Background:

Immune checkpoint inhibitors (ICIs) have changed the treatment paradigm of advanced-stage non-small-cell lung cancer (NSCLC) and small-cell lung cancer (SCLC). The aim of this study was to evaluate the effectiveness and tolerance of ICIs in a real-world patient population and to investigate the predictive factors associated with survival outcomes.

Methods:

Medical records of patients with advanced lung cancer who started ICI monotherapy were reviewed for data collection. Treatment outcomes included objective response rate, progression-free survival (PFS), and overall survival (OS). Immune-related adverse events (irAEs) were assessed. Multiple Cox regression models were fit to investigate the predictive factors for survival outcomes.

Results:

We included 220 patients (median 66.5 years). Seventy-nine (35.9%) patients had Eastern Cooperative Oncology Group (ECOG) performance-status (PS) score ⩾2. Median follow-up was 11.4 months. In NSCLC, median PFS was 3.8 months (4.7 months for first line and 3.7 months for subsequent line). Median OS was 12.4 months (15.6 months for first line therapy and 11.5 months for subsequent line). In SCLC, median PFS was 1.8 months, and median OS was 4.6 months. A quarter of patients developed irAEs. There was 1 disease flare among 17 patients with pre-existing autoimmune diseases. ECOG PS of 0 to 1 and body mass index (BMI) ⩾ 25 kg/m² (but not occurrence of irAE) were independently associated with improved OS in NSCLC, with a hazard ratio of 0.41 (95% confidence interval [CI], 0.29-0.59) and 0.62 (95% CI, 0.44-0.87), respectively.

Conclusions:

The clinical benefit of ICIs appears to persist in a real-world population of relatively older age, including those with poor PS and pre-existing autoimmune diseases. ECOG PS of 0 to 1 and BMI ⩾ 25 kg/m² were independently associated with improved OS.

中文翻译：

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晚期肺癌免疫检查点抑制剂单药治疗的真实世界结果和临床预测因素

背景：

免疫检查点抑制剂（ICIs）改变了晚期非小细胞肺癌（NSCLC）和小细胞肺癌（SCLC）的治疗范式。本研究的目的是评估 ICI 在真实世界患者群体中的有效性和耐受性，并调查与生存结果相关的预测因素。

方法：

对开始 ICI 单药治疗的晚期肺癌患者的医疗记录进行审查以收集数据。治疗结果包括客观缓解率、无进展生存期 (PFS) 和总生存期 (OS)。评估了免疫相关不良事件 (irAE)。多元 Cox 回归模型适用于研究生存结果的预测因素。

结果：

我们纳入了 220 名患者（中位年龄为 66.5 岁）。79 名 (35.9%) 患者的东部肿瘤协作组 (ECOG) 表现状态 (PS) 评分为 ⩾2。中位随访时间为 11.4 个月。在 NSCLC 中，中位 PFS 为 3.8 个月（一线为 4.7 个月，后续线为 3.7 个月）。中位 OS 为 12.4 个月（一线治疗为 15.6 个月，后续治疗为 11.5 个月）。在 SCLC 中，中位 PFS 为 1.8 个月，中位 OS 为 4.6 个月。四分之一的患者出现了 irAE。17 名既往存在自身免疫性疾病的患者中有 1 次疾病发作。ECOG PS 0 到 1 和体重指数 (BMI) ⩾ 25 kg/m ² （但不是 irAE 的发生）与 NSCLC 的 OS 改善独立相关，风险比分别为 0.41（95% 置信区间 [CI]，0.29-0.59）和 0.62（95% CI，0.44-0.87）。

结论：

ICI 的临床益处似乎在现实世界中年龄相对较大的人群中持续存在，包括那些 PS 较差和预先存在自身免疫疾病的人群。ECOG PS 为 0 到 1 和 BMI ⩾ 25 kg/m ²与改善的 OS 独立相关。