IMPORTANCE OF BLEOMYCIN IN FAVORABLE-PROGNOSIS DISSEMINATED GERM-CELL TUMORS - AN EASTERN-COOPERATIVE-ONCOLOGY-GROUP TRIAL

Purpose: This prospective, randomized trial was designed to determine if three cycles of cisplatin plus etoposide (PVP16) can produce therapeutic results comparable to three cycles of cisplatin, etoposide, and bleomycin (PVP16B) in patients with disseminated germ cell tumors. Patients and Methods: One hundred seventy-eight moderate-stage disease (Indiana staging system) were randomized to receive cisplatin (20 mg/m(2) on days 1 to 5) plus etoposide (100 mg/m(2) on days 1 to 5) with or without weekly bleomycin (30 IU/wk for 9 consecutive weeks). Following three cycles of chemotherapy over 9 weeks, patients with residual radiographic disease underwent surgical resection, If persistent carcinoma was noted, two additional 3-week courses of chemotherapy were administered. Results: One hundred seventy-one patients were fully assessable for response and survival. The two treatment groups were similar with respect to patient characteristics. The toxicities were comparable between the two arms. No clinically significant incidence of pulmonary toxicity occurred with PVP16B. Overall, 81 of 86 patients (94%) who received PVP16B and 75 of 85 patients (88%) who received PVP16 achieved a disease-free status with chemotherapy and/or surgery. However, greater numbers of treatment failures, including persistent carcinoma in postchemotherapy resected residual disease and relapses from complete remission, occurred on the arm without bleomycin (overall adverse outcome, P=.004). The failure-free (86% v 69%; P=.01) and overall survival (95% v 86%; P=.01) rates were inferior on the PVP16 arm. Conclusion: Bleomycin is an essential component of PVP16B therapy in patients who receive three cycles of treatment for minimal or moderate-stage disseminated germ cell tumors.