阿美替尼作为辅助治疗用于II-IIIA期EGFR突变非小细胞肺癌的疗效和安全性：一项回顾性研究

摘要(中文译文)

比较辅助阿美替尼与埃克替尼在已切除的II-IIIA期表皮生长因子受体（EGFR）突变非小细胞肺癌（NSCLC）患者中的疗效与安全性。本回顾性研究纳入80例在完全切除后接受辅助阿美替尼或埃克替尼治疗的患者。无病生存期（DFS）为主要终点；次要终点包括总生存期（OS）和安全性。采用多因素Cox回归分析与DFS和OS相关的因素。基线特征均衡良好。中位随访40.0个月后，阿美替尼显示出显著的DFS优势（HR=0.36，95% CI：0.16-0.82），中位DFS未达到，而埃克替尼为29.0个月（=0.0142）。24个月DFS率分别为85.1%和61.2%。亚组分析显示，在男性患者、年龄小于65岁患者、IIIA期患者及有吸烟史患者中获益一致。OS也倾向于阿美替尼（HR=0.43，95% CI：0.19-0.94），中位OS未达到，而埃克替尼为41.2个月（=0.0355）。阿美替尼组复发率为17.5%，埃克替尼组为45.0%（=0.0150）。24个月中枢神经系统（CNS）无转移生存率在阿美替尼组达到100%，而埃克替尼组为96.6%；然而，CNS转移事件总数非常少（=3），因此这一数值差异仅应解释为探索性趋势，而非CNS保护作用的确定性证据。安全性特征相当，尽管阿美替尼组≥3级治疗中出现的不良事件（TEAE）较少见（7.5% vs. 25.6%，=0.0367）。未观察到导致死亡的TEAE或治疗相关不良事件（TRAE）。在该回顾性队列中，与埃克替尼相比，辅助阿美替尼与显著改善的DFS和OS、复发预防及更有利的安全性特征相关。观察到CNS转移减少的数值趋势，但CNS事件有限，无法就CNS保护活性得出确切结论。观察到倾向于阿美替尼的初步早期OS生存趋势，但OS数据仍不成熟且死亡事件有限；需要长期随访以验证这一潜在的生存获益。

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 ( = 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 ( = 0.0355). Recurrence occurred in 17.5% of the almonertinib group and 45.0% of the icotinib group ( = 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 ( = 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%, = 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.

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