Trial shows single dose of drug is as effective as two week's radiotherapy for testicular cancer

Man contemplating his future

22 July 2005

The largest-ever randomised trial in testicular cancer, devised by a Queen Mary scientist and 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. Tim Oliver, Professor of Medical Oncology at Barts and The London, Queen Mary’s School of Medicine and Dentistry, initiated the idea for the trial which was developed in collaboration with scientists from the University of Wales, Cardiff and the MRC Clinical Trials Unit. They show that carboplatin could become the preferred treatment for the most common type of testicular cancer as well as greatly assist resource-poor countries where access to radiotherapy equipment is limited.  The results of the nine year trial are published in this week’s edition of The Lancet.

Nearly 2,000 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 1 disease. The most common type of stage 1 testicular cancer is seminoma for which standard treatment is surgery to remove the cancerous testicle, followed by a course of radiotherapy. Whilst radiotherapy is extremely effective in preventing recurrence of the cancer, it has known disadvantages. In the short term, there is a risk of temporary infertility and of developing gastric irritation. Longer term, more serious problems 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 Queen Mary’s Professor Oliver had suggested that a single injection of an existing cancer drug called carboplatin may be an effective alternative treatment to radiotherapy.

The large-scale randomised trial was funded by the MRC Clinical Trials Unit, and conducted 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.

Lead 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, it’s less toxic. It might also open the way to enabling lumpectomy surgery for stage 1 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 development has been prevented rather than just delayed, but these results are nevertheless extremely encouraging. They are particularly good news for those countries where radiotherapy treatment is scarce.” 

For further information, please contact:

Alexandra Fernandes
Deputy Head of Communications
Queen Mary, University of London
Tel: +44 (0) 20 7882 7910
email: a.fernandes@qmul.ac.uk

Notes to Editors:

Professor Tim Oliver

• 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.
• 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 3 years, they found that relapse-free survival was similar between the two groups (98.1% for the carboplatin group vs. 97.2% for radiation therapy at 2 years, and 95.4% vs. 96.6% at 3 years), and that differences of 3% or more could be excluded reliably. More surprising was that at 5 years there was a 72% reduction (0.54% v 1.96%) of seminomatous tumour in the remaining testis in the carboplatin group compared to the radiation therapy group.
  

The Medical Research Council

• 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. Web site at: http://www.mrc.ac.uk.

National Cancer Reserach Network

• The researchers would like to acknowledge the National Cancer Research Network (NCRN), for its help in recruiting patients. 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 from 5% to 10%. 
  

Queen Mary, University of London

• Queen Mary is one of the leading colleges in the federal University of London, with over 11,000 undergraduate and postgraduate students, and an academic and support staff of around 2,600.

• Queen Mary is a research university, with over 80 per cent of research staff working in departments where research is of international or national excellence (RAE 2001).  It has a strong international reputation, with around 20 per cent of students coming from over 100 countries.

• The College has 21 academic departments and institutes organised into three sectors: Science and Engineering; Humanities, Social Sciences and Laws; and the School of Medicine and Dentistry.

• It has an annual turnover of £200 million, research income worth £43 million, and it generates employment and output worth nearly £400 million to the UK economy each year.

• Queen Mary’s roots lie in four historic colleges: Queen Mary College, Westfield College, St Bartholomew’s Hospital Medical College and the London Hospital Medical College.

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