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01-12-2020 | Breast Cancer | Research article

A prospective, randomized study of Toremifene vs. tamoxifen for the treatment of premenopausal breast cancer: safety and genital symptom analysis

Authors: Jin Hong, Jiahui Huang, Lili Shen, Siji Zhu, Weiqi Gao, Jiayi Wu, Ou Huang, Jianrong He, Li Zhu, Weiguo Chen, Yafen Li, Xiaosong Chen, Kunwei Shen

Published in: BMC Cancer | Issue 1/2020

Abstract

Background

Toremifene (TOR) is a selective oestrogen receptor modulator (SERM) and has comparable efficacy to that of tamoxifen (TAM) in breast cancer patients. Herein, we compared the safety of TOR to that of TAM in the adjuvant treatment of premenopausal breast cancer.

Methods

This was a prospective randomized and open-label clinical study. Premenopausal patients with hormonal receptor (HR)-positive early breast cancer were randomly assigned (1:1) to receive TOR) or TAM treatment. The follow-up period was 1 year. The primary end point was the incidence of ovarian cysts, and secondary end points were the incidence of endometrial thickening, changes in female hormones, the incidence of fatty liver, changes in the modified Kupperman index (mKMI) and changes in quality of life.

Results

There were 92 patients in the final analysis. The incidences of ovarian cysts were 42.6% in the TOR group and 51.1% in the TAM group (p = 0.441). Forty-one patients (87.2%) in the TOR group and 36 patients (80.0%) in the TAM group experienced endometrial thickening (p = 0.348). The proportions of patients with fatty liver were 31.9% in the TOR group and 26.7% in the TAM group (p = 0.581). No significant differences in the mKMI or quality of life were observed between the two groups.

Conclusions

TOR and TAM have similar side effects on the female genital system and quality of life in premenopausal early breast cancer patients.

Trial registration

ClinicalTrials.gov NCT02344940. Registered 26 January 2015 (retrospectively registered).

Available only for authorised users

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Title: A prospective, randomized study of Toremifene vs. tamoxifen for the treatment of premenopausal breast cancer: safety and genital symptom analysis
Authors: Jin Hong
Jiahui Huang
Lili Shen
Siji Zhu
Weiqi Gao
Jiayi Wu
Ou Huang
Jianrong He
Li Zhu
Weiguo Chen
Yafen Li
Xiaosong Chen
Kunwei Shen
Publication date: 01-12-2020
Publisher: BioMed Central
Keywords: Breast Cancer
Breast Cancer
Fatty Liver
Tamoxifen
Published in: BMC Cancer / Issue 1/2020
Electronic ISSN: 1471-2407
DOI: https://doi.org/10.1186/s12885-020-07156-x

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Abstract

Background

Methods

Results

Conclusions

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