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

Abstract

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.

Locoregional Therapies for Hepatobiliary Tumors: Contemporary Strategies and Novel Applications

“…These have not consistently reported the improved mortality of treatment response with DEB-TACE, although a recently published prospective randomized trial did report improved overall survival with DEB-TACE [26]. Clinical trials have consistently reported reduced severity of post-embolization syndrome with DEB-TACE, as well as, however, a reduced need for retreatment [27][28][29][30].…”

In the Era of Systemic Therapy for Hepatocellular Carcinoma Is Transarterial Chemoembolization Still a Card to Play?

“…No significant difference in terms of adverse events was found. Nevertheless, DEM-TACE requires a shorter in-hospital stay [74].…”

Efficacy and safety analysis of dexamethasone + palonosetron in prevention of post-embolization syndrome after D-TACE: A retrospective study

“…D-TACE is the use of drug-eluting microspheres loaded with chemotherapeutic drugs for tumor embolization, which has been widely used in clinic in recent years. The most common side effect after D-TACE is post-embolization syndrome, [7,8] including All participants information, images and inspection results are agreed to be published and have obtained informed consent. The details, images will be freely available on the internet and may be seen by the general public.…”

“…D-TACE is the use of drug-eluting microspheres loaded with chemotherapeutic drugs for tumor embolization, which has been widely used in clinic in recent years. The most common side effect after D-TACE is post-embolization syndrome, [ 7 , 8 ] including abdominal pain, fever, nausea, and vomiting. Post-embolization syndrome will increase the physiological and psychological burden of patients, reduce their treatment compliance, prolong their hospitalization time, and increase their medical expenses.…”