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

Tadao Takano, Hitoshi Niikura, Kiyoshi Ito, Satoru Nagase, Hiroki Utsunomiya, Takeo Otsuki, Masafumi Toyoshima, Hideki Tokunaga, Michiko Kaiho-Sakuma, Naomi Shiga, Tomoyuki Nagai, Sota Tanaka, Ai Otsuki, Hiroki Kurosawa, Shogo Shigeta, Keita Tsuji, Takuhiro Yamaguchi, Nobuo Yaegashi

研究成果: Article査読

18 被引用数 (Scopus)

抄録

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.

本文言語English
ページ(範囲)897-905
ページ数9
ジャーナルInternational Journal of Clinical Oncology
19
5
DOI
出版ステータスPublished - 2014 10 16

ASJC Scopus subject areas

  • 外科
  • 血液学
  • 腫瘍学

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