Postoperative Adjuvant Anastrozole for 10 or 5 Years in Patients With Hormone Receptor–Positive Breast Cancer: AERAS, a Randomized Multicenter Open-Label Phase III Trial

阿那曲唑 医学 三苯氧胺 乳腺癌 危险系数 内科学 芳香化酶抑制剂 临床终点 肿瘤科 随机对照试验 外科 癌症 妇科 置信区间
作者
Takuji Iwase,Shigehira Saji,Kotaro Iijima,Kenji Higaki,Shoichiro Ohtani,Yasuyuki Sato,Yasuo Hozumi,Yoshie Hasegawa,Yasuhiro Yanagita,Hiroyuki Takei,Maki Tanaka,Hideji Masuoka,Masahiko Tanabe,Chiyomi Egawa,Yoshifumi Komoike,Toshitaka Nakamura,Hiroshi Ohtsu,Hirofumi Mukai
出处
期刊:Journal of Clinical Oncology [Lippincott Williams & Wilkins]
卷期号:41 (18): 3329-3338 被引量:15
标识
DOI:10.1200/jco.22.00577
摘要

Treatment with an aromatase inhibitor for 5 years is the standard treatment for postmenopausal hormone receptor-positive breast cancer. We investigated the effects of extending this treatment to 10 years on disease-free survival (DFS).This prospective, randomized, multicenter open-label phase III study assessed the effect of extending anastrozole treatment for an additional 5 years in postmenopausal patients who were disease-free after treatment with either 5 years of anastrozole alone or 2-3 years of tamoxifen followed by 2-3 years of anastrozole. Patients were allocated randomly (1:1) to continue anastrozole for an additional 5 years or stop anastrozole. The primary end point was DFS, including breast cancer recurrence, second primary cancers, and death from any cause. This study is registered with University Hospital Medical Information Network, Japan (UMIN) clinical trials registry (UMIN000000818).We enrolled 1,697 patients from 117 facilities between November 2007 and November 2012. Follow-up information was available for 1,593 patients (n = 787 in the continue group, n = 806 in the stop group), who were defined as the full analysis set, including 144 patients previously treated with tamoxifen and 259 patients who underwent breast-conserving surgery without irradiation. The 5-year DFS rates were 91% (95% CI, 89 to 93) in the continue group and 86% (95% CI, 83 to 88) in the stop group (hazard ratio, 0.61; 95% CI, 0.46 to 0.82; P < .0010). Notably, extended anastrozole treatment reduced the incidence of local recurrence (continue group, n = 10; stop group, n = 27) and second primary cancers (continue group, n = 27; stop group, n = 52). There was no significant difference in overall or distant DFS. Menopausal or bone-related all-grade adverse events were more frequent among patients in the continue group than those in the stop group, but the incidence of grade ≥3 adverse events was <1% in both groups.Continuing adjuvant anastrozole for an additional 5 years after 5 years of initial treatment with anastrozole or tamoxifen followed by anastrozole was well tolerated and improved DFS. Although no difference in overall survival was observed as in other trials, extended anastrozole therapy could be one treatment choice in postmenopausal patients with hormone receptor-positive breast cancer.
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