辅助派姆单抗显着改善肾细胞癌 (RCC) 的总生存期 (OS)，但序贯治疗的真实数据很少。我们试图评估基于辅助免疫肿瘤学 (IO) 方案的一线 (1L) 全身治疗的临床结果。我们对 29 个国际机构进行了一项回顾性研究，纳入了辅助 IO 后复发性 RCC 患者。主要终点是使用 Kaplan-Meier 方法估计的 1L 全身治疗的无进展生存期 (PFS)。按 1L 全身治疗类型、复发时间和国际转移性肾细胞癌数据库联盟 (IMDC) 风险组对临床结果进行预先计划的亚分析。对导致治疗停止、剂量减少或皮质类固醇使用的治疗相关不良事件进行了评估。总共包括 94 名患者。大多数患者接受了辅助治疗：帕博利珠单抗 (n = 37, 39%)、阿替利珠单抗 (n = 28, 30%) 或纳武单抗伊匹单抗 (n = 15, 16%)。该队列包括 49 名 (52%) 名患者，他们在最后一次辅助 IO 剂量后 3 个月内复发，而 45 名 (48%) 名患者在 3 个月后复发。 <3个月时复发的肿瘤（10/49，20%）的骨转移明显高于>3个月时复发的肿瘤（1/45，2.2%；p = 0.008）。大多数患者接受 1L 血管内皮生长因子靶向治疗 (VEGF-TT; n = 37, 39%)、IO VEGF-TT (n = 26, 28%) 或 IO IO (n = 12, 13%)。其余患者接受局部治疗。 1L 全身治疗队列的中位随访时间为 15 个月。 18 个月的 PFS 和 OS 率分别为 45%（95% 置信区间 [CI]：34-60）和 85%（95% CI：75-95）。 32 名患者 (42%) 发生了治疗相关的不良事件，包括皮肤毒性 (n = 7, 9.2%)、疲劳 (n = 6, 7.9%) 和腹泻/结肠炎 (n = 4, 5.3%)。局限性包括从大型学术中心选择患者和较短的随访期。辅助 IO 后复发 RCC 的一部分患者对全身治疗有反应，包括 VEGF-TT 和基于 IO 的治疗方案。值得注意的是，在这种情况下，患有有利风险疾病的患者可能从 VEGF-TT 中获得比 IO 治疗更多的益处。未来的方法需要利用放射照相工具和基于生物标志物的液体活检来检测隐匿性转移性疾病并确定辅助 IO 治疗的候选患者。辅助帕博利珠单抗显着改善肾细胞癌 (RCC) 的总体生存率。关于辅助免疫治疗后肾细胞癌肿瘤复发后的临床结果的数据有限。在这项研究中，我们发现患者对不同治疗方案的后续全身治疗有反应。版权所有 © 2024 欧洲泌尿外科协会。由 Elsevier B.V. 出版。保留所有权利。

Adjuvant pembrolizumab significantly improved overall survival (OS) in renal cell carcinoma (RCC), but real-world data on sequential treatment are scarce. We sought to evaluate the clinical outcomes of first-line (1L) systemic therapy following adjuvant immune oncology (IO)-based regimens.A retrospective study including patients with recurrent RCC following adjuvant IO across 29 international institutions was conducted. The primary endpoint was progression-free survival (PFS) on 1L systemic therapy estimated using the Kaplan-Meier method. Preplanned subanalyses of clinical outcomes by type of 1L systemic therapy, recurrence timing, and International Metastatic RCC Database Consortium (IMDC) risk groups were performed. Treatment-related adverse events leading to treatment discontinuation, dose reduction, or corticosteroid use were assessed.A total of 94 patients were included. Most received adjuvant pembrolizumab (n = 37, 39%), atezolizumab (n = 28, 30%), or nivolumab + ipilimumab (n = 15, 16%). The cohort included 49 (52%) patients who had recurrence within 3 mo of the last adjuvant IO dose, whereas 45 (48%) recurred beyond 3 mo. Bone metastases were significantly higher in tumors recurring at <3 mo (10/49, 20%) than those recurring at >3 mo (1/45, 2.2%; p = 0.008). Most patients received 1L vascular endothelial growth factor-targeted therapy (VEGF-TT; n = 37, 39%), IO + VEGF-TT (n = 26, 28%), or IO + IO (n = 12, 13%). The remaining underwent local therapy. The median follow-up for the 1L systemic therapy cohort was 15 mo. The 18-mo PFS and OS rates were 45% (95% confidence interval [CI]: 34-60) and 85% (95% CI: 75-95), respectively. Treatment-related adverse events occurred in 32 (42%) patients and included skin toxicity (n = 7, 9.2%), fatigue (n = 6, 7.9%), and diarrhea/colitis (n = 4, 5.3%). Limitations included selecting patients from large academic centers and the short follow-up period.A subset of patients with recurrent RCC following adjuvant IO respond to systemic therapies, including VEGF-TT and IO-based regimens. Notably, patients with favorable-risk disease may derive more benefit from VEGF-TT than from IO therapies in this setting. Future approaches utilizing radiographic tools and biomarker-based liquid biopsies are warranted to detect occult metastatic disease and identify candidate patients for adjuvant IO therapy.Adjuvant pembrolizumab significantly improved overall survival in renal cell carcinoma (RCC). There are limited data on clinical outcomes after the recurrence of RCC tumors following adjuvant immunotherapy. In this study, we find that patients respond to subsequent systemic therapies across different treatment options.Copyright © 2024 European Association of Urology. Published by Elsevier B.V. All rights reserved.