TOPOTECAN VERSUS PACLITAXEL FOR THE TREATMENT OF RECURRENT EPITHELIALOVARIAN-CANCER

Purpose: Topotecan and paclitaxel were evaluated in a randomized, mult icenter study of patients with advanced epithelial ovarian carcinoma w ho had progressed during or after one platinum-based regimen. Patients and Methods: Patients received either topotecan (1.5 mg/m(2)) as a 30 -minute infusion daily for 5 days every 21 days (n = 112) or paclitaxe l (175 mg/m(2)) infused over 3 hours every 21 days (n = 114). Patients had bidimensionally measurable disease and were assessed for efficacy and toxicity. Results: Response rate was 23 of 112 (20.5%) in topotec an-treated patients and 15 of 114 (13.2%) in paclitaxel-treated patien ts (P = .138). Disease stabilization for at least 8 weeks was noted in 30% of patients with topotecan and 33% of patients with paclitaxel. M edian durations of response to topotecan and paclitaxel were 32 and 20 weeks, respectively (P = .222) and median times to progression were 2 3 and 14 weeks, respectively (P = .002). Median survival was 61 weeks for topotecan and 43 weeks for paclitaxel (P = .515). Response rates f or topotecan and paclitaxel were 13.3% versus 6.7% (P = .303) in resis tant patients (not responded to prior platinum-based therapy or progre ssed within 6 months of an initial response) and 28.8% versus 20.0% (P = .213) in sensitive patients (progressed > 6 months after response). Neutropenia wets significantly more frequent on the topotecan arm 79% versus paclitaxel arm 23% (P < .01). It was short-lasting and noncumu lative in both arms. Nonhematologic toxicities were generally mild (gr ades 1 to 2) for both agents. Conclusion: Topotecan has efficacy at le ast equivalent to paclitaxel manifested by the higher response rate an d significantly longer time to progression. (C) 1997 by American Socie ty of Clinical Oncology.