为了综合现有的关于肾细胞癌（RCC）患者行辅助免疫检查点抑制剂（ICIs）治疗疾病无复发生存（DFS）益处的数据，并评估ICIs在这种情况下的整体安全性。我们利用PubMed、Embase和相关会议记录来确定III期随机对照试验，比较行辅助ICIs与安慰剂/观察治疗。感兴趣的主要结果是DFS。亚组分析的变量是编程死亡配体1（PD-L1）表达，肉瘤特征，肾切除类型和疾病风险类别。次要结果包括≥3级不良事件（AEs），免疫相关AEs和由于AEs而中断治疗。由于研究之间的异质性，所有结果都使用随机效应模型进行分析。在四项包括的研究中，有一项展示了显著的DFS益处。由于纳入标准和干预的差异，存在相当大的临床和统计学异质性（I2 = 64%）。虽然跨越四项研究的汇总结果没有总体上证明DFS有显著的益处（危险比[HR] 0.85，95%置信区间[CI] 0.69-1.04），但在PD-L1表达阳性（HR 0.72，95% CI 0.55-0.94）和肉瘤特征（HR 0.59，95% CI 0.38-0.91）的患者中有显著益处。迄今为止，关于ICIs作为辅助治疗的证据基础是混合的，结论受到多项研究之间巨大的异质性的限制。然而，汇总分析表明，PD-L1阳性或肉瘤特征的患者最有可能获益于辅助免疫治疗。 © 2023 BJU国际。

To synthesise available data regarding the disease-free survival (DFS) benefit of adjuvant immune checkpoint inhibitors (ICIs) for patients with renal cell carcinoma (RCC) and evaluate the overall safety profile of ICIs in this setting.We utilised PubMed, Embase, and relevant conference proceedings to identify phase III randomised controlled trials comparing adjuvant ICIs vs placebo/observation for RCC. The primary outcome of interest was DFS. Variables for subgroup analyses were programmed death-ligand 1 (PD-L1) expression, sarcomatoid features, nephrectomy type, and disease-risk category. Secondary outcomes included Grade ≥3 adverse events (AEs), immune-related AEs, and treatment discontinuation due to AEs. All outcomes were analysed using random-effects models owing to inter-study heterogeneity.Among the four included studies, one demonstrated a significant DFS benefit. There was considerable clinical and statistical heterogeneity (I2  = 64%) due to differences in inclusion criteria and interventions. While pooled results across the four studies did not demonstrate a significant benefit in DFS overall (hazard ratio [HR] 0.85, 95% confidence interval [CI] 0.69-1.04) there was significant benefit among patients with positive PD-L1 expression (HR 0.72, 95% CI 0.55-0.94) and sarcomatoid features (HR 0.59, 95% CI 0.38-0.91).The evidence base to date regarding ICIs as adjuvant therapy in RCC is mixed - conclusions are limited by considerable heterogeneity between studies. However, pooled analyses suggest that patients with positive PD-L1 expression or sarcomatoid features are most likely to benefit from adjuvant immunotherapy.© 2023 BJU International.