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

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Author(s)
Hyun-Ah KimJong Won LeeSeok Jin NamByeong-Woo ParkSeock-Ah ImEun Sook LeeYong Sik JungJung Han YoonSung Soo KangSoo-Jung LeeKyong Hwa ParkJoon JeongSe-Heon ChoSung Yong KimLee Su KimByung-In MoonMin Hyuk LeeTae Hyun KimChanheun ParkSung Hoo JungGeumhee GwakJeryong KimSun Hee KangYoung Woo JinHee Jeong KimSe-Hwan HanWonshik HanMin Hee HurWoo Chul Noh
Keimyung Author(s)
Kang, Sun Hee
Department
Dept. of Surgery (외과학)
Journal Title
Journal of Clinical Oncology
Issued Date
2020
Volume
38
Issue
5
Abstract
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.
Keimyung Author(s)(Kor)
강선희
Publisher
School of Medicine (의과대학)
Citation
Hyun-Ah Kim et al. (2020). Adding Ovarian Suppression to Tamoxifen for Premenopausal Breast Cancer: A Randomized Phase III Trial. Journal of Clinical Oncology, 38(5), 434–443. doi: 10.1200/JCO.19.00126
Type
Article
ISSN
1527-7755
Source
https://ascopubs.org/doi/10.1200/JCO.19.00126
DOI
10.1200/JCO.19.00126
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/43158
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Surgery (외과학)
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