本研究旨在调查尼伐珠单抗治疗非小细胞肺癌（NSCLC）患者不良事件与治疗疗效之间的可能关联。我们以严重不良事件（即≥3级别）为重点，评估了整体生存期（OS）、无进展生存期（PFS）以及治疗的客观反应率（ORR）。我们回顾性地分析了来自TULUNG NSCLC数据库的尼伐珠单抗治疗患者，并在八家肿瘤学中心评估了此数据集上的OS数据。为了减少可能的偏倚，我们进一步评估了在比尔森大学医院接受治疗的患者亚组，该亚组的不良事件发生率、PFS和ORR由两位经验丰富的医生独立检查。我们使用Kaplan-Meier方法和Cox分析评估了生存统计学。我们观察到，在接受尼伐珠单抗治疗的患者组中，与没有此类事件的患者相比，生存期、无进展生存期和治疗的客观反应率均明显增加。尽管单变量模型分析了所有患者的数据集，显示出严重不良事件患者的生存期更长，但考克斯多变量模型仅观察到非显著趋势。在一个评估PFS和ORR的患者亚组中，我们确实观察到了严重不良影响对患者产生的显著有利效果。相较于未经历或仅有轻微不良事件的患者，经历严重不良事件的患者在生存期、无进展生存期和治疗的客观反应率方面表现出更好的趋势。 版权所有 © 2023 International Institute of Anticancer Research (George J. Delinasios博士)，保留所有权利。

The aim of this study was to investigate possible association between adverse events of nivolumab therapy and the effectiveness of treatment in patients with non-small cell lung cancer (NSCLC). Focusing on serious adverse events (i.e., those of grade ≥3), we evaluated overall survival (OS), progression-free survival (PFS), as well as objective response rate (ORR) to treatment.We retrospectively analyzed a set of patients from the TULUNG database of NSCLC treated with nivolumab in eight oncology centers. We evaluated OS data based upon this set. To reduce possible bias, we further evaluated a subgroup of patients treated at the University Hospital in Pilsen, where the occurrence of adverse events, PFS, and ORR were independently examined by two experienced physicians. Survival statistics were evaluated using the Kaplan-Meier method and Cox analysis.We observed significantly greater OS, PFS, and ORR in the group of patients experiencing adverse events upon nivolumab treatment versus in those patients without such events. Although the univariable model analyzing the data set of all patients demonstrated higher OS in patients with serious adverse events, only a nonsignificant trend was observed in the Cox multivariable model. In a subgroup of patients with PFS and ORR evaluation, we did observe significant, favorable effects for patients having had serious adverse effects.Patients experiencing severe adverse events show a tendency toward better OS, PFS, and ORR compared to patients without or having only mild adverse events with nivolumab treatment.Copyright © 2023, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.