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/m2 nor docetaxel at a dose of 100 mg/m2 are approved for use. For this reason, we evaluated the combination of 900 mg/m2 gemcitabine plus 70 mg/m2 docetaxel regimen without prophylactic G-CSF support in advanced or recurrent LMS and UES in Japanese patients.