本文由小咖机器人翻译整理

期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.4840

摘要内容如下：

重要性

对乳腺癌存活者的观察性研究和阿司匹林治疗心血管疾病的前瞻性试验表明，阿司匹林使用者的乳腺癌生存率有所提高，但缺乏阿司匹林预防乳腺癌复发的前瞻性研究。

目的

确定阿司匹林是否能降低乳腺癌幸存者发生侵袭性癌症事件的风险。

设计、设置和参与者

A011502是一项在美国和加拿大进行的3期、随机、安慰剂对照、双盲试验，有3020名患有高风险非转移性乳腺癌的参与者，从2017年1月6日至2020年12月4日，从534个地点招募参与者，随访至2023年3月4日。

干预措施

参与者被随机分组（根据激素受体状态[阳性vs阴性]、身体质量指数[≤30 vs>30]、II期vs III期和确诊时间[<18 vs≥18个月]进行分层），接受300 mg阿司匹林（n=1510）或安慰剂（n=1510），每日一次，为期5年。

主要成果和措施

主要结果是侵袭性无病生存率。总生存率是一个关键的次要结果。

结果

当数据和安全监测委员会建议在第一次中期分析时暂停研究时，共有3020名参与者被随机分配，因为风险比已经超过了预先指定的无效性界限。中位随访33.8个月（范围0.1-72.6个月），观察到253例侵袭性无病生存事件（阿司匹林组141例，安慰剂组112例），产生的风险比为1.27（95%CI，0.99-1.63；P=.06）。所有侵袭性无病生存事件，包括死亡、侵袭性进展（远距离和局部区域）和新的原发事件，在阿司匹林组中数值较高，尽管差异无统计学意义。总生存率无差异（风险比，1.19；95%可信区间，0.82-1.72）。两组的3级和4级不良事件发生率相似。

结论和相关性

在患有高危非转移性乳腺癌的参与者中，每日阿司匹林治疗并不能改善早期随访中乳腺癌复发或生存的风险。尽管阿司匹林具有良好的前景和广泛的可获得性，但不应推荐其作为乳腺癌的辅助治疗。

试用注册

ClinicalTrials.gov标识符：NCT02927249。

英文原文如下：

Abstracts

Importance  Observational studies of survivors of breast cancer and prospective trials of aspirin for cardiovascular disease suggest improved breast cancer survival among aspirin users, but prospective studies of aspirin to prevent breast cancer recurrence are lacking.

Objective  To determine whether aspirin decreases the risk of invasive cancer events among survivors of breast cancer.

Design, Setting, and Participants  A011502, a phase 3, randomized, placebo-controlled, double-blind trial conducted in the United States and Canada with 3020 participants who had high-risk nonmetastatic breast cancer, enrolled participants from 534 sites from January 6, 2017, through December 4, 2020, with follow-up to March 4, 2023.

Interventions  Participants were randomized (stratified for hormone receptor status [positive vs negative], body mass index [≤30 vs >30], stage II vs III, and time since diagnosis [<18 vs ≥18 months]) to receive 300 mg of aspirin (n = 1510) or placebo once daily (n = 1510) for 5 years.

Main Outcomes and Measures  The primary outcome was invasive disease-free survival. Overall survival was a key secondary outcome.

Results  A total of 3020 participants were randomized when the data and safety monitoring committee recommended suspending the study at the first interim analysis because the hazard ratio had crossed the prespecified futility bound. By median follow-up of 33.8 months (range, 0.1-72.6 months), 253 invasive disease-free survival events were observed (141 in the aspirin group and 112 in the placebo group), yielding a hazard ratio of 1.27 (95% CI, 0.99-1.63; P = .06). All invasive disease-free survival events, including death, invasive progression (both distant and locoregional), and new primary events, were numerically higher in the aspirin group, although the differences were not statistically significant. There was no difference in overall survival (hazard ratio, 1.19; 95% CI, 0.82-1.72). Rates of grades 3 and 4 adverse events were similar in both groups.

Conclusion and Relevance  Among participants with high-risk nonmetastatic breast cancer, daily aspirin therapy did not improve risk of breast cancer recurrence or survival in early follow-up. Despite its promise and wide availability, aspirin should not be recommended as an adjuvant breast cancer treatment.

Trial Registration  ClinicalTrials.gov Identifier: NCT02927249.

-----------分割线---------

点击链接：https://www.mediecogroup.com/community/user/vip/categories/ ，成为医咖会员，获取12项专属权益。