Department of General Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China.
Emergency Medicine Department, Xuanwu Hospital, Capital Medical University, Beijing, China.
Ann Surg Oncol. 2024 Nov;31(12):7860-7869. doi: 10.1245/s10434-024-15933-2. Epub 2024 Aug 1.
Locoregional treatment with transarterial chemoembolization (TACE) or hepatic artery infusion chemotherapy (HAIC) and systemic targeted immunotherapy with tyrosine kinase inhibitors (TKI) and programmed cell death protein-1 (PD-1) inhibitors in the treatment of unresectable hepatocellular carcinoma (uHCC) have achieved promising efficacy. The retrospective study aimed to evaluate the efficacy and safety of TACE and HAIC plus TKI with or without PD-1 for uHCC.
From November 2020 to February 2024, the data of 44 patients who received TACE-HAIC + TKI + PD-1 (THKP group) and 34 patients who received TACE-HAIC + TKI (THK group) were retrospectively analyzed. Primary outcomes were overall survival (OS) and progress-free survival (PFS), and secondary outcomes were objective response rate (ORR), disease control rate (DCR), conversion rates, and adverse events (AEs).
A total of 78 patients were recruited in our single-center study. The patients in THKP group had prolonged median OS [25 months, 95% confidence interval (CI) 24.0-26.0 vs 18 months, 95% CI 16.1-19.9; p = 0.000278], median PFS [16 months, 95% CI 14.1-17.9 vs 12 months 95% CI 9.6-14.4; p = 0.004] and higher ORR (38.6% vs 23.5%, p = 0. 156) and DCR (88.6% vs 64.7%, p = 0.011) compared with those in THK group. Multivariate analysis showed that treatment option and alpha-fetoprotein (AFP) level were independent prognostic factors of OS and PFS. The frequency of AEs were similar between the two groups.
The THKP group had better efficacy for uHCC than the THK group, with acceptable safety.
经动脉化疗栓塞（TACE）或肝动脉灌注化疗（HAIC）联合酪氨酸激酶抑制剂（TKI）和程序性死亡蛋白-1（PD-1）抑制剂的局部区域治疗在不可切除肝细胞癌（uHCC）的治疗中已取得了有希望的疗效。本回顾性研究旨在评估 TACE 和 HAIC 联合 TKI 加或不加 PD-1 治疗 uHCC 的疗效和安全性。
从 2020 年 11 月至 2024 年 2 月，回顾性分析了 44 例接受 TACE-HAIC+TKI+PD-1（THKP 组）和 34 例接受 TACE-HAIC+TKI（THK 组）治疗的患者数据。主要终点是总生存期（OS）和无进展生存期（PFS），次要终点是客观缓解率（ORR）、疾病控制率（DCR）、转化率和不良事件（AEs）。
本单中心研究共纳入 78 例患者。THKP 组的中位 OS 更长[25 个月，95%置信区间（CI）24.0-26.0 与 18 个月，95%CI 16.1-19.9；p=0.000278]，中位 PFS 更长[16 个月，95%CI 14.1-17.9 与 12 个月，95%CI 9.6-14.4；p=0.004]，ORR（38.6%与 23.5%，p=0.156）和 DCR（88.6%与 64.7%，p=0.011）更高。多变量分析显示，治疗选择和甲胎蛋白（AFP）水平是 OS 和 PFS 的独立预后因素。两组的 AEs 发生率相似。
与 THK 组相比，THKP 组治疗 uHCC 的疗效更好，安全性可接受。
