Gemcitabine and Docetaxel in Patients With Unresectable Leiomyosarcoma: Results of a Phase II Trial

• DOI: 10.1200/jco.2002.11.050
• Publication Date: 2002-10-11T20:11:44Z
• Authors: Martee L. Hensley; Robert Maki; E. Venkatraman; Gennifer Geller; Meghan Lovegren; Carol Aghajanian; Paul Sabbatini; William Tong; Richard Barakat; David R. Spriggs
• Keywords: Adult; Leiomyosarcoma; 0301 basic medicine; Neutropenia; Paclitaxel; Injections, Subcutaneous; Docetaxel; Middle Aged; Deoxycytidine; Thrombocytopenia; Gemcitabine; 3. Good health; 03 medical and health sciences; Treatment Outcome; Drug Resistance, Neoplasm; Antineoplastic Combined Chemotherapy Protocols; Granulocyte Colony-Stimulating Factor; Uterine Neoplasms; Humans; Female; Taxoids; Infusions, Intravenous; Aged

PURPOSE: Few chemotherapy agents are active in leiomyosarcoma (LMS), particularly LMS that has progressed after doxorubicin treatment. We sought to determine the response gemcitabine plus docetaxel among patients with LMS. PATIENTS AND METHODS: Patients unresectable of uterine (n = 29) or other 5) primary sites who did not respond zero two prior regimens were enrolled onto a phase II study 900 mg/m 2 intravenously (IV) on days 1 and 8 100 IV day granulocyte colony-stimulating factor given subcutaneously 9 15, delivered every 21 days. pelvic radiation received 25% lower doses both agents. Gemcitabine was over 30 90 minutes cycles by 90-minute infusion all subsequent cycles. Pharmacokinetic studies assessed vivo differences concentrations different rates infusion. RESULTS: Thirty-four (median age, 55 years; range, 32 74 years) have enrolled. Fourteen had radiation. Sixteen 34 doxorubicin-based therapy; 18 no chemotherapy. Among patients, complete observed three partial for an overall rate 53% (95% confidence interval, 35% 70%). Seven stable disease. Fifty percent previously treated responded. Hematologic toxicity common (neutropenia: grade 3, 15%; 4, 6%; thrombocytopenia: 26%; 3%), but neutropenic fever (6%) bleeding events (0%) rare. The median time progression 5.6 months (range, 4 10 months). CONCLUSION: is tolerable highly untreated