Osimertinib is a tyrosine kinase inhibitor of the epidermal growth factor receptor (EGFR) that is used for first-line therapy inEGFRmutated non-small cell lung cancer (NSCLC) based on the results of the randomized FLAURA trial (ClinicalTrials.gov number NCT02296125). We performed a retrospective analysis of baseline characteristics and clinical outcomes in 56 real-world patients treated with osimertinib. In total, 45% of patients were determined to be FLAURA-eligible and 55% were FLAURA-ineligible based on the published inclusion/exclusion criteria of the aforementioned trial. For clinical outcomes, the median osimertinib time to treatment discontinuation (TTD) for all patients was 16.9 months (95% CI: 12.6–35.1), whereas the median TTD was 31.1 months (95% CI: 14.9–not reached) in the FLAURA-eligible cohort and the median TTD was 12.2 months (95% CI: 8.1–34.6 months) in the FLAURA-ineligible cohort. Re-biopsy at acquired resistance disclosed both on- and off-target mechanisms. The most common therapies following osimertinib included local therapies followed by post-progression osimertinib, platinum-doublet chemotherapy with or without osimertinib, and osimertinib combinatory targeted therapies. The median overall survival for all patients was 32.0 months (95% CI: 15.7–not reached), the median survival was not reached for the FLAURA-eligible cohort, and it was 16.5 months for the FLAURA-ineligible cohort. Our data support the use of osimertinib in real-word settings and highlight the need for designing registration trials that are more inclusive of patient/disease characteristics seen in routine clinical practice. It is yet to be determined if the use of evolving first-line EGFR inhibitor combination strategies (either platinum-doublet chemotherapy plus osimertinib or amivantamab plus lazertinib) will similarly translate from clinical trials to real-word settings.
奥希替尼是一种表皮生长因子受体（EGFR）酪氨酸激酶抑制剂，基于随机FLAURA试验（ClinicalTrials.gov编号NCT02296125）的结果，被用于EGFR突变的非小细胞肺癌（NSCLC）的一线治疗。我们对56例接受奥希替尼治疗的真实世界患者的基线特征和临床结局进行了回顾性分析。根据上述试验已公布的纳入/排除标准，45%的患者被判定为符合FLAURA试验条件，55%为不符合条件。在临床结局方面，所有患者的中位奥希替尼治疗至停药时间（TTD）为16.9个月（95% CI：12.6–35.1），而符合FLAURA条件队列的中位TTD为31.1个月（95% CI：14.9–未达到），不符合FLAURA条件队列的中位TTD为12.2个月（95% CI：8.1–34.6个月）。获得性耐药后的再次活检揭示了靶内和靶外耐药机制。奥希替尼治疗后最常见的后续治疗包括局部治疗联合进展后继续使用奥希替尼、含铂双药化疗（联合或不联合奥希替尼）以及奥希替尼联合靶向治疗。所有患者的中位总生存期为32.0个月（95% CI：15.7–未达到），符合FLAURA条件队列的中位生存期未达到，不符合FLAURA条件队列的中位生存期为16.5个月。我们的数据支持奥希替尼在真实世界中的应用，并强调需要设计更具包容性的注册试验，以涵盖常规临床实践中观察到的患者/疾病特征。目前尚不确定不断演进的一线EGFR抑制剂联合策略（无论是含铂双药化疗联合奥希替尼，还是amivantamab联合lazertinib）是否同样能够从临床试验成功转化到真实世界应用。
肿瘤(癌症)患者之家