免疫检查点抑制剂（ICIs）广泛用于治疗晚期尿路上皮癌（aUC）患者，但其在PS低的aUC患者中的表现尚不清楚。我们旨在评估患者表现状态对接受ICIs治疗的aUC患者的肿瘤学结局的影响。我们检索了PubMed、Web of Science和Scopus等数据库，以确定符合PRISMA声明的随机（RCT）和非随机（NRCT）对照研究中评估东部协作肿瘤治疗组（ECOG）PS与ICIs治疗下aUC患者肿瘤学结局之间关联的研究。我们关注的结果是总生存期（OS）、癌症特异性生存期（CSS）、无进展生存期（PFS）和客观反应率（ORR）。总体而言，本文纳入了6个包括5428名患者的RCT和32个包括6069名患者的NRCT。RCT的Meta分析显示，与接受化疗治疗相比，ECOG PS = 0和PS ≥1的患者通过ICIs具有趋势性的更好OS（HR合并：0.86，95％置信区间[CI]：0.71 - 1.04和HR合并：0.74，95％CI：0.53 - 1.03，分别）。在患者表现差和表现好的ICIs反应方面没有显着差异（I2 = 0％，p = 0.46）。NRCT的Meta分析表明，与PS <2的患者相比，PS ≥ 2的患者OS显着较差（HR合并：2.52，95％CI：2.00-3.17），CSS更差（HR合并：3.35，95％CI：1.90-5.91），PFS更差（HR合并：2.89，95％CI：1.67-5.01），ORR更低（型合并比：0.47，95% CI：0.27-0.82）。同样，PS ≥1的患者的肿瘤学结局显着较差，相对于PS = 0的患者。在NRCT中，aUC患者接受ICIs治疗，低PS与肿瘤学结局较差相关。在RCT中，ICIs通过所有PS分类的表现优于化疗。由于研究和患者群体的高异质性，这些发现应该谨慎解释。需要进行更多包括PS糟糕的RCT以评估PS对ICI治疗结果的影响。对于患有尿路上皮癌的患者，免疫疗法不应基于表现状态的限制。然而，应该考虑到患者的预期寿命和合并症等其他因素。版权所有 ©2023。由Elsevier B.V. 发布。

Immune checkpoint inhibitors (ICIs) are widely used in the management of patients with advanced urothelial carcinoma (aUC). However, its performance in aUC patients with poor performance status (PS) remains unknown.We aimed to assess the impact of patients' performance status on the oncologic outcomes in patients with aUC treated with ICIs.We searched PubMed, Web of Science, and Scopus from inception until July 2022 to identify studies assessing the association between the Eastern Cooperative Oncology Group (ECOG) PS and the oncologic outcomes in patients with aUC treated with ICIs in randomised (RCTs) and nonrandomised (NRCTs) control studies according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. The outcomes of our interests were overall survival (OS), cancer-specific survival (CSS), progression-free survival (PFS), and objective response rate (ORR).Overall, six RCTs comprising 5428 patients and 32 NRCTs comprising 6069 patients were included. The meta-analysis of the RCTs revealed that patients with ECOG PS = 0 and PS ≥1 had a trend towards better OS with ICIs compared with those treated with chemotherapy (pooled hazard ratio [HR]: 0.86, 95% confidence interval [CI]: 0.71-1.04, and HR: 0.74, 95% CI: 0.53-1.03, respectively). There was no significant difference in terms of response to ICIs between patients with poor and good PS (I2 = 0%, p = 0.46). The meta-analysis of the NRCTs revealed that patients with PS ≥2 had significantly worse OS than those with PS <2 (pooled HR: 2.52, 95% CI: 2.00-3.17), as well as worse CSS (pooled HR: 3.35, 95% CI: 1.90-5.91), PFS (pooled HR: 2.89, 95% CI: 1.67-5.01), and ORR (pooled odds ratio: 0.47, 95% CI: 0.27-0.82). Similarly, patients with PS ≥1 had significantly worse oncologic outcomes than those with PS = 0.In the NRCTs, poor PS was correlated with worse oncologic outcomes in aUC patients treated with ICIs. In the RCTs, ICIs performed better than chemotherapy across all PS categories. These findings should be interpreted with caution due to the high heterogeneity across the studies and patient populations. More RCTs including poor PS are needed to assess the impact of PS on ICI therapy outcomes.Immune therapy for patients with urothelial carcinoma should not be restricted on the grounds of performance status. However, patients with poor performance status should be considered for other factors such as life expectancy and comorbidities.Copyright © 2023. Published by Elsevier B.V.