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

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.MethodsForty-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.ResultsTACE 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 wasmore » 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).ConclusionHepaSphere 30–60 μm is an effective drug-eluting embolic material with a favourable pharmacokinetic profile.« less
Authors:
 [1] ;  [2] ;  [3] ;  [1] ; ; ;  [2] ;  [1] ;  [2] ; ;  [4] ;  [1] ;  [2] ;  [5] ;  [6] ;  [7]
  1. University of Athens, 2nd Department of Radiology (Greece)
  2. University of Athens, Imaging and Research Unit (Greece)
  3. Tzanion Hospital, Department of Radiology (Greece)
  4. Research Academy of University of Athens (Greece)
  5. Tzanion Hospital, 1st Department of Surgery (Greece)
  6. University of Athens, 2nd Department of Internal Medicine and Hepatology (Greece)
  7. University of Athens, Imaging and Research Unit, 2nd Department of Radiology (Greece)
Publication Date:
OSTI Identifier:
22318102
Resource Type:
Journal Article
Resource Relation:
Journal Name: Cardiovascular and Interventional Radiology; Journal Volume: 37; Journal Issue: 1; Other Information: Copyright (c) 2014 Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE); Article Copyright (c) 2013 The Author(s); http://www.springer-ny.com; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; AUC; BASES; CHILDREN; COMPARATIVE EVALUATIONS; DIAGRAMS; DOSES; DOXORUBICIN; HEPATOMAS; LIPIODOL; MICROSPHERES; MORTALITY; NITROGEN 16; PATIENTS; PLASMA; POLYMERS; SAFETY; SOLIDS; WHO