Phase II trial of topotecan in patients with advanced, persistent, or recurrent uterine leiomyosarcomas - A Gynecologic Oncology Group study

From October 1995 to March 1997, a phase II trial of topotecan was carried out in chemotherapy-naive women with advanced, persistent, or recurrent ute rine leiomyosarcomas. Thirty-six patients were entered. Median age was 53 y ears. Performance status was 0 (50%) in 18, 1 (36%) in 13, and 2 (14%) in 5 . Most patients, 33 (92%), had undergone prior surgery, and 8 (22%) prior r adiation therapy. Topotecan, 1.5 mg/m(2), was administered intravenously da ily for 5 days, every 3 weeks, until progression of disease or adverse affe cts prohibited further therapy. Patients received 1 to 13 courses with a me dian of 3 courses. The most frequent grade 4 adverse effects were neutropen ia in 28 (78%), leukopenia in 8 (22%), thrombocytopenia in 3 (8%), and anem ia in 3 (8%). Complete response was seen in 1 (3%), partial response in 3 ( 8%), stable disease in 12 (33%), and increasing tumor in 20 (56%). Thus top otecan at this dose and schedule does not appear to have major activity in uterine leiomyosarcomas.