Department of Urology, Iwate Medical University, Iwate, Japan;
Department of Urology, University of Tsukuba, Ibaraki, Japan.
Anticancer Res. 2021 Dec;41(12):6199-6209. doi: 10.21873/anticanres.15439.
BACKGROUND/AIM: To evaluate the effectiveness and safety of nivolumab plus ipilimumab for untreated metastatic renal cell carcinoma in real-world clinical practice in Japan based on 1-year follow-up results.
This multicentre, retrospective study analysed 45 metastatic renal cell carcinoma patients who received nivolumab plus ipilimumab between August 2018 and January 2019 in Japan. Data were extracted from patients' medical records. Subgroup analyses were performed based on baseline demographic data and treatment history.
The objective response rate was 42.5% (complete response rate: 10.0%). The 12-month overall survival rate was 81.4% and the progression-free survival rate was 56.1%. Thirty-five patients (77.8%) showed any grade treatment-related adverse events and 17 (37.8%) showed grade ≥3 treatment-related adverse events, with no significant difference in safety between subgroups.
The effectiveness and safety of nivolumab plus ipilimumab in real-world clinical practice with 1-year follow-up were comparable with those of the CheckMate 214 trial.
背景/目的：基于 1 年随访结果，评估纳武利尤单抗联合伊匹单抗在日本真实世界临床实践中治疗未经治疗的转移性肾细胞癌的疗效和安全性。
这项多中心、回顾性研究分析了 2018 年 8 月至 2019 年 1 月期间在日本接受纳武利尤单抗联合伊匹单抗治疗的 45 例转移性肾细胞癌患者。数据从患者的病历中提取。根据基线人口统计学数据和治疗史进行亚组分析。
客观缓解率为 42.5%（完全缓解率：10.0%）。12 个月总生存率为 81.4%，无进展生存率为 56.1%。35 例患者（77.8%）出现任何级别治疗相关不良事件，17 例（37.8%）出现≥3 级治疗相关不良事件，各亚组间安全性无显著差异。
在具有 1 年随访的真实世界临床实践中，纳武利尤单抗联合伊匹单抗的疗效和安全性与 CheckMate 214 试验相当。
