Chemotherapy for advanced germinal cell neoplasms: preliminary report of an Eastern Cooperative Oncology Group Study.

A series of 45 evaluable patients with stage III germ cell tumors have been treated between July 1977 and May 1978, with two cycles of an intensive five-drug regimen including cyclophosphamide, actinomycin D, vinblastine, bleomycin, and cis-dichlorodiammineplatinum(II) (cis-platinum). The patients were randomly assigned to receive the cis-platinum as a high dose 1-hour infusion with mannitol diuresis or as a low-dose 8-hour infusion without diuresis. The overall response rates were 36% complete response (CR) and 47% partial response (PR) after two cycles of induction therapy. Patients who achieved a CR or PR after two cycles were randomized to continue treatment with either a three-drug program of vinblastine, actinomycin D, and cis-platinum or a cyclic crossover regimen of three regimens (each containing three drugs) given in sequence at 3-week intervals with the entire sequence repeated at 9 weeks. During continuing treatment a minimum of five patients improved from PR to CR, so that the minimum CR rate will be 47%. A major determinant of response was extent of disease, with limited-disease patients having an 83% CR rate and advanced-disease patients having 22% CR rate. At present, there are no statistically significant differences between response rates for the two induction regimens. Patients have not been followed long enough on the continuing treatment arms to allow evaluation of improvement from PR to CR, duration of response, or duration of survival. Hematologic and renal toxiciity were not significantly different on the two induction treatment arms.