Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
Br J Hosp Med (Lond). 2024 Jul 30;85(7):1-12. doi: 10.12968/hmed.2024.0159. Epub 2024 Jul 16.
The combination of lenvatinib and programmed cell death protein 1 (PD-1) inhibitor has demonstrated significant efficacy in treating unresectable hepatocellular carcinoma. Our study aimed to evaluate the safety and efficacy of triple therapy that includes hepatic arterial infusion chemotherapy, lenvatinib and PD-1 inhibitor for treating unresectable hepatocellular carcinoma. Patients with a primary diagnosis of advanced hepatocellular carcinoma between June 2020 and August 2023 were included in this study. Initially, 53 patients with hepatocellular carcinoma were enrolled. Then, 13 patients were excluded based on the inclusion criteria, resulting in 40 patients included for analysis. Among them, 31 patients received triple therapy, including 16 Barcelona Clinic Liver Cancer C stage, 12 Barcelona Clinic Liver Cancer-B, and 3 Barcelona Clinic Liver Cancer-A hepatocellular carcinoma patients. The primary endpoint was the objective response rate, while the secondary endpoints included the conversion resection rate, pathological complete response rate, pathological partial response rate, and treatment-related adverse events. The objective response rate was 80.65% at a median follow-up of 24.5 months (range: 12.6-55.8 months). Of the 14 patients (45.2%) who underwent conversion therapy and were eligible for surgery, 7 patients underwent liver resection and the remaining 7 patients underwent liver transplantation. The median interval between the start of triple therapy and surgery was 117 days, ranging from 25 to 215 days. The pathological complete response was observed in six patients (19.4%) and the pathological partial response rate in eight patients (25.8%). All adverse events occurred in 77.4% of the patients. In patients with unresectable hepatocellular carcinoma, the combination of hepatic arterial infusion chemotherapy, lenvatinib, and PD-1 inhibitor exhibits favourable efficacy and well tolerability, achieving a desirable pathological complete response rate while maintaining manageable drug toxicity.
仑伐替尼联合程序性死亡蛋白 1（PD-1）抑制剂治疗不可切除肝细胞癌显示出显著疗效。我们的研究旨在评估包括肝动脉灌注化疗、仑伐替尼和 PD-1 抑制剂在内的三联疗法治疗不可切除肝细胞癌的安全性和有效性。
该研究纳入了 2020 年 6 月至 2023 年 8 月期间初诊为晚期肝细胞癌的患者。最初，共有 53 例肝细胞癌患者入组，然后根据纳入标准排除了 13 例患者，最终有 40 例患者纳入分析。其中，31 例患者接受了三联治疗，包括巴塞罗那临床肝癌 C 期 16 例、巴塞罗那临床肝癌 B 期 12 例和巴塞罗那临床肝癌 A 期 3 例。主要终点为客观缓解率，次要终点包括转化性切除率、病理完全缓解率、病理部分缓解率和治疗相关不良反应。
中位随访 24.5 个月（范围：12.6-55.8 个月）时，客观缓解率为 80.65%。在 14 例（45.2%）接受转化治疗且有手术适应证的患者中，7 例接受了肝切除术，其余 7 例接受了肝移植术。三联治疗开始至手术的中位间隔时间为 117 天，范围为 25-215 天。6 例（19.4%）患者出现病理完全缓解，8 例（25.8%）患者出现病理部分缓解。所有不良事件均发生在 77.4%的患者中。
在不可切除肝细胞癌患者中，肝动脉灌注化疗、仑伐替尼和 PD-1 抑制剂联合应用具有良好的疗效和耐受性，可获得理想的病理完全缓解率，同时保持可管理的药物毒性。
