Adjuvant transarterial chemoembolization for hepatocellular carcinoma following curative resection: A randomized, open-label, phase 3 trial

IF 15.8 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Hepatology Pub Date : 2025-01-14 DOI:10.1097/hep.0000000000001233

Tao Ma, Xueli Bai, Qi Zhang, Wen Chen, Kaiquan Huang, Tao Qian, Yongzi Xu, Peiwei Sun, Yiwen Chen, Wenbo Xiao, Ke Sun, Shunliang Gao, Tingbo Liang

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引用次数: 0

Abstract

Background & Aims: The role of adjuvant transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC) following curative resection remains controversial. We aimed to determine the effectiveness of postoperative adjuvant TACE in HCC patients. Approach & Results: In this randomized phase 3 trial, histologically confirmed HCC patients (AJCC TNM stage I and II) were randomly assigned (1:1) to adjuvant TACE or observation groups. The primary endpoint was recurrence-free survival (RFS) in the intention-to-treat (ITT) population. The secondary endpoints included overall survival (OS) and safety. A total of 332 patients (ITT population) were randomly assigned to the TACE group (n=166) or the observation group (n=166) between March 2014 and June 2021. The RFS was comparable between the two groups from the ITT population (median, both unreached; hazard ratio, 0.88; 95% CI, 0.62–1.24; p=0.468). The RFS rates at 1 year, 3 years, and 5 years were 87.3% (95% CI, 81.2-91.5), 70.7% (95% CI, 63.0-77.0), and 60.6% (95% CI, 51.9-68.3) in the adjuvant TACE group and 84.8% (95% CI, 78.3-89.5), 69.3% (95% CI, 61.6-75.8), and 58.1% (95% CI, 49.5-65.8) in the observation group, respectively. The OS was comparable between the TACE group and the observation group in the ITT population (median, both unreached, hazard ratio, 1.06; 95% CI, 0.63–1.76; p=0.838). There was no grade ≥ 3 adverse event or treatment-related death in either group. Conclusions: Postoperative adjuvant TACE was not associated with prolonged RFS or OS in AJCC TNM stage I or II HCC patients.

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肝细胞癌根治性切除后的辅助经动脉化疗栓塞：一项随机、开放标签、3期试验

背景,目的：辅助经动脉化疗栓塞（TACE）在肝细胞癌（HCC）根治性切除后的作用仍然存在争议。我们的目的是确定肝癌患者术后辅助TACE的有效性。的方法,结果：在这项随机的3期试验中，组织学证实的HCC患者（AJCC TNM期I和II期）被随机（1:1）分配到辅助TACE组或观察组。主要终点是意向治疗（ITT）人群的无复发生存（RFS）。次要终点包括总生存期（OS）和安全性。2014年3月至2021年6月，共有332例患者（ITT人群）随机分为TACE组（n=166）和观察组（n=166）。ITT人群中两组的RFS具有可比性(中位数，均未达到；风险比0.88；95% ci, 0.62-1.24；p = 0.468)。辅助TACE组1年、3年和5年的RFS率分别为87.3% （95% CI, 81.2-91.5）、70.7% （95% CI, 63.0-77.0）和60.6% (95% CI, 51.9-68.3)，观察组分别为84.8% （95% CI, 78.3-89.5）、69.3% （95% CI, 61.6-75.8）和58.1% （95% CI, 49.5-65.8）。在ITT人群中，TACE组和观察组的OS具有可比性(中位数，均未达到，风险比，1.06；95% ci, 0.63-1.76；p = 0.838)。两组均无≥3级不良事件或治疗相关死亡。结论：AJCC TNM期I或II期HCC患者术后辅助TACE与延长RFS或OS无关。

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来源期刊

Hepatology 医学-胃肠肝病学

CiteScore

27.50

自引率

3.70%

发文量

609

审稿时长

1 months

期刊介绍： HEPATOLOGY is recognized as the leading publication in the field of liver disease. It features original, peer-reviewed articles covering various aspects of liver structure, function, and disease. The journal's distinguished Editorial Board carefully selects the best articles each month, focusing on topics including immunology, chronic hepatitis, viral hepatitis, cirrhosis, genetic and metabolic liver diseases, liver cancer, and drug metabolism.