Low-Dose Aspirin Reduces the Risk of Recurrence in Colorectal Cancer with PI3K Mutations
Reading tools
In this article
Low-Dose Aspirin for PI3K-Altered Localized Colorectal Cancer
New England Journal of Medicine — Sept 17, 2025 • ALASCCA RCT • ClinicalTrials.gov: NCT02647099
Primary Outcome
3-yr recurrence (PIK3CA exon 9/20):
7.7%
Aspirin
14.1%
Placebo
HR 0.49 (95% CI 0.24–0.98), p=0.04
Key Secondary
3-yr recurrence (other PI3K/PTEN):
7.7%
Aspirin
16.8%
Placebo
HR 0.42 (95% CI 0.21–0.83)
Who & How
- Stage I–III rectum or II–III colon
- Somatic PI3K-pathway alteration
- 160 mg daily for 3 years
- Double-blind, placebo-controlled
Disease-Free Survival (3-yr)
PIK3CA exon 9/20
88.5%
Aspirin
81.4%
Placebo
HR 0.61 (0.34–1.08)
Other PI3K/PTEN
89.1%
Aspirin
78.7%
Placebo
HR 0.51 (0.29–0.88)
Lower HR <1 favors aspirin.
Safety Snapshot
16.8%
Severe AEs (aspirin)
11.6%
Severe AEs (placebo)
- Bleeding/GI events remain key monitoring focus.
- Use shared decision-making; weigh benefit vs risk.
Design & Population
- Double-blind, randomized, placebo-controlled (1:1)
- PI3K-pathway alterations found in 37.0% (1103/2980) with complete genomics
- Randomized: Group A (PIK3CA exon 9/20 hotspots) n=314; Group B (other PI3K/PTEN) n=312
- Intervention: Aspirin 160 mg once daily × 3 years
Take-Home
- Aspirin significantly reduces recurrence in PI3K-altered CRC.
- Benefit observed across hotspot and other PI3K/PTEN variants.
- Safety profile requires bleeding vigilance.
Reference: Martling A, Myrberg IH, Nilbert M, Grönberg H, Granath F, Eklund M, Öresland T, et al. Low-Dose Aspirin for PI3K-Altered Localized Colorectal Cancer. New England Journal of Medicine. 2025;393:1051–1064. DOI: 10.1056/NEJMoa2504650.
Was this article helpful?
Your feedback helps us improve our content.
Reader comments
Share your comment
Your name and comment are published only after administrator approval. Your email address is never shown to visitors.
Be the first to comment.