Background: Pembrolizumab (PEM) has been shown to be effective in clinical trials for the treatment of advanced non-small cell lung cancer (NSCLC), but clinical trials were based on cohorts of patients selected on specific criteria, and whether the findings are consistent with real-world patients is debatable. The aim of this study is to evaluate the efficacy and safety of PEM in the treatment of advanced NSCLC based on real-world data.
Methods: A retrospective collection of real-world data from patients with advanced NSCLC receiving PEM was conducted. Propensity score matching was used to eliminate inter-group differences and assess the efficacy and safety of PEM compared to chemotherapy.
Results: Among 450 matched patients, the incidence rates of any-grade adverse events were 79.87% in the PEM group and 86.71% in the chemotherapy group, while the incidence rates of grade ≥3 adverse events were 4.03% and 7.31%, respectively. The objective response rates were 48.63% for PEM and 36.00% for chemotherapy (P=0.011). The median progression-free survival was 15.5 months for PEM and 8.8 months for chemotherapy (P<0.001), and the median overall survival was not reached for PEM and 26.2 months for chemotherapy (P<0.001).
Conclusions: PEM treatment for advanced NSCLC demonstrates favorable survival outcomes and acceptable safety in real-world clinical practice.
【中文题目：帕博利珠单抗治疗晚期非小细胞肺癌 安全性和有效性的真实世界研究】 【中文摘要：背景与目的 帕博利珠单抗（Pembrolizumab, PEM）治疗晚期非小细胞肺癌（non-small cell lung cancer, NSCLC）在临床试验中被证实有效，但这些试验是基于按照特定标准筛选的患者群体，因此这些结果是否能够代表真实世界中患者的普遍情况，仍然值得讨论。本研究旨在基于真实世界数据评估PEM治疗晚期NSCLC的有效性和安全性。方法 回顾性收集接受PEM治疗的晚期NSCLC患者的真实世界数据，使用倾向性评分匹配消除组间差异，评估PEM与化疗的有效性和安全性。结果 在倾向性评分匹配后的450例患者中PEM组和化疗组任何等级不良事件发生率分别为79.87%和86.71%，≥3级不良事件发生率分别为4.03%和7.31%。PEM组和化疗组的客观缓解率分别为48.63%和36.00%（P=0.011），中位无进展生存期分别为15.5和8.8个月（P<0.001），中位总生存期分别为未达到和26.2个月（P<0.001）。结论 PEM治疗晚期NSCLC在实际临床应用中显示出较好的生存率和可接受的安全性。 】 【中文关键词：真实世界数据；帕博利珠单抗；肺肿瘤；安全性；有效性】.
Keywords: Efficacy; Lung neoplasms; Pembrolizumab; Real-world data; Safety.