Oral topotecan as single-agent second-line chemotherapy in patients with advanced ovarian cancer

Purpose: To evaluate oral topotecan as single-agent, second-line therapy in patients with ovarian cancer previously treated with a platinum-based regi men. Patients and Methods: Patients (N = 116) received oral topotecan 2.3 mg/m(2 ) daily for 5 days every 21 days. Eligibility criteria included histologic diagnosis of International Federation of Gynecology and Obstetrics stage II I or IV epithelial ovarian cancer, bidimensionally measurable disease, prio r platinum-containing chemotherapy, age greater than or equal to 18 years, performance status less than or equal to 2, and life expectancy greater tha n or equal to 12 weeks. Results: Overall response rate was 21.6% (25 of 116 patients). Median durat ion of response was 25.0 weeks; median time to response was 8.4 weeks. Medi an time to progression was 14.1 weeks; median survival was 62.2 weeks. Grad e 4 neutropenia was experienced by 50.4% of patients in 13.4% of courses ad ministered. Grade 4 thrombocytopenia was experienced by 22.1% of patients i n 5.1% of courses. Grade 3 or 4 anemia was experienced by 29.2% of patients in 8.5% of courses. Most frequent nonhematologic toxicities were predomina ntly (> 90%) grade 1 or 2 and included nausea, alopecia, diarrhea, and vomi ting. Conclusion: Second-line oral topotecan administered at 2.3 mg/m(2) for 5 da ys every 21 days demonstrated activity in patients with progressive or recu rrent ovarian cancer after first-line platinum-based chemotherapy. This act ivity was comparable to that seen in previous studies with intravenous topo tecan. Grade 4 neutropenia was less frequent with oral topotecan than previ ously reported for intravenous topotecan. Oral topotecan is an active, tole rable, and convenient formulation of an established agent for the second-li ne treatment of advanced epithelial ovarian cancer and may also facilitate exploring prolonged treatment schedules. (C) 2001 by American Society of Cl inical Oncology.