Zhang Shijia, Pease Daniel F, Kulkarni Amit A, Kumar Manoj, Shanley Ryan M, Xu Beibei, Joshi Shilvi P, Patel Manish R
Division of Hematology, Oncology and Transplantation, Department of Medicine, University of Minnesota, Minneapolis, MN, USA.
Department of Medicine, Hennepin Healthcare, Minneapolis, MN, USA.
Clin Med Insights Oncol. 2021 Mar 31;15:11795549211004489. doi: 10.1177/11795549211004489. eCollection 2021.
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.
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.
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/m (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.
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/m were independently associated with improved OS.
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）的治疗模式。本研究旨在评估ICIs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。
回顾开始ICI单药治疗的晚期肺癌患者的病历以收集数据。治疗结果包括客观缓解率、无进展生存期（PFS）和总生存期（OS）。评估免疫相关不良事件（irAEs）。采用多个Cox回归模型来研究生存结果的预测因素。
我们纳入了220例患者（中位年龄66.5岁）。79例（35.9%）患者东部肿瘤协作组（ECOG）体能状态（PS）评分⩾2。中位随访时间为11.4个月。在NSCLC中，中位PFS为3.8个月（一线治疗为4.7个月，后续治疗为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。四分之一的患者发生了irAEs。17例患有自身免疫性疾病的患者中有1例出现疾病复发。NSCLC中ECOG PS为0至1以及体重指数（BMI）⩾25 kg/m²（但不包括irAE的发生）与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）。
ICIs的临床获益似乎在年龄相对较大的真实世界人群中持续存在，包括那些PS较差和患有自身免疫性疾病的患者。ECOG PS为0至1以及BMI⩾25 kg/m²与OS改善独立相关。
