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Adding Ovarian Suppression to Tamoxifen for Premenopausal Breast Cancer: A Randomized Phase III Trial

 Hyun-Ah Kim  ;  Jong Won Lee  ;  Seok Jin Nam  ;  Byeong-Woo Park  ;  Seock-Ah Im  ;  Eun Sook Lee  ;  Yong Sik Jung  ;  Jung Han Yoon  ;  Sung Soo Kang  ;  Soo-Jung Lee  ;  Kyong Hwa Park  ;  Joon Jeong  ;  Se-Heon Cho  ;  Sung Yong Kim  ;  Lee Su Kim  ;  Byung-In Moon  ;  Min Hyuk Lee  ;  Tae Hyun Kim  ;  Chanheun Park  ;  Sung Hoo Jung  ;  Geumhee Gwak  ;  Jeryong Kim  ;  Sun Hee Kang  ;  Young Woo Jin  ;  Hee Jeong Kim  ;  Se-Hwan Han  ;  Wonshik Han  ;  Min Hee Hur  ;  Woo Chul Noh  ;  Korean Breast Cancer Study Group 
 JOURNAL OF CLINICAL ONCOLOGY, Vol.38(5) : 434-443, 2020 
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PURPOSE: The addition of ovarian function suppression (OFS) for 5 years to tamoxifen (TAM) for treatment of premenopausal patients with breast cancer after completion of chemotherapy has beneficial effects on disease-free survival (DFS). This study evaluated the efficacy of adding 2 years of OFS to TAM in patients with hormone receptor-positive breast cancer who remain in a premenopausal state or resume ovarian function after chemotherapy. PATIENTS AND METHODS: We enrolled 1,483 premenopausal women (age ≤ 45 years) with estrogen receptor-positive breast cancer treated with definitive surgery after completing adjuvant or neoadjuvant chemotherapy. Ovarian function was assessed every 6 months for 2 years since enrollment on the basis of follicular-stimulating hormone levels and vaginal bleeding history. If ovarian function was confirmed to be premenopausal at each visit, the patient was randomly assigned to complete 5 years of TAM alone (TAM-only) group or 5 years of TAM with OFS for 2 years that involved monthly goserelin administration (TAM + OFS) group. DFS was defined from the time of enrollment to the time of the first event. RESULTS: A total of 1,293 patients were randomly assigned, and 1,282 patients were eligible for analysis. The estimated 5-year DFS rate was 91.1% in the TAM + OFS group and 87.5% in the TAM-only group (hazard ratio, 0.69; 95% CI, 0.48 to 0.97; P = .033). The estimated 5-year overall survival rate was 99.4% in the TAM + OFS group and 97.8% in the TAM-only group (hazard ratio, 0.31; 95% CI, 0.10 to 0.94; P = .029). CONCLUSION: The addition of 2 years of OFS to TAM significantly improved DFS compared with TAM alone in patients who remained premenopausal or resumed ovarian function after chemotherapy.
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1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Park, Byeong Woo(박병우) ORCID logo https://orcid.org/0000-0003-1353-2607
Jeong, Joon(정준) ORCID logo https://orcid.org/0000-0003-0397-0005
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