经动脉化疗栓塞联合乐伐替尼加程序性死亡-1抑制剂治疗合并肝静脉和/或下腔静脉肿瘤血栓的肝细胞癌的疗效和安全性
Efficacy and Safety of Transarterial Chemoembolization Combined with Lenvatinib Plus Programmed Death-1 Inhibitor for Hepatocellular Carcinoma with the Hepatic Vein and/or Inferior Vena Cava Tumor Thrombus.
作者信息
Lin Long-Wang, Nian Yu-Xia, Lin Xin, Ke Kun, Yang Wei-Zhu, Lin Jun-Qing, Huang Ning
机构信息
Department of Interventional Radiology, Fujian Medical University Union Hospital, Fuzhou, 350001, China.
Department of Prevention and Healthcare, Fujian Medical University Union Hospital, Fuzhou, 350001, China.
出版信息
Cardiovasc Intervent Radiol. 2025 Mar;48(3):314-326. doi: 10.1007/s00270-024-03919-2. Epub 2024 Dec 10.
PURPOSE
The aim of this study was to assess the safety and effectiveness of transarterial chemoembolization (TACE) plus lenvatinib with a programmed death-1 (PD-1) inhibitor compared with TACE plus lenvatinib and TACE alone for hepatocellular carcinoma (HCC) with the hepatic vein and/or inferior vena cava tumor thrombus (HVTT and IVCTT).
METHODS
Data on HCC accompanied by HVTT and IVCTT from June 2015 to August 2022 were analyzed in this single-center retrospective study. Drug-eluting bead TACE (DEB-TACE) or conventional TACE (cTACE) was used. The primary study outcomes were overall survival (OS) and progression-free survival (PFS). Univariate and multivariate Cox analyses were performed to determine the predictive factors for OS and PFS. A subgroup analysis was conducted.
RESULTS
Overall, 214 patients were enrolled. Among them, 60 received triple therapy consisting of TACE, lenvatinib, and PD-1 inhibitors (TACE + L + P), 72 received dual therapy consisting of TACE and lenvatinib (TACE + L), and 82 received TACE alone. The TACE + L + P group (16.2; 95% confidence interval [CI]: 12.8-19.5 months) had a significantly longer median OS compared with the TACE + L group (11.2; 95% CI: 10.0-12.3 months) (P = 0.001) and the TACE group (8.3; 95% CI: 7.7-8.5 months) (P < 0.001); the TACE + L + P group (12.3; 95% CI: 10.9-13.7 months) had a significantly longer median PFS compared with the TACE + L group (8.5; 95% CI: 7.7-9.2 months) (P < 0.001) and the TACE group (6.2; 95% CI: 5.8 ~ 6.3 months) (P < 0.001). Multivariate Cox analysis demonstrated that treatment strategy was a significant factor for OS and PFS. Skin rash was more common in the triple therapy group and might be attributed to PD-1 ligand inhibitor therapy (33.33% vs. 16.66%, P = 0.026).
CONCLUSIONS
Triple therapy consisting of TACE plus lenvatinib with a PD-1 inhibitor showed promising efficacy for advanced HCC patients with HVTT and IVCTT, with manageable safety profiles.
目的
本研究旨在评估经动脉化疗栓塞术（TACE）联合乐伐替尼及程序性死亡受体1（PD-1）抑制剂与TACE联合乐伐替尼以及单纯TACE相比，用于治疗伴有肝静脉和/或下腔静脉肿瘤血栓（HVTT和IVCTT）的肝细胞癌（HCC）的安全性和有效性。
方法
在这项单中心回顾性研究中，分析了2015年6月至2022年8月期间伴有HVTT和IVCTT的HCC患者的数据。采用了载药微球TACE（DEB-TACE）或传统TACE（cTACE）。主要研究结局为总生存期（OS）和无进展生存期（PFS）。进行单因素和多因素Cox分析以确定OS和PFS的预测因素。进行了亚组分析。
结果
总共纳入214例患者。其中，60例接受了由TACE、乐伐替尼和PD-1抑制剂组成的三联疗法（TACE + L + P），72例接受了由TACE和乐伐替尼组成的双联疗法（TACE + L），82例仅接受TACE治疗。与TACE + L组（11.2；95%置信区间[CI]：10.0 - 12.3个月）（P = 0.001）和TACE组（8.3；95%CI：7.7 - 8.5个月）（P < 0.001）相比，TACE + L + P组的中位OS显著更长（16.2；95%CI：12.8 - 19.5个月）；与TACE + L组（8.5；95%CI：7.7 - 9.2个月）（P < 0.001）和TACE组（6.2；95%CI：5.8 - 6.3个月）（P < 0.001）相比，TACE + L + P组的中位PFS显著更长（12.3；95%CI：10.9 - 13.7个月）。多因素Cox分析表明，治疗策略是OS和PFS的重要因素。皮疹在三联疗法组中更常见，可能归因于PD-1配体抑制剂治疗（33.33%对16.66%，P = 0.026）。
结论
TACE联合乐伐替尼及PD-1抑制剂的三联疗法对伴有HVTT和IVCTT的晚期HCC患者显示出有前景的疗效，且安全性可控。
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