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

BACKGROUND AND AIMS

The role of adjuvant transarterial chemoembolization (TACE) for HCC following curative resection remains controversial. We aimed to determine the effectiveness of postoperative adjuvant TACE in patients with HCC​​​​​.

APPROACH AND RESULTS

In this randomized phase 3 trial, histologically confirmed patients with HCC (American Joint Committee on Cancer 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 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 2 groups from the ITT population (median, both unreached; HR, 0.88; 95% CI: 0.62-1.24; p =0.468). The RFS rates at 1, 3, 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 overall survival was comparable between the TACE group and the observation group in the ITT population (median, both unreached, HR, 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 overall survival in patients with American Joint Committee on Cancer TNM stage I or II HCC.