Donald G Gallup1, John A Blessing, Willie Andersen, Mark A Morgan. 1. Department of Gynecologic Oncology, Memorial Health University Medical Center, Mercer University School of Medicine, Savannah, GA 31404, USA. galludoi@memorialhealth.com
Abstract
OBJECTIVE: The purpose of this phase II trial was to evaluate the efficacy of intravenous paclitaxel in patients with recurrent or advanced leiomyosarcoma of the uterus. METHODS: To be eligible, patients with recurrent or persistent leiomyosarcoma of the uterus were to have measurable disease not previously treated with paclitaxel and adequate hematologic (WBC >or=3000/microl, platelet count >or=100000/microl), renal (serum creatinine <or=2.0 mg%), and hepatic (bilirubin <or= 1.5 x institutional normal) functions. Paclitaxel was given at a dose of 175 mg/m(2) (135 mg/m(2) for patients with prior radiotherapy) intravenously over 3 h every 3 weeks. RESULTS: Fifty-three patients were entered on this study; 48 were evaluable for toxicity and response. Fifteen had prior irradiation and 39 had prior chemotherapy. A median of 2 (range: 1-12) courses was given. Grade 4 neutropenia occurred in 3 (6.3%) patients. No grade 4 thrombocytopenia was reported and no deaths were attributable to therapy. Four (8.4%) patients had a complete or partial response and 22.9% had stable disease. CONCLUSIONS: Although toxicity was minimal, this regimen demonstrated modest activity in patients with previously treated advanced or recurrent leiomyosarcoma of the uterus.
OBJECTIVE: The purpose of this phase II trial was to evaluate the efficacy of intravenous paclitaxel in patients with recurrent or advanced leiomyosarcoma of the uterus. METHODS: To be eligible, patients with recurrent or persistent leiomyosarcoma of the uterus were to have measurable disease not previously treated with paclitaxel and adequate hematologic (WBC >or=3000/microl, platelet count >or=100000/microl), renal (serum creatinine <or=2.0 mg%), and hepatic (bilirubin <or= 1.5 x institutional normal) functions. Paclitaxel was given at a dose of 175 mg/m(2) (135 mg/m(2) for patients with prior radiotherapy) intravenously over 3 h every 3 weeks. RESULTS: Fifty-three patients were entered on this study; 48 were evaluable for toxicity and response. Fifteen had prior irradiation and 39 had prior chemotherapy. A median of 2 (range: 1-12) courses was given. Grade 4 neutropenia occurred in 3 (6.3%) patients. No grade 4 thrombocytopenia was reported and no deaths were attributable to therapy. Four (8.4%) patients had a complete or partial response and 22.9% had stable disease. CONCLUSIONS: Although toxicity was minimal, this regimen demonstrated modest activity in patients with previously treated advanced or recurrent leiomyosarcoma of the uterus.
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