Blas Leandro, Shiota Masaki, Tsukahara Shigehiro, Nagakawa Shohei, Matsumoto Takashi, Eto Masatoshi
Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Clin Genitourin Cancer. 2024 Feb;22(1):e122-e127.e1. doi: 10.1016/j.clgc.2023.09.003. Epub 2023 Sep 18.
Recently, many agents and combinations for metastatic and advanced renal cell carcinoma have been approved. This study aims to highlight the comprehensive differences in adverse events (AEs) between cabozantinib (CAB) plus nivolumab (NIVO) and ipilimumab (IPI) plus NIVO based on a real-world big dataset.
We downloaded AE datasets of IPI + NIVO and CAB + NIVO from the Food and Drug Administration Adverse Event Reporting System database. We used the Medical Dictionary for Regulatory Activities to treat each AE as a preferred term and grouped it into the System Organ Class (SOC). We performed logistic regression analyses to compare IPI + NIVO and CAB + NIVO.
The incidence rates of 7 types of toxicities were higher for CAB + NIVO than for IPI + NIVO. On the other hand, the incidence rates of 3 types of toxicities were higher for IPI + NIVO than for CAB + NIVO. Serious AEs were higher in patients receiving IPI + NIVO.
Our findings suggest that both combination therapies presented a disproportionate distribution of toxicities in several SOC. These findings may help clinicians select suitable therapy for the individual and improve the safety profile in patients with advanced renal cell carcinoma receiving NIVO + IPI and NIVO + CAB in a real-world setting.
最近，许多用于转移性和晚期肾细胞癌的药物及联合用药方案已获批准。本研究旨在基于真实世界的大数据集，突出卡博替尼（CAB）联合纳武利尤单抗（NIVO）与伊匹木单抗（IPI）联合NIVO在不良事件（AE）方面的全面差异。
我们从美国食品药品监督管理局不良事件报告系统数据库下载了IPI + NIVO和CAB + NIVO的AE数据集。我们使用《医学监管活动词典》将每个AE作为首选术语，并将其归入系统器官分类（SOC）。我们进行了逻辑回归分析以比较IPI + NIVO和CAB + NIVO。
CAB + NIVO的7种毒性发生率高于IPI + NIVO。另一方面，IPI + NIVO的3种毒性发生率高于CAB + NIVO。接受IPI + NIVO的患者严重AE发生率更高。
我们的研究结果表明，两种联合治疗方案在几个SOC中均呈现出毒性分布不均衡的情况。这些发现可能有助于临床医生为个体选择合适的治疗方法，并在真实世界环境中改善接受NIVO + IPI和NIVO + CAB治疗的晚期肾细胞癌患者的安全性。
