Chemoembolization of hepatocellular carcinoma with drug eluting beads:: Efficacy and doxorubicin pharmacokinetics

Background/Aims: This study assesses the safety, pharmacokinetics and efficacy of transarterial chemoembolization using drug eluting beads (DEB), an embolizing device that slowly releases chemotherapy to decrease systemic toxicity. Methods: Twenty-seven Child-Pugh A cirrhotics (76% male, 59% HCV) with untreated large/multifocal HCC received chemoembolization with doxorubicin loaded DEBs at doses adjusted for bilirubin and body surface (range: 47-150 mg). Clinical and analytical data were recorded at 24 and 48 h, 7, 14 and 30 days after first and second TACE. Response rate was assessed by CT at 6 months. Blood samples were obtained in 13 patients at 5, 20, 40, 60, 120 min, 6, 24, 48 and 168 h to determine doxorubicin C-max and AUC. Results: DEB-TACE was well tolerated with an acceptable safety profile. Two cases developed liver abscess, one leading to death. Response rate was 75% (66.6% on intention-to-treat). Doxorubicin C-max and AUC were significantly lower in DEB-TACE patients (78.97 +/- 38.3 ngAnL and 662.6 +/- 417.6 ng/mL min) than in conventional TACE (2341.5 +/- 3951.9 ng/mL and 1812.2 +/- 1093.7 ng/mL min, p = 0.00002 and p = 0.001, respectively). After a median follow-up of 27.6 months, 1-and 2-year survival is 92.5% and 88.9%, respectively. Conclusions: Chemoembolization using DEBs is an effective procedure with a favorable pharmacokinetic profile. (c) 2007 Published by Elsevier B.V. on behalf of the European Association for the Study of the Liver.