2018 ASCO Annual Meeting!
Session: Breast Cancer—Local/Regional/Adjuvant
Type: Oral Abstract Session
Time: Monday June 4, 8:00 AM to 11:00 AM
Location: Hall D2
Role of adding ovarian function suppression to tamoxifen in young women with hormone-sensitive breast cancer who remain premenopausal or resume menstruation after chemotherapy: The ASTRRA study.
2018 ASCO Annual Meeting
J Clin Oncol 36, 2018 (suppl; abstr 502)
Author(s): Woo Chul Noh, jong Won Lee, Seok Jin Nam, Seho Park, Seock-Ah Im, Eun Sook Lee, Yongsik Jung, Jung Han Yoon, Sung Soo Kang, Soo-Jung Lee, Kyong Hwa Park, Joon Jeong, Se-heon Cho, Sung Yong Kim, hee Jeong Kim, Chanheun Park, Se-Hwan Han, Wonshik Han, Min Hee Hur, Hyun-Ah Kim, Korea Breast Cancer Study Group; KIRAMS, Seoul, Republic of Korea; Department of Surgery, University of Ulsan, College of Medicine, Asan Medical Center, Seoul, Korea, Republic of (South); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea, Republic of (South); Yonsei University College of Medicine, Seoul, Korea, Republic of (South); Seoul National University Hospital Cancer Research Institute, Seoul, Republic of Korea; National Cancer Center, Center for Breast Cancer, Goyang-Si, Korea, Republic of (South); Department of Surgery, Ajou University School of Medicine, Suwon, Republic of Korea; Chonnam National University Hwasun Hospital, Gwangju, Korea, Republic of (South); Cheil General Hospital and Women's Healthcare Center, Seoul, Korea, Republic of (South); Yeungnam University Hospital, Daegu, Korea, Republic of (South); Division of Oncology/Hematology, Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea, Republic of (South); Gangnam Severance Hospital, Yonsei University, Seoul, Korea, Republic of (South); Dong-A University Medical Center, Busan, Korea South; Department of Surgery, Soonchunhyang University Cheonan Hospital, Cheonan, Republic of Korea; Sungkyunkwan University School of Medicine, Kangbuk Samsung Hospital, Seoul, Korea, Republic of (South); Ajou University, School of Medicine, Suwon, Korea, Republic of (South); Department of Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea; Kwandong Univ College of Medicine, Seoul, Korea South; Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, Korea, Republic of (South)
Background: The role of adding ovarian function suppression (OFS) to tamoxifen (T) for premenopausal patients with breast cancer after completing (neo) adjuvant chemotherapy is uncertain. The prospective randomized phase III trial was conducted to evaluate the efficacy of adding OFS to T in patients with hormone receptor-positive breast cancer who remain in premenopausal status or resume ovarian function after chemotherapy (NCT00912548). The primary and key secondary endpoints were to compare the 5-year disease-free survival and overall survival, respectively, between patients who received T and those who received T and OFS. Methods: We enrolled 1483 premenopausal women (aged ¡Â45 years) with estrogen receptor-positive breast cancer who were treated with definitive surgery after completing neoadjuvant or adjuvant chemotherapy. Ovarian function was assessed every 6 months for 2 years since enrollment based on follicular-stimulating hormone levels and menstruation history. If ovarian function was confirmed to be premenopausal at each visit, the patient was randomized to receive 5 years of T (T-only group) or 5 years of T plus 2 years of OFS by monthly goserelin (T + OFS group). A total of 1282 patients was randomly assigned. Disease-free survival was defined as the time from enrollment to the detection of recurrence of breast cancer, contralateral breast cancer, secondary malignancy, or death by any cause. Results: After a median follow-up of 63 months, the estimated disease-free survival rate at 5 years was 91.1% in the T + OFS group and 87.5% in the T-only group (hazard ratio 0.686; 95% confidence interval [CI], 0.483 to 0.972; P = 0.033). The estimated overall survival rate after 5 years was 99.4% in the T + OFS group and 97.8% in the T-only group (hazard ratio 0.310; 95% CI, 0.102 to 0.941; P = 0.029). Conclusions: Ovarian function needs to be monitored for at least 24 months after completing chemotherapy to establish eligibility for OFS. Adding 2 years of OFS to T significantly improved disease-free survival as compared to T alone in those who remained premenopausal or resumed ovarian function after chemotherapy. Clinical trial information: NCT00912548
1. TAILORx: Phase III trial of chemoendocrine therapy versus endocrine therapy alone in hormone receptor-positive, HER2-negative, node-negative breast cancer and an intermediate prognosis 21-gene recurrence score.