{"entity":{"id":"alascca","kind":"trial","name":"ALASCCA","aka":[],"tldr":"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.","status":"positive","asOf":"2026-09-08","links":[{"label":"ClinicalTrials.gov NCT02647099","url":"https://clinicaltrials.gov/study/NCT02647099"},{"label":"Martling et al. (NEJM 2025)","url":"https://doi.org/10.1056/NEJMoa2504650"}],"tags":[],"related":["idea-reg-aspirin-pik3ca-implementation"],"cancers":["colorectal"],"sections":["nutrition-lifestyle","prevention"],"technologies":["aspirin-cancer-prevention","drug-repurposing","ngs"],"targets":["pik3ca"],"drugs":["aspirin"],"companies":[],"institutions":["karolinska"],"pathways":["pi3k-akt-mtor"],"terms":["germline-vs-somatic"],"trials":[],"people":[],"bottlenecks":["b-generic-repurposing","b-knowledge-diffusion"],"keyPapers":["paper-alascca-n-engl-j-med-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"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","result":"3-year recurrence HR 0.49 (PIK3CA hotspot) and 0.42 (other PI3K alterations).","started":"2016-04-07","startedType":"actual","yearReported":2025,"enrolled":626,"enrolledBasis":"registry","outcomes":[{"endpoint":"Time to recurrence at 3 years, group A (PIK3CA exon 9/20)","primary":true,"unit":"%","arms":[{"name":"Aspirin","value":7.7},{"name":"Placebo","value":14.1}],"hr":0.49,"ci":[0.24,0.98],"source":"https://doi.org/10.1056/NEJMoa2504650"},{"endpoint":"Time to recurrence at 3 years, group B (other PI3K-pathway alterations)","unit":"%","arms":[{"name":"Aspirin","value":7.7},{"name":"Placebo","value":16.8}],"hr":0.42,"ci":[0.21,0.83],"source":"https://doi.org/10.1056/NEJMoa2504650"}],"replication":"Awaits confirmation; the ADD-ASPIRIN trial includes a pre-planned PIK3CA analysis. Observational cohorts are concordant."},"route":"/trials/alascca/","neighbours":{"idea":[{"id":"idea-reg-aspirin-pik3ca-implementation","kind":"idea","name":"Get biomarker-directed aspirin after colorectal surgery into labels and guidelines","route":"/ideas/idea-reg-aspirin-pik3ca-implementation/"}],"cancer":[{"id":"colon-cancer","kind":"cancer","name":"Colon cancer (adenocarcinoma of the colon)","route":"/cancers/colon-cancer/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"section":[{"id":"nutrition-lifestyle","kind":"section","name":"Diet, Exercise & Lifestyle","route":"/fronts/nutrition-lifestyle/"},{"id":"prevention","kind":"section","name":"Prevention & Risk","route":"/fronts/prevention/"}],"technology":[{"id":"aspirin-cancer-prevention","kind":"technology","name":"Aspirin for cancer prevention and adjuvant therapy","route":"/technologies/aspirin-cancer-prevention/"},{"id":"drug-repurposing","kind":"technology","name":"Systematic drug repurposing","route":"/technologies/drug-repurposing/"}],"term":[{"id":"germline-vs-somatic","kind":"term","name":"Germline vs somatic mutations","route":"/terms/germline-vs-somatic/"},{"id":"ngs","kind":"term","name":"Next-generation sequencing (NGS)","route":"/terms/ngs/"}],"target":[{"id":"pik3ca","kind":"target","name":"PIK3CA / PI3K-alpha","route":"/targets/pik3ca/"}],"drug":[{"id":"aspirin","kind":"drug","name":"Aspirin","route":"/drugs/aspirin/"}],"institution":[{"id":"karolinska","kind":"institution","name":"Karolinska University Hospital","route":"/institutions/karolinska/"}],"pathway":[{"id":"pi3k-akt-mtor","kind":"pathway","name":"PI3K / AKT / mTOR","route":"/pathways/pi3k-akt-mtor/"}],"bottleneck":[{"id":"b-knowledge-diffusion","kind":"bottleneck","name":"Knowledge reaches practice too slowly","route":"/bottlenecks/b-knowledge-diffusion/"},{"id":"b-generic-repurposing","kind":"bottleneck","name":"No incentive to repurpose cheap drugs","route":"/bottlenecks/b-generic-repurposing/"}],"paper":[{"id":"paper-alascca-n-engl-j-med-2025","kind":"paper","name":"Low-Dose Aspirin for PI3K-Altered Localized Colorectal Cancer","route":"/key-papers/paper-alascca-n-engl-j-med-2025/"}],"roadmap":[{"id":"prevention-roadmap","kind":"roadmap","name":"Cancer prevention roadmap: tobacco control and vaccines → biomarker-guided chemoprevention → interception in carriers","route":"/roadmaps/prevention-roadmap/"}]}}