Prevalence and clinical impact of PIK3CA and PTEN alterations from reflex genomic testing of newly diagnosed colorectal cancer: a population-based series
- Study type
- Observational study
- Design
- Real-world population-based series of reflex genomic testing (next-generation sequencing panel) in newly diagnosed colorectal cancer
- Sample size
- 1516 patients
- Source
- Front. Oncol. · 2026
In plain words
Trials have shown that low-dose aspirin may help some patients with colorectal (bowel) cancer that has not spread live longer, when their tumour has changes in the PIK3CA or PTEN genes. In this study, the tumours of more than 1500 patients were tested for these genes at the time of diagnosis. About 14.6% of patients had such a change, and about 11.1% of all patients might be candidates for aspirin treatment. Decisions about taking aspirin should always be made with your treating doctor.
Key results
Study population
Patients with newly diagnosed colorectal cancer (CRC) in the Northern Ireland Cancer Network who underwent genomic profiling at diagnosis between January 2024 and March 2025. Profiling of all newly diagnosed CRCs had started in 2022 as part of the Lynch syndrome screening service. All disease stages were included in the analysis.
Endpoints
Main measures: prevalence of PIK3CA and PTEN mutations in newly diagnosed CRC, and the number and proportion of patients potentially eligible for aspirin treatment (non-metastatic patients with PI3K pathway alterations and no absolute contraindication to aspirin).
Safety and side effects
This study did not assess treatment adverse events. The abstract reports only that of 174 non-metastatic patients with a PIK3CA/PTEN alteration, 6 (3.4%) had an absolute contraindication to aspirin.
Clinical significance and place in guidelines
This study shows that reflex PIK3CA/PTEN testing at CRC diagnosis is feasible in routine practice and identifies about one ninth of patients as potential candidates for adjuvant aspirin. The observed prevalence was lower than in the ALASCCA trial. The authors support implementing the testing, but the abstract says nothing about its status in clinical guidelines, which should be checked separately. This study did not assess the efficacy of aspirin.
Limitations
Based on the abstract: this study is descriptive and does not report clinical outcomes (survival or response to aspirin). Eligibility is "potential". The prevalence of alterations differed from the ALASCCA trial population (14.6% vs 37%). The detection limit of the assay was 4% VAF. Further details should be checked in the full text of the paper.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.