TOPOTECAN FOR THE TREATMENT OF ADVANCED EPITHELIAL OVARIAN-CANCER - AN OPEN-LABEL PHASE-II STUDY IN PATIENTS TREATED AFTER PRIOR CHEMOTHERAPY THAT CONTAINED CISPLATIN OR CARBOPLATIN AND PACLITAXEL

Purpose: Topatecan, a topoisomerase I inhibitor, was evaluated in a mu lticenter, phase II study of women with epithelial ovarian carcinoma w ho relapsed after one or two prior regimens that included platinum and paclitaxel. Patients and Methods: Topotecan 1.5 mg/m(2) daily was adm inistered as a 30-minute infusion for 5 consecutive days on a 21-day c ycle. Eligibility criteria included bidimensionally measurable disease , Eastern Cooperative Oncology Group performance status of 2 or less, and adequate bone marrow, liver, and renal function. Efficacy was asse ssed by independent radiologic review. Results: One hundred thirty-nin e patients were treated; 81% were platinum resistant. Sixty-two patien ts had received one prior regimen and 77 patients had received two pri or regimens. Nine patients were not assessable for response; however, all patients were included in the response analysis. The overall respo nse rate was 13.7%; 12.4% in platinum-resistant and 19.2% in platinum- sensitive patients. Stable disease lasted at least 8 weeks in 27.3% of the patients. The median duration of response and time to progression were 18.1 and 12.1 weeks, respectively. The median survival was 47.0 weeks. Grade 4 neutropenia occurred in 82% of the patients (34% of the courses) and thrombocytopenia in 30% of the patients (9% of the cours es). Infectious complications occurred in 6% of the courses. Nonhemato logic toxicities were mild. There were no drug-related toxic deaths. C onclusion: As a single agent, topotecan has modest activity in women w ith advanced epithelial ovarian carcinoma who have progressed or not r esponded after one or two prior regimens with platinum and paclitaxel. Further investigation of combination regimens is indicated in the pri mary therapy for ovarian cancer based on the mechanism of action and t olerability. (C) 1998 by American Society of Clinical Oncology.