Chemotherapy of disseminated testicular cancer. A random prospective study.

Seventy-eight patients with disseminated testicular cancer were entered on a random prospective study evaluating three separate remission induction arms. Therapy with cis-diamminedichloroplatinum (20 mg/M2 for five consecutive days every three weeks for 3-4 courses) and bleomycin (30 units intravenous push weekly for 12 consecutive weeks) was constant. Patients were allocated at random to one of the following induction regimens (in combination with platinum plus bleomycin): (1) vinblastine 0.4 mg/kg every three weeks for four courses; (2) vinblastine 0.3 mg/kg every three weeks for four courses; or (3) vinblastine 0.2 mg/kg plus Adriamycin 50 mg/M2 every three weeks for four courses. All patients received maintenance therapy with vinblastine 0.3 mg/kg once a month for 20 months (total therapy two years) unless progressive disease intervened. The incidence of granulocytopenic fever and sepsis was highest with regimen 1, as 9 patients (35%) developed granulocytopenic fever requiring hospitalization and antibiotics; only 4 (15%) patients on regimen 2 developed granulocytopenic fever. No patients on regimen 2 had documented sepsis. Fifty-three patients (68%) achieved complete remission and an additional 11 patients were rendered free of disease with surgical resection of residual localized disease. Fifty-three patients (68%) remain alive and continuously free of disease from 15+ to 39+ months. There was no difference in the complete remission rate or disease-free status with the higher dosage of vinblastine (regimen 1) during remission induction therapy compared to the less toxic lower dosage of vinblastine (regimen 2). This suggests that dosage reduction of vinblastine to 0.3 mg/kg can produce equivalent therapeutic results with diminished toxicity, and we no longer recommend the 0.4 mg/kg vinblastine dosage.

RCT Entities:   Population Interventions Outcomes