The International SUPREMO trial (Selective Use of Postoperative Radiotherapy after Mastectomy) trial, will recruit 3700 women internationally to assess the benefits of radiotherapy after mastectomy in women at intermediate risk of recurrence of cancer. The study will also look at the long-term risks of damage to the heart posed by cancer treatments.
Principal investigator Dr. Ian Kunkler, a University of Edinburgh lecturer and clinician at the city's Western General Hospital said: "Approximately 1200 women each year in the UK undergo mastectomy for this type of breast cancer. Radiotherapy can be very effective in reducing the risk of recurrence of breast cancer on the chest wall in 'high risk' patients. However the role of radiotherapy in women at lower risk of recurrence is uncertain and is important to determine.
"The trial aims to identify a molecular signature of breast cancer which may refine the selection of patients for radiotherapy. This will involve a small portion of each patient's cancer tissue being archived in a tissue microarray for future analysis."
Dr. Kunkler added: "Many women are successfully treated by chemotherapy and radiotherapy after a mastectomy. However, chemotherapy and radiotherapy may cause damage to the heart after several years. In UK patients, a protein called brain natriuretic peptide will be investigated as a possible early marker of cardiac damage. Echocardiography and electrocardiography (ECGs) will also be used additionally to identify cardiac toxicity.
"There is little information on the effects of radiotherapy after a mastectomy on patients' quality of life. Increasingly, young women may undergo breast reconstruction after mastectomy. They may also need radiotherapy to reduce the risk of recurrence. Internationally recognised measures will be used to study the impact of radiotherapy on quality of life of UK patients, including those who have undergone breast reconstruction. "Radiotherapy is a relatively cost-effective treatment. However, if the trial shows significant benefits from radiotherapy, there will be a cost to the NHS. The cost effectiveness of radiotherapy in this setting will be studied."
Researchers from universities, hospitals and the charity Cancer Research UK, in Glasgow, London and Leeds will link with colleagues in Edinburgh to look at the risk of heart problems in those who have been treated for the disease. They will also explore the general quality of life in women who have had chemotherapy and radiotherapy to treat breast cancer, and who may also have had breast reconstruction.
The trial is funded by the UK Medical Research Council and is co-sponsored by the University of Edinburgh and Lothian Health Board, and supported by the European Organisation for Research on Treatment of Cancer (EORTC) and the Breast International Group (BIG) which coordinates breast cancer trials worldwide.
More than 120 centres have registered to participate in the trial.
Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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