Dr Jeanne Tie talks to ecancer about her study on circulating tumour DNA analysis and how it can help identify the need for adjuvant therapy in stage II colon cancer.
The role of adjuvant chemotherapy (CT) in stage II colon cancer continues to be debated. The presence of circulating tumour DNA (ctDNA) after surgery predicts very poor recurrence-free survival (RFS), while its absence predicts a low recurrence risk.
Patients were randomly assigned 2:1 to ctDNA-guided management or standard management (clinician-guided based on conventional criteria), after stratification for T stage.
Dr Tie notes that the primary efficacy endpoint was non-inferiority in RFS rate at 2 years. A key secondary endpoint was adjuvant CT use. The target sample size of 450 provided 80% power with 95% confidence to confirm non-inferiority between the two arms with a margin of 8.5%.
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