Background: In recent years, a number of clinical trials have shown that immunocheckpoint inhibitors (ICI) have brought survival benefits to patients with advanced non-small cell lung cancer (NSCLC), however, such clinical trials comprise cohorts selected based on strict and complex entry and exclusion criteria, and the results cannot fully reflect the real world situation. The purpose of this study was to investigate the clinical efficacy and safety of immunotherapy in the real world, as well as possible prognostic factors.
Methods: Patients with advanced NSCLC receiving immunotherapy in Beijing Chest Hospital from January 2017 to July 2019 were retrospectively collected, and the following information were collected: curative effect, progression-free surival (PFS) and adverse reactions. The occurrence of adverse reactions and clinical curative effect and prognosis factors that may be relevant were explored.
Results: 34 patients were enrolled in this study, median PFS was 5.66 months (95%CI: 4.48-6.84), grade 1-2 and 3-4 incidence of adverse events was 61.71% (22/34) and 14.71% (5/34), there were 3 patients (8.82%) experienced fatal immune related adverse events (irAE), 2 cases were immune associated pneumonia, 1 case was immune related myocarditis. Univariate analysis showed that tumor-node-metastasis (TNM) stage and metastatic site were correlated with median PFS (P<0.05), and multivariate analysis showed that patients with extrapulmonary metastasis (OR=6.42, P=0.029) and pleural metastasis (OR=14.14, P=0.006) had shorter median PFS.
Conclusions: In the real world, immunotherapy has good efficacy in patients with advanced NSCLC, but the incidence of severe irAE is also higher. Distant metastasis and pleural metastasis are poor prognostic factors for advanced NSCLC patients receiving immunotherapy.
【中文题目：单中心晚期非小细胞肺癌免疫治疗真实世界数据分析】 【中文摘要：背景与目的 近些年，多项临床试验显示免疫检查点抑制剂（immunocheckpoint inhibitor, ICI）为晚期非小细胞肺癌（non-small cell lung cancer, NSCLC）患者带来生存获益，但临床试验有着严格而复杂的纳入与排除标准，其结果不能完全反映真实世界的实际情况。本研究拟探讨真实世界中免疫治疗的临床疗效和安全性以及可能相关的预后因素。方法 回顾性分析2017年1月-2019年7月在北京胸科医院接受免疫治疗的晚期NSCLC患者，收集患者基本临床资料、治疗疗效、无进展生存期（progression-free survival, PFS）和药物不良反应等资料，探讨临床疗效、不良反应及可能相关的预后因素。结果 研究共纳入34例患者，中位PFS为5.66个月（95%CI：4.48个月-6.84个月），1级-2级不良反应和3级-4级不良反应发生率分别为61.71%（22/34）和14.71%（5/34），共有3例（8.82%）患者出现致死性免疫相关不良反应（immune-related adverse event, irAE），其中2例为免疫相关肺炎，1例为免疫相关心肌炎。单因素分析显示肿瘤-淋巴结-转移（tumor-node-metastasis, TNM）分期、转移部位与中位PFS相关（P<0.05），多因素分析显示存在肺外转移（OR=6.42, P=0.029）、胸膜转移（OR=14.14, P=0.006）为患者PFS的独立预后因素。结论 真实世界中免疫治疗对晚期NSCLC患者具有良好的疗效，但其严重irAE的发生率也较高。存在肺外转移、胸膜转移是接受免疫治疗的晚期NSCLC患者的不良预后因素。】 【中文关键词：肺肿瘤；免疫治疗；临床疗效；不良反应】.
Keywords: Adverse events; Clinical efficacy; Immunotherapy; Lung neoplasms.