Li Xiaowei, Cao Kunkun, Fu Zhigang, Chen Xiaoxia, Zhong Jiaming, Liu Li, Ding Ning, Zhang Xiaoli, Qu Zengqiang, Zhu Lijun, Zhai Jian
Department II of Interventional Radiology, Shanghai Eastern Hepatobiliary Surgery Hospital, Shanghai, 200438, People's Republic of China.
J Hepatocell Carcinoma. 2025 Jan 25;12:169-182. doi: 10.2147/JHC.S488734. eCollection 2025.
To assess the activity and toxicity of hepatic arterial infusion chemotherapy (HAIC)+tislelizumab+lenvatinib (HAIC+tisle+len) in hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT) type IV (Vp4 hCC) in a real-world context.
Fifty-five patients, with Vp4 hCC receiving HAIC+tisle+len therapy from April 2021 to December 2022, were analyzed retrospectively. Data on patient characteristics, adverse events (AEs), treatment, and survival were collected. Outcomes were disease control rate (DCR), overall response rate (ORR), overall survival (OS), progression-free survival (PFS), and treatment-related AEs (TRAEs).
As of December 20, 2023, the median follow-up was 17.5 months (95% confidence interval [CI]: 14.7-22.5). The ORR was 52.7% (3 complete response [CR], 26 partial response [PR]) as per RECIST v1.1 and 65.5% (12 CR, 24 PR) as per mRECIST. The DCR was 94.5% using both RECIST v1.1 and mRECIST. The median PFS and the median OS were 8.0 months (95% CI: 6.2-12.3) and 16.7 months (95% CI: 12.0-not reached), respectively. Additionally, PFS was independently predicted only by the best tumor response. In patients with the best tumor response (PR or CR), the median PFS was 11.7 months (95% CI: 8.02-not reached) by mRECIST and 15.4 months (95% CI: 7.39-not reached) by RECIST v1.1. Hypertension (14.5%), decreased albumin levels (10.9%) and anorexia (9.1%) were the most frequently observed grade 3-4 TRAEs.
HAIC+tisle+len regimen demonstrated a promising efficacy and favorable safety for patients with HCC and Vp4, providing valuable real-world evidence to complement the trial data for Vp4 hCC.
在真实世界背景下评估肝动脉灌注化疗（HAIC）+替雷利珠单抗+仑伐替尼（HAIC+tisle+len）治疗伴有IV型门静脉癌栓（PVTT）的肝细胞癌（HCC，Vp4 hCC）的活性和毒性。
回顾性分析了2021年4月至2022年12月期间接受HAIC+tisle+len治疗的55例Vp4 hCC患者。收集了患者特征、不良事件（AE）、治疗和生存数据。观察指标包括疾病控制率（DCR）、总缓解率（ORR）、总生存期（OS）、无进展生存期（PFS）和治疗相关不良事件（TRAEs）。
截至2023年12月20日，中位随访时间为17.5个月（95%置信区间[CI]：14.7-22.5）。根据RECIST v1.1标准，ORR为52.7%（3例完全缓解[CR]，26例部分缓解[PR]）；根据mRECIST标准，ORR为65.5%（12例CR，24例PR）。使用RECIST v1.1和mRECIST标准时，DCR均为94.5%。中位PFS和中位OS分别为8.0个月（95% CI：6.2-12.3）和16.7个月（95% CI：12.0-未达到）。此外，仅最佳肿瘤反应可独立预测PFS。在最佳肿瘤反应（PR或CR）的患者中，根据mRECIST标准，中位PFS为11.7个月（95% CI：8.02-未达到）；根据RECIST v1.1标准，中位PFS为15.4个月（95% CI：7.39-未达到）。高血压（14.5%）、白蛋白水平降低（10.9%）和厌食（9.1%）是最常观察到的3-4级TRAEs。
HAIC+tisle+len方案对HCC和Vp4患者显示出有前景的疗效和良好的安全性，为补充Vp4 hCC的试验数据提供了有价值的真实世界证据。
