Neoadjuvant immune checkpoint inhibitors for muscle-invasive urothelial carcinoma: a systematic review and meta-analysis.

IF 2.3 4区医学 Q3 IMMUNOLOGY

Immunotherapy Pub Date : 2026-02-01 Epub Date: 2026-03-12 DOI:10.1080/1750743X.2026.2643128

Ana Luíza Rocha Soares Menegat, Brenda Luana Rocha Soares Menegat, Luana Diniz Guerra Braz, Maria Victória Ferreira Piccoli, Thiago Gorayeb Rebelo, Francisco Cezar Aquino de Moraes

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引用次数: 0

Abstract

Introduction: Muscle-invasive urothelial carcinoma (MIUC) represents one-quarter of cancers and carries morbidity and mortality. Although cisplatin neoadjuvant chemotherapy plus radical cystectomy improves survival, patients may be ineligible due to renal dysfunction or comorbidities. Immune checkpoint inhibitors (ICIs), established in metastatic disease, are emerging as neoadjuvant options.

Methods: A systematic search of PubMed, Embase, and the Cochrane Library identified clinical trials evaluating ICIs in MIUC. Meta-analysis was conducted using a random-effects model. Statistical analyses were performed in R software (version 4.4.1), with p < 0.05 considered significant.

Results: Eleven studies comprising 573 patients (82.02% male) were included. The pooled pathologic complete response (pCR) rate was 35% (95% CI: 31%-39%). Overall survival (OS), recurrence-free survival (RFS), and event-free survival (EFS) at 2 years were 85% (95% CI: 77%-90%), 78% (95% CI: 72%-83%), and 73% (95% CI: 66%-79%), respectively. Additionally, the incidence of grade ≥3 cardiovascular, hematological, and immune-related adverse events (AEs) was 3% (95% CI: 2%-6%), 16% (95% CI: 11%-23%), and 5% (95% CI: 3%-8%), respectively.

Conclusions: Neoadjuvant ICIs demonstrate favorable efficacy and acceptable safety in MIUC, particularly among cisplatin-ineligible patients. Randomized trials are needed to confirm long-term oncological outcomes and establish their role in curative treatment.

Protocol registration: www.crd.york.ac.uk/prospero identifier is CRD42025640278.

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新辅助免疫检查点抑制剂治疗肌肉侵袭性尿路上皮癌：系统回顾和荟萃分析。

肌肉侵袭性尿路上皮癌（MIUC）占癌症的四分之一，具有发病率和死亡率。虽然顺铂新辅助化疗加根治性膀胱切除术可提高生存率，但患者可能因肾功能不全或合并症而不适合。免疫检查点抑制剂（ICIs），建立在转移性疾病，正在成为新的辅助选择。方法：系统检索PubMed， Embase和Cochrane图书馆，确定评估MIUC中ICIs的临床试验。采用随机效应模型进行meta分析。结果：纳入11项研究，573例患者，其中男性82.02%。合并病理完全缓解（pCR）率为35% （95% CI: 31%-39%）。2年总生存率（OS）、无复发生存率（RFS）和无事件生存率（EFS）分别为85% （95% CI: 77%-90%）、78% （95% CI: 72%-83%）和73% （95% CI: 66%-79%）。此外，≥3级心血管、血液和免疫相关不良事件（ae）的发生率分别为3% （95% CI: 2%-6%）、16% （95% CI: 11%-23%）和5% （95% CI: 3%-8%）。结论：新辅助ICIs在MIUC中表现出良好的疗效和可接受的安全性，特别是在顺铂不合格的患者中。需要随机试验来确认长期肿瘤预后并确定其在治愈性治疗中的作用。协议注册：www.crd.york.ac.uk/prospero标识为CRD42025640278。

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来源期刊

Immunotherapy 医学-免疫学

CiteScore

5.00

自引率

3.60%

发文量

113

审稿时长

6-12 weeks

期刊介绍： Many aspects of the immune system and mechanisms of immunomodulatory therapies remain to be elucidated in order to exploit fully the emerging opportunities. Those involved in the research and clinical applications of immunotherapy are challenged by the huge and intricate volumes of knowledge arising from this fast-evolving field. The journal Immunotherapy offers the scientific community an interdisciplinary forum, providing them with information on the most recent advances of various aspects of immunotherapies, in a concise format to aid navigation of this complex field. Immunotherapy delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for this vitally important area of research. Unsolicited article proposals are welcomed and authors are required to comply fully with the journal''s Disclosure & Conflict of Interest Policy as well as major publishing guidelines, including ICMJE and GPP3.