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Purpose: To evaluate the feasibility of drug-eluting bead (DEB)-transarterial chemoembolization (TACE) with 75 mg epirubicin for hepatocellular carcinoma (HCC) in Japanese patients with unresectable HCC prior to conducting a planned randomized controlled trial. Materials and Methods: This study was conducted as a prospective multi-center feasibility study. Eligible patients had unresectable Barcelona Clinic Liver Cancer stage A or B HCC that was unsuitable for curative treatments, and all patients received TACE with 75 mg epirubicin-loaded DEB. Tumor response, as the primary endpoint, was assessed after 4 weeks by computed tomography or magnetic resonance imaging, based on the modified Response Evaluation Criteria in Solid Tumors. Adverse events after treatment were evaluated as the secondary endpoint, based on the Common Terminology Criteria for Adverse Events version 4.0. Results: Between May and August 2014, 8 patients from two institutions were enrolled in this clinical study. There were no instances of complete response observed, partial response was obtained in 4 patients, and the overall response rate was 50%. No patients experienced grade 4 or higher adverse events. Grade 3 thrombocytopenia occurred in 1 patient. One patient experienced a grade 3 increase in aspartate aminotransferase, alanine aminotransferase, and bilirubin levels. All adverse events were well managed with conservative medical care. There were no procedure-related deaths. Conclusions: DEB-TACE with 75 mg epirubicin was found to be feasible in Japanese patients, and it was deemed appropriate to proceed to a randomized controlled trial comparing DEB-TACE and conventional TACE.

Feasibility Study of Transcatheter Arterial Chemoembolization with Epirubicin Drug-eluting Beads for Hepatocellular Carcinoma in Japanese Patients