对乳腺癌幸存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提高,但缺乏阿司匹林预防乳腺癌复发的前瞻性研究。
■确定阿司匹林是否降低乳腺癌幸存者发生浸润性癌症事件的风险。
■A011502,第三阶段,随机,安慰剂对照,在美国和加拿大对3020名高风险非转移性乳腺癌患者进行了双盲试验,从2017年1月6日至2020年12月4日,纳入534个研究点的参与者,随访至2023年3月4日.
■参与者被随机分组(对激素受体状态进行分层[阳性与阴性],体重指数[≤30vs>30],第二阶段对第三阶段,和自诊断以来的时间[<18vs≥18个月])每天一次接受300mg阿司匹林(n=1510)或安慰剂(n=1510),持续5年。
■主要结果是无侵袭性生存率。总生存率是关键的次要结果。
■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名参与者被随机分组,因为风险比已经超过了预设的无效界限。通过中位随访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),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,侵入性进展(远处和局部),和新的主要事件,在阿司匹林组中数字更高,尽管差异无统计学意义。总生存率没有差异(风险比,1.19;95%CI,0.82-1.72)。两组中3级和4级不良事件的发生率相似。
■在高风险非转移性乳腺癌患者中,在早期随访中,每日服用阿司匹林并不能改善乳腺癌复发或生存率的风险.尽管它的前景和广泛的可用性,阿司匹林不应推荐作为乳腺癌的辅助治疗。
■ClinicalTrials.gov标识符:NCT02927249。
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.
To determine whether aspirin decreases the risk of invasive cancer events among survivors of breast cancer.
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.
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.
The primary outcome was invasive disease-free survival. Overall survival was a key secondary outcome.
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.
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.
ClinicalTrials.gov Identifier: NCT02927249.