Hepatobiliary and Pancreatic Interventional Treatment Center, Division of Hepatobiliary and Pancreatic Surgery.
Zhejiang Provincial Research Center for Diagnosis and Treatment of Hepatobiliary Diseases, Hangzhou, Zhejiang Province, China.
Int J Surg. 2024 Sep 1;110(9):5527-5537. doi: 10.1097/JS9.0000000000001691.
Drug-eluting bead transarterial chemoembolization (DEB-TACE) has shown efficacy for treating hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT). However, whether DEB-TACE is superior to conventional TACE (cTACE) remains unclear.
This randomized controlled trial aimed to compare the efficacy and safety of DEB-TACE versus cTACE in treating HCC with PVTT.
The study was conducted at a tertiary care center in Southeast China. HCC patients with PVTT were randomized at a 1:1 ratio into the DEB-TACE or cTACE groups. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were overall survival (OS) and the incidence of adverse events (AEs). An independent review committee assessed the radiologic response according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST). AEs were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Systemic therapies were not restricted.
Between September 2018 and July 2020, 163 patients were randomized to undergo DEB-TACE ( n =82) or cTACE ( n =81). Nine patients were excluded, and 154 patients were included in the final analysis; the median age was 55 years (range, 24-78 years), and 140 (90.9%) were male. The median PFS in the DEB-TACE group was 6.0 months (95% CI, 5.0-10.0) versus 4.0 months (95% CI, 3.0-5.0) in the cTACE group (hazard ratio, 0.63; 95% CI, 0.42-0.95; P =0.027). The DEB-TACE group showed a higher response rate [51 (66.2%) vs. 36 (46.8%); P =0.0015] and a longer median OS [12.0 months (95% CI, 9.0-16.0) vs. 8.0 months (95% CI, 7.0-11.0), P =0.039] than the cTACE group. Multivariate analysis showed that the treatment group, ALBI score, distant metastasis and additional TKIs were the four independent prognostic factors correlated with PFS. In addition, the treatment group, PVTT group and combination with surgery were independently associated with OS. AEs were similar in the two groups, and postembolization syndrome was the most frequent AE.
DEB-TACE is superior to cTACE in treating HCC patients with PVTT, demonstrating improved PFS and OS with an acceptable safety profile, and may thus emerge as a promising treatment strategy for HCC patients with PVTT.
Chinese Clinical Trial Registry ChiCTR1800018035.
载药微球动脉化疗栓塞术（DEB-TACE）已被证明对伴有门静脉癌栓（PVTT）的肝细胞癌（HCC）具有疗效。然而，DEB-TACE 是否优于传统 TACE（cTACE）尚不清楚。
本随机对照试验旨在比较 DEB-TACE 与 cTACE 治疗伴有 PVTT 的 HCC 的疗效和安全性。
该研究在我国东南部的一家三级治疗中心进行。将伴有 PVTT 的 HCC 患者按 1:1 的比例随机分为 DEB-TACE 或 cTACE 组。主要终点为无进展生存期（PFS），次要终点为总生存期（OS）和不良事件（AE）的发生率。独立评估委员会根据实体瘤反应评估标准（mRECIST）评估影像学反应。AE 采用 CTCAE 版本 4.0 进行评估。不限制系统治疗。
2018 年 9 月至 2020 年 7 月，共有 163 例患者被随机分配至 DEB-TACE 组（n=82）或 cTACE 组（n=81）。排除 9 例患者后，最终有 154 例患者纳入了最终分析；中位年龄为 55 岁（范围 24-78 岁），140 例（90.9%）为男性。DEB-TACE 组的中位 PFS 为 6.0 个月（95%CI：5.0-10.0），cTACE 组为 4.0 个月（95%CI：3.0-5.0）（风险比，0.63；95%CI：0.42-0.95；P=0.027）。DEB-TACE 组的客观缓解率[51 例（66.2%）vs. 36 例（46.8%）；P=0.0015]和中位 OS[12.0 个月（95%CI：9.0-16.0）vs. 8.0 个月（95%CI：7.0-11.0），P=0.039]均优于 cTACE 组。多因素分析显示，治疗组、ALBI 评分、远处转移和额外的 TKI 是与 PFS 相关的四个独立预后因素。此外，治疗组、PVTT 组和联合手术与 OS 独立相关。两组的 AE 相似，栓塞后综合征是最常见的 AE。
DEB-TACE 治疗伴有 PVTT 的 HCC 患者优于 cTACE，具有改善的 PFS 和 OS，且安全性可接受，因此可能成为伴有 PVTT 的 HCC 患者有前景的治疗策略。
中国临床试验注册中心 ChiCTR1800018035。
