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 Cmax 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 Cmax and AUC were significantly lower in DEB-TACE patients (78.97+/-38.3 ng/mL and 662.6+/-417.6 ng/mLmin) than in conventional TACE (2341.5+/-3951.9 ng/mL and 1812.2+/-1093.7 ng/mLmin, 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.