Transarterial Chemoembolization of Unresectable Hepatocellular Carcinoma with Drug Eluting Beads: Results of an Open-Label Study of 62 Patients

Abstract

The purpose of this study was to assess the safety and efficacy of doxorubicin-loaded beads (DC Beads) delivered by transarterial embolization for the treatment of unresectable hepatocellular carcinoma (HCC). This open-label, single-center, single-arm study included 62 cirrhotic patients with documented single unresectable HCC. Mean tumor diameter was 5.6 cm (range, 3-9 cm) classified as Okuda stages 1 (n = 53) and 2 (n = 9). Patients received repeat embolizations with doxorubicin-loaded beads every 3 months (maximum of three). The maximum doxorubicin dose was 150 mg per embolization, loaded in DC Beads of 100-300 or 300-500 microm. Regarding efficacy, overall, an objective response according to the European Association for the Study of the Liver criteria was observed in 59.6%, 81.8%, and 70.8% across three treatments. A complete response was observed in 4.8% after the first procedure and 3.6% and 8.3% after the second and third procedures, respectively. At 9 months a complete response was seen in 12.2%, an objective response in 80.7%, progressive disease in 6.8%, and 12.2% showed stable disease. Mean tumor necrosis ranged from 77.4% to 83.9% (range, 28.6%-100%) across three treatments. alpha-Fetoprotein levels showed a mean decrease of 1123 ng/ml (95% CI = 846-1399; p = 3 x 10(-11)) after the first session and remained stable after the second and third embolizations (42 and 70 ng/ml decrease, respectively). Regarding safety, bilirubin, gamma-glutamyl transferase, aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase showed only transient increases during the study period. Severe procedure-related complications were seen in 3.2% (cholecystitis, n = 1; liver abscess, n = 1). Postembolization syndrome was observed in all patients. We conclude that hemoembolization using doxorubicin-loaded DC Beads is a safe and effective treatment of HCC as demonstrated by the low complication rate, increased tumor response, and sustained reduction of alpha-fetoprotein levels.

Comparison of conventional transarterial chemoembolization (TACE) and chemoembolization with doxorubicin drug eluting beads (DEB) for unresectable hepatocelluar carcinoma (HCC)

“…Patients with Child-Pugh classes A and B disease did not experience any major complications after treatment with DEB but did experience liver failure after treatment with conventional chemoembolization. Complication rates of our DEB group in Child-Pugh classes A and B mirror low complication rates reported by Varela et al [14] and Malagari et al [19]. Recent randomized multicenter study also showed improved…”

Advances in endovascular therapy to treat primary hepatocellular carcinoma

“…The appearance of drug-loaded microspheres has changed the nature and form of TACE (7,9). However, there is disparity in the development and use of those microspheres due to social and economic factors in various countries.…”

“…The former consists of a biocompatible polymer such as polyvinyl alcohol hydrogel while the latter consists of a super-absorbent polymer. DC Beads (the brand name in Europe) were approved by the FDA under the name LC Beads (7,8). Hepasphere microspheres were approved by the European Union in 2004 and by the FDA in 2006.…”

Hepatocellular carcinoma treated with transarterial chemoembolization: Evaluation with parametric contrast-enhanced ultrasonography

“…TACE was performed using a technique similar to that described in previous studies [1,2] . All patients were treated with subsegmental and/or segmental TACE.…”

“…One of the many evolving roles of contrast-enhanced ultrasonography (CEUS) in oncologic imaging is in the evaluation of the efficacy of transarterial chemoembolization (TACE) of liver tumors [1][2][3] . CEUS has been proved to be efficient in differentiating residual (enhancing) from necrotic (non-enhancing) tumor after TACE, and the therapeutic effect can be assessed by subjective, visual evaluation or by simple calculations (for example, by uni-or bi-dimensional measurements of the residual enhancing tumor at a representative section).…”