Phase II evaluation of a 3-day infusion of topotecan in patients with recurrent ovarian or primary peritoneal cancer

Objective.To assess the efficacy and toxicity profile in patients treated with topotecan at 2.0 mg/m2/day × 3 days every 3 weeks.Materials and methods.Eligibility criteria included patients with recurrent primary peritoneal or epithelial ovarian cancer with ≥ 6 months elapsed from time of prior platinum treatment. Patients were required to have a performance status of ≤ 2 and normal hepatic and renal function. Response to therapy and toxicity was assessed using standard criteria. Chi-square and Student's t tests were used as appropriate. Survival was assessed with Kaplan–Meier method.Results.All 40 patients enrolled were assessable for response. The mean age of the patients was 63.2 years (range 43–85). Median time to progression from initial treatment was 11.8 months. A total of 286 cycles of chemotherapy were administered with an average of 7.1 cycles per patient. Overall median time to progression (TTP) with 3-day topotecan treatment was 21 weeks (range 6–43 weeks). Of the 33 patients with measurable disease, 24% (11–42%, 95% CI) demonstrated a response. Seven patients had CA-125 evaluable disease with a response of 43% (10–89%, 95% CI). Median progression-free survival (PFS) was 16 weeks (range 12–21 weeks, 95% CI). Median overall survival was 106 weeks (range 76–117 weeks, 95% CI). Assessment of toxicity by patient showed 90% demonstrating grade 3/4 neutropenia with the vast majority being uncomplicated. No severe non-hematological toxicity was observed.Conclusion.Administration of topotecan as a 3-day regimen is feasible with demonstrable activity and tolerable toxicity. Critical comparison to the 5-day regimen in a randomized fashion is warranted.