Use of anastrozole for breast cancer prevention (IBIS-II): long-term results of a randomised controlled trial
Use of anastrozole for breast cancer prevention (IBIS-II): long-term results of a randomised controlled trial
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DOI：
10.1016/s0140-6736(19)32955-1
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发表时间：
2020-01-11
期刊：
影响因子：
168.9
通讯作者：
Howell, Anthony
中科院分区：
文献类型：
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作者：
Cuzick, Jack;Sestak, Ivana;Howell, Anthony
两项大型临床试验显示，在使用芳香化酶抑制剂后的最初5年随访中，高危女性的乳腺癌发生率降低（MAP.3和国际乳腺癌干预研究II [IBIS-II]）。在这里，我们报告盲长期随访结果的IBIS-II试验，比较阿那曲唑与安慰剂，目的是确定阿那曲唑预防乳腺癌（浸润性和导管原位癌）在治疗后period. Methods IBIS-II是一个国际性的，随机，双盲，安慰剂对照试验。招募发生乳腺癌风险增加的绝经后妇女，并随机（1：1）分配至阿那曲唑（1 mg/天，口服）或匹配的安慰剂组，每日一次，持续5年。治疗完成后，每年对女性进行随访，收集乳腺癌发病率、死亡率、其他癌症和主要不良事件（心血管事件和骨折）的数据。主要结果是所有的乳腺癌。结果3864名妇女之间招募2003年2月2日，2012年1月31日。1920名妇女被随机分配到5年阿那曲唑和1944安慰剂。中位随访131个月后（IQR 105 - 156），观察到阿那曲唑组乳腺癌发生率降低49%（85例vs 165例，风险比[HR] 0.51，95%CI 0.39 - 0.66，p
Background Two large clinical trials have shown a reduced rate of breast cancer development in high-risk women in the initial 5 years of follow-up after use of aromatase inhibitors (MAP.3 and International Breast Cancer Intervention Study II [IBIS-II]). Here, we report blinded long-term follow-up results for the IBIS-II trial, which compared anastrozole with placebo, with the objective of determining the efficacy of anastrozole for preventing breast cancer (both invasive and ductal carcinoma in situ) in the post-treatment period.Methods IBIS-II is an international, randomised, double-blind, placebo-controlled trial. Postmenopausal women at increased risk of developing breast cancer were recruited and were randomly assigned (1:1) to either anastrozole (1 mg per day, oral) or matching placebo daily for 5 years. After treatment completion, women were followed on a yearly basis to collect data on breast cancer incidence, death, other cancers, and major adverse events (cardiovascular events and fractures). The primary outcome was all breast cancer.Findings 3864 women were recruited between Feb 2,2003, and Jan 31,2012.1920 women were randomly assigned to 5 years anastrozole and 1944 to placebo. After a median follow-up of 131 months (IQR 105-156), a 49% reduction in breast cancer was observed for anastrozole (85 vs 165 cases, hazard ratio [HR] 0.51, 95% CI 0.39-0.66, p