Adjuvant Aspirin Shows Protective Effect Among Patients With PIK3CA-Mutant Colon Cancer
According to the phase 3 SAKK 41/13 trial, there is evidence of a protective effect with adjuvant aspirin for patients with resected, PIK3CA0mutant colon cancer.
These results were first presented by Ulrich Güller, MD, MHS, Kantonsspital St Gallen, Switzerland, at the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain.
Previous retrospective studies have suggested that aspirin may have protective value in the adjuvant treatment of patients with colon cancer, particularly for those patients with a PIK3CA mutation. This placebo-controlled, double-blinded, multinational, multicenter trial enrolled 112 patients with stage II and III colon cancer and a centrally-assessed activating PIK3CA mutation in Exon 19 or 20. Patients were randomized on a 2-to-1 basis to receive either 100 mg aspirin (n = 74) or placebo (n = 38), for 3 years. The primary end point was disease-free survival (DFS) with seconday end points including overall survival (OS) and adverse events. This trial was prematurely closed, due to financial constraints.
After a median follow-up duration of 4 years, there were 19 DFS events. The hazard ratio (HR) for DFS was 0.57 in favor of the aspirin arm (90% confidence interval [CI], 0.23 to 1.22; P = .11). The DFS rate at 3 years was 88.3% in the aspirin arm and 82.4% in the placebo arm. The HR for OS was 0.70 (90% CI, 0.23 to 2.12; P = .3). No severe adverse events related to aspirin were observed.
Dr Güller et al concluded, “Even though the result is not statistically significant due to the small sample size, adjuvant aspirin warrants individual consideration in patients with resected, PIK3CA-mutant stage II and III colon cancer.
Source:
Güller U, Hayoz S, Horber D, et al. Adjuvant aspirin treatment in PIK3CA mutated colon cancer patients: The phase III, prospective-randomized placebo-controlled multicenter SAKK 41/13 trial. Presented at the 2024 ESMO Congress. September 13-17, 2024; Barcelona, Spain. Abstract 512O.
