文章：

伊匹单抗与纳武单抗作为转移性肾细胞癌一线治疗在老年及体能状态较差亚群患者中的真实世界疗效与毒性评估

Real-World Efficacy and Toxicity of Ipilimumab and Nivolumab as First-Line Treatment of Metastatic Renal Cell Carcinoma (mRCC) in a Subpopulation of Elderly and Poor Performance Status Patients

原文发布日期：4 February 2025

DOI: 10.3390/cancers17030522

类型: Article

开放获取: 是

英文摘要：

Background: Ipilimumab and nivolumab (ipi/nivo) improved overall survival (OS) compared to sunitinib in the pivotal Checkmate 214 trial of metastatic renal cell carcinoma (mRCC) with International Metastatic RCC Database Consortium (IMDC) intermediate/poor risk disease. We evaluated the efficacy and toxicity of ipi/nivo in older and frailer populations in a real-world mRCC cohort. Methods: Analysis was conducted on a real-world cohort with mRCC (N = 551) treated with first-line ipi/nivo from the Canadian Kidney Cancer information system (CKCis) database from January 2014 to December 2021. A comparison was made between outcomes and toxicity in patients 1. <70 versus (vs.) ≥70 yo, 2. <75 vs. ≥75 yo, and 3. KPS ≥70 vs. <70 yo. OS, progression-free survival (PFS), and time to treatment failure (TTF) were calculated by Kaplan–Meier analysis. Log-rank tests were used for comparison between groups. Results: Ipi/nivo treatment had no impact on survival outcomes or toxicity for patients >70 yo and >75 yo when controlled for IMDC. However, when comparing patients with KPS > 70 vs. KPS < 70, patients with a poor performance status had decreased median OS at 54.5 m vs. 10.8 m (p-value < 0.0001) and PFS at 11.6 vs. 3.1 m (p-value < 0.0001). Conclusions: The use of ipi/nivo in mRCC demonstrated similar survival outcomes and toxicity in an older patient population. In patients with a poor performance status, it was associated with inferior OS and PFS. We believe that ipi/nivo is a reasonable treatment option for these patient populations, particularly in older patients.

摘要翻译： 

背景：在针对国际转移性肾细胞癌数据库联盟（IMDC）中危/高危分组的转移性肾细胞癌（mRCC）患者开展的关键性Checkmate 214试验中，伊匹单抗联合纳武利尤单抗（ipi/nivo）相较于舒尼替尼显著改善了总生存期（OS）。本研究基于真实世界mRCC队列，评估了伊匹单抗联合纳武利尤单抗在老年及体能状态较差患者中的疗效与毒性。方法：从加拿大肾癌信息系统（CKCis）数据库中提取2014年1月至2021年12月期间接受一线伊匹单抗联合纳武利尤单抗治疗的mRCC患者真实世界队列（N=551）进行分析。比较以下分组间的疗效结局与毒性反应：1. <70岁 vs. ≥70岁；2. <75岁 vs. ≥75岁；3. 卡氏功能状态评分（KPS）≥70分 vs. <70分。采用Kaplan-Meier法计算总生存期、无进展生存期（PFS）和治疗失败时间（TTF），组间比较使用对数秩检验。结果：在控制IMDC风险分层后，伊匹单抗联合纳武利尤单抗治疗对≥70岁及≥75岁患者的生存结局与毒性反应均无显著影响。然而，在比较KPS>70分与KPS<70分患者时，体能状态较差患者的中位总生存期显著缩短（54.5个月 vs. 10.8个月，p值<0.0001），无进展生存期亦显著降低（11.6个月 vs. 3.1个月，p值<0.0001）。结论：在老年mRCC患者中，伊匹单抗联合纳武利尤单抗治疗显示出与年轻患者相似的生存结局与毒性特征。但对于体能状态较差的患者，该治疗方案与较差的总生存期和无进展生存期相关。我们认为伊匹单抗联合纳武利尤单抗仍是这些患者群体（尤其是老年患者）的合理治疗选择。

原文链接：

Real-World Efficacy and Toxicity of Ipilimumab and Nivolumab as First-Line Treatment of Metastatic Renal Cell Carcinoma (mRCC) in a Subpopulation of Elderly and Poor Performance Status Patients