EBCC Calls For European Countries To Speed Access To Innovative Advances For All Breast Cancer Patients

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EBCC Calls For European Countries To Speed Access To

Innovative Advances For All Breast Cancer Patients

Main Category: Breast Cancer News

Article Date: 25 Mar 2006 - 0:00am (UK)

Breast cancer specialists and advocates at the 5th

European Breast Cancer Conference (EBCC-5) called

today for patients to have equal and speedy access to

new breast cancer treatments and procedures, as soon

as they are validated by comparative clinical trials.

Doctors and patient groups fear that women across

Europe are not getting timely access to new drugs and

devices that could help prolong their survival and

well-being. Recent advances in intra-operative

radiation therapy and reconstructive surgery to the

breast have been made accessible quickly to women in

the United States, but even getting on to the relevant

clinical trial has proved almost impossible for their

European counterparts.

Last year Italian and English studies demonstrated the

feasibility of intra-operative radio- therapy. They

found that delivering radiation directly to the open

breast during surgery appeared to be potentially as

effective as six weeks of external radiotherapy.

Patients had their breast cancer surgically removed

and their radiotherapy treatment all in one stay in

hospital. The new treatment also limited radiation

exposure to the rest of the patients' skin and other

organs, preventing further tissue damage. However,

there are only a few centres across Europe that can

carry out intra-operative radiotherapy and many

patients cannot benefit from these advances. Patients

are still facing long waiting times and have to travel

long and tiring distances to radiotherapy centres.

The psychological impact of having a breast removed

due to cancer has been well documented. However, new

advances in reconstructive breast surgery can

significantly improve a patient's confidence and

well-being; unfortunately these surgical techniques

are not available to all European patients. Breast

surgeons can now perform a mastectomy that removes the

malignant tumour and surrounding breast tissue whilst

sparing the nipple. Nipple saving surgery can vastly

improve the look and feel of the breast and improve a

patient's self confidence.

Surgeons can now reconstruct a breast immediately

after the cancer is removed using artificial implants

or even the body's own tissue (autologous tissue

reconstruction) or a combination of tissue

reconstruction and implants. Breast reconstruction is

a complex procedure that needs to be performed by a

skilled plastic surgeon, unfortunately not all

patients have access to surgeons who can carry out

these new techniques.

Another topical example of complexity in access to

treatments is the case of the drug trastuzumab

(Herceptin). Currently the drug is licensed by the

EMEA (European Medicines Agency) for women with

advanced stage breast cancer but not for those with

the early stages of the disease. The recent results of

four large clinical trials showed a significant

reduction in breast cancer recurrence for women with

HER2 positive breast cancer, when given the drug

post-surgery. Breast cancer doctors claim that the

results of the four trials are sufficiently compelling

to recommend adjuvant trastuzumab as a standard option

after surgery in appropriate patients. The lagtime

between the announcement of the results of the

clinical trials and the submission of the applications

by the industry, the lack of clear definition of

‘appropriate patients', the diversity of the national

healthcare systems (even within the EU) and their

heterogeneous policies of reimbursement may prevent

hundreds of patients enjoying the benefits of this

drug when they need it.

Dr Alberto Costa, President of the EBCC-5 conference

comments, “Action needs to be taken so that women in

different countries have equal and quick access to new

and better treatments and procedures. It is

regrettable that so many women are still not receiving

the treatment that gives them the best chance of

survival and best quality of life.”

EMEA European Medicines Agency is a decentralised body

of the European Union. Its main responsibility is the

protection and promotion of public health, through the

evaluation and supervision of medicines for human use.

The EMEA coordinates the evaluation and supervision of

medicinal products throughout the European Union. The

EMEA was founded in 1995, when the European system for

authorising medicinal products was introduced,

providing for a centralised and a mutual recognition

procedure.

The EMEA has a role in both, but is primarily involved

in the centralised procedure. Where the centralised

procedure is used, companies submit one single

marketing authorisation application to the EMEA. A

single evaluation is carried out through the Committee

for Medicinal Products for Human Use (CHMP). If the

Committee concludes that quality, safety and efficacy

of the medicinal product is sufficiently proven, it

adopts a positive opinion. This is sent to the

Commission to be transformed into a single market

authorisation valid for the whole of the European

Union. http://www.emea.eu.int

Catalognr: 436

Herceptin adjuvant trials - 2006 update

J. Baselga, Hospital Universitari Vall d'Hebron,

Department of Medical Oncology, Barcelona, Spain

HER2 overexpressing breast cancers display an

aggressive clinical course.

Trastuzumab (Herceptin) a recombinant monoclonal

antibody against HER2, improves the survival in women

with advanced HER2 overexpressing breast cancer. In

order to test the hypothesis of whether its use in the

adjuvant setting may prolong survival, four large

multicenter trials were designed to test the role of

trastuzumab as adjuvant therapy after surgical

treatment of primary breast cancer. These trials have

enrolled over 11,000 patients and their initial

results have been recently reported (the HERA trial,

the combined analysis of the B-31 and N9831 studies,

and the BCIRG006 study)(1-3)Importantly, these trials

had different designs that looked at the trastuzumab

question from different angles: The HERA trial was a

pure sequential study with trastuzumab given for 1 or

2 years after the chemotherapy of choice; the B-31 and

N9831 trials were anthracycline and taxane-based and

included one arm with concomitant administration of a

taxane and trastuzumab.

Finally, the BCIRG study had a non-anthracycline

containing arm. With a very brief follow-up (one to

two and a half years), all four trials show highly

significant reductions in the risk of recurrence. The

HERA trial at a one year of follow up shows a 46

percent reduction in risk and an absolute benefit in

terms of disease-free survival at 2 years of 8.4 %.

The trials B-31 and N9831 result in a risk reduction

of a breast cancer event at 3 years by 52% and with a

longer follow than the HERA trial shows a survival

advantage. Finally, the BCIRG at a median follow up of

23 months shows an improvement in disease free

survival of 51% in the trastuzumab-anthracycline

containing arm and of 39% in the trastuzumab

non-anthracycline arm (no statistically significant

difference between the 2 trastuzumab containing arms)

unresolved questions remain.

What is the optimal schedule for therapy with

trastuzumab: should it be given simultaneously with or

sequentially after chemotherapy? What is the nature

and reversibility of cardiac dysfunction? The data so

far provides reassuring information about recovery and

symptomatic control of heart failure in the majority

of patients, although longer follow up is required. It

will also be important to have a longer follow up in

the non-anthracycline containing arm in the BCIRG

trial. Finally, the adequate duration of trastuzumab

administration is still unknown.

In the meantime, the results of the these 4 are

sufficiently compelling to consider adjuvant

trastuzumab as a standard option at completion of

locoregional therapy and (neo) adjuvant chemotherapy

for women who fulfil the study eligibility criteria

for these trials.

1. Piccart-Gebhart, M. J. et al. N Engl J Med 353,

1659-1672 (2005)

2. Romond, E. H. et al. N Engl J Med 353, 1673-1684

(2005).3. Slamon, D. et al. 28 th Annual San

Breast Cancer Symposium (2005).

http://www.fecs.be/emc.asp?pageId=611 & Type=P