SYSTEMATIC REVIEW article
Front. Immunol.
Sec. Cancer Immunity and Immunotherapy
Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1592761
This article is part of the Research TopicCommunity Series in Novel Biomarkers for Predicting Response to Cancer Immunotherapy: Volume IIIView all 15 articles
Role of tumor mutation burden in patients with urothelial carcinoma treated with immune checkpoint inhibitors: a systematic review and meta-analysis
Provisionally accepted
- Liaoning Cancer Hospital, China Medical University, Shenyang, China
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The predictive value of tumor mutation burden (TMB) on the efficacy of immunotherapy across multiple cancer types has been confirmed in previous studies. For urothelial carcinoma (UC) patients treated with immune checkpoint inhibitors (ICIs), whether TMB is a suitable biomarker to predict the benefit of ICIs still remains a matter of much debate. We conducted this meta-analysis to evaluate the role of TMB in patients with UC treated with ICIs. Methods: Two investigators independently searched literature, screened eligible studies, extracted valid data, and scored quality assessment. Meta-analyses of the effect size hazard ratio (HR) for overall survival (OS) and progression-free survival (PFS) as well as the effect size odds ratio (OR) for objective response rate (ORR) were performed and visualized with forest plots using STATA14.0 software. The statistical difference of benefit from ICIs for UC patients between the high TMB group and the low TMB group was significant when p-value < 0.05. Sensitivity analysis and publication bias further verified stability and reliability. Results: A total of 2499 patients from fourteen studies were included in this meta-analysis. The results indicated that UC patients with high TMB showed significantly longer OS and PFS than those with low TMB after ICIs treatment (OS: HR 0.69, 95% CI 0.62, 0.76, p<0.05; PFS: HR 0.67, 95% CI 0.59, 0.76, p<0.05). The high TMB group exhibited a superior response to ICIs than the low TMB group with no significant difference (OR 1.64, 95% CI 0.94, 2.86, p=0.08). The results were stable, reliable, and with no publication bias. Conclusions: This meta-analysis demonstrated UC patients with high TMB exhibited significantly longer survival than those with low TMB after ICIs treatment. TMB might be a favorable predictor for UC immunotherapy in future clinical practice.
Keywords: Tumor mutation burden, Immune checkpoint inhibitor, urothelial carcinoma, overall survival, Progression-free survival, overall response rate, Meta-analysis
Received: 13 Mar 2025; Accepted: 02 May 2025.
Copyright: © 2025 Wang, Huang, Li and Ke. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Liyuan Ke, Liaoning Cancer Hospital, China Medical University, Shenyang, China
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