nivolumab加卡博替尼与pembrolizumab加阿昔替尼作为晚期肾细胞癌（aRCC）的一线治疗，其相对疗效和健康相关生命质量（HRQoL）结果尚未在头对头试验中进行评估。为评估nivolumab加卡博替尼与pembrolizumab加阿昔替尼的疗效和HRQoL结果。使用CheckMate 9ER试验中的nivolumab加卡博替尼的患者级数据和KEYNOTE-426试验中发表的pembrolizumab加阿昔替尼的数据。重新权衡CheckMate 9ER数据，以匹配KEYNOTE-426中报告的重要基线特征。nivolumab（每2周240毫克）加卡博替尼（每日40毫克）和pembrolizumab（每3周200毫克）加阿昔替尼（每日两次5毫克，最初）。 使用基于权重的Cox比例风险模型，以sunitinib作为公共锚点，评估了无进展生存期（PFS），反应持续时间，总生存期（OS）和HRQoL恶化的危险比率（HR），并以sunitinib为基准评估客观反应率（ORR）和基线相对于sunitinib的HRQoL评分变化的差异。平衡试验之间的患者特征后，与pembrolizumab加阿昔替尼相比，nivolumab加卡博替尼与显著改善PFS（HR [95％置信区间{CI}] 0.70 [0.53-0.93]；p = 0.01）和显著降低HRQoL中肾癌治疗相关症状的确认恶化风险（HR [95％CI] 0.48 [0.34-0.69]）相关。OS在两种治疗间相似（HR [95％CI] 0.99 [0.67-1.44]；p = 0.94）。相对于pembrolizumab加阿昔替尼，nivolumab加卡博替尼与数值上较大的ORR（差异-差异[95％CI] 8.4％[-1.7至18.4];p = 0.10）和更长的反应持续时间（HR [95%CI] 0.79 [0.47-1.31];p = 0.36）相关。还需要使用更长的随访时间的比较研究。 nivolumab加卡博替尼与pembrolizumab加阿昔替尼相比作为aRCC的一线治疗，nivolumab加卡博替尼显著改善了PFS和HRQoL。本研究旨在间接比较两种免疫治疗联合方案-nivolumab加卡博替尼与pembrolizumab加阿昔替尼-对于未接受任何治疗的晚期肾细胞癌患者。接受nivolumab加卡博替尼治疗的患者与接受pembrolizumab加阿昔替尼治疗的患者相比，在疾病恶化的时间长度和感知的身体和心理健康方面有显著改善。从开始任何一种治疗措施的时间长度相似的患者存活。这项分析进一步增加了我们对这两种治疗方案的相对优势的了解，并有助于医生和患者的治疗决策。版权所有©2023年。由Elsevier BV发表。

The comparative efficacy and health-related quality of life (HRQoL) outcomes of nivolumab plus cabozantinib versus pembrolizumab plus axitinib as first-line treatments for advanced renal cell carcinoma (aRCC) have not been assessed in head-to-head trials.To assess the efficacy and HRQoL outcomes of nivolumab plus cabozantinib versus pembrolizumab plus axitinib.Patient-level data for nivolumab plus cabozantinib from the CheckMate 9ER trial and published data for pembrolizumab plus axitinib from the KEYNOTE-426 trial were used. CheckMate 9ER data were reweighted to match the key baseline characteristics as reported in KEYNOTE-426.Nivolumab (240 mg every 2 wk) plus cabozantinib (40 mg once daily) and pembrolizumab (200 mg every 3 wk) plus axitinib (5 mg twice daily, initially).Hazard ratios (HRs) for progression-free survival (PFS), duration of response, overall survival (OS), and deterioration in HRQoL were assessed using weighted Cox proportional-hazard models, with sunitinib as a common anchor. Objective response rates (ORRs) and changes in HRQoL scores from baseline were assessed as difference-in-differences for the two treatments relative to sunitinib.After balancing patient characteristics between the trials, nivolumab plus cabozantinib was associated with significantly improved PFS (HR [95% confidence interval {CI}] 0.70 [0.53-0.93]; p = 0.01) and a significantly decreased risk of confirmed deterioration in HRQoL (Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms: HR [95% CI] 0.48 [0.34-0.69]) versus pembrolizumab plus axitinib. OS was similar between treatments (HR [95% CI] 0.99 [0.67-1.44]; p = 0.94). Nivolumab plus cabozantinib was associated with numerically greater ORRs (difference-in-difference [95% CI] 8.4% [-1.7 to 18.4]; p = 0.10) and longer duration of response (HR [95% CI] 0.79 [0.47-1.31]; p = 0.36) than pembrolizumab plus axitinib. Comparative studies using data with a longer duration of follow-up are warranted.Nivolumab plus cabozantinib significantly improved PFS and HRQoL compared with pembrolizumab plus axitinib as first-line treatment for aRCC.This study was conducted to indirectly compare the results of two immunotherapy-based combinations-nivolumab plus cabozantinib versus pembrolizumab plus axitinib-for patients who have not received any treatment for advanced renal cell carcinoma. Patients who received nivolumab plus cabozantinib had a significant improvement in the length of time without worsening of their disease and in their perceived physical and mental health compared with pembrolizumab plus axitinib; patients remained alive for a similar length of time from the start of either treatment. This analysis further adds to our current knowledge of the relative benefits of these two treatment regimens and will help with physician and patient treatment decisions.Copyright © 2023. Published by Elsevier B.V.