Single-center randomized trial comparing conventional chemoembolization versus doxorubicin-loaded polyethylene glycol microspheres for early- and intermediate-stage hepatocellular carcinoma

According to Barcelona Clinic Liver Cancer classification, transarterial chemoembolization (TACE) is preferred treatment for stage B and in certain cases for stage A hepatocellular carcinoma (HCC). Conventional TACE (c-TACE) and drug-eluting microspheres TACE (DEM-TACE) are available intraarterial therapies. Screening of patients with cirrhosis is of great importance for early detection of malignant liver nodules. Primary endpoint of this study was to compare DEM-TACE with c-TACE in terms of 12- and 24-month survival. Secondary endpoints were comparison of intensity and duration of the postembolization syndrome (PES) and severe adverse events. We randomized 60 patients with unresectable HCC one-to-one with c-TACE or DEM-TACE and followed them for at least 24 months or until death. TACE was repeated ‘on-demand. Most patients underwent two TACE sessions and the median hospital stay was 3 days for c-TACE and 2 days for DEM-TACE group. The overall 12- and 24-month survival rates were 89.8 and 70.7%, respectively, precisely 85.7 and 63.6% after c-TACE and 90.2 and 75.8% after DEM-TACE, without any significant difference ( P = 0.18). Median overall survival was 21.1 months. Significant difference in the overall 12- and 24-month survival was found in patients with Child-Pugh A compared to Child-Pugh B class ( P = 0.001). Child-Pugh class, aspartate aminotransferase levels and ascites independently predicted survival ( P = 0.003). Both, DEM-TACE and c-TACE showed excellent 12- and 24-month survival rates. No significant difference in terms of adverse events was found. PES was slightly more severe after c-TACE, because of elevated temperature. DEM-TACE requires shorter in-hospital stay.