Background & aim: A single-arm expanded treatment efficacy and safety study of transcatheter arterial chemoembolization (TACE) for unresectable hepatocellular carcinoma (HCC) was conducted in Japan and Korea (Korea-Japan study), and showed a markedly favorable efficacy with mild toxicity. The aim of this study was to elucidate the efficacy and safety of TACE in the Japanese subgroup and investigate the relationship between the doses of epirubicin and Lipiodol and treatment efficacy and safety.
Methods: The subjects were 73 Japanese patients with unresectable HCC enrolled in the Korea-Japan study. The patients underwent TACE using an emulsion of epirubicin and Lipiodol, followed by injection of gelatin particles. TACE was repeated on demand.
Results: In 73 evaluable patients, the response rate was 82% by the modified response evaluation criteria for solid tumors. The median time-to-progression, median overall survival, and 2-year survival were 8.8 months, 36.9 months and 76.7%, respectively. The major grade 3 - 5 toxicities were an increased AST level (38%), increased ALT level (36%), and thrombocytopenia (14%), but all toxicities were generally transient. The patients treated with higher dose of epirubicin and Lipiodol tended to have a higher proportion of liver dysfunction, lower response rate and shorter time to progression, but tolerated these agents well.
Conclusion: TACE exerted a markedly favorable efficacy and was well-tolerated regardless of the doses of epirubicin and Lipiodol in Japanese patients with unresectable HCC.
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