A prospective randomized controlled trial of selective transarterial chemoembolization using drug-eluting beads loaded with epirubicin versus selective conventional transarterial chemoembolization using epirubicin-lipiodol for hepatocellular carcinoma: The JIVROSG-1302 PRESIDENT study.

Abstract

4518 Background: Transarterial chemoembolization (TACE) with selective catheterization into the segmental or subsegmental hepatic arteries supplying HCC is often performed to achieve the complete local control of HCC in the patients with a limited number of small sized nodules. To clarify which of TACE with drug-eluting beads loaded with epirubicin (DEB-TACE) or conventional TACE with epirubicin-lipiodol (cTACE) can achieve the complete response (CR) more frequently, we performed a randomized controlled trial of DEB-TACE vs. cTACE. Methods: Between March 2016 and May 2019, unresectable HCC patients with Child-Pugh class A or B who were scheduled to receive selective TACE were randomly assigned 1:1 to the DEB-TACE group and the cTACE group. The primary endpoint was the CR rate at 3 months, and the secondary endpoints were the CR rate at 1 month and rate of adverse events (AEs). The response and AEs were assessed according to the modified RECIST by an independent review committee and the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0., respectively. Results: A total of 200 patients (DEB-TACE, 99 patients; cTACE 101 patients) were enrolled from 22 Japanese institutions. The patient characteristics were well-balanced between the two groups. The median number of tumors was one in both groups and the median tumor size was 20.0 mm in the DEB-TACE group and 20.5 mm in the cTACE group. The table shows the CR rates and frequencies of AEs. The CR rates of cTACE at 3 and 1 months were significantly higher than those of DEB-TACE. The frequency of AEs (all grades), including pyrexia, malaise, increased serum total bilirubin (T-Bil) and increased serum alanine transaminase (ALT), was significantly higher in the cTACE group than in the DEB-TACE group. Conclusions: Selective cTACE appeared to have greater efficacy for local tumor control as compared to selective DEB-TACE, however, the frequencies of post-embolization syndromes were higher in the cTACE group than in the DEB-TACE group. Clinical trial information: UMIN000021250 . [Table: see text]