Adding Ovarian Suppression to Tamoxifen for Premenopausal Breast Cancer: A Randomized Phase III Trial
- Author(s)
- Hyun-Ah Kim; Jong Won Lee; Seok Jin Nam; Byeong-Woo Park; Seock-Ah Im; Eun Sook Lee; Yong Sik Jung, MSc; Jung Han Yoon; 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; Sung Soo Kang
- Keimyung Author(s)
- Kang, Sun Hee
- Department
- Dept. of Surgery (외과학)
- Journal Title
- Journal of clinical oncology
- Issued Date
- 2019
- 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.
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