Why the study?
Aspirin hypersensitivity occurs in 1% to 5% of patients with atherosclerotic cardiovascular disease and poses a clinical management dilemma due to unclear treatment approaches and lack of specific recommendations.
Does adjuvant aspirin 200 mg daily improve disease-free survival in patients with resected early-stage colorectal cancer, specifically those with PIK3CA mutations or COX-2 overexpression?
RCT (n=465)
Double-blind
Randomized
Yes
Does adjuvant aspirin 200 mg daily improve disease-free survival in patients with resected early-stage colorectal cancer, specifically those with PIK3CA mutations or COX-2 overexpression?
Hazard Ratio: 0.93 (95% CI 0.35–2.47)
Absolute Event Rate: 23% vs 24%
While the ASCOLT TR substudy did not show a significant disease-free survival benefit with adjuvant aspirin in colorectal cancer patients with PIK3CA mutations or COX-2 overexpression, a pooled meta-analysis suggests potential benefit specifically in the PIK3CA exon 9/20 mutation subgroup.
Low-dose aspirin remains the most commonly used antiplatelet agent among patients with atherosclerotic cardiovascular disease. Aspirin hypersensitivity occurs in 1% to 5% of patients and is among the most frequent causes for prohibiting the use of aspirin, posing a significant dilemma on how to manage these patients in clinical practice. Aspirin hypersensitivity is often misinterpreted and confused with aspirin intolerance, with treatment approaches being often unclear and lacking specific recommendations. Aspirin desensitization and low-dose aspirin challenge have emerged as pragmatic, effective, and safe approaches in patients with suspected or confirmed aspirin hypersensitivity who require aspirin therapy, but they are underused systematically in clinical practice. Furthermore, there is confusion over alternative antiplatelet agents to be used in these patients. The pathophysiological mechanisms and classification of aspirin hypersensitivity, as well as alternative strategies and practical algorithms to overcome the need for aspirin use in patients with atherosclerotic cardiovascular disease with suspected aspirin hypersensitivity, are discussed.
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Galli et al. (2024) conducted an RCT in Colorectal cancer (n=465). Aspirin vs. Placebo was evaluated on Disease-free survival in patients with PIK3CA mutations (HR 0.93, 95% CI 0.35-2.47).
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