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CardioVascular and Interventional Radiology

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Open Access 01-02-2014 | Clinical Investigation

Chemoembolization of Hepatocellular Carcinoma with Hepasphere 30–60 μm. Safety and Efficacy Study

Authors: Katerina Malagari, Maria Pomoni, Hippokratis Moschouris, Alexios Kelekis, Angelos Charokopakis, Evanthia Bouma, Themistoklis Spyridopoulos, Achilles Chatziioannou, Vlasios Sotirchos, Theodoros Karampelas, Constantin Tamvakopoulos, Dimitrios Filippiadis, Enangelos Karagiannis, Athanasios Marinis, John Koskinas, Dimitrios A. Kelekis

Published in: CardioVascular and Interventional Radiology | Issue 1/2014

Abstract

Background

This study examined the safety, pharmacokinetics, and efficacy of transarterial chemoembolization of hepatocellular carcinoma (HCC) using a newly developed size of a superabsorbent polymer drug-eluting embolic material.

Methods

Forty-five patients with documented HCC (Child–Pugh score A/B: 55.5 %/44.5 %) were embolized with HepaSphere microspheres 30–60 μm with escalation of lesion, dose, and frequency of re-embolization. Local response was evaluated with modified response evaluation criteria in solid tumors (mRECIST). Plasma levels of doxorubicin were measured in 24 patients at baseline and at 5, 20, 40, 60, and 120 min, at 6, 24, and 48 h, and at 7 days, respectively, to determine doxorubicin in plasma (Cmax) and area under the curve (AUC). Measurements of three patients who underwent lipiodol-based conventional chemoembolization (c-TACE) were also performed.

Results

TACE with HepaSphere was well tolerated with an acceptable safety profile and no 30-day mortality. Response rates were calculated on intention-to-treat basis with complete response (CR) in 17.8 % reaching 22.2 % for the target lesion. Overall partial response (PR) was seen in 51.1 %, stable disease in 20 %, and progressive disease in 11.1 % of patients. Overall objective response (CR + PR), including patients treated at all dosages of doxorubicin, was seen in 68.9 % of cases. After a median follow-up of 15.6 months, 1-year survival is 100 %. Doxorubicin AUC was significantly lower in patients with HepaSphere 30–60 μm (35,195 ± 27,873 ng × min/ml) than in patients with conventional TACE (103,960 ± 16,652 ng × min/ml; p = 0.009). Cmax was also significantly lower with HepaSphere 30–60 μm (83.9 ± 32.1 ng/ml) compared with c-TACE (761.3 ± 58.8 ng/ml; p = 0.002).

Conclusion

HepaSphere 30–60 μm is an effective drug-eluting embolic material with a favourable pharmacokinetic profile.

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Title: Chemoembolization of Hepatocellular Carcinoma with Hepasphere 30–60 μm. Safety and Efficacy Study
Authors: Katerina Malagari
Maria Pomoni
Hippokratis Moschouris
Alexios Kelekis
Angelos Charokopakis
Evanthia Bouma
Themistoklis Spyridopoulos
Achilles Chatziioannou
Vlasios Sotirchos
Theodoros Karampelas
Constantin Tamvakopoulos
Dimitrios Filippiadis
Enangelos Karagiannis
Athanasios Marinis
John Koskinas
Dimitrios A. Kelekis
Publication date: 01-02-2014
Publisher: Springer US
Published in: CardioVascular and Interventional Radiology / Issue 1/2014
Print ISSN: 0174-1551
Electronic ISSN: 1432-086X
DOI: https://doi.org/10.1007/s00270-013-0777-x

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Chemoembolization of Hepatocellular Carcinoma with Hepasphere 30–60 μm. Safety and Efficacy Study

Abstract

Background

Methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

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