Department of Urology, Changhai Hospital, Naval Medical University, Shanghai, China.
Department of Health Statistics, Naval Medical University, Shanghai, China.
Eur Urol. 2022 Apr;81(4):414-425. doi: 10.1016/j.eururo.2022.01.028. Epub 2022 Jan 31.
Therapies based on immune checkpoint inhibitors (ICIs) are transforming the treatment landscape of urologic oncology. Nevertheless, an exhaustive overview of the toxicity spectrum of these novel therapies has yet to be provided.
To comprehensively investigate the incidence and profile of ICI therapy-related adverse events (AEs) across urologic cancers.
We searched for all clinical trials investigating the role of ICI therapy published between January 2010 and September 2021. Studies involving urologic cancers with reported overall incidence or tabulated data of treatment-related AEs (trAEs) or immune-related AEs (irAEs) were included. A systematic review and meta-analysis was performed after protocol registration in PROSPERO (CRD42021276435).
We identified 2638 records, of which 92 studies (including 22942 participants) met the inclusion criteria. The pooled overall incidence was 81.6% (95% confidence interval [CI] 78.0-84.7) for any-grade trAEs and 29.3% (95% CI 24.9-34.1) for grade ≥3 trAEs. The pooled overall incidence was 34.3% (95% CI 28.5-40.7) for any-grade irAEs and 10.2% (95%CI 8.2-12.7) for grade ≥3 irAEs. On a multivariable analysis, cancer type, therapy combination, clinical settings (perioperative vs advanced/metastatic), and drug exposure were independently associated with the occurrence of trAEs or irAEs. The overall rate of treatment-related mortality was 0.94% (140 of 14 899 participants), with pneumonitis (9.3%), pneumonia (7.9%), and respiratory failure (7.1%) being the most common causes. Immune-related mortality occurred in 0.26% (28 of 10 723) patients, with pneumonitis (35.7%), hepatic failure (10.7%), and hepatitis (7.1%) being most common.
Our study provides a comprehensive overview of ICI-associated AEs in urologic cancer patients. The spectrum and incidence of AEs vary across cancer types, ICI types, clinical settings, and therapy combinations. These findings provide important guidance to clinicians in counseling and management of patients with urologic cancers.
A high proportion of patients experience immune checkpoint inhibitor-associated toxicity. Physician and patient education is critical for early recognition and proper management.
免疫检查点抑制剂（ICI）为泌尿科肿瘤的治疗带来了变革。然而，这些新型疗法的毒性谱仍未得到全面概述。
全面研究ICI 治疗相关不良反应（AE）在各种泌尿科癌症中的发生情况和特征。
我们检索了 2010 年 1 月至 2021 年 9 月期间发表的所有探索 ICI 治疗作用的临床试验。纳入报告了总体发生率或列出了治疗相关 AE（trAE）或免疫相关 AE（irAE）的表格数据的泌尿科癌症研究。在 PROSPERO（CRD42021276435）中进行方案注册后进行了系统评价和荟萃分析。
我们共检索到 2638 篇记录，其中 92 项研究（包括 22942 名参与者）符合纳入标准。任何级别的 trAE 的总体发生率为 81.6%（95%置信区间 [CI] 78.0-84.7），≥3 级 trAE 的总体发生率为 29.3%（95%CI 24.9-34.1）。任何级别的 irAE 的总体发生率为 34.3%（95%CI 28.5-40.7），≥3 级 irAE 的总体发生率为 10.2%（95%CI 8.2-12.7）。多变量分析显示，癌症类型、治疗组合、临床环境（围手术期与晚期/转移性）和药物暴露与 trAE 或 irAE 的发生独立相关。治疗相关死亡率总体为 0.94%（140/14899 名参与者），主要死因是肺炎（9.3%）、肺炎（7.9%）和呼吸衰竭（7.1%）。免疫相关死亡率为 0.26%（28/10723 名患者），主要死因是肺炎（35.7%）、肝功能衰竭（10.7%）和肝炎（7.1%）。
本研究全面概述了泌尿科癌症患者中与 ICI 相关的 AE。AE 的发生情况和发生率因癌症类型、ICI 类型、临床环境和治疗组合而异。这些发现为泌尿科癌症患者的临床医生提供了重要的指导，帮助他们进行患者咨询和管理。
相当一部分患者会出现免疫检查点抑制剂相关毒性。医生和患者教育对于早期识别和正确管理至关重要。
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