Introduction: Immune checkpoint inhibitor (ICI) therapy, although effective in treating patients with a variety of advanced malignancies, can result in potentially severe or even fatal immune-related adverse events (irAEs). This study aimed to generate real-world evidence on irAE characteristics, clinical management and clinical outcomes among patients with advanced (unresectable or metastatic) malignant melanoma (a/mMM) or advanced renal cell carcinoma (aRCC) treated with nivolumab (NIVO) and/or ipilimumab (IPI) in the UK.

Methods: This was a multi-centre, retrospective cohort study of adult patients with a/mMM or aRCC, who received NIVO and/or IPI at one of five specialist treatment centres in the UK between 1 January 2016 and 31 March 2020. The incidence and grading of irAEs were described, as well as time to irAE onset, the management of irAEs and overall survival (OS).

Results: In total, 199 patients were included in the study: 162 with a/mMM and 37 with aRCC. The majority of patients in both a/mMM (75.3%) and aRCC (62.2%) cohorts reported any irAE, while 45.9% and 30.4% in the a/mMM and aRCC cohorts reported grade 3 or 4 irAEs, respectively. Colitis/diarrhoea, skin reactions and hepatitis were most frequently reported, and the predominant treatment prescribed for any irAE was corticosteroids only. Analysis indicated a positive association between the development of an irAE and longer OS.

Conclusions: Findings from this study support current literature, provide further insights into the characteristics and clinical management of irAEs and support an association between the development of an irAE and improved OS in these patient groups.

Keywords: Advanced or metastatic malignant melanoma (a/mMM); Advanced renal cell carcinoma (aRCC); Immune checkpoint inhibitors (ICI); Immune-related adverse events (irAEs); irAE management.

© 2025. The Author(s).

简介： 免疫检查点抑制剂（ICI）疗法虽然在治疗多种晚期恶性肿瘤方面有效，但也可能导致潜在严重甚至致命的免疫相关不良事件（irAEs）。本研究旨在生成真实世界证据，探讨在接受纳武单抗（NIVO）和/或伊匹木单抗（IPI）治疗的英国晚期（不可切除或转移性）黑色素瘤（a/mMM）或肾细胞癌（aRCC）患者中，irAEs的特点、临床管理和临床结果。

方法： 这是一项多中心回顾性队列研究，在2016年1月1日至2020年3月31日期间，5个英国专科治疗中心接受了纳武单抗（NIVO）和/或伊匹木单抗（IPI）治疗的成年患者中进行。描述了irAEs的发生率和分级、irAEs出现的时间、irAEs管理以及总生存期（OS）。

结果： 共199名患者被纳入研究：其中162名为a/mMM，37名为aRCC。在两个组中，大多数患者报告了任何irAEs，而a/mMM和aRCC队列中有45.9%和30.4%的患者分别报告了三级或四级irAEs。最常见的报道是结肠炎/腹泻、皮肤反应和肝炎，并且治疗irAEs的主要处方为单独使用皮质类固醇。分析表明，发生irAE与更长的OS存在正相关。

结论： 本研究的结果支持当前文献，进一步探讨了irAEs的特点和临床管理，并支持这些患者群体中发生irAE与改善OS之间的关联。

关键词： 晚期或转移性恶性黑色素瘤（a/mMM）；晚期肾细胞癌（aRCC）；免疫检查点抑制剂（ICI）；免疫相关不良事件（irAEs）；irAE管理。

© 2025. The Author(s).