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

Abstract

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/m(2) days one and eight over 90 min, plus docetaxel 100 mg/m(2) 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.

• Authors: Martee L Hensley, John A Blessing, Koen Degeest, Ovadia Abulafia, Peter G Rose, Howard D Homesley
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 109 Issue 3 Pg. 323-8 (Jun 2008) ISSN: 1095-6859 [Electronic] United States
• PMID: 18394689 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural)

Chemical References

• Taxoids
• Deoxycytidine
• Docetaxel
• Gemcitabine

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
• Disease-Free Survival
• Docetaxel
• Female
• Humans
• Leiomyosarcoma (drug therapy)
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy)
• Taxoids (administration & dosage, adverse effects)
• Uterine Neoplasms (drug therapy)
• Gemcitabine