title: Chemoembolization of hepatocellular carcinoma with drug eluting beads: efficacy and doxorubicin pharmacokinetics.
abstract: OBJECTIVE
  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.
authors.affiliation: Liver Unit, IMDM, Barcelona Clínic Liver Cancer (BCLC) Group, Hospital Clínic, CIBER HEPAD, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi I Sunyer, IDIBAPS, Barcelona, Spain.
authors.forename: María
authors.initials: M
authors.lastname: Varela
authors.forename: María Isabel
authors.initials: MI
authors.lastname: Real
authors.forename: Marta
authors.initials: M
authors.lastname: Burrel
authors.forename: Alejandro
authors.initials: A
authors.lastname: Forner
authors.forename: Margarita
authors.initials: M
authors.lastname: Sala
authors.forename: Mercé
authors.initials: M
authors.lastname: Brunet
authors.forename: Carmen
authors.initials: C
authors.lastname: Ayuso
authors.forename: Lluis
authors.initials: L
authors.lastname: Castells
authors.forename: Xavier
authors.initials: X
authors.lastname: Montañá
authors.forename: Josep M
authors.initials: JM
authors.lastname: Llovet
authors.forename: Jordi
authors.initials: J
authors.lastname: Bruix
mesh_terms: D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000493:pharmacokinetics*; D019540:Area Under Curve; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy*; D016461:Chemoembolization, Therapeutic / Q000009:adverse effects / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage / Q000493:pharmacokinetics*; D016503:Drug Delivery Systems; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D007269:Injections, Intra-Arterial; D008113:Liver Neoplasms / Q000188:drug therapy*; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D004317:Doxorubicin