KEYNOTE-564 随机对照试验显示，与安慰剂相比，辅助派姆单抗 (aPZB) 对于复发风险高的透明细胞肾细胞癌 (ccRCC) 患者具有无病生存获益。尽管欧洲泌尿外科协会指南推荐了 aPZB，但 aPZB 的最终价值最近受到质疑。可以说，从 aPZB 中获益最多的患者是那些在术后合理时间内 RCC 复发的可能性超过因其他原因死亡的可能性的患者。为了评估这一假设对 aPZB“资格”的潜在影响，我们查询了前瞻性收集的多机构数据库，其中包含 2015 年至 2021 年间接受非转移性肾肿块 (cT1-4 N0-1 M0) 手术的连续患者，以确定 ccRCC 病例满足 KEYNOTE-564 标准。我们使用 Stewart-Merrill 等人提出的风险适应模型对患者进行分层（当其他原因死亡 [OCM] 的估计风险超过 RCC 复发的估计风险时，有必要停止随访）。然后我们探讨了理论上可以在 2 年、5 年、10 年或 20 年停止随访的患者比例，对于这些人来说，aPZB 的“资格”可能更具争议性。总体而言，纳入了 1745 名 ccRCC 患者，其中 419 名 (24%) 符合 KEYNOTE-564 标准。在“推荐”随访≤2.0、≤5、≤时，由于 OCM 复发概率高于 RCC 复发概率而“不符合”aPZB 的患者比例分别为 81%、66%、43% 和 29%分别为10岁和≤20岁。据我们所知，这是第一项为支持非转移性 ccRCC 患者接受 aPZB 资格的共同决策提供见解的研究，重点关注肿瘤驱动的预后评分之外的患者相关因素。患者摘要：非转移性肾癌手术后给予一种名为派姆单抗（pembrolizumab）的免疫治疗药物可能会使一些疾病复发风险较高的患者受益，但它可能会产生免疫相关的副作用。我们发现，比较其他原因导致的死亡风险和癌症复发的风险有助于减少可能无法从该药物中受益的患者的过度治疗。版权所有 © 2023 欧洲泌尿外科协会。由 Elsevier B.V. 出版。保留所有权利。

The KEYNOTE-564 randomised controlled trial showed a disease-free survival benefit of adjuvant pembrolizumab (aPZB) in comparison to placebo for patients with clear cell renal cell carcinoma (ccRCC) at high risk of recurrence. Despite its recommendation by the European Association of Urology guidelines, the ultimate value of aPZB has recently been questioned. Arguably, patients who might benefit the most from aPZB are those whose probability of RCC recurrence outweighs their probability of dying from other causes over a reasonable timeframe after surgery. To assess the potential impact of this hypothesis on "eligibility" for aPZB, we queried our prospectively collected multi-institutional database for consecutive patients undergoing surgery for nonmetastatic renal masses (cT1-4 N0-1 M0) between 2015 and 2021 to identify ccRCC cases meeting the KEYNOTE-564 criteria. We stratified the patients using the risk-adapted model proposed by Stewart-Merrill et al (whereby stopping follow-up is warranted when the estimated risk of other-cause mortality [OCM] outweighs the estimated risk of RCC recurrence). Then we explored the proportion of patients whose follow-up could theoretically be stopped at 2, 5, 10, or 20 yr, for whom "eligibility" for aPZB might be more controversial. Overall, 1745 patients with ccRCC were included, of whom 419 (24%) met the KEYNOTE-564 criteria. The proportion of patients "not eligible" for aPZB because of higher probability of OCM than of RCC recurrence would have been 81%, 66%, 43%, and 29% at "recommended" follow-up of ≤2.0, ≤5, ≤10, and ≤20 yr, respectively. To the best of our knowledge, this is the first study providing insights to support shared decision-making regarding eligibility for aPZB for patients with nonmetastatic ccRCC with a focus on patient-related factors beyond tumour-driven prognostic scores. PATIENT SUMMARY: An immunotherapy drug call pembrolizumab given after surgery for nonmetastatic kidney cancer may benefit some patients who have a high risk of disease recurrence, but it can have immune-related side effects. We found that comparing the risk of death from other causes and the risk of cancer recurrence could help in reducing overtreatment of patients who might not benefit from this drug.Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.