A randomised trial of BEP (bleomycin, etoposide, cisplatin) vs BOP/VIP-B (bleomycin, vincristine, cisplatin, etoposide, ifosfamide cisplatin, bleomycin) and of the same regimens with or without G-CSF in poor prognosis metastatic germ cell tumours
Which chemotherapy drugs should be used to treat testis cancer?
What was this study about?
Doctors normally use a combination of chemotherapy drugs called BEP (bleomycin, etoposide and cisplatin) to treat men with a testis cancer called non-seminoma which has spread to other parts of their body. Many men are cured by this treatment, but there are group of men who do not do well - even with this treatment, about half of these men did not live for very long. Doctors thought that a more intensive chemotherapy treatment called BOP/VIP-B (drugs called bleomycin, vincristine, cisplatin (BOP) and etoposide, ifosfamide, cisplatin and bleomycin (VIP-B)) might help more of these men to live for longer.
The TE13 trial aimed to compare BEP with BOP/VIP-B. It also looked at the use of a drug called filograstim, or G-CSF, to see if it could reduce some of the side effects associated with the drugs. This could allow more men to complete the treatment and have a better chance of their cancer being cured.
What difference did this study make?
Researchers found that BOP/VIP-B did not help men to live longer than those who were given BEP. Men who were given BOP/VIP-B also had more unwanted side effects. The addition of G-CSF did not help to improve survival in patients treated with normal BEP chemotherapy. The researchers also found that men treated in larger hospitals were more likely to live longer than those treated in smaller centres.
The results of this study led to guidelines suggesting that men with non-seminoma which has spread should be treated in larger hospitals.
Type of study
Who funded the study?
The Medical Research Council and the European Organisation for Research and Treatment of Cancer (EORTC).
When did it take place?
Men were recruited to take part in this study between 1990 and 1994. The results of the study were published in 1998.
Who was included?
380 men with metastatic testis cancer who had a poor prognosis took part in this study. They came from hospitals in the UK and across Europe.