Department of Urology, Akita University Graduate School of Medicine, 1-1-1 Hondo, Akita, 010-8543, Japan.
Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Int J Clin Oncol. 2023 Nov;28(11):1530-1537. doi: 10.1007/s10147-023-02394-y. Epub 2023 Aug 8.
Although nivolumab plus ipilimumab is the standard treatment for metastatic renal cell carcinoma (RCC), its efficacy and safety in older patients remain unclear. Therefore, this study aimed to assess the clinical outcomes of nivolumab plus ipilimumab for metastatic RCC in patients aged ≥ 75 years.
We enrolled 120 patients with metastatic RCC treated with nivolumab plus ipilimumab from August 2015 to January 2023. Objective response rates (ORRs) were compared between patients aged < 75 and ≥ 75 years. Progression-free survival (PFS), overall survival (OS), and adverse events were compared between the groups. Adverse events were evaluated according to the Response Evaluation Criteria in Solid Tumors 1.1.
Among the patients, 57 and 63 were classified as intermediate and poor risk, respectively, and one could not be classified. The median follow-up duration after the initiation of treatment was 16 months. The patient characteristics between the groups, except for age, were not significantly different. Intergroup differences in ORR (42% vs. 40%; p = 0.818), PFS (HR: 0.820, 95% CI 0.455-1.479; p = 0.510), and median OS (HR: 1.492, 95% CI 0.737-3.020; p = 0.267) were not significant. The incidence of adverse events (50% vs. 67%; p = 0.111) and nivolumab plus ipilimumab discontinuation due to adverse events was not significantly different between the groups (14% vs. 13%; p = 0.877).
The effectiveness of nivolumab plus ipilimumab was comparable between patients with metastatic RCC aged < 75 and those ≥ 75 years with respect to their ORRs, PFS, OS, and adverse event rates.
纳武利尤单抗联合伊匹单抗是转移性肾细胞癌（RCC）的标准治疗方法，但在老年患者中的疗效和安全性仍不清楚。因此，本研究旨在评估纳武利尤单抗联合伊匹单抗治疗年龄≥75 岁转移性 RCC 患者的临床结局。
我们纳入了 2015 年 8 月至 2023 年 1 月期间接受纳武利尤单抗联合伊匹单抗治疗的 120 例转移性 RCC 患者。比较了年龄<75 岁和≥75 岁患者的客观缓解率（ORR）。比较了两组患者的无进展生存期（PFS）、总生存期（OS）和不良事件。根据实体瘤反应评价标准 1.1 评估不良事件。
在患者中，57 例和 63 例患者分别被归类为中危和高危，1 例无法分类。治疗开始后中位随访时间为 16 个月。两组患者的特征除年龄外无显著差异。两组间 ORR（42% vs. 40%；p=0.818）、PFS（HR：0.820，95%CI 0.455-1.479；p=0.510）和中位 OS（HR：1.492，95%CI 0.737-3.020；p=0.267）差异无统计学意义。不良事件发生率（50% vs. 67%；p=0.111）和因不良事件而停止纳武利尤单抗联合伊匹单抗治疗的比例（14% vs. 13%；p=0.877）在两组间无显著差异。
纳武利尤单抗联合伊匹单抗治疗年龄<75 岁和≥75 岁的转移性 RCC 患者的 ORR、PFS、OS 和不良事件发生率相当。
