Division of Interventional Radiology, Icahn School of Medicine at Mount Sinai, 5 East 98th Street, 12th Floor, New York, NY, 10029.
Division of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.
J Vasc Interv Radiol. 2020 Nov;31(11):1729-1738.e1. doi: 10.1016/j.jvir.2020.07.009. Epub 2020 Oct 2.
To assess the safety of locoregional treatment (LRT) combined with nivolumab for intermediate and advanced hepatocellular carcinoma (HCC).
A single-center retrospective review included 29 patients undergoing 41 LRTs-transarterial chemoembolization or yttrium-90 transarterial radioembolization-60 days before or concurrently with nivolumab. Demographic, clinical, and laboratory values and adverse events were reviewed before and after nivolumab initiation and after each LRT. Treatment response and time to progression were assessed using Modified Response Evaluation Criteria in Solid Tumors. Clinical events, including nivolumab termination, death, and time of last follow-up, were assessed.
Over a median nivolumab course of 8.1 months (range, 1.0-30) with a median of 14.2 2-week cycles (range, 1-53), predominantly Child-Pugh A (22/29) patients-12 Barcelona Clinic Liver Cancer (BCLC) B and 17 BCLC C-underwent 20 transarterial chemoembolization and 21 transarterial radioembolization LRTs at a median of 67 days (range, 48-609) after nivolumab initiation. Ten patients underwent multiple LRTs. During a median follow-up of 11.5 months (range, 1.8-35.1), no grade III/IV adverse events attributable to nivolumab were observed. There were five instances of grade III/IV hypoalbuminemia or hyperbilirubinemia within 3 months after LRT. There were no nivolumab-related deaths, and 30-day mortality after LRT was 0%.
LRTs performed concurrently with nivolumab immunotherapy demonstrate an acceptable safety profile in patients with intermediate and advanced HCC.
评估局部区域治疗 (LRT) 联合纳武利尤单抗治疗中晚期肝细胞癌 (HCC) 的安全性。
单中心回顾性研究纳入了 29 例在接受纳武利尤单抗治疗前 60 天或同时接受 41 次 LRT(经动脉化疗栓塞或钇-90 经动脉放射栓塞)的患者。回顾了纳武利尤单抗治疗前、后和每次 LRT 后的人口统计学、临床和实验室值以及不良事件。使用实体瘤反应评估标准 (mRECIST) 评估治疗反应和无进展时间。评估了临床事件,包括纳武利尤单抗停药、死亡和最后随访时间。
中位纳武利尤单抗疗程为 8.1 个月(范围 1.0-30),中位 2 周疗程为 14.2 个(范围 1-53),主要为 Child-Pugh A 级(22/29)患者-12 例巴塞罗那临床肝癌 (BCLC) B 期和 17 例 BCLC C 期-在接受纳武利尤单抗治疗后 67 天(范围 48-609)进行了 20 次经动脉化疗栓塞和 21 次经动脉放射栓塞 LRT。10 例患者接受了多次 LRT。在中位随访 11.5 个月(范围 1.8-35.1)期间,未观察到归因于纳武利尤单抗的 III/IV 级不良事件。LRT 后 3 个月内有 5 例出现 III/IV 级低白蛋白血症或高胆红素血症。无纳武利尤单抗相关死亡,LRT 后 30 天死亡率为 0%。
在中晚期 HCC 患者中,与纳武利尤单抗免疫治疗同时进行的 LRT 显示出可接受的安全性。