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MRC trial shows single dose of drug is as effective as two weeks' radiotherapy for testicular cancer

22 July 2005

The largest-ever randomised trial in testicular cancer, funded by the Medical Research Council (MRC), has shown that a single dose of a drug called carboplatin is as effective as two to three weeks of daily radiotherapy. The results of the nine-year trial are published in this week's edition of The Lancet. The lead scientists, from Barts and The London, Queen Mary's School of Medicine and Dentistry, University of Wales, Cardiff and the MRC Clinical Trials Unit, say carboplatin could become the preferred treatment for the most common type of testicular cancer. It could also greatly assist resource-poor countries where access to radiotherapy equipment is limited.

Nearly 2000 men in the UK are diagnosed with testicular cancer each year and the incidence has doubled in the last 30 years. Most men are diagnosed when the cancer is confined to the testis, known as stage I disease. The most common type of stage I testicular cancer is seminoma and the standard treatment for it is surgery to remove the cancerous testicle, followed by a course of radiotherapy. Radiotherapy is extremely effective in preventing recurrence of the cancer, but has known disadvantages. In the short term, there is a risk of temporary infertility and of developing gastric irritation. In the longer term, more serious problems can include damage to the cardiovascular system and a slightly increased risk of developing new primary cancers in other organs.

Earlier small-scale trials led by Tim Oliver, Professor of Medical Oncology at Barts and The London, Queen Mary's School of Medicine and Dentistry, had suggested that a single injection of an existing cancer drug called carboplatin may be an effective alternative treatment to radiotherapy.

This large-scale randomised trial was conducted by the MRC Clinical Trials Unit, in collaboration with Professor Oliver and radiotherapy specialist Professor Malcolm Mason, University of Wales, Cardiff. It directly compared a group of patients treated with radiotherapy and another group treated with carboplatin. Nearly 1500 men from 70 hospitals in 14 countries took part in the trial. The results showed that a single injection of carboplatin was as effective in preventing recurrence as two to three weeks of daily radiotherapy. In addition, in the three months after starting treatment, patients treated with carboplatin took less time off work and suffered substantially less lethargy than those having radiotherapy. Another preliminary finding was that patients receiving carboplatin were less likely to develop tumours in their remaining testicle.

The principal investigator, Professor Tim Oliver said, "This large trial establishes, after 20 years of research and uncertainty, that one dose of carboplatin in the short term is as safe as radiation and it's less toxic. It might also open the way to enabling lumpectomy surgery for stage I seminoma and using chemotherapy for testis conservation."

Sally Stenning, senior statistician at the MRC Clinical Trials Unit added, "We will need to follow patients for several more years before we can be certain that tumour recurrence has been prevented rather than just delayed, but these results are nevertheless extremely encouraging. They are particularly good news for those countries where radiotherapy equipment is scarce."

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For further information, or to arrange an interview, please contact the MRC press office on 020 7637 6011

Notes to editors:

  • 1. Professor Oliver initiated the idea for the trial; this was developed in collaboration with Professor Mason and Sally Stenning, senior statistician at the MRC Clinical Trials Unit where the trial was coordinated and analysed, on behalf of the Medical Research Council's testicular tumour working party. It was run in collaboration with the genitourinary cancer group of the European Organisation for Research and Treatment of Cancer (EORTC), based in Brussels.
  • 2. Between 1996 and 2001, the researchers randomly assigned 543 patients with stage I seminoma to receive a single course of carboplatin and 904 patients to receive radiation therapy. After a median follow-up of 4 years, they found that relapse-free survival was similar between the two groups (97.7% for the carboplatin group vs. 96.7% for radiation therapy at 2 years). While it is impossible to prove that two treatments are identically effective, the margin of error in this large trial is small and allows differences in the two-year relapse-free rates or more than 3% to be excluded reliably. More unexpected was the finding that at 5 years the risk of developing a new tumour in the remaining testis was reduced by approximately three quarters - from 1.96% after radiotherapy to 0.54% after carboplatin.
  • 3. The Medical Research Council (MRC) is a national organisation funded by the UK tax-payer. Its business is medical research aimed at improving human health; everyone stands to benefit from the outputs. The research it supports and the scientists it trains meet the needs of the health services, the pharmaceutical and other health-related industries and the academic world. MRC has funded work which has led to some of the most significant discoveries and achievements in medicine in the UK. About half of the MRC's expenditure of more than £500 million is invested in its 40 Institutes, Units and Centres. The remaining half goes in the form of grant support and training awards to individuals and teams in universities and medical schools.
  • 4. Queen Mary is the fourth largest of the Colleges of the University of London. Its roots lie in four historic colleges: Queen Mary College, Westfield College, St Bartholomew's Hospital Medical College and the London Hospital Medical College. Pooling strengths, expertise and resources, Queen Mary is now fully integrated. The College currently has over 9600 undergraduate and postgraduate students, with an academic and support staff of around 2600. It is organised into the four faculties of Arts; Engineering and mathematical Sciences; Law and Social Sciences; and Natural Sciences, and Barts and The London, Queen Mary's School of Medicine and Dentistry. It is a research university, with over 80% of research staff working in departments where research is of international or national excellence (RAE 2001). It has a strong international reputation, with over 20 per cent of students coming from over 100 countries.
  • 5. The researchers would like to acknowledge the National Cancer Research Network (NCRN), which provided the infrastructure to support patient recruitment. NCRN was set up by the UK government, as part of the NHS Cancer Plan, to increase the number of cancer patients participating in clinical trials.
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