联合使用免疫肿瘤学（IO）药剂伊皮利莫布和尼伏莫布（IPI-NIVO）以及靶向血管内皮生长因子治疗（VEGF-TT）与IO结合（IO-VEGF）是当前治疗转移性肾细胞癌（mRCC）的标准一线治疗。基于国际mRCC数据库联盟（IMDC）标准，建立IO联合治疗的实际临床标准。根据IMDC数据库，鉴定了2002-2021年接受一线IPI-NIVO、IO-VEGF或VEGF-TT治疗的mRCC患者，并按IMDC风险分组进行分层。利用Kaplan-Meier方法计算总生存率（OS）、下一次治疗的时间（TTNT）和治疗持续时间（TD），并通过log-rank检验在每个治疗组内比较IMDC风险组之间的差异。总体应答率（ORR）是根据医师评估的最佳总体反应计算的。主要结果是18个月的OS。总共有728名患者接受了IPI-NIVO、282名接受了IO-VEGF和7,163名接受了VEGF-TT。对于仍然存活的患者，IPI-NIVO的中位随访时间是14.3个月，IO-VEGF是14.9个月，VEGF-TT是34.4个月。IPI-NIVO接受者的良好、中等和差劣风险的OS分别为90%、78%和50%；IO-VEGF为93%、83%和74%；VEGF-TT为84%、64%和28%。接受IPI-NIVO者的良好、中等和差劣风险组的ORR分别为41.3%、40.6%和33.0%；IO-VEGF为60.3%、56.8%和40.9%；VEGF-TT为39.3%、33.5%和20.9%。IMDC模型将每个治疗组的患者分层为统计上不同的风险组，对于OS、TTNT和TD这三个终点。这项研究的局限性是回顾性设计和短期的随访。这项研究表明，IMDC模型继续区分接受现代一线IO联合治疗的mRCC患者，并提供了真实世界的存活基准。国际转移性肾细胞癌数据库联盟模型继续对接受现代组合治疗的转移性肾细胞癌患者进行风险分层。版权所有 © 2023年作者。由Elsevier B.V.出版。保留所有权利。

The combination of immuno-oncology (IO) agents ipilimumab and nivolumab (IPI-NIVO) and vascular endothelial growth factor targeted therapies (VEGF-TT) combined with IO (IO-VEGF) are current standard of care first-line treatments for metastatic renal cell carcinoma (mRCC).To establish real-world clinical benchmarks for IO combination therapies based on the International mRCC Database Consortium (IMDC) criteria.Patients with mRCC who received first-line IPI-NIVO, IO-VEGF, or VEGF-TT from 2002 to 2021 were identified using the IMDC database and stratified according to IMDC risk groups.Overall survival (OS), time to next treatment (TTNT), and treatment duration (TD) were calculated using the Kaplan-Meier method and compared between IMDC risk groups within each treatment cohort by the log-rank test. The overall response rate (ORR) was calculated by physician assessment of the best overall response. The primary outcome was OS at 18 mo.In total, 728 patients received IPI-NIVO, 282 IO-VEGF, and 7163 VEGF-TT. The median follow-up times for patients remaining alive were 14.3 mo for IPI-NIVO, 14.9 mo IO-VEGF, and 34.4 mo for VEGF-TT. OS at 18 mo for favorable, intermediate, and poor risk was, respectively, 90%, 78%, and 50% for those receiving IPI-NIVO; 93%, 83%, and 74% for IO-VEGF; and 84%, 64%, and 28% for VEGF-TT. ORRs in favorable-, intermediate-, and poor-risk groups were 41.3%, 40.6%, and 33.0% for those receiving IPI-NIVO; 60.3%, 56.8%, and 40.9% for IO-VEGF; and 39.3%, 33.5%, and 20.9% for VEGF-TT, respectively. The IMDC model stratified patients into statistically distinct risk groups for the three endpoints of OS, TTNT, and TD within each treatment cohort. Limitations of this study were the retrospective design and short follow-up.This study demonstrated that the IMDC model continues to risk stratify patients with mRCC treated with contemporary first-line IO combination therapies and provided real-world survival benchmarks.The International Metastatic Renal Cell Carcinoma Database Consortium model continues to stratify patients with metastatic renal cell carcinoma receiving modern combination treatments in the real-world setting.Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.