Phase II trial of paclitaxel in leiomyosarcoma of the uterus: A Gynecologic Oncology Group study

Objective. The aim of this study was to determine the activity of paclitaxe l in chemotherapy-naive patients with advanced or recurrent uterine leiomyo sarcoma. Methods. Patients received 175 mg/m(2) of paclitaxel iv over 3 h. Courses w ere repeated every 3 weeks until disease progression or adverse side effect s supervened. Results. Thirty-four women were entered, but 1 patient was ineligible becau se of wrong cell type. Median age was 55 years (range: 35-84 years). GOG pe rformance status was 2 in 2 instances, 1 in 9 cases, and 0 in 22 others. Ei ght patients (23.4%) had received radiotherapy. A median of 2.5 courses was given (range: 1-18). Eleven patients (33.3%) experienced grade 3 or 4 neut ropenia, 1 (2.9%) had grade 4 thrombocytopenia, and 1 had grade 3 anemia. T here were no cases of grade 3 or 4 gastrointestinal or dermatologic toxicit y. One patient each developed deep venous thrombosis and a grade 3 allergic reaction. Eight patients (24.2%) had stable disease for at least 2 courses of therapy. Three complete responses were reported (9.1%). Conclusion. With the dose and schedule tested, paclitaxel has limited activ ity in patients with uterine leiomyosarcoma. Modest toxicity suggests that a higher dose of paclitaxel might be evaluated. (C) 1999 Academic Press.