The Aspirin Conundrum—Navigating Negative Results, Age, Aging Dynamics, and Equity
Mené sur 3 020 patientes ayant survécu à un cancer du sein à haut risque de récidive et non métastatique (durée médiane de suivi : 33,8 mois), cet essai randomisé de phase III évalue l'intérêt, du point de vue de la survie sans maladie invasive, d'une utilisation quotidienne d'aspirine pour prévenir le risque de récidive
The Alliance trial led by Chen and colleagues1 and published in this issue of JAMA addresses an important topic in the management of breast cancer: can daily use of 300 mg of aspirin improve invasive disease–free survival among persons with a diagnosis of nonmetastatic, high-risk breast cancer? The answer is a fairly definitive no based on prespecified futility rules in a rigorous phase 3, randomized, placebo-controlled, double-blind trial. The trial (A011502) enrolled 3020 persons (3004 women [99.5%] and 16 men [0.5%]) from 534 academic and community sites across the US and Canada. Although the trial was planned for 5 years, it was suspended at the first interim safety analysis (median follow-up, 33.8 months; range, 0.1-72.6) because the results indicated futility: 141 vs 112 invasive disease–free events in the aspirin vs placebo group, respectively (hazard ratio, 1.27; 95% CI, 0.99-1.63; P = .06).