Anastrozole for prevention of breast cancer in high-risk postmenopausal women (IBIS-II): an international, double-blind, randomised placebo-controlled trial
Anastrozole for prevention of breast cancer in high-risk postmenopausal women (IBIS-II): an international, double-blind, randomised placebo-controlled trial
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DOI：
10.1016/s0140-6736(13)62292-8
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发表时间：
2014-03-22
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
芳香化酶抑制剂能有效预防绝经后妇女乳腺癌复发和对侧新肿瘤的发生。我们评估了芳香化酶抑制剂阿那曲唑预防绝经后妇女乳腺癌的有效性和安全性，这些妇女处于疾病的高风险中。方法在2003年2月2日至2012年1月31日期间，我们招募了来自18个国家的40-70岁的绝经后妇女参加一项国际性、双盲、随机安慰剂对照试验。要符合条件，妇女必须有较高的乳腺癌风险（根据具体标准判断）。符合条件的妇女通过中心计算机随机分配（1：1），每天接受1 mg口服阿那曲唑或匹配的安慰剂，持续5年。随机化按国家分层，并采用区组（6、8或10号）进行。所有试验人员、受试者和临床医生均对治疗分配设盲;仅试验统计学家揭盲。主要终点是组织学证实的乳腺癌（浸润性癌或非浸润性导管原位癌）。本试验已注册，编号为ISRCTN 31488319。结果1920名妇女被随机分配接受阿那曲唑治疗，1944名妇女被随机分配接受安慰剂治疗。在中位随访5.0年后（IQR 3.0-7.1），阿那曲唑组有40名妇女（2%）和安慰剂组有85名妇女（4%）发生乳腺癌（风险比0.47，95%CI 0.32-0.68，p
Background Aromatase inhibitors effectively prevent breast cancer recurrence and development of new contralateral tumours in postmenopausal women. We assessed the efficacy and safety of the aromatase inhibitor anastrozole for prevention of breast cancer in postmenopausal women who are at high risk of the disease.Methods Between Feb 2, 2003, and Jan 31, 2012, we recruited postmenopausal women aged 40-70 years from 18 countries into an international, double-blind, randomised placebo-controlled trial. To be eligible, women had to be at increased risk of breast cancer (judged on the basis of specific criteria). Eligible women were randomly assigned (1:1) by central computer allocation to receive 1 mg oral anastrozole or matching placebo every day for 5 years. Randomisation was stratified by country and was done with blocks (size six, eight, or ten). All trial personnel, participants, and clinicians were masked to treatment allocation; only the trial statistician was unmasked. The primary endpoint was histologically confirmed breast cancer (invasive cancers or non-invasive ductal carcinoma in situ). Analyses were done by intention to treat. This trial is registered, number ISRCTN31488319.Findings 1920 women were randomly assigned to receive anastrozole and 1944 to placebo. After a median follow-up of 5.0 years (IQR 3.0-7.1), 40 women in the anastrozole group (2%) and 85 in the placebo group (4%) had developed breast cancer (hazard ratio 0.47, 95% CI 0.32-0.68, p