Abstract

Background

Treatment with immune checkpoint inhibitors (ICPi) has revolutionized cancer treatment over the past few years. Despite the clinical benefits, there is a wide range of toxicities related to the mechanism of action of such group of therapies. Almost every system of organs may be affected. Although rare, fulminant and even fatal toxicities may occur and so, high level of suspicion is the key element to detect and treat them. The purpose of this analysis was to present real world data of programmed death-1 receptor (PD-1) and its ligand (PD-L1) blockade immune-related toxicities in a population of patients treated in a Community Hospital.

Methods

A descriptive retrospective analysis of 65 consecutive patients with advanced non-small cell lung cancer (NSCLC), thymoma, head and neck cancer, urothelial and clear cell kidney cancer treated between February 2016 and December 2018 with anti-PD-1/PD-L1 checkpoint inhibitors, was performed. The variables analyzed were the prevalence of toxicities, evaluated according to the system of organs affected and the drug used, their severity according to the Common Terminology Criteria for Adverse Events (CTCAE) classification (v 5.0) and timing of onset. Analyses were performed with use of SPSS v.18 software.

Results

On our population, 94% received treatment with anti-PD-1 checkpoint inhibitor and 89% had NSCLC. Treatment-related adverse events (AE) were observed in 40% of the patients, for any AE. Grade 3-4 toxicities were reported in 6,2% of the patients. Rheumatologic and cutaneous AE were the most frequent ones. They were all reported amongst patients treated with anti-PD-1 checkpoint inhibitors. The reported treatment-related AEs for the nivolumab and pembrolizumab-treated groups were 42,9% and 30,4% (any AE) and grade 3-4 AEs were 7,1% and 4,3%, respectively. No deaths related to toxicity were documented. Rheumatologic and cutaneous AEs were the earliest ones to appear, median time of onset 4 and 6 weeks respectively. Pneumonitis was the latest toxicity, with a median time to appearance of 45 weeks.

Conclusion

The data we present here represents an heterogeneous population in real world settings and it similar to the literature. Implementing careful follow-up for immune related events contributes to promptly diagnose and treat.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

中文翻译：

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57P免疫相关不良事件：社区医院的经验

抽象的

背景

在过去的几年中，使用免疫检查点抑制剂（ICPi）的治疗彻底改变了癌症的治疗方法。尽管具有临床益处，但是与这类疗法的作用机理有关的毒性范围很广。几乎每个器官系统都可能受到影响。尽管可能会发生罕见，爆发性甚至致命的毒性，因此，高度怀疑是检测和治疗它们的关键因素。该分析的目的是在社区医院接受治疗的患者群体中，提供编程的死亡1受体（PD-1）及其配体（PD-L1）阻断免疫相关毒性的真实数据。

方法

描述性回顾性分析对2016年2月至2018年12月间使用抗PD-1 / PD-L1治疗的65例晚期非小细胞肺癌（NSCLC），胸腺瘤，头颈癌，尿路上皮和透明细胞肾癌连续患者进行了描述性回顾性分析进行检查点抑制剂。分析的变量是毒性的发生率，根据受影响的器官系统和使用的药物评估的程度，根据不良事件通用术语标准（CTCAE）分类（v 5.0）和发作时间的严重程度。使用SPSS v.18软件进行分析。

结果

在我们的人群中，有94％的患者接受了抗PD-1检查点抑制剂的治疗，而89％的患者则接受了NSCLC。对于任何AE，在40％的患者中均观察到与治疗相关的不良事件（AE）。在6.2％的患者中报告了3-4级毒性。风湿病和皮肤AE是最常见的。据报道，所有患者均接受过抗PD-1检查点抑制剂治疗。据报道，用nivolumab和pembrolizumab治疗的组与治疗相关的不良事件分别为42.9％和30.4％（任何不良事件），而3-4级不良事件分别为7.1％和4.3％。没有记录到与毒性有关的死亡。风湿病和皮肤病是最早出现的AE，中位发病时间分别为4周和6周。肺炎是最新的毒性反应，平均出现时间为45周。

结论

我们在此提供的数据代表了现实世界中的异类种群，与文献相似。对免疫相关事件进行认真的随访有助于及时诊断和治疗。

负责研究的法人实体

作者。

资金

尚未收到任何资金。

揭露

所有作者均声明没有利益冲突。