Lack of efficacy of 24-h infusional topotecan in platinum-refractory ovarian cancer: A gynecologic oncology group trial

Background. The aim of this study was to evaluate the efficacy of a more convenient topotecan administration schedule in the second-line treatment of advanced platinum-refractory ovarian cancer. Methods and materials. The Gynecologic Oncology Group conducted a Phase II trial of 24-h infusional topotecan (8.5 mg/m²), repeated every 3 weeks in 26 patients with platinum- refractory ovarian cancer (failure to respond to initial platinum-based treatment or development of recurrent disease within 6 months of completion of chemotherapy). Results. Grade 4 neutropenia (85% of patients) and thrombocytopenia (12%) were the major toxicities encountered. Of the 25 patients evaluable for response, only a single patient experienced an objective response (4%). Conclusions. When employed at this dose and schedule (24-h infusion every 3 weeks), topotecan has minimal second-line activity in platinum-refractory ovarian cancer.