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首页> 外文期刊>The Lancet >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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Anastrozole for prevention of breast cancer in high-risk postmenopausal women (IBIS-II): An international, double-blind, randomised placebo-controlled trial

机译：阿那曲唑预防绝经后高危妇女的乳腺癌（IBIS-II）：一项国际，双盲，随机安慰剂对照试验

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Background Aromatase inhibitors eff ectively prevent breast cancer recurrence and development of new contralateral tumours in postmenopausal women. We assessed the effi cacy 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 specifi c 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 stratifi ed 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 confi rmed 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<0.0001). The predicted cumulative incidence of all breast cancers after 7 years was 5.6% in the placebo group and 2.8% in the anastrozole group. 18 deaths were reported in the anastrozole group and 17 in the placebo group, and no specifi c causes were more common in one group than the other (p=0.836). Interpretation Anastrozole eff ectively reduces incidence of breast cancer in high-risk postmenopausal women. This fi nding, along with the fact that most of the side-eff ects associated with oestrogen deprivation were not attributable to treatment, provides support for the use of anastrozole in postmenopausal women at high risk of breast cancer. Funding Cancer Research UK, the National Health and Medical Research Council Australia, Sanofi -Aventis, and AstraZeneca.
机译：背景芳香酶抑制剂有效地预防绝经后妇女的乳腺癌复发和新的对侧肿瘤的发展。我们评估了芳香酶抑制剂阿那曲唑预防高风险绝经后妇女乳腺癌的有效性和安全性。方法在2003年2月2日至2012年1月31日期间，我们从18个国家/地区招募了40-70岁的绝经后妇女参加了一项国际双盲，随机安慰剂对照试验。为了符合条件，妇女必须增加患乳腺癌的风险（根据特定标准判断）。通过中央计算机分配将符合条件的妇女随机分配（1：1），以连续5年每天接受1 mg口服阿那曲唑或匹配的安慰剂。随机分组按国家/地区进行，并按块（大小为6、8或10）进行。所有试验人员，参与者和临床医生都被掩盖了治疗分配;只有审判统计学家才被揭露。主要终点是经组织学确认的乳腺癌（浸润性癌或非浸润性导管癌）。分析是按意向进行的。该试验已注册，编号ISRCTN31488319。调查结果1920名妇女被随机分配接受阿那曲唑治疗，1944名妇女接受安慰剂治疗。在进行了5.0年的中位随访（IQR 3.0-7.1）后，阿那曲唑组中的40名女性（占2％）和安慰剂组中的85名女性（占4％）患了乳腺癌（危险比0.47，95％CI 0.32- 0.68，p <0.0001）。安慰剂组7年后所有乳腺癌的预测累积发生率分别为5.6％和阿那曲唑组2.8％。在阿那曲唑组中报告了18例死亡，在安慰剂组中报告了17例死亡，并且在一组中没有比在另一组中更常见的特定原因（p = 0.836）。解释阿那曲唑有效降低了绝经后高危妇女的乳腺癌发病率。这一发现以及与雌激素剥夺有关的大多数副作用均不归因于治疗的事实，为在患有乳腺癌高风险的绝经后妇女中使用阿那曲唑提供了支持。为英国癌症研究，澳大利亚国家卫生与医学研究委员会，赛诺菲-安万特和阿斯利康提供资金。

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