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Efficacy and safety of ixabepilone in taxane-resistant patients with metastatic breast cancer previously treated with anthracyclines: results of a phase II study in Japan

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Abstract

Purpose

Anthracycline and taxane resistance is a key issue in the treatment of metastatic breast cancer (MBC), particularly in Asian patients who often present with advanced disease. The objective of this study was to investigate the efficacy and safety of ixabepilone monotherapy in Japanese patients with taxane-resistant MBC previously treated with anthracycline.

Patients and methods

Japanese patients with taxane-resistant MBC previously treated with anthracycline were treated with 40 mg/m2 ixabepilone every 3 weeks. Primary endpoint was overall response rate. Secondary endpoints included duration of response, time to progression (TTP), and safety.

Results

Fifty-two patients were treated with ixabepilone. Overall response rate was 11.5 % (95 % confidence interval 4.4–23.4), stable disease rate was 38.5 %, duration of response was 3.6 months (range 2.4−5.3 months), and TTP was 2.8 months (range 0.7–8.1 months). The most frequent grade 3/4 toxicities were neutropenia (82.7 %), leukopenia (75 %), myalgia (19.2 %), and peripheral neuropathy (19.2 %).

Conclusion

Ixabepilone monotherapy was effective and toxicities were manageable in this phase II study of Japanese patients with taxane-resistant metastatic breast cancer previously treated with anthracyclines.

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Acknowledgments

The Ixabepilone Breast Cancer Study Group consists of the following centers: Department of Breast Surgery, Hakuaikai Sagara Hospital; Department of Breast Oncology, National Hospital Organization Shikoku Cancer Center; Department of Breast and Endocrine Surgery (2nd Surg.), Gunma University Hospital; Department of Medical Oncology, Cancer Institute Ariake Hospital; Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital; Department of Women’s Health, Shizuoka Cancer Center; Department of Surgery, Niigata Cancer Center Hospital; Department of Endocrinology, Saitama Cancer Center; Department of Breast Oncology, Aichi Cancer Center Hospital; Department of Drug Therapy, Tochigi Cancer Center; Department of Clinical Oncology, Saitama Medical University Hospital; Department of Chemotherapy, National Cancer Center Hospital East; Breast and Medical Oncology Division, National Cancer Center Hospital; Department of Medical Oncology, Kinki University School of Medicine Nara Hospital; Department of Breast and Thyroid Surgery, Kawasaki Medical School Hospital; Department of Surgery, Tokyo Metropolitan Komagome Hospital; Breast and Endocrine Surgery, Tokai University Hospital; Department of Breast Surgical Oncology, St. Luke’s International Hospital; and Department of Breast Oncology, National Hospital Organization Kyushu Cancer Center. The authors take full responsibility for the content of this publication and confirm that it reflects their views and scientific expertise. This study was supported by a grant from Bristol-Myers K.K.

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Authors and Affiliations

  1. Department of Breast Oncology, National Hospital Organization Shikoku Cancer Center, 160 Kou, Minamiumemoto-cho, Matsuyama, Ehime, 791-0280, Japan

    Kenjiro Aogi & Shigemitsu Takashima

  2. Department of Breast Surgery, Sagara Hospital, Hakuaikai, 3-31 Matsubara-cho, Kagoshima-shi, Kagoshima, 892-0833, Japan

    Yoshiaki Rai

  3. Department of Medical Oncology, Breast Oncology Center, Cancer Institute Hospital, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan

    Yoshinori Ito

  4. Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, 2-1-14 Hoenzaka, Chuo, Osaka-shi, Osaka, 540-0006, Japan

    Norikazu Masuda

  5. Division of Medical Oncology, Shizuoka Cancer Center Hospital, 1007 Shimonagakubo, Nagaizumi, Sunto, Shizuoka, 411-8777, Japan

    Junichiro Watanabe

  6. Breast and Endocrine Surgery, Gunma University Hospital, 3-39-15 Showa-machi, Maebashi, Gunma, 371-8511, Japan

    Jun Horiguchi

  7. Research and Development, Bristol-Myers K.K, 6-5-1 Nishi-shinjuku, Shinjuku-ku, Tokyo, 163-1328, Japan

    Takuto Tokudome

Authors
  1. Kenjiro Aogi
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  2. Yoshiaki Rai
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  3. Yoshinori Ito
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  4. Norikazu Masuda
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  5. Junichiro Watanabe
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  6. Jun Horiguchi
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  7. Takuto Tokudome
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  8. Shigemitsu Takashima
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Corresponding author

Correspondence to Kenjiro Aogi.

Additional information

This study was registered in a clinical trial registry as NCT01019577.

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Aogi, K., Rai, Y., Ito, Y. et al. Efficacy and safety of ixabepilone in taxane-resistant patients with metastatic breast cancer previously treated with anthracyclines: results of a phase II study in Japan. Cancer Chemother Pharmacol 71, 1427–1433 (2013). https://doi.org/10.1007/s00280-013-2140-y

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  • DOI: https://doi.org/10.1007/s00280-013-2140-y

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