common side-effect of taking lapatinib. It usually
develops within the first 2 weeks of treatment. The rash will
usually improve or disappear after a few weeks. Most people
who develop a rash are able to continue their treatment. If a
rash develops, or if your skin feels dry, itchy or painful, inform
your doctor or nurse.
Management guidelines based on those developed by the
American Society of Clinical Oncology (ASCO)9 may be followed
on diarrhoea occurrence with lapatinib treatment.
Management of diarrhoea associated with
lapatinib + capecitabine
Early identification is critical for optimal
management of this embarrassing and distressing
side effect, so it is important that nurses both
find ways to encourage patients to talk freely
about this symptom in order to help them as
quickly as possible and undertake a rigorous
assessment. The diarrhoea triggered by targeted
therapies is due to damage of
the epithelium in the colon due
to the presence of the EGFR
receptor in this region. As this
damage is repaired, the body
recovers and for this reason
the symptom experience is of
short duration.
Evaluation
It is important to evaluate patients for disorders that
may dispose them to diarrhoea, such as surgical shortening of
the bowel, concurrent non-malignant bowel disorders, or prior
bowel irradiation. The assessment and record of medications
that may induce diarrhoea, such as antibiotics, should also be
completed.
EONS New insight 09.indd 5
Figure 1. Uncomplicated Diarrhoea
25/1/10 17:22:51
Figure 2. Complicated Diarrhoea
In a pooled analysis of eleven clinical trials of patients receiving
lapatinib and/or capecitabine (n = 1,811), diarrhoea occurred in
around 55% of patients and was mainly mild and that it tended
to last around 5 days10. Most (92%) diarrhoea events were grade
1 or 2. The majority (85%) of patients required no interruption of
therapy or dose adjustment; 2% discontinued treatment because
of diarrhoea. Patients who required intervention responded
to standard anti-diarrhoeal management (e.g. loperamide). In
more severe cases, management included hydration and use of
antibiotics. Women are more likely to suffer from diarrhoea than
men because of the physiology of their gut; older women will
suffer a worse experience than younger women.
Management of skin rash associated with lapatinib +
capecitabine
A rash is an obvious side effect and many patients will be sensitive
about their appearance, particularly if they experienced hair loss
during their initial chemotherapy. Rash is a common side effect of
drugs that target the ErbB1 receptor.11
Among lapatinib-treated patients across several trials (n=1,417)12,
skin events were reported by 50% treated with lapatinib
monotherapy; 70% with lapatinib + capecitabine; 76% with
lapatinib + paclitaxel. The majority of events were of low-grade
severity (Grade 1 or 2); there were no Grade 4 events. Events tend
to present early in the course of treatment and are usually selflimiting (median duration 29 days).
The correct term for the rash is ‘papulopustular rash’ or ‘pustular
eruptions’. The rash may resemble seborrhoeic dermatitis,
folliculitis or acneiform drug eruption and it is commonly, (though
EONS New insight 09.indd 6
technically incorrectly), called
an acne-form rash because it
is similar in initial appearance
to acne vulgaris. However, it
is not the same since the rash
is not associated with the
same clinical or histological
characteristics, such as the
presence of comedones
(“blackheads”). Nevertheless,
for women experiencing
metastatic breast cancer, the
visibility of this rash and obvious
further change to their body
image may be quite upsetting
and worrying.
The papules are small, rounded,
elevated lesions in the skin.
They tend to be smaller than
half a centimetre diameter.
A pustule is a collection of
purulent exudates in the top
layer of the skin and the epidermis, or beneath it in the dermis.
Pustules frequently form in sweat glands or hair follicles. The
papulopustular rash commonly affects areas such as the face, the
upper back and the V-shaped open neckline area of
the chest.
The CTCAE grading gives a common standard to describe the
severity of the rash.
CTCAE grading
Grade 1
Macular or papular eruption or erythema without
associated symptoms
Grade 2
Macular or papular eruption or erythema + itching / other
associated symptoms. Local desquamation. Covering
<50% BSA
Grade 3
Severe. Confluent lesions, or vesicular eruption;
desquamation covering >50% BSA
Grade 4
Generalised rash, deep ulcerations, exfoliative or bullous
dermatitis
Grade 5
Death
Nurses should perform a skin examination (scalp, radiated areas,
hair, nails and oral/genital mucosa) and identification of skin type
at baseline and perform follow-up dermatological assessments
every 4 weeks throughout treatment or until an adverse reaction
appears; after a dermatological event perform skin examinations
at every visit until one month after resolution. This will necessarily
mean that nurses need to be conversant with the anatomy and
physiology of the skin and be able to articulate their findings
in language appropriate to this aspect of practice. Patients
should be encouraged to avoid exposure to sunlight and apply
25/1/10 17:22:55
broad spectrum sunscreens (containing titanium dioxide or zinc
oxide) with an SPF ≥15. A full body skin examination should be
performed on any patient who displays signs or symptoms of
dermatological disease.
Fig 4 Management of papulopustular reaction
Fig 3, management of maculopapular reaction
There are no clear evidence-based treatment options for
management of lapatinib-associated rash, however see Figs 3
and 4 for management guidelines derived from one study11. The
management of mild rash is relatively simple and may include the
application of topical corticosteroids, although there is not consensus
for this decision. No discontinuation of treatment is required for mild
rash but, if the rash is severe and covering more than 50% of the
body surface area or symptomatic, the treatment may be suspended
and a short course of oral corticosteroids prescribed and the effect
reviewed after 2 weeks. Patients with extensive or persistent skin
involvement should be referred to a dermatologist.
Nursing considerations for oral agents
for cancer.
Sultan Kav, Faculty member at Baskent University, Faculty of Health
Sciences, Department of Nursing, Ankara, Turkey.
We all want to see our patients’ experience of their cancer and its
treatment improve; the attraction of an oral medication is obvious.
Administering IV chemotherapy is costly in staff time, clinic space
and equipment. It is habitually inconvenient and worrying for
patients, often associated with long journeys to hospitals, lengthy
waiting times etc. Assuming efficacy and toxicity are equal, it has
been shown that patients prefer oral therapies to IV as this reduces
disruption to daily schedules, and enables a better quality of life13.
Nevertheless there are many things that we need to consider for the
whole process to be safe and to ensure the best possible outcome
for the patient.
Oral medication is associated with a degree of non-compliance.
Reasons given for poor adherence to oral anti-cancer agents include
a lack of information about the treatment; the perception of the
drug’s influence over their disease experience and a dislike of certain
Taken as a whole, side effects with this combination of treatments
are less severe than with standard chemotherapy. As always, the
nursing contribution to side effect management can make a big
difference to the patient experience and quality of life that they
will gain from these new therapeutic modalities. In particular,
effective communication with patients and efficient education
of how to monitor for side effects will be especially important in
helping them to get the best from their treatment. Most cancer
patients wish to be involved in decision making and are entitled
to be treated with dignity and respect - a proactive approach
to symptom management will help patients and their carers
achieve this.
unbearable aspects of treatment e.g. unpleasant side-effects14.
A patient’s beliefs may be influential in their decision about whether
or not to continue with treatment. Providing support beyond the
initial consultation, based on open and honest dialogue combined
with a firm, friendly and therapeutic relationship is an important
factor in managing such essential outpatient-based services. Other
straightforward suggestions for improving adherence include follow
up via telephone links; consultations at key points in timeline of
patients treatment; involving the support of a third party, such as a
carer; informing the patient about reliable and appropriate patient
support groups or other voluntary and non-statutory organisations
that can help. Even advocating the use of simple measures such as
diaries, timers, or post-it notes which serve to remind the patient to
take their medication to time could be a useful nursing intervention.
In order to make this a positive and valuable treatment option for
the long term, nurses will play a vital role in supporting patients for
optimising successful outcomes.
A teaching tool for patients receiving oral agents for cancer has been
developed by MASCC’s professional education study group and can
be found at www.mascc.org/mc/page.do?sitePageId=8976015.
This article was supported by an unrestricted educational grant from GSK Oncology.
EONS New insight 09.indd 1
25/1/10 17:22:37
Summary
Breast cancer remains the leading cause of cancer-related
mortality in European women1. ErbB2-positive breast cancer
accounts for 20 – 30% of invasive breast carcinomas and
is a particularly aggressive form of the disease with a poor
prognosis3.
Knowledge of how intracellular processes are controlled in
ErbB2-positive breast cancer has led to the development
of targeted therapies which block key signal transduction
pathways. Trastuzumab (Herceptin®) is a humanised
monoclonal antibody that acts on the extra cellular domain of
the ErbB2 receptor and is a crucial component of therapy for
ErbB2-positive breast cancer. Lapatinib (Tyverb®) is the first oral
References
1. Ferlay, J; Autier, P; Boniol, M; Heanue, M; Colombet, M; Boyle, P. Estimates of the cancer
incidence and mortality in Europe in 2006. Annals of Oncology 2007;18: 581-592.
2. Brenton J, Carey L, Ahmed AA, Caldas C. Molecular classification and molecular
forecasting of breast cancer: Ready for Clinical Application? Journal of Clinical Oncology
2005;23(29):7350-7360.
3. Slamon DJ, Clark GM, Wong SG et al. Human breast cancer: correlation of relapse and
survival with amplification of the HER2/neu oncogene. Science 1987;235:177-182
4. Robinson D, Wu YM, Lin SF. The protein tyrosine kinase family of the human genome.
Oncogene 2000;19:5548-5557.
5. Rowinsky EK. The ErbB family: targets for therapeutic development against cancer and
therapeutic strategies using monoclonal antibodies and tyrosine kinase inhibitors. Annu Rev
Med 2004;55:433-57.
6. Scaltriti et al. Expression of p95HER2, a truncated form of the HER2 receptor, and response
to anti-HER2 therapies in breast cancer. J Natl Cancer Inst 2007;99(8):628–38
7. Rusnak DW et al. The effects of the novel, reversible, epidermal growth factor receptor
ErbB-2 Tyrosine Kinase inhibitor GW2016, on the growth of human normal and tumour
derived cell lines in vitro and in vivo. Mol Cancer Ther 2001;1(2):85–94
Prescribing Information
Abbreviated Prescribing Information (Please refer to full SmPC before prescribing)
Tyverb®(lapatinib) 250mg film-coated tablets. Each tablet contains 250mg lapatinib as ditosylate
monohydrate. Indications In combination with capecitabine for treatment of patients with advanced or
metastatic breast cancer whose tumours overexpress ErbB2 (HER2). Patients should have progressive disease
following prior therapy which must include anthracyclines and taxanes and therapy with trastuzumab in
the metastatic setting. Dosage and administration Only to be initiated by physician experienced in use of
anti-cancer agents. Lapatinib: 1250mg (5 tablets) once daily continuously. Taken at least one hour before,
or at least one hour after food. Standardise administration in relation to food intake. Capecitabine: 2000
mg/m2 /day taken in 2 doses 12 hours apart on days 1-14 in a 21-day cycle. Taken with food or within
30 mins after food. Renal impairment: No lapatinib dose adjustment necessary in mild to moderate renal
impairment. Caution advised in severe renal impairment as no experience of lapatinib in this population.
Hepatic impairment : Discontinue lapatinib if changes in liver function are severe and do not retreat patients.
Insufficient data available to provide a dose adjustment recommendation. Use with caution in moderate to
severe hepatic impairment due to increased exposure to product. Elderly: Limited data in patients ≥ 65 years.
Paediatrics: Not recommended. Dose delay and dose reduction Cardiac events: Discontinue lapatinib in
patients with symptoms associated with decreased LVEF that are NCI CTCAE grade ≥ 3 or if LVEF drops below
institution’s LLN. May be restarted at 1000mg/day after ≥ 2 weeks and if LVEF recovers to normal and patient
is asymptomatic. Interstitial lung disease/pneumonitis: Discontinue lapatinib in patients who experience
pulmonary symptoms that are NCI CTCAE grade ≥ 3. Other toxicities: Consider discontinuation or interruption
of lapatinib dosing if patient develops toxicity that is NCI CTCAE grade ≥ 2. Can be restarted at 1250mg/day
when toxicity improves to ≤ grade 1. If recurs, restart lapatinib at 1000mg/day. Consult capecitabine SmPC
for guidance on dose delay and dose reduction recommendations for capecitabine. Contra-indications
Hypersensitivity to active substance or excipients. Refer to capecitabine SmPC for relevant contraindications
and safety information. Special Warnings and Precautions Decreases in LVEF reported. Caution advised
if lapatinib given to patients with conditions that could impair LVEF. Evaluate LVEF in all patients prior to
starting treatment to ensure baseline LVEF within institution’s normal limits. Evaluate LVEF during treatment
to ensure it does not decline to unacceptable level;.Hepatotoxicity has occurred (may rarely be fatal). Monitor
liver function before initiation of treatment and monthly thereafter or as clinically indicated; Pulmonary
toxicity including interstitial lung disease reported. Monitor for symptoms of pulmonary toxicity; Diarrhoea
including severe diarrhoea reported. Proactive management of diarrhoea with anti-diarrhoeal agents is
important. Severe cases may require oral or i.v. electrolytes and fluids, and interruption/discontinuation of
EONS New insight 09.indd 2
tyrosine kinase inhibitor licensed for use in ErbB2-positive breast
cancer and has been shown to target both the EGFR and ErbB2
receptor kinase domains inside the cell.
The main side effects of the lapatinib + capecitabine
combination are diarrhoea and rash. Taken as a whole, side
effects with this combination are less severe than with standard
chemotherapy. Nurses need to be able to explain to patients
how their prescribed treatment works, discuss the benefits of
the treatment, how to monitor for any side effects and what
to do if they occur. Management and education of patients
receiving oral anti-cancer therapy needs to be especially
thorough to ensure that patients get the best from their
treatment. The importance of the nursing contribution for this
cannot be underestimated.
8. Xia W, Liu LH, Ho P, Spector N. Truncated ErbB2 receptor (p95ErbB2) is regulated by
heregulin through heterodimer formation with ErbB3 yet remains sensitive to the dual
EGFR/ErbB2 kinase inhibitor GW572016. Oncogene 2004;23:646-653.
9. Benson AB et al. Recommended guidelines for the treatment of cancer-treatment induced
diarrhoea. J Clin Oncol 2004; 22(14): 2918 – 2926.
10. Crown J, Burris HA, Boyle F, et al. Pooled analysis of diarrhoea events in patients with cancer
treated with lapatinib. Breast Cancer Res Treat 2008.
11. Moy B & Goss PE. Lapatinib-associated toxicity and practical management
recommendations. Oncologist 2007;12:756-765.
12. Lacouture ME. et al. Analysis of dermatologic events in patients with cancer treated with
lapatinib. Breast Cancer Res Treat. 2008.
13. Liu G, Franssen E, Fitch MI, Warner E. Patient preferences for oral versus intravenous
palliative chemotherapy. J Clin Oncol 1997;15:110-15.
14. Atkins, S & Fallowfield, L. Intentional and non-intentional non-adherence to medication
amongst breast cancer patients. Eur J Cancer 2006; 42: 2271-6.
15. Kav S, Schulmeister L, Nirenberg A, Barber L, Johnson J, Rittenberg C. Development of the
MASCC teaching tool for patients receiving oral agents for cancer. Support Care Cancer
2009 Jul 10. [Epub ahead of print].
therapy. Interactions Lapatinib undergoes extensive metabolism, primarily by CYP3A4 and CYP3A5, with
minor contributions from CYP2C19 and CYP2C8. Lapatinib inhibits CYP3A4 and CYP2C8 in vitro at clinically
relevant concentrations. Avoid grapefruit juice during lapatinib treatment; Avoid concomitant treatment with
inducers (incl. St. John’s Wort) and strong inhibitors of CYP3A4, and with medical products with narrow
therapeutic windows that are substrates of CYP3A4 or CYP2C8; Avoid concomitant use of substances
that increase gastric pH as lapatinib solubility and absorption may decrease. Pregnancy and lactation No
adequate data on use in pregnant women. Not to be used unless clearly necessary. Contraception advised;
Not known whether lapatinib excreted in human milk. Breastfeeding should be discontinued. Effects on
ability to drive and use machines No studies conducted. Detrimental effect cannot be predicted from
pharmacology of lapatinib. Undesirable effects Following adverse reactions reported in association with
lapatinib + capecitabine therapy: Very common: Diarrhoea (may lead to dehydration), nausea, vomiting,
dyspepsia, stomatitis, constipation, abdominal pain; Rash (including dermatitis acneiform), dry skin, PPE;
Anorexia; Fatigue, mucosal inflammation; Pain in extremity; back pain. Insomnia. Common: Decreased LVEF;
Nail disorders including paronychia Headache; Hyperbilirubinaemia, hepatotoxicity. Uncommon: interstitial
lung disease/pnuemonitis. Rare: Hypersensitivity reactions including anaphylaxis. Specific events: Decreased
LVEF: Reported in ~1% of all patients receiving lapatinib across clinical programme and asymptomatic in
> 90% cases. Symptomatic LVEF decreases observed in ~ 0.1% of patients on lapatinib monotherapy.
Symptoms included dyspnoea, cardiac failure, palpitations. LVEF decreases reported in 2.5% of patients on
lapatinib + capecitabine vs. 1% for capecitabine alone. Diarrhoea: Occurred in ~ 65% of patients on lapatinib
+ capecitabine. Most cases grade 1 or 2 and did not result in discontinuation of lapatinib. Rash: Occurred in
~ 28% of patients on lapatinib + capecitabine. Generally low grade and did not result in discontinuation of
lapatinib. Overdose No specific antidote. Haemodialysis not expected to be effective method of elimination
as lapatinib is not significantly renally excreted and is highly bound to plasma proteins. Marketing
authorisation (MA) no. EU/1/07/440/001 and EU/1/07/440/002 MA holder Glaxo Group Limited, Berkeley
Avenue, Greenford, Middlesex UB6 ONN. Legal category POM. TYV0110/105/1 January 2010.
Adverse events should be reported. Reporting forms and information can be found at:
www.yellowcard.gov.uk GlaxoSmithKline encourages healthcare professionals to report adverse
events, pregnancy, overdose and unexpected benefits to the company on 0800 221 441.
Further contact information is available from http://www.gsk.com/contactus.htm or email
[email protected]
Tyverb is a registered trademark of the GlaxoSmithKline group of companies.
25/1/10 17:22:44