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SYSTEMATIC REVIEW article

Front. Immunol.
Sec. Cancer Immunity and Immunotherapy
Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1430673
This article is part of the Research Topic The Role of Immunotherapy in Urothelial Cancer View all 8 articles

Effectiveness and safety of PD-1/L1 inhibitors as first-line therapy for patients with advanced or metastatic urothelial carcinoma who are ineligible for platinum-based chemotherapy: a meta-analysis

Provisionally accepted
Weiming Liang Weiming Liang ZHILONG HUANG ZHILONG HUANG Yanping Huang Yanping Huang Chunyan Li Chunyan Li Yiwen Liang Yiwen Liang Miaoyan Huang Miaoyan Huang Duo Zhang Duo Zhang *
  • Guangxi University of Science and Technology, Liuzhou, Guangxi Zhuang Region, China

The final, formatted version of the article will be published soon.

    Objective: To evaluate the efficacy and safety of programmed cell death protein 1 or its ligand (PD-1/L1) inhibitors as first-line therapy in advanced or metastatic urothelial carcinoma (mUC) who are ineligible for platinum-based chemotherapy.A systematic search was conducted in four databases (Pubmed, Embase, Web of Science, and the Cochrane Library) to find articles that evaluate the effectiveness of first-line PD-1/L1 inhibitors for mUC, from the establishment of the databases to 22 November 2023. Meta-analyses were performed to evaluate the frequencies of progression-free survival (PFS), overall survival (OS), complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), objective response rate (ORR), disease control rate (DCR), and grade ≥ 3 treatment-related adverse events (trAEs).Results: Totally six studies were included for meta-analysis. The CR, PR, SD, PD, ORR, DCR, and grade ≥ 3 trAEs rate were 0.06 [95% confidence interval (CI), 0.04 to 0.07] , 0.22 (95% CI, 0.16 to 0.30) , 0.27 (95% CI, 0.23 to 0.31), 0.31 (95% CI, 0.20 to 0.44), 0.28 (95% CI, 0.21 to 0.37), 0.57 (95% CI, 0.47 to 0.67) and 0.26 (95% CI, 0.14 to 0.40), respectively. The median PFS and OS were 4.5 months and 13.7 months, respectively. Subgroup analysis showed that PD-1/L1 inhibitors monotherapy had an ORR rate of 0.25 (95% CI, 0.21 to 0.29) and a DCR rate of 0.50(95% CI, 0.44 to 0.56), while PD-1/L1 dual immunotherapy had a better ORR rate of 0.33 (95% CI, 0.15 to 0.52) and a DCR rate of 0.65 (95% CI, 0.49 to 0.80). However, there was no significant difference in PFS and OS between the two groups. † These authors contributed equally to this study.The findings indicated that PD-1/L1 inhibitors could be used as a safe and viable first-line treatment option for patients with advanced or metastatic urothelial carcinoma who were not suitable candidates for platinum-based chemotherapy. Specifically, the combination of Enfortumab vedotin (EV) and pembrolizumab (Pembro) showed more effectiveness in treating patients compared to trials using the current standard treatment, suggesting that it could be a promising alternative treatment option..

    Keywords: Pembrolizumab, Enfortumab vedotin, Immunotherapy, urothelial carcinoma, Metastatic, Objective response rate, Meta-analysis, PD-1 inhibitor

    Received: 10 May 2024; Accepted: 15 Jan 2025.

    Copyright: © 2025 Liang, HUANG, Huang, Li, Liang, Huang and Zhang. 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: Duo Zhang, Guangxi University of Science and Technology, Liuzhou, 545026, Guangxi Zhuang Region, China

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