Adjuvant lenvatinib in combination with transarterial chemoembolization for hepatocellular carcinoma patients with high risk of postoperative recurrence: A multicenter prospective cohort study

IF 4.4 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

Hepatobiliary & Pancreatic Diseases International Pub Date : 2025-03-26 DOI:10.1016/j.hbpd.2025.03.001

Jin-Hong Chen , Lu Lu , Xiao-Yun Zhang , Bang-De Xiang , Xiao Xu , Xiang-Cheng Li , Zhi-Yong Huang , Tian-Fu Wen , Liu-Ping Luo , Jing Huang , Jian-Hong Zhong , Zhi-Kun Liu , Chang-Xian Li , Xin Long , Wen-Wei Zhu , Xin Yang , Chao-Qun Wang , Hu-Liang Jia , Ju-Bo Zhang , Yong-Yi Zeng , Lun-Xiu Qin

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引用次数: 0

Abstract

Background

The high recurrent rate after surgery hinders the survival of patients with hepatocellular carcinoma (HCC). This prospective cohort study aimed to evaluate the efficacy and safety of lenvatinib plus transarterial chemoembolization (TACE) as an adjuvant therapy in HCC patients with high risk of recurrence.

Methods

Patients were enrolled from eight hepatobiliary centers in China. The primary endpoint was disease-free survival (DFS). The secondary endpoints were overall survival (OS) and safety. Additionally, propensity score matching (PSM) and other three propensity score analyses were performed to balance the potential baseline bias to validate the conclusion. The adverse events (AEs) were recorded throughout the study. The study was registered at ClinicalTrials.gov (NCT03838796).

Results

A total of 297 patients were enrolled, with 147 in the LEN + TACE group and 150 in the TACE group. Before PSM, the LEN + TACE group achieved significantly better DFS than the TACE group (19.0 vs. 10.0 months, P = 0.011). PSM analysis identified 111 matched pairs. After PSM, the LEN + TACE group also showed better DFS (19.0 vs. 9.0 months, P = 0.018). Other three propensity score analyses yielded similar DFS benefit tendency. Furthermore, favorable OS was also obtained in the LEN + TACE group before PSM. Lenvatinib related AEs of grade 3 or 4 occurred in 28.6% of the patients in the LEN + TACE group.

Conclusions

Adjuvant lenvatinib plus TACE might be a promising adjuvant approach for HCC patients with high risk of recurrence, which could significantly prolong DFS and potentially OS with a manageable safety profile.

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辅助lenvatinib联合经动脉化疗栓塞治疗术后复发高危肝癌患者：一项多中心前瞻性队列研究

背景：肝细胞癌（HCC）术后高复发率阻碍了患者的生存。本前瞻性队列研究旨在评估lenvatinib +经动脉化疗栓塞（TACE）作为HCC高复发风险患者辅助治疗的有效性和安全性。方法：患者来自中国8个肝胆中心。主要终点为无病生存期（DFS）。次要终点是总生存期（OS）和安全性。此外，通过倾向得分匹配（PSM）和其他三种倾向得分分析来平衡潜在的基线偏差，以验证结论。在整个研究过程中记录不良事件（ae）。该研究已在ClinicalTrials.gov注册（NCT03838796）。结果：共纳入297例患者，其中LEN + TACE组147例，TACE组150例。PSM前，LEN + TACE组的DFS显著优于TACE组（19.0个月vs 10.0个月，P = 0.011）。PSM分析鉴定出111对配对。PSM后，LEN + TACE组也表现出更好的DFS（19.0比9.0个月，P = 0.018）。其他三种倾向得分分析也产生了类似的DFS获益趋势。此外，LEN + TACE组在PSM前也获得了良好的OS。LEN + TACE组中28.6%的患者发生Lenvatinib相关的3级或4级ae。结论：lenvatinib + TACE可能是一种有希望的HCC复发高风险患者的辅助治疗方法，可以显著延长DFS和潜在的OS，且安全性可控。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Hepatobiliary & Pancreatic Diseases International 医学-胃肠肝病学

CiteScore

5.40

自引率

6.10%

发文量

152

审稿时长

3.0 months

期刊介绍： Hepatobiliary & Pancreatic Diseases International (HBPD INT) (ISSN 1499-3872 / CN 33-1391/R) a bimonthly journal published by First Affiliated Hospital, Zhejiang University School of Medicine, China. It publishes peer-reviewed original papers, reviews and editorials concerned with clinical practice and research in the fields of hepatobiliary and pancreatic diseases. Papers cover the medical, surgical, radiological, pathological, biochemical, physiological and historical aspects of the subject areas under the headings Liver, Biliary, Pancreas, Transplantation, Research, Special Reports, Editorials, Review Articles, Brief Communications, Clinical Summary, Clinical Images and Case Reports. It also deals with the basic sciences and experimental work. The journal is abstracted and indexed in SCI-E, IM/MEDLINE, EMBASE/EM, CA, Scopus, ScienceDirect, etc.