在KEYNOTE-564中，辅助使用PD-1抗体的pembrolizumab显著提高了具有高复发风险的局限性透明细胞肾癌（ccRCC）患者的无病生存期（DFS）。2021年，欧洲泌尿外科协会RCC指南小组基于该试验的定义，弱推荐辅助使用pembrolizumab作为高危ccRCC的治疗方案，直到最终总生存数据和其他试验结果出现。与此同时，辅助使用atezolizumab（PD-L1抑制剂；IMmotion010），辅助使用nivolumab加ipilimumab（CheckMate 914）或围手术期nivolumab（PROSPER）均未达到主要DFS终点。由于异质性，不建议进行荟萃分析。Pembrolizumab仍然是目前在这种情况下唯一推荐的免疫检查点抑制剂。总生存数据尚不成熟，并缺乏预测预后的生物标志物。存在不确定性和过度治疗。治疗决策应谨慎，并要求每个患者的参与。 患者简介：针对肾癌手术后免疫治疗减少复发风险的三项新试验结果显示，这些治疗方法未能改善预期效果。这些结果与早期研究相反，显示出抗体pembrolizumab可以延长肾癌复发前的时间，尽管目前尚不清楚总体生存时间是否更长。因此，我们谨慎地推荐在高风险肾癌手术后使用pembrolizumab作为附加治疗，但应仔细考虑患者偏好并讨论过度治疗的风险。版权所有©2022欧洲泌尿外科协会。由Elsevier B.V.出版。保留所有权利。

In KEYNOTE-564, adjuvant pembrolizumab, a PD-1 antibody, significantly improved disease-free survival (DFS) in localised clear-cell renal cell carcinoma (ccRCC) with a high risk of relapse. In 2021, the European Association of Urology RCC Guidelines Panel issued a weak recommendation for adjuvant pembrolizumab for high-risk ccRCC as defined by the trial until final overall survival data and results from other trials were available. Meanwhile, the primary DFS endpoints were not met for adjuvant atezolizumab (PD-L1 inhibitor; IMmotion010), adjuvant nivolumab plus ipilimumab (CheckMate 914), or perioperative nivolumab (PROSPER). Owing to heterogeneity, a meta-analysis is not recommended. Pembrolizumab remains the only immune checkpoint inhibitor currently recommended in this setting. Overall survival data are immature and biomarkers to predict outcome are lacking. Uncertainty exists and overtreatment is occurring. Treatment decisions should be made with caution and with the involvement of each patient. PATIENT SUMMARY: New results from three trials of immunotherapy after surgery for kidney cancer to reduce the risk of recurrence showed no improvement with these treatments. These results are in contrast to an earlier study that showed that the antibody pembrolizumab did extend the time before kidney cancer recurrence, even though it is not yet clear if overall survival is longer. Thus, we cautiously recommend pembrolizumab as additional treatment in high-risk kidney cancer after surgery, but patient preference should be carefully considered and the risk of overtreatment should be discussed.Copyright © 2022 European Association of Urology. Published by Elsevier B.V. All rights reserved.