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. www.emea.eu.int
For further information please contact:
Stéphanie Makin, Tonic Life Communications, firstname.lastname@example.org
EBCC5 press office: Tuesday 21st March – Friday 24th March 2006
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Fax: +33 4 93 92 84 04
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 Antonio Breast Cancer Symposium (2005).
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