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Session:: ESCP Best Paper

OD100 - ESCP Best Paper: Low-dose Aspirin Reduced Recurrence Rate in PI3K-Altered Early-Stage Colorectal Cancer – Results from the ALASCCA Trial

Saturday, May 9, 2026
On-Demand

    Video Abstract Presenter(s)

  • Anna Martling, M.D, PhD (she/her/hers)

    Professor of Surgery, Senior Consultant Surgeon, FRCS (Hon), FACS (Hon), FASCRS (Hon), FESCP (Hon)
    Karolinska Institutet
    Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
    Stockholm, Stockholms Lan, Sweden

    All disclosed relationships have been reviewed and managed prior to the start of this activity. Any relevant relationships will be listed below. This individual has no relevant financial relationships.

Purpose/Background: Colorectal cancer (CRC) affects 1.9 million people globally each year, with 20–40% of stage II–III patients developing metastases. Observational studies suggest that aspirin can improve survival in patients with PIK3CA mutated, but not wild-type, CRC tumours. Randomized controlled trials are needed to confirm these findings. The ALASCCA (Adjuvant Low-dose Aspirin in Colorectal Cancer) trial was designed to prospectively evaluate the efficacy of adjuvant aspirin in patients with resected stage I–III CRC harboring somatic alterations in the PI3K signaling pathway.

Methods: The ALASCCA trial was a randomized, double-blind, multicentre, placebo-controlled trial in patients in the Nordic countries with stage II-III colon cancer or stage I-III rectal cancer with somatic alterations in the PI3K-pathway. Patients were screened for tumour somatic alterations in PIK3CA exon 9/20 hotspots (Group A), and PIK3R1, PTEN, or other PIK3CA alterations and randomized 1:1 post-surgery to receive 160 mg of aspirin or placebo once daily for three years. The primary endpoint was time to local recurrence or distant metastases (TTR) in Group A, analysed using a Cox proportional hazards model.

Results: In total, 3,508 patients were screened for somatic alterations, of which 2,980 had complete genomic data, with PI3K-altered tumours in 1,103 patients (37%). Of these, 626 patients were randomized; 314 in Group A, and 312 in Group B. The hazard ratio (HR) for TTR was 0.49 (0.24-0.98; p=0.044) in Group A, and 0.42 (95% CI 0.29-0.88; p=0.017) in Group B. HRs for DFS in Group A and B were 0.61 (95% CI 0.34-1.08; p=0.091) and 0.51 (0.29-0.88; p=0.017). Four patients experienced aspirin-related severe adverse events.

Conclusion: Adjuvant aspirin compared to placebo reduced recurrence rate in patients with PI3K-altered CRC. These findings offer a safe, globally available, and cheap treatment option that can change clinical practice for around a third of patients with early-stage CRC.