Abstract
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).
Funder
National Natural Science Foundation of China
Medical Guidance Foundation of Shanghai Municipal Science and Technology Commission
Shanghai Municipal Education Commission Gaofeng Clinical Medicine Grant Support
Guangci Distinguished Young Scholars Training Program
Publisher
Springer Science and Business Media LLC
Subject
Cancer Research,Genetics,Oncology
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