Irinotecan (CPT-11) and Cisplatin as First-Line Chemotherapy for Advanced Ovarian Cancer

Objective: To evaluate the efficacy and toxicity of a combination of irinotecan (CPT-11) and cisplatin as first-line chemotherapy in advanced ovarian cancer. Methods: Twenty-six patients with previously untreated advanced epithelial ovarian cancer were enrolled in this study. CPT-11 60 mg/m 2 was administered intravenously on days 1, 8, and 15 in combination with cisplatin 60 mg/m 2 on day 1. Cycles were repeated every 28 days for at least two cycles. The median patient age was 55 years (range, 37–75), and the median performance status was 1. Results: Objective responses were recorded in 19 of 25 eligible patients (76%; 95% confidence interval, 55–91%). Complete responses were obtained in 2 patients (8%), and partial response in 17 patients (68%). Stable disease was recorded in 2 patients (8%) and progressive disease in 2 (8%). The median time to response was 62 days (range, 28–234 days). The median survival time for all 25 patients was 30.9+ months (range, 4.1–60.0+ months). The major toxic effects were leukopenia, neutropenia, and diarrhea. Grade 3 or 4 leukopenia, neutropenia, and diarrhea occurred in 17 (68%), 20 (83.3%), and 5 patients (20%), respectively. Thrombocytopenia was less common. No treatment-related deaths occurred. Conclusion: The combination of CPT-11 and cisplatin showed significant activity in chemotherapy-naive patients with advanced ovarian cancer. Neutropenia was the dose-limiting adverse effect, whereas diarrhea was mainly mild to moderate.