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 PIK3CA mutations, with 112 randomized to aspirin (N = 74) and placebo (N = 38). The median age was 66 years, and 42.9% were female. After a median follow-up of 4 years, 19 DFS events occurred, including 10 in the aspirin and nine in the placebo arm. The HR for DFS was 0.57 [90% confidence interval (CI), 0.27-1.22], in favor of aspirin (P = 0.11). DFS rates at 5 years were 86.5% (90% CI, 77.7%-92.0%) in the aspirin and 72.9% (90% CI, 55.7%-84.3%) in the placebo arm. The HR for TTR was 0.49 (90% CI, 0.21-1.19, P = 0.089) in favor of aspirin. No patient experienced aspirin-related serious adverse events.
Conclusions: The SAKK 41/13 is the first randomized trial to provide clinical evidence of a protective…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,040 participants or records.
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