FLAURA试验证明一线奥希替尼治疗表皮生长因子受体（EGFR）突变的晚期非小细胞肺癌（NSCLC）患者的总生存（OS）得到改善。我们研究了COVID-19大流行期间使用奥希替尼治疗的疗效和安全性。我们在加拿大不列颠哥伦比亚省进行了回顾性研究，确定了2020年3月11日至2021年12月31日期间诊断为EGFR突变的晚期NSCLC患者，他们接受了一线奥希替尼治疗。我们绘制了奥希替尼治疗开始后的OS和无进展生存期（PFS）的Kaplan-Meier曲线。使用单变量和多变量Cox模型估计的风险比评估了基线特征与PFS、肺炎和毒性导致的剂量减少与OS之间的关联。 该队列包括231名患者。58.7%的新发晚期NSCLC患者最初在急诊室就诊时被诊断。在奥希替尼治疗开始时，31.6%的患者年龄≥75岁，45.5%的患者的Eastern Cooperative Oncology Group疗效评分（ECOG PS）≥2。中位PFS和中位OS分别为18.0个月（95%置信区间[CI]：16.1-26.2）和25.4个月（95% CI：20.3-未到达）。多变量分析显示，年龄≥75岁（与<75岁比较）、ECOG PS 2/3（与0/1比较）、ECOG PS 4（与0/1比较）、吸烟者（与不吸烟者比较）、程序性死亡配体1（PD-L1）表达≥50%（与<1%比较）和L858R突变（与外显子19缺失比较）与较短的PFS相关。在110名疾病进展的患者中，33.6%接受了后续治疗。队列中16.5%的患者出现了≥3级不良事件。奥希替尼引起的肺炎（发病率为3.9%）与较短的OS弱相关（风险比：2.59，95% CI：0.94-7.12，P=0.066）；剂量减少与较差的OS无关。10.8%的患者患上了COVID-19。 在COVID-19大流行期间接受一线奥希替尼治疗的队列中，ECOG PS≥2观察到了近一半的患者，在治疗开始时导致了中位OS比FLAURA试验中更短的结果。严重不良事件的发生率较低，药物毒性的剂量减少对OS没有影响。需要识别和降低COVID-19大流行期间NSCLC诊断的障碍。 © 2023 Translational Lung Cancer Research. 版权所有。

The FLAURA trial demonstrated improved overall survival (OS) with first-line osimertinib for patients with epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC). We studied the efficacy and safety of osimertinib in a cohort treated during the coronavirus disease 2019 (COVID-19) pandemic.Patients diagnosed with EGFR-mutated advanced NSCLC between 11 March 2020 to 31 December 2021 who received first-line osimertinib in British Columbia, Canada were identified retrospectively. Kaplan-Meier curves of OS and progression-free survival (PFS) from the start of osimertinib were plotted. The associations of baseline characteristics with PFS, and development of pneumonitis or dose reductions due to toxicity with OS were evaluated with hazard ratios estimated using univariable and multivariable Cox models.The cohort comprised 231 individuals. 58.7% of patients with de novo advanced NSCLC were initially diagnosed after presentation to the Emergency Room. At osimertinib initiation, 31.6% were aged ≥75 years and 45.5% had an Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2. Median PFS and OS were 18.0 months [95% confidence interval (CI): 16.1-26.2] and 25.4 months (95% CI: 20.3-not reached), respectively. On multivariable analysis, age ≥75 years (vs. <75), ECOG PS 2/3 (vs. 0/1), ECOG PS 4 (vs. 0/1), current smokers (vs. never smokers), programmed death ligand 1 (PD-L1) expression ≥50% (vs. <1%), and L858R mutation (vs. exon 19 deletion) were associated with shorter PFS. Among 110 patients who progressed, 33.6% received subsequent therapy. A proportion of 16.5% of the cohort developed grade ≥3 adverse events. Pneumonitis from osimertinib (3.9% incidence) was weakly associated with shorter OS (hazard ratio: 2.59, 95% CI: 0.94-7.12, P=0.066); dose reductions were not associated with worse OS. 10.8% of patients developed COVID-19.In a cohort receiving first-line osimertinib during the COVID-19 pandemic, ECOG PS ≥2 was observed in nearly half of patients at treatment initiation contributing to a median OS shorter than in FLAURA. The incidence of severe adverse events was low and dose reduction for drug toxicity did not impact OS. Identifying and reducing barriers to the diagnosis of NSCLC during the COVID-19 pandemic are required.2023 Translational Lung Cancer Research. All rights reserved.