ECOG 体能状态 (PS) 是许多实体瘤的关键预后因素。我们进行了一项荟萃分析，以评估 ECOG PS 在单独接受免疫疗法或与其他抗癌治疗联合治疗的 ECOG PS 0 或 ECOG PS 1 患者的生存方面的作用。按照系统评价和荟萃分析的首选报告项目，检索了所有在实体瘤患者中比较免疫疗法或基于免疫的组合的 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 单药治疗或联合治疗）、原发肿瘤类型、背景（一线治疗、后续治疗）。总体而言，分析中纳入了 60 项研究，涉及总共 35.020 名患者。汇总结果表明，单独或联合免疫治疗可降低 ECOG PS 0 和 1 人群的死亡或进展风险。所有亚组的生存获益均一致。无论 ECOG PS 0 或 1，免疫检查点抑制剂单一疗法或基于免疫的联合疗法都与改善生存相关。临床试验应包括更多虚弱患者，以评估免疫疗法对这些患者的价值。

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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.