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

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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/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.

Methods

Eligible women with advanced or recurrent LMS and UES were treated with 900 mg/m2 gemcitabine on days 1 and 8, plus 70 mg/m2 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.

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Acknowledgments

This study was supported, in part, by the Coordination, Support and Training Program for Translational Research, by the Kurokawa Cancer Research Foundation, by the Tohoku Gynecologic Cancer Unit, by the Japan Clinical Oncology Group, by a grant-in-aid from the Ministry of Education, Culture, Sports, Science and Technology, and by a grant-in-aid from the Ministry of Health, Labor and Welfare, Japan.

Conflict of interest

The authors declare that they have no conflict of interest.

Author information

Authors and Affiliations

  1. Clinical Research, Innovation, and Education Center, Tohoku University Hospital, 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan

    Tadao Takano

  2. Department of Gynecology, Tohoku University School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan

    Hitoshi Niikura, 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 & Nobuo Yaegashi

  3. Disaster Medical Science Division, Disaster Obstetrics and Gynecology, International Research Institute of Disaster Science, Tohoku University, 6-6-04 Aramaki Aza Aoba, Aoba-ku, Sendai, Miyagi, 980-8579, Japan

    Kiyoshi Ito

  4. Department of Biostatistics, Tohoku University Graduate School of Medicine, 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan

    Takuhiro Yamaguchi

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  1. Tadao Takano
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  2. Hitoshi Niikura
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Correspondence to Tadao Takano.

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Takano, T., Niikura, H., Ito, K. et al. Feasibility study of gemcitabine plus docetaxel in advanced or recurrent uterine leiomyosarcoma and undifferentiated endometrial sarcoma in Japan. Int J Clin Oncol 19, 897–905 (2014). https://doi.org/10.1007/s10147-013-0627-5

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  • DOI: https://doi.org/10.1007/s10147-013-0627-5

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