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- Title
Feasibility study of gemcitabine plus docetaxel in advanced or recurrent uterine leiomyosarcoma and undifferentiated endometrial sarcoma in Japan.
- Authors
Takano, Tadao; Niikura, Hitoshi; Ito, Kiyoshi; Nagase, Satoru; Utsunomiya, Hiroki; Otsuki, Takeo; Toyoshima, Masafumi; Tokunaga, Hideki; Kaiho-Sakuma, Michiko; Shiga, Naomi; Nagai, Tomoyuki; Tanaka, Sota; Otsuki, Ai; Kurosawa, Hiroki; Shigeta, Shogo; Tsuji, Keita; Yamaguchi, Takuhiro; Yaegashi, Nobuo
- Abstract
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/m, days 1 and 8) plus docetaxel (100 mg/m, day 8) with granulocyte colony-stimulating factor (G-CSF, 150 μg/m, days 9-15) has been shown to have activity in LMS. In Japan, neither prophylactic G-CSF at a dose of 150 μg/m nor docetaxel at a dose of 100 mg/m are approved for use. For this reason, we evaluated the combination of 900 mg/m gemcitabine plus 70 mg/m docetaxel 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/m gemcitabine on days 1 and 8, plus 70 mg/m docetaxel 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.
- Subjects
JAPAN; ENDOMETRIAL cancer; DOCETAXEL; CANCER invasiveness; CANCER relapse; UTERINE fibroids; PATIENTS
- Publication
International Journal of Clinical Oncology, 2014, Vol 19, Issue 5, p897
- ISSN
1341-9625
- Publication type
Article
- DOI
10.1007/s10147-013-0627-5