Change in liver function after selective TACE for unresectable hepatocellular carcinoma: JIVROSG-2001 PRESIDENT-ALBI, a secondary analysis of a multicenter randomized controlled trial

Introduction Liver function deterioration after transarterial chemoembolization (TACE) may preclude systemic therapy. The JIVROSG-1302 PRESIDENT study, a prospective, randomized controlled trial, showed a significantly higher local complete response rate with selective conventional TACE (cTACE) than with selective TACE using drug-eluting beads (DEB-TACE). However, this study did not assess the changes in liver function after selective TACE. The purpose of this study, JIVROSG-2001 PRESIDENT-ALBI, was to evaluate the change in liver function after selective TACE for unresectable hepatocellular carcinoma (HCC) using the same patient cohort. Methods The primary endpoint was ALBI grade deterioration rate after 3 months of TACE compared to DEB-TACE and cTACE. Secondary endpoints included the ALBI grade and score change and the identification of risk factors associated with liver function deterioration. Results A total of 197 patients with unresectable HCC were enrolled in this study. The ALBI grade deterioration rate at 3 months was 11% for the DEB-TACE group and 6% for the cTACE group, with no significant difference (p=0.203). The mean ALBI score deterioration at 1 and 3 months was 0.06 and 0.02, respectively, and no notable deterioration in liver function was observed. The risk factors for ALBI score deterioration 1 month after selective TACE included large tumor diameter, high number of treated tumors, and treated vessels. Conclusions Selective TACE, whether DEB-TACE or cTACE, did not significantly impair the liver function. Even with selective TACE, larger tumors, multiple tumors, and a large number of treated blood vessels were associated with worsening liver function one month after TACE.