Fixed-dose rate gemcitabine plus docetaxel as second-line therapy for metastatic uterine leiomyosarcoma: A Gynecologic Oncology Group phase II study

Martee L. Hensley, John A. Blessing, Koenraad De Geest, Ovadia Abulafia, Peter G. Rose, Howard D. Homesley

Research output: Contribution to journalArticle

176 Scopus citations


Objective: Doxorubicin-based treatment is standard therapy for metastatic uterine leiomyosarcoma. There is no standard second-line therapy. We determined activity of fixed-dose rate gemcitabine plus docetaxel as second-line treatment for metastatic uterine leiomyosarcoma. Methods: Eligible women with unresectable uterine leiomyosarcoma progressing after prior cytotoxic therapy were treated with gemcitabine 900 mg/m2 days one and eight over 90 min, plus docetaxel 100 mg/m2 on day 8 of a 21-day cycle with granulocyte growth factor. Patients with prior pelvic radiation received lower doses. Response Evaluation Criteria in Solid Tumors (RECIST) response was assessed by computed tomography (CT). Results: Forty-eight of 51 women were evaluable for response (one wrong histology, two never treated). Prior therapy was doxorubicin-based in 90%, and ifosfamide-based in 6%. The overall objective response rate is 27%, with complete response in 6.3% (3/48), and partial response in 20.8% (10/48). An additional 50% (24/48) had stable disease (median duration 5.4 months). The median number of cycles per patient was 5.5 (range 1-22); 73% of patients remained progression-free at 12 weeks and 52% at 24 weeks. The predominant toxicity was uncomplicated myelosuppression: thrombocytopenia grade 3 (29%), grade 4 (10.4%); neutropenia grade 3 (12.5%), grade 4 (8.3%) anemia grade 3 (20.8%), grade 4 (4.2%). While pulmonary toxicity was reported, no patient had drug-related pneumonitis/hypoxia-type toxicity. Median progression-free survival (PFS) was 5.6+ months (range 0.7-27+ months). The median duration of objective response was 9+ months (range 3.9-24.5+ months). Conclusion: Fixed-dose rate gemcitabine plus docetaxel is active second-line therapy for uterine leiomyosarcoma.

Original languageEnglish (US)
Pages (from-to)323-328
Number of pages6
JournalGynecologic Oncology
Issue number3
Publication statusPublished - Jun 2008
Externally publishedYes



  • Docetaxel
  • Gemcitabine
  • Uterine leiomyosarcoma

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

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