Call to speed access to innovative advances for all breast cancer patients

Breast cancer specialists and advocates at the 5th European Breast Cancer Conference (EBCC-5) called 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."