Phase II trial of topotecan by continuous infusion in patients with advanced soft tissue sarcomas,a SWOG study. Southwest Oncology Group

Purpose: Based upon the hypothesisthat prolonged exposure to the S-Phasespecific agent topotecan would be moreefficacious in the treatment of soft tissuesarcomas than a conventional 5-day scheduleof the drug, the Southwest Oncology Groupperformed a Phase II trial of topotecanadministered as a continuous infusion inadult patients with advanced soft tissuesarcomas.Methods: Patients who had receivedno prior chemotherapy for advanced diseasewere treated with topotecan at a dose of0.50 mg/m²/day on days 1–21 ofrepeated 28 day cycles.Results: Twenty-two patients wereenrolled on the study, of whom 21 wereeligible. No objective responses wereobserved (95% confidence interval of 0–16%). The mediansurvival was 12 months(95% confidence interval of 5–16months).Conclusions: We conclude thattopotecan, given either according to a5-day or a 21-day schedule, has minimalactivity in the treatment of adult softtissue sarcomas.