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

Research output: Contribution to journalArticlepeer-review

15 Citations (Scopus)

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/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.

Original languageEnglish
Pages (from-to)897-905
Number of pages9
JournalInternational Journal of Clinical Oncology
Volume19
Issue number5
DOIs
Publication statusPublished - 2014 Oct 16

Keywords

  • Chemotherapy
  • Docetaxel
  • G-CSF
  • Gemcitabine
  • Japanese patients
  • Uterine leiomyosarcoma

ASJC Scopus subject areas

  • Surgery
  • Hematology
  • Oncology

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