Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: results of a phase II trial

Hensley, M. L., Maki, R., Venkatraman, E., Geller, G., Lovegren, M., Aghajanian, C., Sabbatini, P., Tong, W., Barakat, R., Spriggs, D. R. (June 2002) Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: results of a phase II trial. J Clin Oncol, 20 (12). pp. 2824-31. ISSN 0732-183X (Print)0732-183X (Linking)

DOI: 10.1200/jco.2002.11.050


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

Item Type: Paper
Uncontrolled Keywords: Adult Aged Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use Deoxycytidine/administration & dosage/*analogs & derivatives Drug Resistance, Neoplasm Female Granulocyte Colony-Stimulating Factor/administration & dosage Humans Infusions, Intravenous Injections, Subcutaneous Leiomyosarcoma/*drug therapy/pathology Middle Aged Neutropenia/chemically induced Paclitaxel/administration & dosage/*analogs & derivatives *Taxoids Thrombocytopenia/chemically induced Treatment Outcome Uterine Neoplasms/*drug therapy/pathology
Subjects: diseases & disorders > cancer > drugs and therapies
diseases & disorders > cancer > cancer types > sarcoma
CSHL Authors:
Communities: CSHL labs > Maki lab
Depositing User: Matt Covey
Date: 15 June 2002
Date Deposited: 26 Oct 2016 21:05
Last Modified: 26 Oct 2016 21:05
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