1Department of Medicine, Institut Gustave Roussy, Villejuif, France.
Forty poor-risk patients with metastatic nonseminomatous germ cell tumors were treated with a chemotherapy regimen that consisted of either the BEP protocol (bleomycin + etoposide + cisplatin) or the CISCA(II)/VB(IV) regimen (cyclophosphamide + doxorubicin + cisplatin/vinblastine + bleomycin). There was no randomization. Among 17 patients who received the CISCA(II)/VB(IV) protocol, three early deaths, four primary failures, and 10 complete responses were observed. Two relapses and one acute myeloid leukemia were subsequently noted. Nine (53%) of 17 patients remain free of disease 15-38 months after the end of therapy. In the group of patients treated with the BEP regimen, one early death, one primary failure, one toxic death, one partial response, and 19 complete responses were observed. There were eight relapses. Sixteen (70%) of 23 patients remain free of disease 26-52 months after the end of therapy. Myelosuppression and mucositis were clearly more severe with the CISCA(II)/VB(IV) regimen. However, no septic death was registered, whereas one patient died of septic shock after the fourth cycle of BEP. Investigators of the Genitourinary Group of the French Federation of Cancer Centers have now embarked on a prospective randomized trial of BEP versus CISCA(II)/VB(IV) in poor-risk patients.