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

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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.govNCT02344940. Registered 26 January 2015 (retrospectively registered).
Funding Information
  • National Natural Science Foundation of China (81472462 and 81772797)
  • Medical Guidance Foundation of Shanghai Municipal Science and Technology Commission (15411966400)
  • Shanghai Municipal Education Commission Gaofeng Clinical Medicine Grant Support (20172007)
  • Guangci Distinguished Young Scholars Training Program (GCQN-2018-B11)

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