Efficacy and safety of almonertinib as adjuvant therapy in stage II-IIIA EGFR-mutant non-small cell lung cancer: a retrospective study.

OBJECTIVE: To compare the efficacy and safety of adjuvant almonertinib versus icotinib in patients with resected stage II-IIIA epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC). METHODS: This retrospective study included 80 patients treated with adjuvant almonertinib or icotinib after complete resection. Disease-free survival (DFS) was the primary endpoint; secondary endpoints included overall survival (OS) and safety. Multivariate Cox regression was used to identify factors associated with DFS and OS. RESULTS: Baseline characteristics were well balanced. After a median follow-up of 40.0 months, almonertinib demonstrated a significant DFS advantage (HR = 0.36, 95% CI: 0.16-0.82), with the median DFS not reached versus 29.0 months for icotinib (p = 0.0142). The 24-month DFS rates were 85.1 and 61.2%, respectively. Subgroup analyses showed consistent benefits in male patients, patients younger than 65 years, patients with stage IIIA disease and those with smoking history. OS also favored almonertinib (HR = 0.43, 95% CI: 0.19-0.94), with the median OS not reached versus 41.2 months (p = 0.0355). Recurrence occurred in 17.5% of the almonertinib group and 45.0% of the icotinib group (p = 0.0150). The 24-month central nervous system (CNS) metastasis-free survival rate reached 100% in the almonertinib group versus 96.6% in the icotinib group; however, the total number of CNS metastatic events was very small (n = 3), so this numerical difference should only be interpreted as an exploratory trend rather than definitive evidence of CNS protection. Safety profiles were comparable, although grade ≥3 TEAEs were less frequent with almonertinib (7.5% vs. 25.6%, p = 0.0367). No TEAEs or TRAEs leading to death were observed. CONCLUSION: In this retrospective cohort, adjuvant almonertinib was associated with significantly improved DFS and OS, recurrence prevention, and a more favorable safety profile compared with icotinib. A numerical trend of reduced CNS metastasis was observed, but limited CNS events preclude firm conclusions regarding CNS protective activity. A tentative early OS survival trend favoring almonertinib was observed, but OS data remain immature with limited death events; long-term follow-up is needed to verify this potential survival benefit.