Efficacy and Safety of Immune Checkpoint Blockade in Locally Advanced or Metastatic Penile Cancer: A Systematic Review and Meta-Analysis

IF 2.7 3区医学 Q3 ONCOLOGY

Clinical genitourinary cancer Pub Date : 2026-03-01 Epub Date: 2025-12-22 DOI:10.1016/j.clgc.2025.102491

Mariana Macambira Noronha , Luiz Felipe Costa de Almeida , Pedro Robson Costa Passos , Luís Felipe Leite da Silva , Anelise Poluboiarinov Cappellaro , Valbert Oliveira Costa Filho , Leonardo-Gil Santana , Changsu Lawrence Park , Erick Figueiredo Saldanha

{"title":"Efficacy and Safety of Immune Checkpoint Blockade in Locally Advanced or Metastatic Penile Cancer: A Systematic Review and Meta-Analysis","authors":"Mariana Macambira Noronha , Luiz Felipe Costa de Almeida , Pedro Robson Costa Passos , Luís Felipe Leite da Silva , Anelise Poluboiarinov Cappellaro , Valbert Oliveira Costa Filho , Leonardo-Gil Santana , Changsu Lawrence Park , Erick Figueiredo Saldanha","doi":"10.1016/j.clgc.2025.102491","DOIUrl":null,"url":null,"abstract":"<div><div>Locally advanced or metastatic penile cancer (LA/mPC) is an aggressive and rare malignancy with limited treatment options. While promising, the role of Immune Checkpoint Blockade (ICB) in LA/mPC remains controversial. We performed a systematic review and meta-analysis to evaluate the efficacy and safety of ICB in patients with LA/mPC. A literature search was conducted in PubMed, Embase, and Cochrane (up to June 2025). The analysis was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines (CRD420251070583). Proportional outcomes were pooled using a random-effects proportional meta-analysis, and hazard ratios (HR) were pooled using a random-effects model. We used the available Kaplan-Meier curves to recreate time-to-event data from the studies considered. Heterogeneity between studies was evaluated using the I<sup>2</sup> metric and Cochran's Q test. A total of 12 cohorts (488 patients) were included in the analysis. The pooled Objective Response Rate in patients treated with ICB was 34.13% (95% CI, 20.62%-56.48%). Subgroup analysis demonstrated marked variability by treatment strategy, with an ORR of 60.7% for ICB plus chemotherapy versus 16.7% for ICB monotherapy (<em>P</em> < .01). At 12 months, pooled Progression-Free Survival (PFS) and Overall Survival (OS) rates were 62.64% (95% CI, 55.55%-70.63%) and 80.21% (95% CI, 74.11%-86.83%), respectively. The median PFS and OS were 5.7 months and 13.6 months, respectively. The pooled incidence of Immune-related Adverse Events was 40.36% (95% CI, 26.82%-60.74%) for any grade and 13.79% (95% CI, 7.67%-24.80%) for grade ≥ 3 events. ICB, particularly when combined with chemotherapy, shows signals of clinical activity in LA/mPC. However, due to high inter-study variability and the single-arm nature of the analysis, these findings are hypothesis-generating and require prospective, randomized, biomarker-driven validation.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"24 2","pages":"Article 102491"},"PeriodicalIF":2.7000,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical genitourinary cancer","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1558767325001910","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/12/22 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Locally advanced or metastatic penile cancer (LA/mPC) is an aggressive and rare malignancy with limited treatment options. While promising, the role of Immune Checkpoint Blockade (ICB) in LA/mPC remains controversial. We performed a systematic review and meta-analysis to evaluate the efficacy and safety of ICB in patients with LA/mPC. A literature search was conducted in PubMed, Embase, and Cochrane (up to June 2025). The analysis was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines (CRD420251070583). Proportional outcomes were pooled using a random-effects proportional meta-analysis, and hazard ratios (HR) were pooled using a random-effects model. We used the available Kaplan-Meier curves to recreate time-to-event data from the studies considered. Heterogeneity between studies was evaluated using the I² metric and Cochran's Q test. A total of 12 cohorts (488 patients) were included in the analysis. The pooled Objective Response Rate in patients treated with ICB was 34.13% (95% CI, 20.62%-56.48%). Subgroup analysis demonstrated marked variability by treatment strategy, with an ORR of 60.7% for ICB plus chemotherapy versus 16.7% for ICB monotherapy (P < .01). At 12 months, pooled Progression-Free Survival (PFS) and Overall Survival (OS) rates were 62.64% (95% CI, 55.55%-70.63%) and 80.21% (95% CI, 74.11%-86.83%), respectively. The median PFS and OS were 5.7 months and 13.6 months, respectively. The pooled incidence of Immune-related Adverse Events was 40.36% (95% CI, 26.82%-60.74%) for any grade and 13.79% (95% CI, 7.67%-24.80%) for grade ≥ 3 events. ICB, particularly when combined with chemotherapy, shows signals of clinical activity in LA/mPC. However, due to high inter-study variability and the single-arm nature of the analysis, these findings are hypothesis-generating and require prospective, randomized, biomarker-driven validation.

查看原文本刊更多论文

免疫检查点阻断治疗局部晚期或转移性阴茎癌的疗效和安全性：系统综述和荟萃分析

局部晚期或转移性阴茎癌（LA/mPC）是一种侵袭性和罕见的恶性肿瘤，治疗方案有限。尽管有希望，免疫检查点阻断（ICB）在LA/mPC中的作用仍然存在争议。我们进行了系统回顾和荟萃分析，以评估ICB在LA/mPC患者中的有效性和安全性。在PubMed， Embase和Cochrane进行文献检索（截至2025年6月）。根据系统评价和荟萃分析指南的首选报告项目（CRD420251070583）进行分析。比例结果采用随机效应比例荟萃分析合并，风险比（HR）采用随机效应模型合并。我们使用可用的Kaplan-Meier曲线来重新创建所考虑的研究中的事件时间数据。使用I2度量和科克伦Q检验评估研究之间的异质性。共有12个队列（488例患者）纳入分析。ICB治疗患者的综合客观缓解率为34.13% （95% CI, 20.62%-56.48%）。亚组分析显示治疗策略的显著差异，ICB加化疗的ORR为60.7%，而ICB单药治疗的ORR为16.7% （P < 0.01）。12个月时，总无进展生存期（PFS）和总生存期（OS）分别为62.64% （95% CI, 55.55%-70.63%）和80.21% （95% CI, 74.11%-86.83%）。中位PFS和OS分别为5.7个月和13.6个月。任何级别的免疫相关不良事件的总发生率为40.36% (95% CI, 26.82%-60.74%)，≥3级事件的总发生率为13.79% （95% CI, 7.67%-24.80%）。ICB，特别是与化疗联合时，在LA/mPC中显示出临床活性信号。然而，由于研究间的高度可变性和单臂分析的性质，这些发现是假设产生的，需要前瞻性的、随机的、生物标志物驱动的验证。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Clinical genitourinary cancer 医学-泌尿学与肾脏学

CiteScore

5.20

自引率

6.20%

发文量

201

审稿时长

54 days

期刊介绍： Clinical Genitourinary Cancer is a peer-reviewed journal that publishes original articles describing various aspects of clinical and translational research in genitourinary cancers. Clinical Genitourinary Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of genitourinary cancers. The main emphasis is on recent scientific developments in all areas related to genitourinary malignancies. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.