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CardioVascular and Interventional Radiology

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01-08-2011 | Clinical Investigation

Safety Profile of Sequential Transcatheter Chemoembolization with DC Bead^™: Results of 237 Hepatocellular Carcinoma (HCC) Patients

Authors: Katerina Malagari, Mary Pomoni, Themistoklis N. Spyridopoulos, Hippokratis Moschouris, Alexis Kelekis, Spyros Dourakis, Efthymia Alexopoulou, John Koskinas, Michalis Angelopoulos, John Kornezos, Anastasia Pomoni, Savvas Tandeles, Athanasios Marinis, Spyros Rizos, Dimitrios Kelekis

Published in: CardioVascular and Interventional Radiology | Issue 4/2011

Abstract

Introduction

Complications of chemoembolization performed with DC Bead^™ loaded with doxorubicin (DEBDOX) of diameters 100–300 μm and 300–500 μm are presented in this paper. These diameters are currently the smallest available in drug-eluting technology.

Methods

Included are 237 patients who were treated with sequential DEBDOX with doxorubicin loaded at 37.5 mg/ml of DC Bead. The National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0) were used to categorize complications.

Results

Thirty-day mortality was 1.26% (3/237). Incidence of grade 5 complications was 1.26% (3/237). Overall, grade 4 complications resulted in 5.48% (13/237) (irreversible liver failure, cholecystitis). Grade 2 liver function deterioration developed in 10 patients (4.2%). Cholecystitis/grade 2 and 4 incidents were observed in 3.6–5.06% across sessions (overall 13 patients; 5.48%). Postembolization Syndrome (PES) grade 1 or 2 was observed in up to 86.5%; however, grade 2 was observed in 25–42.19% across treatments. Pleural effusion was seen in eight patients (overall 3.37%; grade 1 in 1.8–3.7% across treatments; grade 3 in 0.42%). Grade 1 procedure-related laboratory pancreatitis was seen in 0.45%, and grade 2 gastrointestinal bleeding was seen in 0.84%. Procedure-associated skin erythema/grade 1 was seen in 0.84%. There was no correlation of liver failure or transient liver function deterioration with the diameter of the beads (p = 0.25–0.37 and p = 0.14–0.89, respectively). Stratifying with the diameter of the beads correlation values was: for cholecystitis (p = 0.11–0.96 across treatments), PES (p = 0.35–0.83), temporary/grade 1 elevation of liver enzymes (p = 0.002–0.0001), and bilirubin (p = 0.04–0.99).

Conclusions

DEBDOX chemoembolization is safe and small calibres do not result in increased complication rates compared with results of series using larger diameters of beads.

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Title: Safety Profile of Sequential Transcatheter Chemoembolization with DC Bead™: Results of 237 Hepatocellular Carcinoma (HCC) Patients
Authors: Katerina Malagari
Mary Pomoni
Themistoklis N. Spyridopoulos
Hippokratis Moschouris
Alexis Kelekis
Spyros Dourakis
Efthymia Alexopoulou
John Koskinas
Michalis Angelopoulos
John Kornezos
Anastasia Pomoni
Savvas Tandeles
Athanasios Marinis
Spyros Rizos
Dimitrios Kelekis
Publication date: 01-08-2011
Publisher: Springer-Verlag
Published in: CardioVascular and Interventional Radiology / Issue 4/2011
Print ISSN: 0174-1551
Electronic ISSN: 1432-086X
DOI: https://doi.org/10.1007/s00270-010-0044-3

At a glance: The STEP trials

Springer Medicine

Safety Profile of Sequential Transcatheter Chemoembolization with DC Bead^™: Results of 237 Hepatocellular Carcinoma (HCC) Patients

Abstract

Introduction

Methods

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Introduction

Methods

Results

Conclusions

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