LONG-TERM FOLLOW-UP OF THE FIRST RANDOMIZED STUDY OF CISPLATIN VERSUSCARBOPLATIN FOR ADVANCED EPITHELIAL OVARIAN-CANCER

Purpose: A phase III trial wets performed between October 1981 and Jun e 1984 to compare the efficacy of single-agent cisplatin and single-ag ent carboplatin in previously untreated patients with International Fe deration of Gynecology and Obstetrics stage III or IV carcinoma of the ovary following surgery. This report describes the survival rates of patients in this study after a minimum follow-vp duration of 8 years. Patients and Methods: Sixty-four patients were randomized to receive c isplatin and 67 patients to receive carboplatin. Cisplatin was adminis tered every 4 weeks for a total of 10 courses, courses 1 to 5 at a dos age of 100 mg/m(2) and courses 6 to 10 at 30 mg/m(2). Carboplatin was administered at a dosage of 400 mg/m(2) every 4 weeks for 10 courses. Patients who had clinical or radiologic evidence of response after fiv e courses of chemotherapy underwent second-look surgery. The study was designed to allow crossover between the two arms. Thirteen patients w ere excluded from response analyses because they were incorrectly rand omized. Patients were crossed over to the other arm of the study becau se of progressive disease (PD), nonresponse, or toxicity. Results: The overall response rate for patients randomized to the cisplatin arm wa s 53.8% (28 of 52; 95% confidence interval [CI], 39% to 68%) and for t hose randomized to the carboplatin arm, 38.4% (20 of 52; 95% CI, 25% t o 53%). There were 16 (30.8%) and 14 (26.9%) complete remissions (CRs) in the cisplatin and carboplatin arms, respectively. None of these di fferences were statistically significant. The median duration of respo nse for the cisplatin and carboplatin arms was 21 months and 17 months , and the 5-year relapse-free survival rates were 22% and 25%, respect ively. The median survival durations for the cisplatin and carboplatin arms were 19.5 and 13 months, and the 5-year survival rates were 15% (95% CI, 8% to 26%) and 19% (95% CI, 11% to 30%), respectively. None o f these differences was statistically significant. The median follow u p duration of patients is 9 years. Crossover due to toxicity was more frequent in the cisplatin than the carboplatin arm, occurring in 50% a nd 3.3% of patients, respectively. Conclusion: The mature data from th is study of patients with advanced ovarian cancer show that cisplatin and carboplatin have similar long-term survival results.