According to the ALASCCA study, adjuvant treatment with daily aspirin for 3 years reduced the recurrence rate among patients with colorectal cancer and somatic alterations in the PI3K signaling pathway.

These results were first presented by Anna Martling, MD, PhD, Karolinska Institutet, Stockholm, Sweden, at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium.

This double-blind, multicenter, placebo-controlled study randomized 626 patients with stage II to III colon cancer, or stage Ito III rectal cancer with a PI3K alteration: a PIK3CA mutation in exon 9 and/or 20 (group A) or other PI3K mutations, including PIK3CA mutations outside of exon 9/20 or mutations to PIK3R1 or PTEN genes (group B). Patients were randomly assigned to receive either 160 mg of aspirin daily, or placebo, initiated 3 months post-surgery and continued for 3 years. The primary end point was time to recurrence (TTR).

With 3 years of follow-up, the hazard ratio (HR) for TTR when comparing aspirin to placebo was 0.49 in group A (P = .044) and 0.42 for group B (P = .013). The HRs for disease-free survival were 0.61 (P = .091) and 0.51 (P = .017), respectively. The rate of recurrence for group A was 7.7% in the aspirin arm vs 14.1% in the placebo arm. The rate of recurrence for group B was 7.7% in the aspirin arm vs 16.8% in the placebo arm.

There were 3 patients who experienced aspirin-related severe adverse event (n = 1 each: GI bleeding, hematoma, and allergic reaction).

Dr Martling et al, concluded, “These findings could lead to immediate changes in clinical praxis for about a third of CRC patients.” Dr Martling also added, “This research highlights the importance of precision medicine and the use of advanced diagnostics. These tools can enable tailored treatments and the repurposing of existing drugs for new applications.”

Source:

Martling A, Lindberg J, Hed Myrberg I, et al. Low-dose aspirin to reduce recurrence rate in colorectal cancer patients with PI3K pathway alterations: 3-year results from a randomized placebo-controlled trial. Presented at ASCO Gastrointestinal Cancers Symposium; January 23-25, 2025. San Francisco, CA. Abstract  LBA 125

New findings on aspirin and risk of colorectal cancer recurrence. News Release. American Society of Clinical Oncology. Accessed January 16, 2025. https://society.asco.org/about-asco/press-center/news-releases/new-findings-aspirin-and-risk-colorectal-cancer-recurrence?cid=DM19308&bid=450425113