ECOG表现状态（PS）是许多实体肿瘤中一个重要的预后因素。我们进行了一项荟萃分析，评估ECOG PS在仅接受免疫治疗或免疫治疗联合其他抗癌治疗的ECOG PS 0或ECOG PS 1患者中对生存的作用。根据《系统评价和荟萃分析的首选报告项目》，检索了所有比较实体肿瘤患者中免疫治疗或免疫基于联合治疗的II期和III期随机临床试验。感兴趣的结果是总生存期（OS）和无进展生存期（PFS）。我们还进行了亚组分析，重点关注治疗类型（ICI单一治疗或联合治疗），原发肿瘤类型，治疗设置（首线治疗，随后线治疗）。总体而言，分析包括60项研究，共涉及35,020名患者。汇总结果显示，无论是ECOG PS 0还是ECOG PS 1人群，免疫治疗无论是单独还是联合都能降低死亡或进展的风险。在所有亚组中，生存效益都是一致的。无论是免疫检查点抑制剂单一治疗还是免疫基于联合治疗都与改善ECOG PS 0或1患者的生存相关。临床试验应包括更多脆弱患者以评估免疫治疗在这些患者中的价值。© 2023. 作者，独家授权给Springer Nature Switzerland AG。

ECOG performance status (PS) is a pivotal prognostic factor in a wide number of solid tumors. We performed a meta-analysis to assess the role of ECOG PS in terms of survival in patients with ECOG PS 0 or ECOG PS 1 treated with immunotherapy alone or combined with other anticancer treatments. Following the Preferred Reporting Items for Systematic Reviews and Meta-analyses, all phase II and III randomized clinical trials that compared immunotherapy or immune-based combinations in patients with solid tumors were retrieved. The outcomes of interest were overall survival (OS) and progression-free survival (PFS). We also performed subgroup analyses focused on type of therapy (ICI monotherapy or combinations), primary tumor type, setting (first line of treatment, subsequent lines). Overall, 60 studies were included in the analysis for a total of 35.020 patients. The pooled results showed that immunotherapy, either alone or in combination, reduces the risk of death or progression in both ECOG PS 0 and 1 populations. The survival benefit was consistent in all subgroups. Immune checkpoint inhibitors monotherapy or immune-based combinations are associated with improved survival irrespective of ECOG PS 0 or 1. Clinical trials should include more frail patients to assess the value of immunotherapy in these patients.© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.