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Prospective Randomized Study of Doxorubicin-Eluting-Bead Embolization in the Treatment of Hepatocellular Carcinoma: Results of the PRECISION V Study
- Source :
- Cardiovascular and Interventional Radiology, Vol. 33, No 1 (2010) pp. 41-52, Cardiovascular and Interventional Radiology, Cardiovascular and Interventional Radiology, vol. 33, no. 1, pp. 41-52
- Publication Year :
- 2009
- Publisher :
- Springer Science and Business Media LLC, 2009.
-
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.
- Subjects :
- Male
Hepatocellular carcinoma
Aged
Antibiotics, Antineoplastic/administration & dosage
Carcinoma, Hepatocellular/therapy
Chemoembolization, Therapeutic/methods
Doxorubicin/administration & dosage
Drug Carriers
Drug Implants
Female
Humans
Liver Neoplasms/therapy
Prospective Studies
Single-Blind Method
Treatment Outcome
Chemoembolization, Therapeutic/ methods
Gastroenterology
law.invention
Randomized controlled trial
law
Clinical endpoint
Antibiotics, Antineoplastic
ddc:617
10042 Clinic for Diagnostic and Interventional Radiology
Liver Neoplasms
Liver Neoplasms/ therapy
Drug-eluting beads
Carcinoma, Hepatocellular/ therapy
Tolerability
Radiology Nuclear Medicine and imaging
Chemoembolization
Cardiology and Cardiovascular Medicine
medicine.medical_specialty
Carcinoma, Hepatocellular
Doxorubicin/ administration & dosage
610 Medicine & health
2705 Cardiology and Cardiovascular Medicine
Internal medicine
Antibiotics, Antineoplastic/ administration & dosage
medicine
Carcinoma
2741 Radiology, Nuclear Medicine and Imaging
Radiology, Nuclear Medicine and imaging
Clinical Investigation
Chemoembolization, Therapeutic
Transcatheter arterial chemoembolization
Performance status
business.industry
medicine.disease
digestive system diseases
Surgery
Regimen
Doxorubicin
business
Subjects
Details
- ISSN :
- 1432086X and 01741551
- Volume :
- 33
- Database :
- OpenAIRE
- Journal :
- CardioVascular and Interventional Radiology
- Accession number :
- edsair.doi.dedup.....70e11e5f24eda034b1aa14628e89defe