Safety, Efficacy and Distribution of Doxorubicin Loaded Radiopaque Beads in Chemoembolization in Intermediate Stage Hepatocellular Carcinoma (HCC) with Correlation with Local Response.
Barcelona clinic liver cancer (BCLC)
DC bead LUMI™
Drug eluting microspheres
Hepatocellular carcinoma (HCC)
Radiopaque loadable microspheres
Journal
Cardiovascular and interventional radiology
ISSN: 1432-086X
Titre abrégé: Cardiovasc Intervent Radiol
Pays: United States
ID NLM: 8003538
Informations de publication
Date de publication:
Mar 2023
Mar 2023
Historique:
received:
29
03
2022
accepted:
14
12
2022
pubmed:
19
1
2023
medline:
17
3
2023
entrez:
18
1
2023
Statut:
ppublish
Résumé
The primary objectives of this study were to evaluate safety, and efficacy of Transarterial Chemoembolization (TACE) using doxorubicin-loaded radiopaque microspheres (DC Bead LUMI™) for the treatment of early and intermediate stage Hepatocellular Carcinoma (HCC) not amenable for curative treatments. Distribution of the microspheres was correlated with results post embolization. This was a prospective, single arm, open label study. The primary outcome measures were distribution of the radiopaque microspheres as showed by computerized tomography (CT) and local response measured by modified Response Evaluation Criteria (mRECIST) after Magnetic Resonance Imaging (MRI). Secondary measures were Time to Progression (TTP) and Overall Survival (OS). Fifty patients were enrolled over 36 months. Median age was 69.0 years; mean sum of target lesions diameters was 78.6 ± 36.8 mm. There were no Grade 4 or 5 adverse events (AEs). At 6 months Complete Response (CR) (18%), Partial Response (PR) (62%), Objective Response OR (80%) and Stable Disease (SD) (20%) were recorded. Before embolization, Diffusion Weighted Imaging (DWI) showed high signal (restricted diffusion). Post procedure, patients with dense deposition (< 5 mm distance of microsphere aggregations) showed 100% absence of enhancement and no restriction in 30.6%. Median TTP was 8.3 months. TTP for patients with CR was 13.3 months and 7.2 and 5.6 for PR and SD, respectively. At 6 and 36 months, survival was 94% and 34%, respectively. DC Bead LUMI™ is well tolerated and effective in early and intermediate stage HCC with maximal necrosis obtained in dense deposition in the target.
Identifiants
pubmed: 36653660
doi: 10.1007/s00270-022-03346-1
pii: 10.1007/s00270-022-03346-1
doi:
Substances chimiques
Doxorubicin
80168379AG
Antibiotics, Antineoplastic
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
337-349Subventions
Organisme : The study was supported by 'Biocompatibles UK Ltd., a wholly owned subsidiary of Boston Scientific Corporation
ID : 50
Informations de copyright
© 2023. Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).
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