ABSTRACT
PURPOSE: We evaluated oral metronomic capecitabine (MC) compared to intravenous doxorubicin in patients with advanced or metastatic hepatocellular carcinoma (HCC).METHODS: From January 2013 to December 2015, patients with Child-Pugh class A or early B were randomized either to MC group (500 mg twice daily continuously) or doxorubicin group (60 mg/m² every 21 days).RESULTS: Forty patients were included in each group. The baseline clinical characteristics of the enrolled patients were well balanced between the two groups. No complete response (CR) was reported in either group. In MC group, 2 patients (5%) had partial response (PR), 25 patients (62.5%) stable disease (SD) and 27 patients (67.5%) had disease control. In doxorubicin group, 4 patients (10%) achieved PR, 24 patients (60%) SD and 28 patients (70%) had disease control. The 6 months overall survival (OS) was 77.5% for MC and 75% for doxorubicin. The one year OS was 47.5% for MC and 42.5% for doxorubicin (P=0.521). The median OS survival was 10.2 months for MC and 9.6 months for doxorubicin (95% confidence interval, 3.2–6.5). The 6 month progression-free survival (PFS) was 45% for MC and 50% for doxorubicin. The one year PFS was 12.5% for MC and 7.5% for doxorubicin (P=0.289). The median time to progression was 3.4 months for MC and 3.1 months for doxorubicin. On multivariate analysis no significant impact for tumor stage, previous transhepatic arterial chemoembolization, portal vein thrombosis or median baseline alpha fetoprotein on OS.CONCLUSION: MC showed response rate and survival outcome comparable to doxorubicin in advanced HCC but with a more favorable toxicity profile.