Exploratory study on ctDNA-MRD-guided postoperative adjuvant therapy for patients with stage IB-IIIB non-small cell lung cancer

Abstract Background Molecular residual disease (MRD) is a well-established prognostic biomarker in non-small cell lung cancer (NSCLC) following radical resection. This study aimed to explore the applicability of the circulating tumor DNA (ctDNA)-derived MRD status in determining adjuvant therapy in patients with stage IB-IIIB NSCLC. Methods Patients with stage IB-IIIB NSCLC were retrospectively enrolled into standard management group or to the MRD-guided group. The standard management group received standard treatment according to pathological type, stage, and molecular subtype. The MRD guidance group have additionally incorporated postoperative MRD results. The primary endpoint of this study was the 2-year recurrence-free survival (RFS) rate. Results A total of 80 patients were included in this study. The 2-year RFS rate was 78% (95% CI, 66–92) in the MRD-guided group versus 53% (95% CI, 40–72) in the standard management group (hazard ratio [HR], 0.289; 95% CI, 0.144-0.579; P < 0.001). The 2-year overall survival (OS) rate of two groups was 95% (95% CI, 88–100) and 76% (95% CI, 63–92), respectively, and the corresponding HR was 0.104 (95% CI, 0.039–0.281; P <0.001). Conclusions Our study provides ctDNA-MRD-guided adjuvant therapy significantly improved RFS in patients with stage IB-IIIB NSCLC.