NRG-GI005: ctDNA predicts adjuvant chemo in stage II colon cancer

Van K. Morris, MD, University of Texas MD Anderson Cancer Center, Houston, TX, presents the prospective Phase II/III clinical trial COBRA (NCT04068103) focused on patients with resected stage II colon cancer (CC) without high-risk features. The trial randomized patients into two arms: standard-of-care/observation (Arm A) and ctDNA assay-directed therapy (Arm B). Arm B patients with detected ctDNA were treated with 6 months of adjuvant chemotherapy. The primary endpoint, ctDNA clearance at the 6-month mark, did not meet expectations in the phase II analysis. Clearance rates were 43% in the control arm and 11% in the experimental arm after chemotherapy. Due to these results, further enrollment has been halted. The study emphasizes the need to consider assay specificity in future trials evaluating ctDNA as a biomarker for minimal residual disease in stage IIA CC. This interview took place at the 2024 ASCO Gastrointestinal (GI) Cancers Symposium in San Francisco, CA.
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