# ALASCCA

Source: https://onco.cc/trials/alascca/  
OnCo record `alascca` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A Nordic trial showing that three years of low-dose aspirin roughly halves recurrence in bowel cancers carrying a particular set of mutations, a biomarker-directed use of a drug that costs pennies.

## Summary

3,508 patients were screened for tumour PIK3CA and PI3K-pathway alterations; 626 with alterations were randomised. In group A (PIK3CA exon 9 or 20 hotspot mutations, n=314) recurrence at three years was 7.7% with aspirin vs 14.1% with placebo (HR 0.49, 95% CI 0.24-0.98); in group B (other PIK3CA mutations or PIK3R1/PTEN alterations, n=312) it was 7.7% vs 16.8% (HR 0.42, 95% CI 0.21-0.83). Severe adverse events attributable to aspirin were uncommon (about 2%). ALASCCA validates a decade of observational data from the Nurses' Health Study and CALGB 89803 suggesting PIK3CA-mutant tumours are aspirin-sensitive, and creates an implementation task: routine PIK3CA testing in early colorectal cancer, which most pathology services do not currently perform.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-08
- Registry id: NCT02647099
- Phase: 3
- Setting: Resected stage I-III rectal or stage II-III colon cancer with somatic PIK3CA (exon 9/20) or other PI3K-pathway alterations: aspirin 160 mg/day for 3 years vs placebo
- Sponsor: Karolinska Institutet
- Enrolled: 626
- Result: 3-year recurrence HR 0.49 (PIK3CA hotspot) and 0.42 (other PI3K alterations).
- Outcomes: Time to recurrence at 3 years, group A (PIK3CA exon 9/20): Aspirin 7.7% vs Placebo 14.1%, HR 0.49; Time to recurrence at 3 years, group B (other PI3K-pathway alterations): Aspirin 7.7% vs Placebo 16.8%, HR 0.42
- Replication: Awaits confirmation; the ADD-ASPIRIN trial includes a pre-planned PIK3CA analysis. Observational cohorts are concordant.

## Sources

- ClinicalTrials.gov NCT02647099: https://clinicaltrials.gov/study/NCT02647099
- Martling et al. (NEJM 2025): https://doi.org/10.1056/NEJMoa2504650

## Connected records

- ideas: [Get biomarker-directed aspirin after colorectal surgery into labels and guidelines](https://onco.cc/ideas/idea-reg-aspirin-pik3ca-implementation/)
- cancers: [Colon cancer (adenocarcinoma of the colon)](https://onco.cc/cancers/colon-cancer/), [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- fronts: [Diet, Exercise & Lifestyle](https://onco.cc/fronts/nutrition-lifestyle/), [Prevention & Risk](https://onco.cc/fronts/prevention/)
- technologies: [Aspirin for cancer prevention and adjuvant therapy](https://onco.cc/technologies/aspirin-cancer-prevention/), [Systematic drug repurposing](https://onco.cc/technologies/drug-repurposing/)
- terms: [Germline vs somatic mutations](https://onco.cc/terms/germline-vs-somatic/), [Next-generation sequencing (NGS)](https://onco.cc/terms/ngs/)
- targets: [PIK3CA / PI3K-alpha](https://onco.cc/targets/pik3ca/)
- drugs: [Aspirin](https://onco.cc/drugs/aspirin/)
- institutions: [Karolinska University Hospital](https://onco.cc/institutions/karolinska/)
- pathways: [PI3K / AKT / mTOR](https://onco.cc/pathways/pi3k-akt-mtor/)
- bottlenecks: [Knowledge reaches practice too slowly](https://onco.cc/bottlenecks/b-knowledge-diffusion/), [No incentive to repurpose cheap drugs](https://onco.cc/bottlenecks/b-generic-repurposing/)
- key papers: [Low-Dose Aspirin for PI3K-Altered Localized Colorectal Cancer](https://onco.cc/key-papers/paper-alascca-n-engl-j-med-2025/)
- roadmaps: [Cancer prevention roadmap: tobacco control and vaccines → biomarker-guided chemoprevention → interception in carriers](https://onco.cc/roadmaps/prevention-roadmap/)

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