Pembrolizumab-axitinib versus nivolumab-cabozantinib as first-line therapy in patients with metastatic renal cell carcinoma: a retrospective real-world comparison (ARON-1).

Matteo Santoni, Giandomenico Roviello, Enrique Grande, Ugo De Giorgi, Ondrej Fiala, Emmanuel Seront, Javier Molina-Cerrillo, Renate Pichler, Zin W Myint, Jakub Kucharz, Ravindran Kanesvaran, Thomas Büttner, Martin Pichler, Umberto Basso, Jindrich Kopecky, Maria T Bourlon, Linda Cerbone, Tomas Buchler, Alvaro Pinto, Alfonso Gómez de Liaño, Caterina Gianni, Anca Zgura, Pasquale Rescigno, Jawaher Ansari, Orazio Caffo, Zsófia Küronya, Maria Giuseppa Vitale, Dipen Bhuva, Martina Catalano, Nuno Vau, Ray Manneh Kopp, Sebastiano Buti, Aristotelis Bamias, Camillo Porta, Kaisa Sunela, Francesco Massari
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Abstract

Background: The optimal first-line therapy for metastatic renal cell carcinoma (mRCC) remains uncertain, despite recent advancements in immune-based combinations. This retrospective study compares the effectiveness of pembrolizumab plus axitinib (PA) and nivolumab plus cabozantinib (NC) as first-line treatments for mRCC in a real-world setting.

Methods: Patient data were collected from 55 centers across 16 countries, encompassing individuals diagnosed with mRCC receiving first-line treatment with PA or NC between January 2016 and October 2023. Clinical and tumor features and treatment responses were recorded. The primary endpoints were overall response rate (ORR), overall survival (OS), progression-free survival (PFS), and time to second progression. Statistical analyses included Kaplan-Meier survival estimates, Cox proportional hazard models, and chi-square tests.

Results: A total of 760 patients with a median age of 64 years (range, 29-88) were included. Of them, 607 received PA, and only 153 NC. In the overall study population, ORR was 59% for and 49% for PA. Median OS was 55.7 months and not reached (NR) for PA and NC, respectively (P = .51), while median PFS was longer with NC (27.6 months) than for PA (16.2 months, P = .003). Subgroup analysis suggested a PFS benefits for NC in male, younger patients, intermediate risk group, clear cell histology, and lung involvement, as well as ORR favored NC in good risk patients. Multivariate analysis identified first-line therapy as a significant factor associated with PFS.

Conclusions: In this certainly biased retrospective comparison, NC demonstrated superior ORR and longer PFS compared to PA in mRCC. These findings underscore the importance of considering individual patient characteristics and risk profiles when selecting first-line therapy for mRCC.

Pembrolizumab-axitinib与nivolumab-cabozantinib作为转移性肾细胞癌患者的一线治疗:回顾性现实世界比较(ARON-1)。
背景:尽管最近基于免疫的联合治疗取得了进展,但转移性肾细胞癌(mRCC)的最佳一线治疗仍然不确定。这项回顾性研究比较了派姆单抗加阿西替尼(PA)和纳武单抗加卡博赞替尼(NC)作为mRCC一线治疗的有效性。方法:从16个国家的55个中心收集患者数据,包括2016年1月至2023年10月期间接受PA或NC一线治疗的mRCC患者。记录临床、肿瘤特征及治疗效果。主要终点是总缓解率(ORR)、总生存期(OS)、无进展生存期(PFS)和第二次进展时间。统计分析包括Kaplan-Meier生存估计、Cox比例风险模型和卡方检验。结果:共纳入760例患者,中位年龄64岁(范围29-88岁)。其中607人接受了PA,只有153人接受了NC。在整个研究人群中,PA的ORR为59%,而PA为49%。PA和NC的中位生存期分别为55.7个月和未达到(NR) (P = 0.51),而NC的中位生存期(27.6个月)比PA的中位生存期(16.2个月,P = 0.003)更长。亚组分析表明,在男性、年轻患者、中等风险组、透明细胞组织学和肺部受损伤中,NC的PFS获益,而在高风险患者中,ORR则有利于NC。多变量分析确定一线治疗是与PFS相关的重要因素。结论:在这个肯定有偏见的回顾性比较中,与PA相比,NC在mRCC中表现出更高的ORR和更长的PFS。这些发现强调了在选择mRCC一线治疗时考虑个体患者特征和风险概况的重要性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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