Adding Ovarian Suppression to Tamoxifen for Premenopausal Breast Cancer: A Randomized Phase III Trial
- 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.
- All Author(s)
- H. A. Kim
; J. W. Lee
; S. J. Nam
; B. W. Park
; S. A. Im
; E. S. Lee
; Y. S. Jung
; J. H. Yoon
; S. S. Kang
; S. J. Lee
; K. H. Park
; J. Jeong
; S. H. Cho
; S. Y. Kim
; L. S. Kim
; B. I. Moon
; M. H. Lee
; T. H. Kim
; C. Park
; S. H. Jung
; G. Gwak
; J. Kim
; S. H. Kang
; Y. W. Jin
; H. J. Kim
; S. H. Han
; W. Han
; M. H. Hur
; W. C. Noh
- Issued Date
- 2020
- Type
- Article
- Keyword
- Adult; Antineoplastic Agents, Hormonal/administration & dosage; Breast Neoplasms/blood/drug therapy/surgery/*therapy; Disease-Free Survival; Female; Follicle Stimulating Hormone/blood; Gonadotropin-Releasing Hormone/*agonists; Humans; Middle Aged; Ovary/*drug effects/physiology; Premenopause; Tamoxifen/*administration & dosage
- ISSN
- 0732-183x
- Citation Title
- Journal of Clinical Oncology
- Citation Volume
- 38
- Citation Number
- 5
- Citation Start Page
- 434
- Citation End Page
- 443
- Language(ISO)
- eng
- DOI
- 10.1200/jco.19.00126
- URI
- http://schca-ir.schmc.ac.kr/handle/2022.oak/682
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