HER2 Support Group Forums - Taxanes and anti-convulsants

Hi Rhonda, I have e-mailed the writer for more info, I have included article in this post, it is long but I have spaced where it is reported, there isn't any information only the statement

Hugs Lyn

Breast Cancer
Update
Registered by Australia Post — Publication No. VBG 900 6263
Produced by the Breast Cancer Committee
of the Victorian Cooperative Oncology Group
Centre for Clinical Research in Cancer
Issue Number: 52 Date: June 2004
BREAST CANCER UPDATE
June 2004 Issue No. 52
CONTENTS
Breast Cancer Update Centre for Clinical Research in Cancer
Page 6 Vol 52 ◆ June 2004
Trastuzumab (Herceptin) Usage in Australia
Dr Fran Boyle
Medical Oncologist
Royal North Shore Hospital, Sydney
Herceptin was first registered for use in Australia
in 2000, for patients with metastatic breast
cancer overexpressing Her2 receptors (either as
monotherapy or in combination with taxane
chemotherapy). Its high cost precluded all but
sporadic usage until it was funded by the Health
Insurance Commission in December 2001,
following significant lobbying by both clinicians
and consumer groups. The arrangements for
approval for individual patients were, and remain,
unusual, since it is outside the PBS process. After
initial documentation of eligibility (with pathology
reports and patient consent), monthly phone
approvals must be sought by the oncologist.
There was, as expected, an initial rapid influx of
patients who had been waiting for funded access,
and within the first 6 months 332 patients had
been registered. Since that time, as depicted in
the graph below (figures from www.hic.gov.au),
new registrations have been fairly steady (apart
for June 03, a bumper month, giving the lie to
the notion that no work gets done when ASCO
is on). Over 2 and a half years, a total of 1000
patients have had funded access to the drug,
approximately 50/50 spit between monotherapy
and taxane combinations. It is difficult to discern
from the HIC figures the average duration of
usage. Women of all ages have been prescribed
Herceptin (see figure below) – little is known of
their tolerance. 133 patients are known to be
deceased, and 311 have been withdrawn – it is
not known the proportion withdrawn for reasons
of toxicity vs progressive disease. Usage across
states would appear to be appropriate (see figure
below).
The programme has run smoothly for the most
part, with dedicated staff handling the HIC lines.
Weekly usage is the only approved mode of
delivery at present, with the 3 weekly data
emerging slowly from clinical trials, and not yet
submitted to the TGA. Combinations with either
paclitaxel or docetaxel are permitted, with the
vinorelbine data not yet submitted for approval.
These modifications remain in the hands of the
sponsoring company, Roche, and the HIC has
made it clear that unregistered combinations will
not attract funding. Total expenditure was
predicted at around 11 Million per year, and this
has been exceeded, although the exact details
are not in the public domain. Impact on survival
in the population setting is not known, due to lack
of appropriate data sets. Data from Canada
presented at ASCO in 2003 (Chia et al)
demonstrated improved survival in the population
cohort of patients diagnosed with metastatic
disease in the Herceptin /Capecitabine era,
suggesting that observed survival benefits in
clinical trials do translate into more general
settings. The opportunity for a true cost-benefit
analysis in the Australian context is not provided
by the current programme.
If you have any questions that have not been
adequately addressed by this summary, please
contact Anne Ireland on (02) 6124 6885 at the
HIC.
CNS Metastases in Patients on
Herceptin
One clinical issue that has arisen with use of
Herceptin in patients with metastatic breast
cancer is the perception that brain metastases
are more frequently observed. Analysis of the
cohort of the first 40 patients treated in Northern
Sydney indicates that 40% have developed CNS
metastases (including a high proportion with
posterior fossa disease). Only 2/3 were
symptomatic at the time. In our series all patients
received whole brain radiotherapy, and 5 had
lesions resected. These lesions continued to
overexpress Her2 when tested. Over 80% of
Source: hic.gov.au
Centre for Clinical Research in Cancer Breast Cancer Update
Vol 52 ◆ June 2004 Page 7
these patients had at least some response of their
systemic disease (29% SD, 53% CR+PR). The
median survival from the time of diagnosis of
CNS metastases is 18 months, and patients with
CNS metastases did not have a significantly
worse prognosis overall (Wiseman et al, COSA
2003). We have considered several possible
explanations for this phenomenon:
Hereptin does not penetrate the blood brain
barrier, and so cannot reach the target which
does not appear to be lost.
Taxanes also do not penetrate well, and neither
do anthracyclines, which these patients had
frequently received in the adjuvant setting. Our
usage of chemotherapy in a different manner may
therefore contribute to the problem. Carboplatin
may be of assistance in this regard, and the
recently completed BCIRG 007 study may shed
light on this issue.
These patients may be living longer than
previously, and are not dying of systemic
disease, thus allowing CNS metastases to
emerge.
Active treatment should therefore be considered
if systemic disease is controlled, since survival
may be relatively long. This may include surgery
for lesions which are single, accessible, in the
posterior fossa, and/or are causing
hydrocephalus. Follow-up of whole brain
radiotherapy will reduce the risk of relapse.
Isolated CNS relapse should not be considered
a failure of Herceptin therapy.

We might also consider screening for CNS
metastases when scanning patients to assess
their systemic disease. This may not alter
survival, but may have other benefits:
• avoiding neurological damage, which repairs
poorly,
• avoiding anticonvulsants, which impair the
effectiveness of taxane chemotherapy, and
• minimising the period of time patients are
barred from driving.
The challenges that this highly targeted therapy
present in changing the natural history of the
disease, and our approach to treatment, are just
beginning to emerge.

My Journey Kit
Breast Cancer Network Australia has produced
a comprehensive Kit for women diagnosed with
breast cancer within the last 12 months. The My
Journey Kit is a fabulous resource developed by
women who have had breast cancer. It is
available free of charge by calling 1300 785 562.
Please pass this information on to women who
have been newly diagnosed with breast cancer.
The My Journey Kit includes information about
breast cancer and its treatment, useful contacts
and resources and practical advice from other
women who have had breast cancer. It includes
the My Journey Personal Record, where women
can record details of their appointments,
treatments, costs and questions.
Source: hic.gov.au
Breast Cancer Update Centre for Clinical Research in Cancer
Page 8 Vol 52 ◆ June 2004
4th European Breast Cancer Conference
Hamburg, Germany, 16 - 20 March 2004
Dr Jacquie Chirgwin
Medical Oncologist
Box Hill & Maroondah Hospitals
One of Germany’s most affluent cities welcomed
around 4,000 registrants to rainy winter weather.
Fortunately, we were a week late for subzero
temperatures. It goes without saying that the
EBCC meetings have their distinct European
flavour, reflecting European conservatism in
oncological management, as well as European
style and taste in the mundane aspects of
conference organisation; the mainly excellent
food and beverages (avoid cholesterol
measurement any time soon however), and
classy hotels. It was also of note that this was
not a conference to hear major new data
presented for the first time – but perhaps the
scheme of things is changing, with significant
early results appearing first in journals, without
prior presentation at major meetings (eg.
Adjuvant Exemestane Study). Is this the way of
the future? Is it good?
So, this was a meeting for debate and discussion
of most clinical aspects of Breast Cancer, this
time with a particular focus on adjuvant hormonal
treatment. It provided an excellent forum in
which to reflect and consider the implications of
trial results for our day-to-day practice, for
current trial participants and for the planning of
future trials. An enjoyable and informative aspect
of the EBCC’s is the lunchtime Oxford Union style
debates. There were three debates that I will
summarise, together with related data that was
presented, which in fact will cover much of the
value of the meeting. There was also a “Late
Breaking Session” on the Aromatase Inhibitors
in adjuvant breast cancer management, as well
as several other presentations of interesting and/
or updated results that I will summarise.
The First Debate:
‘This house believes that biological
markers are measured well in clinical
practice’
The motion was Proposed by F. Penault-Llorca
(France); N. Brunner (Denmark) and
Refuted by G. Viale (Italy); R. Holland (The
Netherlands)
There appears to be plenty of data showing poor
concordance of results of ER measurement,
between different laboratories, but somewhat
better results for PR. The poor agreement
between labs appears to relate both to the actual
preparation and staining of the slides and also to
observer interpretation of results. For such an
important predictive marker as ER, this is a
significant problem that can seriously impact on
the optimum management of patients.
The situation for HER2 is no better; agreement
on IHC HER2 results, vary considerably.
Although for “central reference” laboratories,
about 96% of HER2 3+ are also FISH positive,
this is not the case for local laboratories. For
HER2 2+, about a third will be FISH positive; it is
therefore important that these are also not
misclassified locally.
It was argued that some countries have adopted
quite intense quality assurance programs to
minimise these problems, and that in particular,
laboratories that do less than 150 breast cancer
cases per year should send their tumour markers
to a central laboratory for measurement.
There is no easy answer to these problems; the
best that seems possible is careful quality
assurance and audit; routine mechanisms for this
are needed in all countries. Suffice to say, the
“Nays” had this one in the bag.
The Second Debate:
‘This house believes that early
disclosure of positive results of
randomised trials is of benefit to the
patient and the scientific community’
The motion was Proposed by Don Berry (USA);
Joyce O’Shaughnessy (USA) and Refuted by
Rich Gelber (USA); Ian Tannock (Canada)
All four speakers are eloquent presenters and
presented persuasive arguments supporting their
side of the debate. Early benefits of new
treatments rarely are lost with further time, surely
Centre for Clinical Research in Cancer Breast Cancer Update
Vol 52 ◆ June 2004 Page 9
we should use these early results to guide
treatment choices, as well as design of new trials.
In the majority of instances, disease free survival
benefits (at least in Breast Cancer) have later
translated into overall survival benefits; perhaps
it is not ethical to withhold these treatments.
However, disease free survival benefits are
usually all that is available when these results
are released. Such early release of results mean
that the risk:benefit relationships (long term
especially) are not known and it seems prudent
not to change standard practice because of these
results. In fact, all the early release of results
seems good for, is stopping trials early, and often
sabotaging the trials, with the end result that
overall survival benefits can never be estimated.
This is an important contemporary issue which
deserves debate and for which we need to
carefully plan. The most obvious answer seems
to be to design trials and “stopping rules” such
that these are only triggered when OS benefit is
demonstrated. Being a conservative European
audience, again the “Nays” had it!
The Third Debate:
‘This house believes that there is
enough data to bury Tamoxifen’
The motion was Proposed by Walter Jonat
(Germany); P. Lonning (Norway) and Refuted
by: Kathy Pritchard (Canada) and Hazel
Thornton (Consumer advocate, UK)
Much data was presented and noise generated
regarding what appear to be superior results for
adjuvant treatment with all aromatase inhibitors,
when compared to old fashioned Tamoxifen. It
is time to let go of Tamoxifen, they argued; what
patient wants to take an inferior drug….
But, whose government can pay for everybody
to have an aromatase inhibitor (AI)? It seems
likely that not all patients benefit more from an
AI, than Tamoxifen; and it is certainly likely that
some have an increased incidence of side
effects. We need more research on which
patients benefit; and indeed, perhaps the best
treatment of all is a sequence of Tamoxifen and
AI. Countries with minimal resources cannot
afford more than Tamoxifen. It is likely that there
will always be a role for Tamoxifen in advanced
disease. No, Tamoxifen is not yet dead and
buried! Most of the audience agreed that
Tamoxifen should be preserved, although there
was some notable dissent from some consumers.
So the “Nays” had this one too!
All three debates were delivered with
considerable humour and were a great way of
generating discussion of controversial issues.
Their success, though, does depend on the talent
of the presenters.
Late Breaking Session on Aromatase
Inhibitors
The International Exemestane Study (IES)
results had just appeared in the New England
Journal of Medicine (11/3/04). These results
were presented by Charles Coombes.
Altogether, 4742 patients were enrolled from 367
centres, with around 1,000 patients on subprotocols
(bone density, endocrine side effects
and QOL). 8.5% of patients remain on study
treatment, 16.5% had unknown ER and 32% had
prior chemo. Results show an absolute
difference of 4.7% (86.8-91.5%) - in the 3 year
DFS. OS hazard ratio is 0.88 (in favour of
Exemestane), which is not statistically significant.
Hypertension and IHD seem possibly to be
increased, as well as osteoporosis. We need to
wait patiently for more long-term results.
Tony Howell presented the current ATAC results
showing an absolute disease free survival (DFS)
difference at 48 months of 2.6% in favour of the
Arimidex arm (HR positive only). An Italian
Study (Boccardo, SABCS 2003) of 448 patients
HR+ve, node+ve patients completing 2-3 years
of adjuvant Tamoxifen, were randomised to
continue or to swap to Arimidex. After a median
follow up of 3 years, there was an approximate
10% improvement in event free survival for those
swapping to the Aromatase Inhibitor (P=0.0002).
It is of note that in the ATAC study, the relapse
rate peeks before 2.5 years. In the UK, the cost
of adjuvant Arimidex is estimated to be £11,000
per life year gained being an annual cost of
£6.4million (<4% UK 2003 Breast Cancer
Budget). This compares to £17 million spent on
Herceptin.
Ian Smith presented the MA17, or late Letrozole
study results. The median follow up is only 2.4
years, and the absolute DFS benefit was 6.3%
(P=0.0008); the benefit was seen in both node
negative and node positive populations. As has
been widely discussed, this study has been
stopped because this result crossed the
Breast Cancer Update Centre for Clinical Research in Cancer
Page 10 Vol 52 ◆ June 2004
boundaries of the pre-defined stopping rules. It
is likely therefore that we will never know OS
results for this intervention.
What of the ATLAS study, where predominantly
5 vs 10 years of Tamoxifen is being tested?
Martine Piccart told us over 13,000 patients have
been randomised to date, together with another
5,500 in the similar British ATTOM study. 600
events have occurred to date and the IDMC has
allowed the trial to continue. The stopping rules
of this study, however, are only crossed when
an OS benefit is demonstrated. One day,
therefore, we will hear OS results from this study,
without its conduct being compromised by early
suggestions of benefit (or detriment). However,
will we have to wait so long that the result will no
longer be relevant?
This series of studies and results (or lack thereof)
nicely demonstrate the dilemma of when results
should be released, and how we should respond
to them. There is a strong argument that OS
data are the only ones that should precipitate
early release of results and stopping of studies,
both because major shifts in patterns of
management are best guided by this, and in order
to prevent loss of useful information that occurs
when trials are closed early. However, there is
value from making early DFS results available;
this can impact on good patient care (eg. allowing
an alternative to Tamoxifen for some patients)
and can enhance trial design and speed up
progress. It seems a compromise is needed,
which can be best attended in the way our trials
are set up in relation to how they are run and
what the stopping rules are.
I will mention just one more interesting
presentation, this one by Rob Coleman, on
bisphosphonates and skeletal metastases.
Breakdown products of type 1 collagen (as a
result of bone destruction by metastases) can
be measured in urine, eg. NTX. It appears the
level of this is a very good marker of disease
activity and reflects response to treatment/
disease progression well. A kit is being
developed to measure NTX in the Clinic.
Measurement of this may be a very useful way
to monitor progress of patients with bone
metastases - currently often quite a challenge
with difficulties in bone scan interpretation.
Zometa does appear to be 20% better than
Pamidronate in multiple event analysis
(P=0.025); it may be synergistic with
chemotherapy (eg. Paclitaxel) and perhaps with
Doxorubicin (if chemo administered before
Zometa, there appears to be synergy in
producing apoptosis in MCF7 cell line; in the
reverse order there is no synergy). Conclusions
regarding the value of adjuvant bisphosphonates
are still awaited.
So, a meeting for reflection and discussion, to
go away from with renewed enthusiasm, and
new ideas for trials and patient management…
Ten Years of Women’s Voices
Ms Sue Lockwood
Breast Cancer Action Group
Ten years ago in April 1994, Marcia O’Keefe
wrote a letter to The Age about the need for an
advocacy group for women with breast cancer
in Victoria. Enough women replied to set up the
Breast Cancer Action Group. It was the very first
breast cancer advocacy group in Australia. And
many of the other groups developed from our
experiences, including advocacy groups in other
states, and the Breast Cancer Network Australia.
Marcia had previously had some unhappy
experiences with IVF treatment. She transferred
some of her concerns about the lack of
information provided to women at diagnosis,
informed consent, continuity of care to breast
cancer and the Breast Cancer Action Group.
Like all good ideas, Marcia’s identification of the
need for action came at the right time. There
were many different influences on the
development of consumer groups, e.g. the
development of the National Breast Cancer
Centre for Clinical Research in Cancer Breast Cancer Update
Vol 52 ◆ June 2004 Page 11
Centre about this time, the extraordinary
influence that the AIDS community had had on
public policy and the fast tracking of new drugs,
the investment in women’s health more
generally, the rise of evidence based medicine
and its focus on the needs of patients. All these
and other social attitudes combined to ensure
that the Breast Cancer Action Group was in the
right place at the right time.
Subsequently, the development of plans for the
improvement in services to women with breast
cancer, through the work of BreastCare Victoria
has meant that the voices of women with breast
cancer have been heard loudly and clearly in
Victoria.
But the women have done their bit as well. They
have been prepared to become representatives,
they have been trained and supported, they
have learnt heaps about their disease and the
health system, they have been prepared to work
long hours for no financial reward and they have
been committed to ensuring that the voices of
as many women as possible have been heard.
Some of the issues we have been involved with
are
! performance indicators & standards for
public hospital breast units
! waiting times for radiotherapy
! development of lymphoedema services
! reporting of breast cancer issues in the
media
! access to breast care nurses across the state
! effective and efficient provision of external
breast prostheses
! provision of Herceptin to women with
advanced breast cancer in conjunction with
Breast Cancer Action Group NSW and
Breast Cancer Network Australia
! services for women with advanced disease
! a drop in center for women, their partners
and children
! improved information resources designed
especially for the needs of women
! clinical practice and consumer guidelines for
women with early and advanced breast
cancer and women with ductal carcinoma
in situ, lobular carcinoma in situ and atypical
hyperlasia
! services for women under 40.
! speaking to national and international
conferences and clubs and societies
! messages on early detection of breast
cancer
! direct involvement with the formulation of
clinical trial protocols such as SNAC
There have been many achievements. But we
are particularly proud of three. In July this year
a new system for the provision of external breast
prostheses was introduced. This is 7 years after
women started pursuing the issue. This system
will be a vast improvement on the current one.
Another is the current emphasis on
lymphoedema. No longer do we hear the
statement that “none of my women get
lymphoedema”. It is acknowledged as a potential
problem which causes great distress to women
and as a result women are being offered
information and support through lymphoedema
clinics. Thirdly, breast care nurses are now
widely available to women in Victoria. This is, in
part, due to the support for this concept from
women and the obvious improvements in service
which have resulted from the skills of breast care
nurses.
We have not done this alone; we have worked
closely and productively with clinicians, breast
care nurses, health officials, researchers, and
others. We’ve worked in hospital, state, national
and international arenas. We’ve tried and, I think,
largely succeeded in working in partnership with
these all different groups. These relationships
have been one of the hallmarks of our success.
There will be more work to do over the next few
years. But one of the major challenges for breast
cancer consumer representatives is how to
translate what we have learned into support for
the development of consumer groups in other
cancers.
Breast Cancer Update Centre for Clinical Research in Cancer
Page 12 Vol 52 ◆ June 2004
2003 San Antonio Breast Cancer Symposium
Dr Geraldine Goss
Medical Oncologist
Box Hill and Maroondah Hospitals
San Antonio is a lovely place to visit in December;
the weather was warm, the city very attractive
and the meeting overall very interesting.
Margaritas-sensational! Clearly the importance
of this meeting is growing, and it is increasingly
a respected forum for presentation of important
new data. It is certainly less frantic than ASCO,
and thus allows for sessions where cases can
be presented by audience members to a panel
of experts, and meet the professor sessions
involve meeting and discussing data with leaders
in the field. Some selected highlights included:
Extended Adjuvant Therapy with
Letrozole
The study was a randomized, double-blind,
placebo-controlled examining the use of 5 years
of letrozole versus placebo for women with ER
positive breast cancer following 5 years
treatment with tamoxifen. The primary endpoint
was disease-free survival (DFS), with secondary
endpoints of overall survival (OS), quality of life
and long-term safety. A total of 5187 women were
followed-up for a median of 2.4 years. During
this period, 207 breast cancer events were
recorded, 75 in the letrozole group and 132 in
the placebo group, an absolute difference of
2.2%. The projected differences for letrozole vs
placebo groups at 4 years of follow-up: 4-year
DFS of 93% vs 87% (P≤0.001); 4-year OS of
96% vs 94% (p=NS). An unplanned subgroup
analysis showed at least as great benefit among
women with node-negative disease than those
with node-positive disease. Hot flashes,
arthralgia, arthritis and myalgia were significantly
more common in the letrozole group (p<0.05)
and there was a trend towards a higher rate of
newly diagnosed osteoporosis in the letrozole
group. The strengths of the study were its design
and large patient numbers, but the weaknesses
included immaturity of the data in terms of overall
survival and long term safety. No patient had
actually completed 5 years of therapy, so optimal
duration of letrozole is unknown. Overall survival
figures will never be available since women on
the placebo arm were offered active treatment.
Perhaps subgroup analyses may reveal those
more likely to benefit, however emerging data
looking at sequences of tamoxifen and
aromotase inhibitors as adjuvant therapy suggest
that the sequencing rather than the duration may
be important. Hopefully over the next few years
the optimal use of adjuvant hormonal therapy will
be elucidated.
The New Taxane
Abraxane is a nanoparticle bound paclitaxel
which is cremaphor free. It has higher intratumor
concentrations of paclitaxel and more antitumour
activity than Taxol in animal models. In this study
patients were randomly assigned to abraxane
260 mg/m2 without routine premedication
(n=229) or Taxol 175 mg/m2 with premedications
(n=225). The primary goal was to demonstrate
non-inferiority/superiority of Abraxane to Taxol
based on best confirmed response after 6 cycles
of treatment. Abraxane therapy resulted in
significantly higher response rates and longer
time to tumor progression than Taxol in both an
investigator-assessed dataset (31.4% vs 16.4%,
p<0.001; 21.9 wks vs 16.1 wks, p=0.029), and
an independently reviewed dataset (24.0% vs
11.1%, p<0.001; 21.0 wks vs 15.4 wks, p=0.014).
Grade 3/4 hypersensitivity reactions were not
observed among Abraxane treated patients, and
Gr 4 neutropenia occurred less frequently for
Abraxane (7% vs 19%, p<0.001). The incidence
of Gr 3 sensory neuropathy was 10% for ABX
vs 2% for TX, (p<0.001) with no episodes of Gr
4 neuropathy. Nail changes and severe fluid
retention occurred infrequently, with no septic
deaths. Thus ABX increased the therapeutic
index of paclitaxel with less toxicity. This
promising agent has clear activity among heavily
pretreated patients with a very favourable toxicity
profile and further studies in breast and other
cancers are awaited with interest.
Centre for Clinical Research in Cancer Breast Cancer Update
Vol 52 ◆ June 2004 Page 13
Adjuvant Therapy for Older Women
The risk of breast cancer increases with age and
currently almost half of the new patients
diagnosed with breast cancer in the U.S. are 65
years and older. These issues were discussed
in a forum focussing on adjuvant therapy in the
elderly. Although studies of adjuvant therapy
have suffered from insufficient representation of
the over 70 age group, extrapolating from
patients 50 to 69 years old in trials analyzed by
the EBCTCG suggests that patients above 70
are likely to derive the same benefits as other
postmenopausal women in reducing the annual
risk of relapse and death. Figures presented
regarding life expectancy suggested that a 70
year old woman can expect an average of 16
further years of life, while an 80 year old can
expect another 9 years. Despite this, older
women with breast cancer are less likely to have
mammographic screening, less likely to be
offered breast conserving surgery, and breast
radiation, and less likely to be offered adjuvant
systemic therapy. Although breast cancer tends
to have more favorable biologic characteristics
in older patients, age and stage adjusted survival
is similar for older and younger patients - the
exception being the very young (<40 years) and
the very old (85+ years). Clearly comorbidity is
the critical factor in deciding on optimal treatment
but age alone should not exclude women from
optimal adjuvant therapy. Older patients should
be considered for chemotherapy if they have
reasonable life-expectancy (5-10 years) and
large, ER and PR-negative, node negative (N-)
lesions or if they are node-positive (N+).
Additional data were presented regarding quality
of life among older women suggested that body
image disturbance following mastectomy is much
greater than that following breast conservation,
and that age again should not be the sole
determining factor in choice of surgical approach.
TAC versus FAC: Update
Data from this study involving 1,491 women first
presented at ASCO 2002 with a median followup
of 33 months and 289 events showed
significant improvement in disease free survival
(DFS) in favor of TAC. At San Antonio the
second interim analysis at a median follow-up of
55 months with 399 DFS events was reported.
For DFS, there were 172 events on TAC and
227 on FAC: 80% and 75% of pts on TAC were
alive and disease-free at 4 and 5 years
respectively, vs.71% and 68% on FAC. For OS,
there were 91 events on TAC and 130 on FAC:
89% and 87% of pts on TAC were alive at 4
and 5 years respectively, vs. 85% and 81% on
FAC. There were no changes in the toxicity
profile since the first interim analysis. TAC is
clearly one of the most active adjuvant treatments
in patients with node positive early breast cancer,
although with much greater toxicity, especially
of febrile neutropenia. It seems likely that optimal
adjuvant therapy will include both anthracycline
and taxane, however optimal dose interval and
sequencing of these drugs is not yet known.
An enjoyable and informative meeting!
National Breast Cancer Centre Report
Clinical Guidelines for Young Women
with Breast Cancer Released
The National Breast Cancer Centre (NBCC) has
developed Clinical practice guidelines for the
management and support of younger women
with breast cancer to assist younger women with
breast cancer and their doctors in making
decisions about all aspects of their care.
The impact of a diagnosis of breast cancer and
the treatment considerations for a woman aged
40 years or younger may be quite different from
those of an older woman with this disease.
Although the incidence is lower in younger
women, they are more likely to be diagnosed with
larger, more aggressive tumours and have worse
disease-free and overall survival outcomes
compared with their older counterparts.
Younger women are also more likely to
experience psychological distress. Issues of
body image, sexuality and fertility are especially
Breast Cancer Update Centre for Clinical Research in Cancer
Page 14 Vol 52 ◆ June 2004
significant for younger women. In addition, the
decisions about treatment must be balanced
against the survival benefits and impact on the
quality of life.
The NHMRC approved Clinical practice
guidelines for the management and support of
younger women with breast cancer are available
free to clinicians. Information for younger women
with breast cancer, including questions to help
women in their discussions with their treatment
team has been developed and is available on
the National Breast Cancer Centre website. This
information is intended to complement NBCC
publications: A guide for women with early breast
cancer and A Guide for women with metastatic
breast cancer.
Consumer Friendly Guide to DCIS
What’s the difference between ductal carcinoma
in situ (DCIS) and invasive breast cancer? Why
does it need to be treated? And what are the
treatment and support options? These are
commonly asked questions by the 1200
Australian women diagnosed each year with
DCIS. While most women’s prognosis is
excellent, many women may still feel confused
because DCIS has a similar clinical diagnosis
and treatment as invasive breast cancer. The
NBCC’s guide, Ductal carcinoma: Understanding
your diagnosis and treatment, is written in a
friendly, easy-to-read format with anecdotes from
women who have been diagnosed and treated
for this condition.
The publication of this consumer guide follows
the NBCC’s release in September of the clinical
recommendations for the management of DCIS,
LCIS, ADH and ALH (http://www.nbcc.org.au/
bestpractice/dcis/). Consumer Information about
other pre-invasive breast changes, lobular
carcinoma in situ (LCIS) and atypical hyperplasia
(AH) is also available. Copies of NBCC
publications can be downloaded from
www.breasthealth.com.au or can be ordered
through; email directorate@nbcc.org.au or
Freecall 1800 624 973. The National Breast
Cancer Centre is funded by the Australian
Department of Health & Ageing.
The Ovarian Cancer Program Report
First Clinical Practice Guidelines for the
management of women with epithelial ovarian
cancer. Australia’s first guidelines for treating
women with ovarian cancer, have been
approved and are being printed by the NHMRC.
The guidelines have been developed by the
Australian Cancer Network and the National
Breast Cancer Centre’s Ovarian Cancer
Program. The Ovarian Cancer Program will
undertake the dissemination of the guidelines
using a number of strategies such as interactive
seminars for clinicians and health professionals
in metropolitan and regional areas across
Australia. The guidelines will be available in June.
National Ovarian Cancer Forum Report
Available
In February the Ovarian Cancer Program hosted
a national forum – Ovarian cancer: health service
delivery supporting best practice – in Sydney.
The forum was co-sponsored by the Australian
Government Department of Health and Ageing;
OvCa Australia; The Australian Cancer Network;
and the Gynaecological Research Fund
(Westmead Hospital).
Included in the 80 people who attended the
forum, were clinicians and allied health
professionals involved in the care of women with
ovarian cancer; senior representatives from
federal and state health departments and
relevant medical colleges, consumers and
consumer organizations. The Ovarian Cancer
Program will use the issues highlighted at the
forum to guide its work in ovarian cancer.
A report about the forum, including copies of the
presentations, is now available. Publications from
the Ovarian Cancer Program can be downloaded
from the Ovarian Cancer Program website
www.ovariancancerprogram.org.au. Copies of
the guidelines can also be ordered through the
website or email: directorate @nbcc.org.au or
Freecall 1800 624 973.
The Ovarian Cancer Program is managed by the
National Breast Cancer Centre and is funded by
the Australian Department of Health & Ageing.
For information about these and other projects
from National Breast Cancer Centre, Freecall
1800 624 973, email: directorate@nbcc.org.au
or visit www.breasthealth.com.au
Reprinted from Wongi Yabber May 2004; 11(2): 4-5
Centre for Clinical Research in Cancer Breast Cancer Update
Vol 52 ◆ June 2004 Page 15
Key Published Articles Listing—Breast Cancer
Title Author & Journal
Key Published Articles Listing—General
Title Author & Journal
Adjuvant chemotherapy followed by Goserelin
versus either modality alone for premenopausal
lymph node negative breast cancer: A
randomised trial
Ovarian ablation as adjuvant therapy for
premenopausal women with breast cancer –
Another step forward – Editorial
Adjuvant endocrine therapy compared with no
systematic therapy for elderly women with early
breast cancer: 21-year results of International
Breast Cancer Study Group Trial IV
A randomised trial of Exemestane after two to
three years of tamoxifen therapy in
postmenopausal women with primary breast
cancer
Comparison of outcomes in cancer patients
treated within and outside clinical trials:
conceptual framework and structural review
Body mass index as a prognostic feature in
operable breast cancer: the International Breast
Cancer Study Group experience
IBCSG.
J Natl Cancer Inst December 2003; 95(24): 1833–
1846.
Pater JL and Paruleker WR.
J Natl Cancer Inst December 2003; 95(24): 1811–
1812.
Crivellari D, Price K, Gelber RD, et al.
J Clin Oncol 2003; 21: 4517–4523.
Coombes RC, Hall E, Gibson LJ, et al.
New England Journal of Medicine March 2004:350
(11): 1081–1092.
Peppercorn JM, Weeks JC, Cook EF & Joffe S.
Lancet 24 January 2004; 363(9405): 263–270.
Berclaz G, Li S, Price KN et al
Annals of Oncology 2004; 15: 875-884
Potential health risks of complementary alternative
medicines in cancer patients
Werneke U, Earl J, Seydel C, et al.
British Journal of Cancer 26 January 2004; 90(2):
408–413.
What’s the harm? Alternative medicine is not
everything to gain and nothing to lose
Shermer H.
10 November 2003.
www.sciam.com/
The current position of complementary /
alternative medicine in cancer
Ernst E.
European Journal of Cancer November 2003; 39(16):
2273–2277.
Breast Cancer Update Centre for Clinical Research in Cancer
Page 16 Vol 52 ◆ June 2004
The regulation of complementary health:
Sacrificing integrity?
It’s natural so it must be safe – Editorial
Parker MH.
Medical Journal of Australia 15 September 2003;
179(6): 316–318.
Interactions between complementary
medicines and warfarin
Smith A.
Australian Prescriber 2002; 25(3): 50–51.
An analysis of newspaper reports of cancer
breakthroughs: Hype or hope?
Myers SP.
Australian Prescriber 2002; 25(3): 54–56.
Public funding of large-scale clinical trials in
Australia – Letter to Editor
Ooi ES & Chapman S.
Medical Journal of Australia 15 December 2003;
179(11/12): 639–643.
Making sense of trial results: Outcomes and
estimation
A Rodger.
Medical Journal of Australia 2004; 180(5): 255.
Comparison of outcomes in cancer patients
treated within and outside clinical trials:
Conceptual framework and structured review
O’Connell RL, Gebski VJ and Jeech AC.
Medical Journal of Australia 2004; 180(3): 128–130.
The Clinical Support Systems Program
Peppercorn JM, Weeks JC, Cook EF & Joffe S.
The Lancet 24 Jan 2004; 363(9405): 263–270.
Turning an idea into reality to improve patient
care: The development of the Clinical Support
Systems Program
Leigh JA, Long PW, Phillips PA & Mortimer RH.
Medical Journal of Australia 2004; 180 (10
Suppl):S74-S75
The Ethics of Early Stopping Rules: Who is
Protecting Whom?
Sewell J, Leigh JA & Long PW.
Medical Journal of Australia 2004; 180 (10 Suppl):
S76–S78.
Cannistra SA
JCO May 2004 22; (9): 1542-45
Centre for Clinical Research in Cancer Breast Cancer Update
Vol 52 ◆ June 2004 Page 17
Forthcoming Meetings
Date / Place Meeting / Contact
9–11 June 2004
Milan, Italy
6th Milan Breast Cancer Conference
Organising Secretariat: Daniela Mengato, Francesca Marangoni
European School of Oncology, Viale Beatrice d’Este, 37, 20122 Milan, Italy
Ph: +39 02 4335 9611
Fax: +39 02 4335 9640
E-mail: conferences@esoncology.org
16–19 June 2004
Marbella, Malaga, Spain
3rd European Spring Oncology Conference
Bn&Co Congress Management, Avda. Tribuna 7 – Urb. Fuente del Fresno,
S.S. de los Reyes (Madrid) Spain
Ph: +34 91 623 6736
Fax: +34 91 623 6890
E-mail: esocmarbella@bnyco.com
Website: www.esomarbella.com
25–29 June 2004
Montreal, Canada
23rd International Congress of Radiology (ICR)
ICR, 1740 Cote-Vertu Blvd, Saint-Laurent, Quebec H4L 2A4 Canada
Ph: +1 514 738 3111
Fax: +1 514 738 5199
E-mail: info@car.ca
3–6 July 2004
Innsbruck, Austria
18th Meeting of the European Association for Cancer Research (EACR)
EACR 18 Secretariat, Federation of European Cancer Societies, Avenue E
Mounier 83, Brussels, Belgium 1200. Contact: Ms Davi Kaur
Ph: +32 2 775 0201
Fax: +32 2 775 0200
E-mail: eacr18@fecs.be
Website: www.fecs.be/conferences/eacr18
12–17 July 2004
Sydney, NSW, Australia
Joint Annual Scientific Meeting of the ANZ BCTG & IBCSG
Sydney Breast Cancer Trials Symposium Congress Secretariat, GPO Box
2609, Sydney NSW 2001 Australia
Tel: (02) 9241 1478
Fax: (02) 9251 3552
E-mail: info@sbcts.org
Website www.sbcts.org
4–7 August 2004
Cairns, QLD, Australia
Medical Oncology Group of Australia (MOG) Annual Scientific Meeting
Contact: Pharma Events, PO Box 265, Annandale NSW 2038
Ph: (02) 8247 6207
Fax: (02) 9380 9033
E-mail: conferences@pharmaevents.com.au
Website: www.racp.edu.au/moga/index.html
Breast Cancer Update Centre for Clinical Research in Cancer
Page 18 Vol 52 ◆ June 2004
8–12 August 2004
Sydney, NSW, Australia
13th International Conference on Cancer Nursing 2004
Organised in partnership between ISNCC and the Cancer Nurses
Society of Australia (CNSA). Contact Liz Peim
Ph: +44 116 270 3309
Fax: +44 116 270 3763
E-mail: conference@isncc.org
Website: www.isncc.org/conference_2004/2004_Intro.html
8–14 August 2004
Palm Cove, QLD, Australia
Australia & Asia Pacific Clinical Oncology Research
Development (ACORD) Workshop
Contact: Medical Oncology Group of Australia, Level 6, 52 Phillip
Street, Sydney 2000
Ph: (02) 8247 6207
Fax: (02) 9247 3022
E-mail: fmarine@bigpond.com
18–21 August 2004
Couran Cove, QLD, Australia
KConFab & Australian Ovarian Cancer Study (AOCS) & Family
Cancer Clinics of Australia and New Zealand
Email: heather.thorne@petermac.org or
nadia.traficante@petermac.org
Website: www.kconfab.org
3–7 October 2004
Atlanta, Georgia, USA
46th Annual Meeting of the American Society for Therapeutic
Radiology and Oncology (ASTRO)
Secretariat: ASTRO, 12500 Fair Lakes Circle, Suite 375, Fairfax VA
22033, USA
Ph: +1 703 227 0170
Fax: +1 703 502 7852
E-mail: meetings@astro.org
21–24 October 2004
Perth, WA, Australia
55th Annual Scientific Meeting of the Royal Australian & New
Zealand College of Radiologists (RANZCR)
Website: www.ranzcr.edu.au
24–28 October 2004
Amsterdam, Netherlands
23rd Annual Meeting of the European Society for Therapeutic
Radiology & Oncology (ESTRO)
ESTRO Office, Av. E. Mounierlaan 83/4, Brussels, Belgium B-1200
Ph: +32 2 775 9340
Fax: +32 2 779 5494
E-mail: info@estro.be
Website: www.estro.be
29 Oct – 2 Nov 2004
Vienna, Austria
29th Congress of the European Society for Medical Oncology
(ESMO)
ESMO Congress Secretariat, Via La Santa 7, CH-6962 Viganello-
Lugano, Switzerland
Ph: +41 91 973 1919
Fax: +41 91 973 1918
E-mail: alessia@esmo.org
Website: www.esmo.org/congress2004/
Centre for Clinical Research in Cancer Breast Cancer Update
Vol 52 ◆ June 2004 Page 19
8–9 November 2004
Brisbane, QLD, Australia
27th Annual Oncology Nurses Group Conference
10–12 November 2004
Hong Kong, China
11th Hong Kong International Cancer Congress
Contact: 11th HKICC Congress Secretariat
Ph: 852 2818 0232
Fax: 852 2818 1186
E-mail: hkicc04@hku.hk
Website: www.hkicc.org
10–14 November 2004
Sydney, NSW, Australia
Leura V International Breast Cancer Conference
Organised by NSW Breast Cancer Institute. Secretariat: Leura V
Conference Managers, Tour Hosts Conference & Exhibition Organisers,
Level 4, 66 King Street, Sydney NSW 2000, Australia
Ph: (02) 9248 0800
Fax: (02) 9248 0894
E-mail: nswbci@tourhosts.com.au
Website: www.bci.org.au/leura
17–18 November 2004
Melbourne, VIC, Australia
Australian Breast Cancer Conference
Organised by VBCRC and National Breast Cancer Foundation
1st International Conference for Oncologists and Other Health Care
Leaders
Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York NY
10021, USA
Ph: +1 212 639 200
E-mail: cassileth@mskcc.org
31st Annual Scientific Meeting of the Clinical Oncology Society of
Australia (COSA) – Cancer Care: An Integrated Approach
Conference details: Pharma Events
Ph: (02) 9280 0577
Fax: (02) 9280 0533
E-mail: cosa@pharmaevents.com.au
Website: www.cosa.org.au
17–19 November 2004
New York City, New York,
USA
24–26 November 2004
Canberra, ACT, Australia
28 Nov – 3 Dec 2004
Chicago, Illinois, USA
90th Meeting of the Radiological Society of North America
Radiological Society of North America, 820 Jorie Blvd, Oak Brook, IL 60521
USA
Fax: +1 630 571 7837
E-mail: reginfo@rsna.org
Website: www.rsna.org
8–11 December 2004
San Antonio. Texas, USA
27th Annual San Antonio Breast Cancer Symposium
Secretariat: Rich Markow, Symposium Coordinator, CTRC Research
Foundation d.b.a. San Antonio Breast Cancer Symposium, 7979 Wurzbach
Rd, Rm U-531, San Antonio – 78229 – Texas, USA
Ph: +1 210 616 5912
Fax: +1 210 949 5009
E-mail: rmarkow@saci.org
Website: www.sabcs.org
The Cancer Council Victoria
The Cancer Council Victoria is a public institution set up by an Act of Parliament in 1936. It operates as
a charity, relies heavily on volunteer support, and raises and spends $3–$4 per head of population
annually. It is governed by the Council and Executive and other committees. It’s mission is to lead,
coordinate and evaluate action to minimise the human cost of cancer for all Victorians. The Cancer
Council houses three research divisions (behavioural science, clinical research, epidemiology) and units
undertaking public and professional education, cancer registration, cancer information and support
services, anti-smoking campaign (QUIT), finance, administration and fund raising. It employs about 150
staff. The Cancer Council also auspices a cooperating network of cancer specialists through the Victorian
Cooperative Oncology Group and resources an expert Medical & Scientific Committee to dispense
studentships, scholarships, fellowships and research grants to other academic, research and medical
institutions.
Centre for Clinical Research in Cancer — Victorian Cooperative Oncology Group
The Centre for Clinical Research in Cancer (CCRC) formed in 1997, provides a coordinated and effective
resource for collaborative clinical research and development in Victoria. The Centre provides administrative
and research support for the Victorian Cooperative Oncology Group, which brings together Victoria’s
cancer specialists. The Centre fosters and facilitates the development and promotion of a range of
collaborative clinical measures to optimise cancer management.
The Victorian Cooperative Oncology Group (VCOG) established in 1976, provides advice to the Cancer
Council Victoria, through the CCRC, on all clinical aspects of cancer control, in particular research,
screening, diagnosis, treatment, palliative medicine, cancer genetics and professional education. The
strategic role of VCOG is to have a ‘parliament’ of clinical cancer specialists with a view to promoting a
range of cooperative measures to optimise cancer treatment in Victoria. VCOG consists of a primary
committee, 8 cancer-site and 4 task-specific advisory committees, and 5 trial research sub-committees.
These committees bring together in regular meetings approximately 400 key specialist health care
professionals and scientists, representing the various treatment disciplines and centres in Victoria. VCOG
has established unique linkages between public and private health care professionals, institutions and
governments.
Centre for Clinical Research in Cancer
CCRC
Administrative Secretariat
Clinical Trials Office
CCRC-VCOG Executive Committee
Victorian Cooperative Oncology Group: 1976
Breast: 1978
Breast Trials: 1978
Gynaecological: 1984
Ovarian Research: 2000
Palliative Medicine: 1988
Palliative Research: 2000
Urological: 1994
Skin: 1997
Head & Neck: 1999
Gastrointestinal: 1981
Gastrointestinal Trials: 1994
Cancer Trials: 1986
Lung: 1993
Genetics: 1995
Hereditary Bowel: 2000
Psycho-Oncology: 1998
Neuro-Oncology: 1999