Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: Results of a phase II trial Journal Article


Authors: Hensley, M. L.; Maki, R.; Venkatraman, E.; Geller, G.; Lovegren, M.; Aghajanian, C.; Sabbatini, P.; Tong, W.; Barakat, R.; Spriggs, D. R.
Article Title: Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: Results of a phase II trial
Abstract: 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/m2 intravenously (IV) on days 1 and 8 plus docetaxel 100 mg/m2 IV 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 (neutropenic: 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 docetoxel is tolerable and highly active in treated and untreated patients with LMS. © 2002 by American Society of Clinical Oncology.
Keywords: adult; cancer survival; clinical article; treatment outcome; aged; middle aged; clinical trial; fatigue; neutropenia; doxorubicin; area under the curve; cancer combination chemotherapy; diarrhea; gemcitabine; paclitaxel; cancer radiotherapy; phase 2 clinical trial; sensory neuropathy; anemia; thrombocytopenia; antineoplastic combined chemotherapy protocols; drug resistance, neoplasm; docetaxel; dyspnea; fever; vein thrombosis; taxoids; leiomyosarcoma; deoxycytidine; injections, subcutaneous; infusions, intravenous; uterine neoplasms; granulocyte colony stimulating factor; granulocyte colony-stimulating factor; allergic reaction; humans; human; male; female; priority journal; article
Journal Title: Journal of Clinical Oncology
Volume: 20
Issue: 12
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2002-06-15
Start Page: 2824
End Page: 2831
Language: English
DOI: 10.1200/jco.2002.11.050
PUBMED: 12065559
PROVIDER: scopus
DOI/URL:
Notes: Export Date: 14 November 2014 -- Source: Scopus
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MSK Authors
  1. Venkatraman Ennapadam Seshan
    285 Seshan
  2. Gennifer Geller
    1 Geller
  3. William Ping-Yiu Tong
    119 Tong
  4. Richard R Barakat
    586 Barakat
  5. Paul J Sabbatini
    199 Sabbatini
  6. Robert Maki
    211 Maki
  7. Martee L Hensley
    220 Hensley
  8. David R Spriggs
    309 Spriggs