Prospective randomized study of doxorubicin-eluting-bead embolization in the treatment of hepatocellular carcinoma: results of the PRECISION V study.

Détails

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Etat: Public
Version: de l'auteur
ID Serval
serval:BIB_14FF9F0AB2E9
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Prospective randomized study of doxorubicin-eluting-bead embolization in the treatment of hepatocellular carcinoma: results of the PRECISION V study.
Périodique
Cardiovascular and Interventional Radiology
Auteur(s)
Lammer J., Malagari K., Vogl T., Pilleul F., Denys A., Watkinson A., Pitton M., Sergent G., Pfammatter T., Terraz S., Benhamou Y., Avajon Y., Gruenberger T., Pomoni M., Langenberger H., Schuchmann M., Dumortier J., Mueller C., Chevallier P., Lencioni R.
Collaborateur(s)
PRECISION V Investigators
Contributeur(s)
Lammer J., Langenberger H., Schoder M., Funovics M., Loewe C., Moyses J., Grünberger T., Müller C., Waldenberger P., Chemelli A., Graziadei I., Vogl T., Khan V., Hammerstingl R., Lee C., Eichler K., Pitton M., Klöckner R., Düber C., Otto G., Wörns MA., Greten T., Kirchhoff T., Rosenthal H., Lotz J., Huppert P., Wietholtz H., Limmer A., Pilleul F., Ficarelli S., Mennesson N., Rauscher N., Dumortier J., Guillaud O., Vilgrain V., Sibert A., Chevallier P., Novellas S., Tran A., Ouzan D., Gugenheim J., Sergent G., Otal P., Joffre F., Auriol J., Péron JM., Benhamou Y., Ratzui V., Clluzel P., de Baere T., Deschamps F., Roo P., Ajavon Y., Awad S., Bellin MF., Samuel D., Castaing D., Adam R., Vallee JC., Saliba F., Azoulay D., Denys A., Triller J., Kickuth R., Terraz S., Becker CD., Majno P., Spahr L., Pfammatter T., Weishaupt D., Muellhaupt B., Malagari K., Maria P., Kelekis D., Kelekis N., Kelekis A., Emmanouil E.
ISSN
1432-086X (Electronic)
ISSN-L
0174-1551
Statut éditorial
Publié
Date de publication
2010
Volume
33
Numéro
1
Pages
41-52
Langue
anglais
Notes
Publication types: Clinical Trial, Phase II ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Résumé
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.
Mots-clé
Aged, Antibiotics, Antineoplastic/administration & dosage, Carcinoma, Hepatocellular/therapy, Chemoembolization, Therapeutic/methods, Doxorubicin/administration & dosage, Drug Carriers, Drug Implants, Female, Humans, Liver Neoplasms/therapy, Male, Prospective Studies, Single-Blind Method, Treatment Outcome
Pubmed
Web of science
Open Access
Oui
Création de la notice
18/01/2010 16:17
Dernière modification de la notice
20/08/2019 13:43
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