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01.05.2014 | Original Article

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

verfasst von: Morihiko Kimura, Takeshi Tominaga, Izo Kimijima, Yuichi Takatsuka, Shigemitsu Takashima, Yasuo Nomura, Fujio Kasumi, Akihiro Yamaguchi, Norikazu Masuda, Shinzaburo Noguchi, Nobuoki Eshima

Erschienen in: Breast Cancer | Ausgabe 3/2014

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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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Titel: Phase III randomized trial of toremifene versus tamoxifen for Japanese postmenopausal patients with early breast cancer
verfasst von: Morihiko Kimura
Takeshi Tominaga
Izo Kimijima
Yuichi Takatsuka
Shigemitsu Takashima
Yasuo Nomura
Fujio Kasumi
Akihiro Yamaguchi
Norikazu Masuda
Shinzaburo Noguchi
Nobuoki Eshima
Publikationsdatum: 01.05.2014
Verlag: Springer Japan
Erschienen in: Breast Cancer / Ausgabe 3/2014
Print ISSN: 1340-6868
Elektronische ISSN: 1880-4233
DOI: https://doi.org/10.1007/s12282-012-0394-6

Springer Medizin

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