Conventional or drug-eluting beads? Randomized study of chemo-embolization for hepatocellular carcinoma: JIVROSG-1302

Introduction With the advent of effective systemic therapy, transarterial chemoembolization (TACE) is established as a highly effective locoregional treatment modality for carefully selected patients of hepatocellular carcinoma (HCC). This randomized controlled trial was conducted to clarify whether selective TACE with drug-eluting beads loaded with epirubicin (DEB-TACE) or selective conventional TACE with epirubicin-ethiodized oil (cTACE) might be more effective for obtaining complete response (CR) in patients with HCC. Methods Between March 2016 and May 2019, Child-Pugh class A or B patients with unresectable HCC who were scheduled to receive selective TACE were randomly assigned at a 1:1 ratio to the DEB-TACE arm or the cTACE arm. The primary endpoint was the CR rate at 3 months, as evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) by an independent review committee, and the secondary endpoints were the CR rate at 1 month and incidences of adverse events. Results A total of 200 patients (DEB-TACE, 99 patients; cTACE, 101 patients) were enrolled in the study. The CR rates at 3 months and 1 month were significantly higher in the cTACE arm (75.2%, 84.2%) as compared with the DEB-TACE arm (27.6%, 35.7%). However, the frequencies of adverse events of any grade, including pyrexia (DEB-TACE vs. cTACE, 19.4% vs. 45.5%, p=0.0001), fatigue (5.1% vs. 15.8%, p=0.0194), malaise (11.1% vs. 25.7%, p=0.0103), appetite loss (12.1% vs. 28.7%, p=...
Source: Liver Cancer - Category: Cancer & Oncology Source Type: research