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PIK3CA, POLE, and MSI, incorporated in the updated NCCN guidelines to guide adjuvant therapy in Early-Stage CRC

Following the presentation of the ALASCCA trial at ASCO GI 2025, aspirin has emerged as a promising adjuvant therapy in patients with stage II–III colorectal cancer (CRC) harboring PI3K pathway alterations which were present in 37% of trial participants, particularly PIK3CA mutations. Based on these findings, PIK3CA testing has now been incorporated into the latest NCCN Guidelines, recommending the consideration of aspirin in this molecularly defined subgroup.

In parallel, the updated NCCN Guidelines for early-stage colon cancer now also highlight POLE mutations, alongside dMMR/MSI-H, as markers of favorable prognosis. Notably, POLE mutations occur in approximately 2.09% of stage II and 0.66% of stage III CRC cases and are mutually exclusive with mismatch repair deficiency (read more). Although prospective data remain limited, the incorporation of these markers into clinical algorithms supports risk stratification and potential de-escalation of adjuvant therapy in specific subgroups.

Despite current NCCN guidance not supporting routine use of broad multigene assays for determining adjuvant therapy in early-stage CRC, emerging data suggest that selected genomic markers can guide treatment individualization.
Com.pl.i.t DX Colon panel, already utilized in metastatic CRC (mCRC), includes PIK3CA, POLE, and MSI status, offering a comprehensive molecular profile that aligns with these evolving clinical insights.

Given the growing evidence, Com.pl.i.t DX Colon may represent a valuable tool for informing treatment decisions in early-stage (stage II–III) colon cancer, aiding in both escalation (e.g., aspirin therapy in PIK3CA-mutated tumors) and de-escalation strategies (e.g., avoiding overtreatment in POLE-mutant or MSI-H tumors).

Latest NCCN Guidelines: https://genekor.com/wp-content/uploads/2025/07/NCCN_Guidelines.pdf