Qingqing Zuo

and 9 more

Aim To assess the incidence and spectrum of treatment-related and immune-related adverse events (TrAEs, irAEs) associated with immune checkpoint inhibitors (ICIs) in patients with advanced or metastatic renal cell carcinoma (RCC). Methods Following PRISMA guidelines, we analyzed clinical trials and observational studies from databases including CINAHL, Web of Science, PubMed, Cochrane Library, and EMBASE to investigate adverse events related to ICIs administration in RCC patients. Results Among the 12912 patients in 64 studies, 83.54% of patients in 59 arms reported at least one any-grade treatment-related adverse events (TrAEs), and 41.36% of patients in 59 arms reported at least one TRAE of grade 3 or higher. Hypertension was the most common TRAE in any grade (36.99%; 95% CI: [35.30-38.69]) and grade 3 and above (14.89%; 95% CI: 13.64-16.14). The most common any-grade and grade 3 or higher immune-related adverse events (iRAEs) included hypothyroidism (18.04%; 95% CI: [16.83-19.25]) and hepatitis (2.87%; 95% CI: [2.24-3.32]), respectively. Multivariable regression analyses revealed that the cancer type and ICIs treatment regimen independently correlated with the occurrence of TrAEs and iRAEs. Death or withdrawal from ICIs agents occurred in 1.49% and 15.05% of the 7641 patients, respectively. Conclusion This meta-analysis offers a comprehensive synthesis of ICIs-related AE patterns in RCC, highlighting toxicity profiles across organ systems and treatment regimens. These findings may support improved clinical awareness, guide AE anticipation, and inform optimization of RCC-specific management strategies and guideline development.