title: Prospective randomized study of doxorubicin-eluting-bead embolization in the treatment of hepatocellular carcinoma: results of the PRECISION V study.
abstract: Transcatheter arterial chemoembolization (TACE) offers a survival benefit to patients with intermediate hepatocellular carcinoma (HCC). A widely accepted TACE regimen includes administration of doxorubicin-oil emulsion followed by gelatine sponge-conventional TACE. Recently, a drug-eluting bead (DC Bead) has been developed to enhance tumor drug delivery and reduce systemic availability. This randomized trial compares conventional TACE (cTACE) with TACE with DC Bead for the treatment of cirrhotic patients with HCC. Two hundred twelve patients with Child-Pugh A/B cirrhosis and large and/or multinodular, unresectable, N0, M0 HCCs were randomized to receive TACE with DC Bead loaded with doxorubicin or cTACE with doxorubicin. Randomization was stratified according to Child-Pugh status (A/B), performance status (ECOG 0/1), bilobar disease (yes/no), and prior curative treatment (yes/no). The primary endpoint was tumor response (EASL) at 6 months following independent, blinded review of MRI studies. The drug-eluting bead group showed higher rates of complete response, objective response, and disease control compared with the cTACE group (27% vs. 22%, 52% vs. 44%, and 63% vs. 52%, respectively). The hypothesis of superiority was not met (one-sided P = 0.11). However, patients with Child-Pugh B, ECOG 1, bilobar disease, and recurrent disease showed a significant increase in objective response (P = 0.038) compared to cTACE. DC Bead was associated with improved tolerability, with a significant reduction in serious liver toxicity (P < 0.001) and a significantly lower rate of doxorubicin-related side effects (P = 0.0001). TACE with DC Bead and doxorubicin is safe and effective in the treatment of HCC and offers a benefit to patients with more advanced disease.
authors.affiliation: Cardiovascular and Interventional Radiology, Medical University Vienna, Vienna, Austria. johannes.lammer@meduniwien.ac.at
authors.forename: Johannes
authors.initials: J
authors.lastname: Lammer
authors.forename: Katarina
authors.initials: K
authors.lastname: Malagari
authors.forename: Thomas
authors.initials: T
authors.lastname: Vogl
authors.forename: Frank
authors.initials: F
authors.lastname: Pilleul
authors.forename: Alban
authors.initials: A
authors.lastname: Denys
authors.forename: Anthony
authors.initials: A
authors.lastname: Watkinson
authors.forename: Michael
authors.initials: M
authors.lastname: Pitton
authors.forename: Geraldine
authors.initials: G
authors.lastname: Sergent
authors.forename: Thomas
authors.initials: T
authors.lastname: Pfammatter
authors.forename: Sylvain
authors.initials: S
authors.lastname: Terraz
authors.forename: Yves
authors.initials: Y
authors.lastname: Benhamou
authors.forename: Yves
authors.initials: Y
authors.lastname: Avajon
authors.forename: Thomas
authors.initials: T
authors.lastname: Gruenberger
authors.forename: Maria
authors.initials: M
authors.lastname: Pomoni
authors.forename: Herbert
authors.initials: H
authors.lastname: Langenberger
authors.forename: Marcus
authors.initials: M
authors.lastname: Schuchmann
authors.forename: Jerome
authors.initials: J
authors.lastname: Dumortier
authors.forename: Christian
authors.initials: C
authors.lastname: Mueller
authors.forename: Patrick
authors.initials: P
authors.lastname: Chevallier
authors.forename: Riccardo
authors.initials: R
authors.lastname: Lencioni
mesh_terms: D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage*; D006528:Carcinoma, Hepatocellular / Q000628:therapy*; D016461:Chemoembolization, Therapeutic / Q000379:methods*; D004317:Doxorubicin / Q000008:administration & dosage*; D004337:Drug Carriers; D004343:Drug Implants; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000628:therapy*; D008297:Male; D011446:Prospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D004337:Drug Carriers; D004343:Drug Implants; D004317:Doxorubicin