Low-Dose Aspirin for Individualized Cancer Prevention in Older Adults: A Secondary Analysis of the ASPREE Randomized Clinical Trial
Abstract
Importance
The role of low-dose aspirin (LDA) in cancer prevention among older adults is unclear. Identifying individuals likely to experience benefit or harm is crucial for guiding personalized prevention strategies.
Objective
To identify subgroups of the older population who may benefit most from LDA for cancer prevention by developing and validating an effect score model, including individual characteristics such as clonal hematopoiesis of indeterminate potential (CHIP) and other factors, to predict the individualized treatment effects (ITEs) of LDA in cancer incidence.
Design, Setting, and Participants
This comparative effectiveness study is a nonprespecified secondary analysis of the Aspirin in Reducing Events in the Elderly (ASPREE) randomized clinical trial conducted between 2010 and 2014. Australian community-dwelling ASPREE participants (aged ≥70 years) provided biospecimen samples for CHIP testing. CHIP was measured in 18 genes using a targeted sequencing assay. Analyses were conducted between May 2023 and July 2025.
Exposures
LDA (100 mg per day) or placebo.
Main Outcomes and Measures
The primary outcome was overall cancer incidence at 5 years. Twelve candidate models for predicting ITEs were assessed; the final model was selected to maximize cancer risk reduction and internally validated using bootstrapping. Participants were grouped into treatment-favorable (ITE >0) and treatment-unfavorable (ITE <0) subgroups based on the final predictive model.
Results
A total…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 9,350 participants or records.
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