Adjuvant Aspirin Treatment in PIK3CA-Mutated Colon Cancer Patients: The SAKK 41/13 Prospective Randomized Placebo-Controlled Double-Blind Trial.

ABSTRACT:

Purpose

We assessed the benefit of adjuvant aspirin in patients with resected phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-mutated colon cancer.

Patients and methods

This was a phase III, prospective, randomized, placebo-controlled, double-blind, multicenter, and multinational trial. Patients with resected colon cancer stage II and III harboring an activating PIK3CA mutation were included. Because of financial constraints, the trial was prematurely closed. Randomization was 2:1 to aspirin 100 mg versus placebo daily for 3 years. The primary endpoint was disease-free survival (DFS). Secondary endpoints included the time to disease recurrence (TTR), overall survival, and adverse events.

Results

Overall, 1,040 patients were screened for

SUBMITTER: Guller U 

PROVIDER: S-EPMC7617601 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature