Research Article: Efficacy and safety of almonertinib as adjuvant therapy in stage II-IIIA EGFR-mutant non-small cell lung cancer: a retrospective study
Abstract:
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).
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.
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.
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.
Introduction:
Lung cancer remains the leading cause of cancer-related mortality worldwide, with non-small-cell lung cancer (NSCLC) accounting for approximately 85% of all cases. Although surgical resection is potentially curative for early-stage disease, postoperative recurrence remains a major challenge. Large meta-analyses indicate that 45% of stage IB and up to 76% of stage III patients eventually relapse, even after complete resection and standard adjuvant platinum-based chemotherapy ( 1 ). Moreover, as disease stage…
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