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Phase III randomized trial of toremifene versus tamoxifen for Japanese postmenopausal patients with early breast cancer

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Abstract

Background

Toremifene, a selective estrogen receptor modulator, is used as adjuvant therapy for postmenopausal patients with breast cancer in Japan. For Japanese patients, however, only limited data are available on the efficacy and safety profile of toremifene. To establish the long term efficacy and safety of toremifene for Japanese patients, we conducted a prospective, multicenter, randomized phase III trial comparing toremifene and tamoxifen.

Patients and methods

The subjects were postmenopausal Japanese patients who had undergone surgery for node-negative breast cancer. Toremifene or tamoxifen was administered for 2 years. The primary endpoint was demonstration of the non-inferiority of toremifene compared with tamoxifen in respect of 5-year survival. Secondary endpoints were cumulative overall survival, cumulative disease-free survival, effects on lipid profiles, and adverse events.

Results

A total of 253 patients were enrolled. The baseline characteristics of the two treatment groups were well-balanced. Median follow-up was 66.5 months. Five-year survival was similar for toremifene and tamoxifen (97.0 vs. 96.9 %; 90 % confidence interval −3.9 to 4.1), indicating that toremifene is not inferior to tamoxifen for postmenopausal Japanese patients with early breast cancer. Cumulative overall survival and cumulative disease-free survival were also very similar for toremifene and tamoxifen (97.5 vs. 97.3 %, log-rank test P = 0.9458; 88.4 vs. 90.6 %, log-rank test P = 0.3359, respectively). Adverse events in both groups were similar and mostly mild or moderate. Thus, both are equally effective and well tolerated.

Conclusion

Our results suggest that the efficacy and safety of toremifene and tamoxifen are equivalent for postmenopausal Japanese patients with early breast cancer.

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Acknowledgments

The authors wish to acknowledge the patients, physicians, nurses, and clinical research coordinators who participated in the trial. This study was sponsored by Nippon Kayaku Co. Ltd. The study sponsor had no role in the study other than providing information relevant to proper use of the study drugs. All decisions concerning the planning, implementation, and publication of this study were made by the executive committee of this study.

Conflict of interest

The authors indicated no potential conflict of interest.

Author information

Authors and Affiliations

  1. Department of Surgery, Gunma Cancer Center, Ota, Japan

    Morihiko Kimura

  2. Breast Cancer Center, Toyosu Hospital, Showa University, Tokyo, Japan

    Takeshi Tominaga

  3. Breast Center, Northern Fukushima Medical Center, Date, Japan

    Izo Kimijima

  4. Department of Surgery, Kansai Rosai Hospital, Amagasaki, Japan

    Yuichi Takatsuka

  5. Department of Surgery, National Shikoku Cancer Center Hospital, Matsuyama, Japan

    Shigemitsu Takashima

  6. Department of Breast Surgery, Oikawa Hospital, Fukuoka, Japan

    Yasuo Nomura

  7. Department of Breast Oncology, Cancer Institute Hospital, Tokyo, Japan

    Fujio Kasumi

  8. Department of Surgery, Ogaki Municipal Hospital, Ogaki, Japan

    Akihiro Yamaguchi

  9. Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan

    Norikazu Masuda

  10. Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, Suita, Japan

    Shinzaburo Noguchi

  11. Department of Medical Information Analysis, Faculty of Medicine, Oita University, Yufu, Japan

    Nobuoki Eshima

Authors
  1. Morihiko Kimura
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  2. Takeshi Tominaga
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  3. Izo Kimijima
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  4. Yuichi Takatsuka
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  5. Shigemitsu Takashima
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  6. Yasuo Nomura
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  7. Fujio Kasumi
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  8. Akihiro Yamaguchi
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  9. Norikazu Masuda
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  10. Shinzaburo Noguchi
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  11. Nobuoki Eshima
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Corresponding author

Correspondence to Morihiko Kimura.

Additional information

The names of institutions participating in this trial are shown in the Appendix.

Appendix

Appendix

See Table 3.

Table 3 Participating institutions
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Kimura, M., Tominaga, T., Kimijima, I. et al. Phase III randomized trial of toremifene versus tamoxifen for Japanese postmenopausal patients with early breast cancer. Breast Cancer 21, 275–283 (2014). https://doi.org/10.1007/s12282-012-0394-6

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  • DOI: https://doi.org/10.1007/s12282-012-0394-6

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