Department of Urology, Akita University Graduate School of Medicine, Akita, Japan.
Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Int J Clin Oncol. 2020 Aug;25(8):1543-1550. doi: 10.1007/s10147-020-01693-y. Epub 2020 May 11.
Despite nivolumab being increasingly used for treating metastatic renal cell carcinoma (mRCC), differing findings have been reported about its efficacy and safety in elderly patients. Thus, this study was aimed at evaluating nivolumab's efficacy and safety for treating mRCC in Japanese patients aged ≥ 75 years.
From March 2013 to August 2019, 118 mRCC patients (89 men and 29 women) were treated with nivolumab. The objective response rates (ORRs) were compared between patients aged ≥ 75 and < 75 years. Progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were also compared between the two age-groups.
The median follow-up duration after nivolumab initiation was 10 months. At the time of nivolumab initiation, 22 and 96 patients were aged ≥ 75 and < 75 years, respectively. Intergroup differences in patient characteristics except for age were not significant. Furthermore, intergroup differences in ORR (14 vs 23%; P = 0.367), PFS (HR 0.74, 95% CI 0.37-1.51; P = 0.414), and median OS (HR 1.29, 95% CI 0.68-2.46; P = 0.433) were not significant. The incidence of nivolumab discontinuation due to AEs was significantly higher in the ≥ 75 years group (27% vs 7%; P = 0.028), although the intergroup difference in the AE incidence rate was not significant (55% vs 43.8%; P = 0.535).
Nivolumab's effectiveness was comparable between the two patient groups, except for early AE-related discontinuation in the ≥ 75 year group.
尽管纳武利尤单抗越来越多地用于治疗转移性肾细胞癌（mRCC），但在老年患者中的疗效和安全性报道结果不一。因此，本研究旨在评估纳武利尤单抗治疗日本≥75 岁 mRCC 患者的疗效和安全性。
2013 年 3 月至 2019 年 8 月，118 例 mRCC 患者（89 名男性和 29 名女性）接受纳武利尤单抗治疗。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（AE）。
纳武利尤单抗起始后中位随访时间为 10 个月。纳武利尤单抗起始时，分别有 22 名和 96 名患者年龄≥75 岁和＜75 岁，两组患者除年龄外的特征差异无统计学意义。两组间 ORR（14% vs 23%；P=0.367）、PFS（HR 0.74，95%CI 0.37-1.51；P=0.414）和中位 OS（HR 1.29，95%CI 0.68-2.46；P=0.433）无显著差异。因 AE 而停止纳武利尤单抗治疗的发生率在≥75 岁组显著较高（27% vs 7%；P=0.028），但两组 AE 发生率差异无统计学意义（55% vs 43.8%；P=0.535）。
除≥75 岁组因早期 AE 相关停药外，两组患者的疗效相当。
