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J Clin Oncol. 2019 Sep 16:JCO1900126. doi: 10.1200/JCO.19.00126. [Epub ahead of print]

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

Author information

1
Korea Cancer Center Hospital, Seoul, Republic of Korea.
2
Asan Medical Center, Seoul, Republic of Korea.
3
Samsung Medical Center, Seoul, Republic of Korea.
4
Yonsei University College of Medicine, Seoul, Republic of Korea.
5
Seoul National University Hospital Seoul, Republic of Korea.
6
National Cancer Center, Goyang, Republic of Korea.
7
Ajou University, Suwon, Republic of Korea.
8
Chonnam National University Hwasun Hospital, Gwangju, Republic of Korea.
9
Cheil General Hospital and Women's Healthcare Center, Seoul, Republic of Korea.
10
Yeungnam University Hospital, Daegu, Republic of Korea.
11
Korea University Anam Hospital, Seoul, Republic of Korea.
12
Gangnam Severance Hospital, Seoul, Republic or Korea.
13
Dong-A University Hospital, Busan, Republic of Korea.
14
Soonchunhyang University College of Medicine, Cheonan, Republic of Korea.
15
Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.
16
Ewha Woman's University Mokdong Hospital, Seoul, Republic of Korea.
17
Soonchunhyang University College of Medicine, Seoul, Republic of Korea.
18
Inje University Busan Paik Hospital, Busan, Republic of Korea.
19
Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
20
Chonbuk National University Medical School, Jeonju, Republic of Korea.
21
Inje University Sanggye Paik Hospital, Seoul, Republic of Korea.
22
Chungnam National University Hospital, Daejeon, Republic of Korea.
23
Keimyung University School of Medicine, Daegu, Republic of Korea.
24
Korea Institute of Radiological and Medical Sciences, Seoul, Republic of Korea.
25
Seoul National University, Seoul, Republic of Korea.
26
Inha University, Incheon, Republic of Korea.

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.

PMID:
31518174
DOI:
10.1200/JCO.19.00126

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