Randomized trial comparing Bleomycin/Etoposide/Cisplatin with alternating Cisplatin/Cyclophosphamide/Doxorubicin and Vinblastine/Bleomycin regimens of chemotherapy for patients with intermediate- and poor-risk metastatic nonseminomatous germ cell tumors:: Genito-urinary group of the french federation of cancer Centers trial T93MP

Purpose Two chemotherapy regimens for intermediate-and poor-risk metastatic nonseminomatous germ cell tumors were compared for efficacy and toxicity. Patients and Methods From February 1994 to February 2000, 190 patients were randomly assigned between either four cycles of BEP ( bleomycin 30 mg d1, d8, d15; etoposide 100 mg/m(2) d1-5; cisplatin 20 mg/m(2) d1-5) or four to six alternating cycles of CISCA/VB ( cyclophosphamide 400 mg/m(2) d1-2, doxorubicin 35 mg/m(2) d1-2, cisplatin 100 mg/m(2) d3/vinblastine 2.5 mg/m(2) d1-5, bleomycin 25 mg/m(2) d1-5). Risk was initially defined according to the Institut Gustave Roussy ( Villejuif, France) prognostic model based on serum alpha-fetoprotein and human chorionic gonadotropin levels only. Patients were retrospectively assigned into the International Germ Cell Consensus Classification. Results Among 185 assessable patients, favorable responses did not differ statistically between the two arms: 49 in the CISCA/VB arm (56%; 95% CI, 45% to 66%), 57 in the BEP arm (65%; 95% CI, 55% to 75%). The CISCA/VB regimen induced more significant hematologic and mucous toxicities compared with the BEP arm. The 5-year event-free survival rates were 37% ( 95% CI, 27% to 47%) and 47% ( 95% CI, 37% to 57%) in CISCA/VB and BEP arms, respectively ( hazard ratio [HR] = 0.76; 95% CI, 0.52 to 1.11; P =.15). With a median follow-up of 7.8 years, the 5-year overall survival rates were 59% ( 95% CI, 47% to 67%) and 69% ( 95% CI, 58% to 77%) in CISCA/VB and BEP arms, respectively ( HR = 0.73; 95% CI, 0.46 to 1.18; P =.24). Conclusion Because of equivalent efficacy and lesser toxicity, the standard treatment for patients with intermediate-and poor-risk metastatic nonseminomatous germ cell tumors remains four cycles of BEP.