Chemoembolization of hepatocellular carcinoma with drug eluting beads: efficacy and doxorubicin pharmacokinetics.
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.
Varela
María
M
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.
Real
María Isabel
MI
Burrel
Marta
M
Forner
Alejandro
A
Sala
Margarita
M
Brunet
Mercé
M
Ayuso
Carmen
C
Castells
Lluis
L
Montañá
Xavier
X
Llovet
Josep M
JM
Bruix
Jordi
J
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
D000903:Antibiotics, Antineoplastic; D004317:Doxorubicin