LONG-TERM FOLLOW-UP OF A PHASE-III STUDY OF 3 VERSUS 4 CYCLES OF BLEOMYCIN, ETOPOSIDE, AND CISPLATIN IN FAVORABLE-PROGNOSIS GERM-CELL TUMORS - THE INDIANA-UNIVERSITY EXPERIENCE

Purpose: In a previously reported randomized Southeastern Cancer Study Group (SECSG) trial, three cycles of chemotherapy were found to be eq uivalent to four cycles in patients with favorable-prognosis germ-cell cancer. We have conducted a follow-up analysis of patients treated at Indiana University (Indianapolis, IN) to compare long-term survival b etween the two groups and to examine factors associated with survival. Patients and Methods: Sixty-nine patients with minimal-stage and 49 p atients with moderate-stage disseminated germ-cell tumors were randomi zed to either three or four courses of bleomycin, etoposide, and cispl atin (BEP) administered every 3 weeks. Median follow-up time is 10.1 y ears (range, 7 months to 12.6 years). Ninety-two percent of patients h ave an actual follow-up time of > 5 years, and 97.5% of patients have an actual follow-up time of > 3 years. Results: Survival analysis show s no significant difference between the two treatment groups in terms of overall (P = .80) or disease-free (P = .93) survival. Several clini cal variables were examined by univariate analysis; only serum human c horionic gonadotropin (HCG) had an impact on survival. There were two disease-related deaths in 104 patients with HCG less than or equal to 1,000 mIU/mL and five disease-related deaths in 14 patients with HCG g reater than 1,000 mIU/mL (P < .001). Ninety-eight percent (95% CI, 95. 2 to 100) of patients with favorable prognosis germ-cell tumor with an initial HCG of less than or equal to 1,000 mIU/mL are alive without e vidence of disease at 5+ years. Conclusion: With long-term follow up, there is no statistically significant difference in survival between t hree or four cycles of BEP chemotherapy in patients with favorable pro gnosis germ-cell carcinoma. Serum HCG elevation of greater than 1,000 mIU/mL is a significant predictor of poor outcome in patients with oth erwise good-risk disease. (C) 1998 by American Society of Clinical Onc ology.