Background:Osimertinib, a third-generationEGFRtyrosine kinase inhibitor (TKI), demonstrated superior efficacy over first-generation TKIs in the FLAURA trial, resulting in its approval as first-line therapy for metastatic non-small-cell lung cancer (NSCLC). However, the real-world application of these trial results requires an evaluation of sequential therapeutic strategies.Methods:This retrospective, non-interventional study utilized data from the Epidemiological Strategy and Medical Economics (ESME) platform, which includes information on patients treated for lung cancer since 2015. Out of 39,974 patients in the database, 624 patients withEGFR-mutant advanced NSCLC treated with osimertinib as first-line (L1, n = 198) or second-line (L2, n = 426) treatment after first- or second-generation TKIs (n = 1262) were identified. Patient demographics, disease characteristics, treatment strategies, and disease progression were examined. Survival analyses were performed using Kaplan–Meier estimates and Cox proportional-hazards models.Results:In the study population (n = 624), 73.4% were female, with a median age of 70 years (range 28–93). Brain metastases at the start of osimertinib treatment were observed in 282 patients. ECOG PS-2 was reported in 29.4% of patients. TheT790Mmutation in exon 20 was identified in 257/426 patients (60.3%) receiving osimertinib in L2. Median progression-free survival (PFS) was 12.4 months (95% CI [10.7–14.7]) for L1 and 7.4 months (95% CI [6.2–8.7]) for L2. Median overall survival (OS) from advanced diagnosis was 28.5 months (95% CI [26.3–38.7]) for osimertinib L1 and 29.9 months (95% CI [28.6–31.8]) for osimertinib L2 (HR = 0.93; 95% CI [0.75–1.16];p= 0.50). For L1, median OS was 27.1 months (95% CI [22.0–30.2]) for patients with cerebral metastases and 38.7 months (95% CI [26.3–52.8]) for those without (HR = 0.73; 95% CI [0.48–1.11];p= 0.15).Discussion:Patients in the real-world ESME database exhibited a poorer prognosis compared to those in the FLAURA trial. The presence of cerebral metastases at diagnosis worsens the prognosis.
背景：奥希替尼作为第三代EGFR酪氨酸激酶抑制剂（TKI），在FLAURA试验中显示出优于第一代TKI的疗效，因此被批准用于转移性非小细胞肺癌（NSCLC）的一线治疗。然而，这些试验结果在真实世界中的应用需要评估序贯治疗策略。 方法：这项回顾性、非干预性研究利用了流行病学策略与医疗经济学（ESME）平台的数据，该平台收录了自2015年以来接受肺癌治疗的患者信息。在数据库中的39,974名患者中，筛选出624例EGFR突变晚期NSCLC患者，这些患者在接受第一代或第二代TKI（n=1262）治疗后，将奥希替尼作为一线（L1，n=198）或二线（L2，n=426）治疗。研究分析了患者人口统计学特征、疾病特征、治疗策略及疾病进展。生存分析采用Kaplan-Meier估计和Cox比例风险模型进行。 结果：在研究人群（n=624）中，73.4%为女性，中位年龄70岁（范围28-93岁）。282例患者在开始奥希替尼治疗时存在脑转移。29.4%的患者报告ECOG PS-2。在L2接受奥希替尼治疗的426例患者中，257例（60.3%）检测到外显子20的T790M突变。L1组的中位无进展生存期（PFS）为12.4个月（95% CI [10.7–14.7]），L2组为7.4个月（95% CI [6.2–8.7]）。从晚期诊断起算，奥希替尼L1组的中位总生存期（OS）为28.5个月（95% CI [26.3–38.7]），奥希替尼L2组为29.9个月（95% CI [28.6–31.8]）（HR=0.93；95% CI [0.75–1.16]；p=0.50）。在L1组中，伴有脑转移患者的中位OS为27.1个月（95% CI [22.0–30.2]），无脑转移患者为38.7个月（95% CI [26.3–52.8]）（HR=0.73；95% CI [0.48–1.11]；p=0.15）。 讨论：与FLAURA试验中的患者相比，真实世界ESME数据库中的患者预后较差。诊断时存在脑转移会恶化预后。
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