Efficacy and Safety of Drug Eluting Bead TACE with Microspheres <150 μm for the Treatment of Hepatocellular Carcinoma.

BACKGROUND/AIM: To retrospectively evaluate the efficacy and safety of drug eluting bead (DEB) transarterial chemoembolisation (TACE) with microspheres <150 μm for the treatment of hepatocellular carcinoma (HCC) with respect to overall survival, progression-free survival, tumor response and the peri-interventional toxicity.

MATERIALS AND METHODS: In this retrospective, single-center study we analyzed 32 HCC-patients (BCLC A: 10 patients, BCLC B: 17 patients, BCLC C: 5 patients), who were treated with (DEB) <15 μm (DCBeadM1®) loaded with epirubicin between 2011 and 2015. We analyzed MRI and CT-scans as well as blood results like AFP, bilirubin and liver enzymes before (t0) and after (t1=first follow-up, t2=last follow-up within 6 months) locoregional treatment. The tumor response was evaluated by MRI and CT considering m-RECIST and the EASL-criteria as well as alpha-fetoprotein (AFP) levels in the peripheral blood.

RESULTS: We found a significant tumor response at all follow-up times (p<0.05) according to m-RECIST criteria and a significant tumor response between t0 vs. t1 (p<0.05) and t0 vs. t2 (p<0.05) according to EASL criteria. We observed a significant decrease of the AFP-level between t0 and t1. The objective response rates (ORR) of target lesions were 64.3% and 78.5 % corresponding to m-RECIST and EASL, respectively. The median overall survival (OS) was 30.5 months, the progression-free survival in relation to the target lesion was 14.3 months by using m-RECIST and EASL criteria. In the period of 30 days after treatment we found no grade 5 adverse events (AE). During the follow-up period 1 abscess (3.7%) was observed. In a total of 5 patients, 4 (14.7%) biliomas with no need of treatment and 3 (10.7%) widening of the intrahepatic bile ducts were noted.

CONCLUSION: The use of DEB <150 μm (DCBeadM1®) shows promising results in the treatment of HCC without showing substantial hepatic toxicity, but some widening of the intrahepatic bile ducts and one abscess. Further trials are necessary to evaluate the efficacy and toxicity of DEB-TACE with M1®-beads.