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Aspirin significantly reduced colorectal cancer recurrence in patients with PIK3CA mutations. This randomized trial suggests aspirin benefits disease-free survival in these specific cancer patients.

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Area of Science:

  • Oncology
  • Genetics
  • Clinical Trials

Background:

  • Aspirin use is linked to reduced colorectal cancer incidence.
  • Observational studies suggest aspirin may improve survival in patients with PIK3CA-mutated tumors.
  • Randomized trial data are needed to confirm these benefits.

Purpose of the Study:

  • To evaluate aspirin's efficacy in preventing colorectal cancer recurrence.
  • To assess aspirin's impact on disease-free survival in patients with PIK3K pathway gene alterations.
  • To determine the safety profile of aspirin in this patient population.

Main Methods:

  • A double-blind, randomized, placebo-controlled trial was conducted.
  • Patients with stage II/III colon or stage I-III rectal cancer and PI3K pathway gene alterations were enrolled.
  • Participants received aspirin (160 mg daily) or placebo for 3 years, stratified by PIK3CA mutation status.

Main Results:

  • Aspirin significantly reduced 3-year recurrence incidence in patients with PIK3CA hotspot mutations (7.7% vs. 14.1%) and other PI3K pathway alterations (7.7% vs. 16.8%).
  • Disease-free survival at 3 years was improved with aspirin in both groups.
  • Severe adverse events were more frequent in the aspirin group (16.8%) compared to placebo (11.6%).

Conclusions:

  • Aspirin significantly lowered colorectal cancer recurrence in patients with PIK3CA hotspot mutations.
  • A similar benefit was observed in patients with other somatic PI3K pathway gene alterations.
  • The findings support aspirin's role in improving outcomes for specific colorectal cancer patient subgroups.