Feasibility study of gemcitabine plus docetaxel in advanced or recurrent uterine leiomyosarcoma and undifferentiated endometrial sarcoma in Japan

Background: Uterine leiomyosarcoma (LMS) and undifferentiated endometrial sarcoma (UES) are rare, aggressive malignancies. Both are treated similarly; however, few chemotherapy agents are effective. Recently, the combination of gemcitabine (900 mg/m², days 1 and 8) plus docetaxel (100 mg/m², day 8) with granulocyte colony-stimulating factor (G-CSF, 150 μg/m², days 9–15) has been shown to have activity in LMS. In Japan, neither prophylactic G-CSF at a dose of 150 μg/m²nor docetaxel at a dose of 100 mg/m²are approved for use. For this reason, we evaluated the combination of 900 mg/m²gemcitabine plus 70 mg/m²docetaxel regimen without prophylactic G-CSF support in advanced or recurrent LMS and UES in Japanese patients.

Methods: Eligible women with advanced or recurrent LMS and UES were treated with 900 mg/m²gemcitabine on days 1 and 8, plus 70 mg/m²docetaxel on day 8, every 3 weeks. The primary endpoint was overall response rate, defined as a complete or partial response.

Results: Of the eleven women enrolled, 10 were evaluated for a response. One complete response and 2 partial responses were observed (30 %) with an additional 4 (40 %) having stable disease. Mean progression-free survival was 5.4 months (range 1.3–24.8 months), and overall survival was 14 months (range 5.3–38.4 months). Grade 4 neutropenia was the major toxicity (50 %). The median number of cycles was 5 (range 2–18). Twenty-two cycles (44 %) employed G-CSF.

Conclusion: The gemcitabine plus docetaxel regimen without prophylactic G-CSF support was tolerable and highly efficacious in Japanese patients with advanced or recurrent LMS and UES.