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

被引：70

作者：

Kim, Hyun-Ah ^{[1
]}

Lee, Jong Won ^{[2
]}

Nam, Seok Jin ^{[3
]}

Park, Byeong-Woo ^{[4
]}

Im, Seock-Ah ^{[5
]}

Lee, Eun Sook ^{[6
]}

Jung, Yong Sik ^{[7
]}

Yoon, Jung Han ^{[8
]}

Kang, Sung Soo ^{[9
,10
]}

Lee, Soo-Jung ^{[11
]}

Park, Kyong Hwa ^{[12
]}

Jeong, Joon ^{[13
]}

Cho, Se-Heon ^{[14
]}

Kim, Sung Yong ^{[15
]}

Kim, Lee Su ^{[16
]}

Moon, Byung-In ^{[17
]}

Lee, Min Hyuk ^{[18
]}

Kim, Tae Hyun ^{[19
]}

Park, Chanheun ^{[20
]}

Jung, Sung Hoo ^{[21
]}

Gwak, Geumhee ^{[22
]}

Kim, Jeryong ^{[23
]}

Kang, Sun Hee ^{[24
]}

Jin, Young Woo ^{[25
]}

Kim, Hee Jeong ^{[2
]}

Han, Se-Hwan ^{[7
]}

Han, Wonshik ^{[26
]}

Hur, Min Hee ^{[27
]}

Noh, Woo Chul ^{[1
]}

机构：

[1] Korea Canc Ctr Hosp, Seoul, South Korea

[2] Asan Med Ctr, Seoul, South Korea

[3] Samsung Med Ctr, Seoul, South Korea

[4] Yonsei Univ, Coll Med, Seoul, South Korea

[5] Seoul Natl Univ Hosp Seoul, Seoul, South Korea

[6] Natl Canc Ctr, Goyang, South Korea

[7] Ajou Univ, Suwon, South Korea

[8] Chonnam Natl Univ, Hwasun Hosp, Gwangju, South Korea

[9] Cheil Gen Hosp, Seoul, South Korea

[10] Womens Healthcare Ctr, Seoul, South Korea

[11] Yeungnam Univ Hosp, Daegu, South Korea

[12] Korea Univ, Anam Hosp, Seoul, South Korea

[13] Gangnam Severance Hosp, Seoul, South Korea

[14] Dong A Univ Hosp, Busan, South Korea

[15] Soonchunhyang Univ, Coll Med, Cheonan, South Korea

[16] Hallym Univ, Sacred Heart Hosp, Anyang, South Korea

[17] Ewha Womans Univ, Mokdong Hosp, Seoul, South Korea

[18] Soonchunhyang Univ, Coll Med, Seoul, South Korea

[19] Inje Univ, Busan Paik Hosp, Busan, South Korea

[20] Sungkyunkwan Univ, Sch Med, Seoul, South Korea

[21] Chonbuk Natl Univ, Med Sch, Jeonju, South Korea

[22] Inje Univ, Sanggye Paik Hosp, Seoul, South Korea

[23] Chungnam Natl Univ Hosp, Daejeon, South Korea

[24] Keimyung Univ, Sch Med, Daegu, South Korea

[25] Korea Inst Radiol & Med Sci, Seoul, South Korea

[26] Seoul Natl Univ, Seoul, South Korea

[27] Inha Univ, Incheon, South Korea

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2020年 / 38卷 / 05期

关键词：

INTERNATIONAL CONSENSUS GUIDELINES; QUALITY-OF-LIFE; ADJUVANT TAMOXIFEN; YOUNG-WOMEN; AMENORRHEA; MENSTRUATION; GOSERELIN; EFFICACY;

D O I：

10.1200/JCO.19.00126

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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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页数：23