免疫肿瘤学（IO）疗法在过去几年中通过强大的临床试验数据改变了转移性肾细胞癌（mRCC）的一线（1L）治疗范式。我们在美国社区肿瘤医疗情况中研究了接受帕博利珠单抗+阿昔替尼（帕博-阿希）或伊匹利姆单抗+尼伐替尼（伊匹-尼伏）治疗的晴亮细胞转移性肾癌（mccRCC）患者的临床结局。本回顾性队列研究使用美国肿瘤网络中的电子健康记录和图表审核数据，从2019年1月1日至2020年12月31日并随访至2021年3月31日，以识别开始接受1L帕博-阿希或伊匹-尼伏治疗的成年mccRCC患者。以描述性方式评估了医生记录的反应（实际世界总体反应率[rwORR]和实际世界疾病控制率[rwDCR]）。使用Kaplan-Meier分析估计了实际世界无进展生存期（rwPFS）、实际世界下一次治疗时间（rwTTNT）和治疗时间（rwToT）。使用多变量Cox比例风险模型研究了1L全身治疗与时间至事件结果的关联。研究包括331名mccRCC患者（帕博-阿希：44%，伊匹-尼伏：56%）。中位年龄为65岁，75.5%为男性，82.5%的人具有中等/差（I/P）IMDC风险分数。帕博-阿希的rwORR和rwDCR分别为71.0%和80.0%，伊匹-尼伏的rwORR和rwDCR分别为45.2%和58.6%。在多变量分析中，与伊匹-尼伏相比，帕博-阿希与较长的rwToT（aHR，0.53 [95% CI，0.40, 0.71]）、rwTTNT（aHR，0.60 [95% CI，0.42, 0.87]）和rwPFS（aHR，0.70 [95% CI，0.49, 0.99]）相关（P < 0.01）。我们的研究揭示了在实际美国社区环境中新一代mccRCC治疗的耐受性和有效性。我们的实际世界结果与临床试验数据相当，这对mccRCC患者是鼓舞人心的。版权所有 © 2023 Merck Sharp & Dohme有限责任公司, 美国默克公司子公司, 纽泽西州拉厄韦, 美国, 作者. Elsevier Inc.保留所有权利。

Immune-Oncology (IO) therapies have changed first-line (1L) treatment paradigm for metastatic renal cell carcinoma (mRCC) in last few years with robust clinical trial data. We examined clinical outcomes among clear cell mRCC (mccRCC) patients who received pembrolizumab + axitinib (pembro-axi) or ipilimumab + nivolumab (ipi-nivo) in the US community oncology setting.This retrospective cohort study utilized data from electronic health records and chart review within The US Oncology Network to identify adult patients with mccRCC initiating 1L pembro-axi or ipi-nivo from January 01, 2019 to December 31, 2020 and followed through March 31, 2021. Physician-recorded response (real-world overall response rate [rwORR] and real-world disease control rate [rwDCR]) was assessed descriptively. Real-world progression-free survival (rwPFS), real-world time to next treatment (rwTTNT) and time on treatment (rwToT) were estimated using Kaplan-Meier analysis. Association of 1L systemic treatment with time-to-event outcomes was examined using multivariable cox proportional hazards models.Study included 331 mccRCC patients (pembro-axi:44%, ipi-nivo:56%). Median age was 65 years, 75.5% were male, and 82.5% had intermediate/poor (I/P) IMDC risk score. RwORR and rwDCR were 71.0% and 80.0% for pembro-axi and 45.2% and 58.6% for ipi-nivo. In multivariable analysis, pembro-axi was associated with longer rwToT (aHR, 0.53 [95% CI, 0.40, 0.71]), rwTTNT (aHR, 0.60 [95% CI, 0.42, 0.87]), and rwPFS (aHR, 0.70 [95% CI, 0.49, 0.99]) compared to ipi-nivo (P < 0.01).Our study provides insight into newer mccRCC treatment tolerability and effectiveness in the real-world US community setting. Our real-world results were comparable to data from clinical trials, which is encouraging for mccRCC patients.Copyright © 2023 Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, The Author(s). Published by Elsevier Inc. All rights reserved.