Background: The prognosis of stage I non-small cell lung cancer (NSCLC) remains significant heterogeneity. It is not clear whether adjuvant epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) therapy can reduce recurrence and improve survival in patients with stage I disease, especially stage IA.
Methods: This retrospective, single-center, observational, propensity score-matched study enrolled patients with completely resected pathological stage I invasive lung adenocarcinoma (LUAD) with sensitive EGFR mutations. Inverse probability of treatment weighting (IPTW) was applied to address the imbalance in baseline characteristics. The primary endpoint was relapse-free survival (RFS), and the secondary endpoint was overall survival (OS). RFS and OS were calculated using the Kaplan-Meier method, and the log-rank test was used to compare differences between the two groups. The hazard ratio (HR) and 95% confidence interval (CI) were calculated using Cox regression. Stratified analysis was performed according to the risk of recurrence determined by tumor characteristics and surgical procedure.
Results: A total of 819 eligible patients were included in the study. After IPTW, 823 patients were included in the analysis, of which 183 (22.2%) patients were in the EGKF-TKI group and 640 (77.8%) patients were in the observation group. In patients with stage I disease, the 5-year RFS was 92.6% in the EGFR-TKI group, compared with 77.0% in the observation group (HR = 0.26; 95% CI, 0.15-0.46; P < .001). Superior RFS was observed with adjuvant EGFR-TKI therapy in most predefined subgroups. There was no significant difference in OS between the two groups for patients with stage I, stage IA, or stage IB disease.
Conclusions: Our study demonstrates that adjuvant EGFR-TKI therapy improves RFS in patients with stage IA and IB invasive LUAD, but the difference in OS is not statistically significant.
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