Adjuvant bleomycin, vincristine and cisplatin for high-risk stage I non-seminomatous germ cell tumours
Testing a new combination of chemotherapy drugs to treat early testis cancer
What was this study about?
Since the early 1980s, men in the UK with a testes cancer called stage I non seminomatous germ cell tumour (NSGCT) were usually offered an operation to remove one or both testicles (orchidectomy). They were then closely monitored to check whether the cancer had come back. Previous work by the MRC CTU and others (including the TE04 study) had enabled doctors to identify men whose cancer was very likely to come back. These men were offered a short course of chemotherapy. The TE05 trial found that chemotherapy using the drugs bleomycin, etoposide and cisplatin (a combination called BEP) could greatly reduce the risk of the cancer coming back.
The TE17 trial replaced the drug etoposide with one called vincristine, making a combination called BOP. It was hoped that BOP would have fewer side effects than BEP, but it was important to show if BOP worked as well as BEP in preventing the cancer coming back. Therefore men who took part in this trial were also asked about their quality of life.
What difference did this study make?
Researchers followed what happened to the men who took part in the trial for five years to see what happened to them. They found that BOP was as effective as BEP in preventing cancer coming back. BOP didn’t cause as much hair loss as BEP did. But it did cause damage to the nerves in some men, leading to symptoms including pain and numbness.
Researchers concluded that BOP did not have major advantages over BEP. But it could be offered to men with NSGCT who wanted to maximise their chances of avoiding hair loss.
Type of study
Who funded the study?
The UK Medical Research Council.
When did it take place?
This trial opened to recruitment in 1994 and closed in 1996. The results were published in 2005.
Who was included?
114 men with stage I NSGCT.