The evidence supporting this protocol comes from a French multicentre randomised trial involving 257 patients comparing 3 cycles of BEP with 4 cycles of EP in patients with good risk nonseminomatous germ cell cancer defined according to the Institut Gustave Roussy prognostic model.r
Between October 1993 and May 1999 124 patients were randomised to receive three cycles of BEP (bleomycin 30 international units on days 1,8,15, etoposide 100mg/m2 days 1-5, cisplatin 20mg/m2 days 1-5) and 122 patients four cycles of EP (etoposide 100mg/m2 days 1-5, cisplatin 20mg/m2 days 1-5) every three weeks. The primary end point was equivalence.
Another prospective non-randomised multicentre study assessed the efficacy of EP in good prognosis advanced seminoma and the efficacy of VIP in intermediate or poor prognosis advanced seminoma.r Patients were stratified according to the International Germ Cell Cancer Collaboration Group (IGGCCG)r and the Medical Research Council. Between December 1999 and September 2008, 132 patients were accrued from 12 French centres. 108 good prognosis patients received EP (etoposide 100mg/m2 days 1-5, cisplatin 20mg/m2 days 1-5) and 24 intermediate /poor prognosis patients received VIP (etoposide 100mg/m2 days 1-5, ifosfamide 1.2g/m2, cisplatin 20mg/m2 days 1-5) with GCSF support. No formal hypothesis regarding response or survival was initially put forward.
The French study for nonseminomatous germ cell tumours demonstrated similar favourable response rates for 3 cycles of BEP or 4 cycles of EP, but a non-significant trend to worse survival for 3 cycles of BEP. It was not powered to assess survival. The recommendation is to use EP only in selected cases where BEP is contraindicated because of concerns about bleomycin toxicity.
GETUG T93BP Culine et alr
© Ann Oncol 2007
Progression-free survival and overall survivalr
© European Urology 2014
The toxicity of the two regimens is fairly similar, with the difference being pulmonary toxicity, grade 3-4 neutropaenia and peripheral neuropathy is worse with EP compared with BEP.r
© Annals of Oncology 2007
VIP was associated with more haematological toxicity including neutropenic fever (23% vs 12%) and one death due to septic shock. More patients received their planned four cycles of EP (n=104; 97%) than VIP (n=21; 88%).r
© European Urology 2014