Randomized controlled trial of epirubicin and miriplatin using together with TACE for hepatocellular carcinoma

Abstract

Background: The efficacy and safety of anticancer agents using for transcatheter arterial chemoembolization (TACE) to hepatocellular carcinoma(HCC) have not been evaluated. Methods: Forty-two patients with HCC of BCLC-stage B or C were randomly selected to epirubicin (E) or miriplatin (M) by Microsoft Excel 2010. Primary endpoint was response rate by mRECIST. The change of alpha-fetoprotein or DCP, progression-free survival and the adverse events were the secondary endpoints. Results: Thirty-two males and 10 females were assigned. The median age was 71.5 year old. Eight cases were excluded from this study because 5 cases were performed hepatic arterial injection without embolization, two cases were done radiofrequency ablation and one case was performed partial hepatectomy after TACE. The etiology was HCV/ alcohol/HBV/non-B non-C (24/7/1/2, total:34) respectively. No significant difference was observed in the average age, BMI, AFP and or DCP level, BCLC stage, average tumor number (E/M: 3.7/2.8), average tumor diameter (E/M: 25.9mm/33.4mm), Child-Pugh score, response rate of TACE (E group: 31.3%(5/16), M group: 33.3%(6/ 18)), lipiodol dose, changes of tumor markers and the progression-free survival period between E and M groups(unpaired t test). In addition, vascular toxicity, hematotoxicity and non-hematotoxicity (fever, pain, nausea), biochemical markers of ALT, AST, T-Bil and creatinine were neither different between the 2 treatment groups(unpaired t test). Conclusions: Epirubicin and miriplatin can be equally used for TACE in view of efficacy and safety.