Abstract
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. 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. Postoperative adjuvant TACE was not associated with prolonged RFS or OS in AJCC TNM stage I or II HCC patients.
Published Version
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