Adding Ovarian Suppression to Tamoxifen for Premenopausal Breast Cancer: A Randomized Phase III Trial
- 주제(기타) Oncology
- 설명문(일반) [Kim, Hyun-Ah; Noh, Woo Chul] Korea Canc Ctr Hosp, Seoul, South Korea; [Lee, Jong Won; Kim, Hee Jeong] Asan Med Ctr, Seoul, South Korea; [Nam, Seok Jin] Samsung Med Ctr, Seoul, South Korea; [Park, Byeong-Woo] Yonsei Univ, Coll Med, Seoul, South Korea; [Im, Seock-Ah] Seoul Natl Univ Hosp Seoul, Seoul, South Korea; [Lee, Eun Sook] Natl Canc Ctr, Goyang, South Korea; [Jung, Yong Sik; Han, Se-Hwan] Ajou Univ, Suwon, South Korea; [Yoon, Jung Han] Chonnam Natl Univ, Hwasun Hosp, Gwangju, South Korea; [Kang, Sung Soo] Cheil Gen Hosp, Seoul, South Korea; [Kang, Sung Soo] Womens Healthcare Ctr, Seoul, South Korea; [Lee, Soo-Jung] Yeungnam Univ Hosp, Daegu, South Korea; [Park, Kyong Hwa] Korea Univ, Anam Hosp, Seoul, South Korea; [Jeong, Joon] Gangnam Severance Hosp, Seoul, South Korea; [Cho, Se-Heon] Dong A Univ Hosp, Busan, South Korea; [Kim, Sung Yong] Soonchunhyang Univ, Coll Med, Cheonan, South Korea; [Kim, Lee Su] Hallym Univ, Sacred Heart Hosp, Anyang, South Korea; [Moon, Byung-In] Ewha Womans Univ, Mokdong Hosp, Seoul, South Korea; [Lee, Min Hyuk] Soonchunhyang Univ, Coll Med, Seoul, South Korea; [Kim, Tae Hyun] Inje Univ, Busan Paik Hosp, Busan, South Korea; [Park, Chanheun] Sungkyunkwan Univ, Sch Med, Seoul, South Korea; [Jung, Sung Hoo] Chonbuk Natl Univ, Med Sch, Jeonju, South Korea; [Gwak, Geumhee] Inje Univ, Sanggye Paik Hosp, Seoul, South Korea; [Kim, Jeryong] Chungnam Natl Univ Hosp, Daejeon, South Korea; [Kang, Sun Hee] Keimyung Univ, Sch Med, Daegu, South Korea; [Jin, Young Woo] Korea Inst Radiol & Med Sci, Seoul, South Korea; [Han, Wonshik] Seoul Natl Univ, Seoul, South Korea; [Hur, Min Hee] Inha Univ, Incheon, South Korea
- 등재 SCIE, SCOPUS
- OA유형 Bronze
- 발행기관 AMER SOC CLINICAL ONCOLOGY
- 발행년도 2020
- 총서유형 Journal
- URI http://www.dcollection.net/handler/ewha/000000169170
- 본문언어 영어
- Published As https://dx.doi.org/10.1200/JCO.19.00126
- PubMed https://pubmed.ncbi.nlm.nih.gov/31518174
초록/요약
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. (C) 2019 by American Society of Clinical Oncology
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