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Wednesday 01 November 2006

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

By: Herzog TJ, Powell MA, Rader JS, Gibb R, Mutch DG.

Gynecol Oncol 2006 Nov;103(2):637-41

OBJECTIVE.: To assess the efficacy and toxicity profile in patients treated with topotecan at 2.0 mg/m(2)/dayx3 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.

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