title: Chemoembolization of hepatocellular carcinoma with HepaSphere 30-60 μm. Safety and efficacy study.
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).
  
  
  CONCLUSIONS
  HepaSphere 30-60 μm is an effective drug-eluting embolic material with a favourable pharmacokinetic profile.
authors.affiliation: 2nd Department of Radiology, University of Athens, Athens, Greece, kmalag@otenet.gr.
authors.forename: Katerina
authors.initials: K
authors.lastname: Malagari
authors.forename: Maria
authors.initials: M
authors.lastname: Pomoni
authors.forename: Hippokratis
authors.initials: H
authors.lastname: Moschouris
authors.forename: Alexios
authors.initials: A
authors.lastname: Kelekis
authors.forename: Angelos
authors.initials: A
authors.lastname: Charokopakis
authors.forename: Evanthia
authors.initials: E
authors.lastname: Bouma
authors.forename: Themistoklis
authors.initials: T
authors.lastname: Spyridopoulos
authors.forename: Achilles
authors.initials: A
authors.lastname: Chatziioannou
authors.forename: Vlasios
authors.initials: V
authors.lastname: Sotirchos
authors.forename: Theodoros
authors.initials: T
authors.lastname: Karampelas
authors.forename: Constantin
authors.initials: C
authors.lastname: Tamvakopoulos
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Filippiadis
authors.forename: Enangelos
authors.initials: E
authors.lastname: Karagiannis
authors.forename: Athanasios
authors.initials: A
authors.lastname: Marinis
authors.forename: John
authors.initials: J
authors.lastname: Koskinas
authors.forename: Dimitrios A
authors.initials: DA
authors.lastname: Kelekis
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics; D006528:Carcinoma, Hepatocellular / Q000175:diagnosis / Q000628:therapy*; D016461:Chemoembolization, Therapeutic / Q000379:methods*; D003287:Contrast Media; D003952:Diagnostic Imaging; D004317:Doxorubicin / Q000008:administration & dosage* / Q000493:pharmacokinetics; D004337:Drug Carriers; D004998:Ethiodized Oil / Q000008:administration & dosage* / Q000493:pharmacokinetics; D005260:Female; D006801:Humans; D008111:Liver Function Tests; D008113:Liver Neoplasms / Q000175:diagnosis / Q000628:therapy*; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D010743:Phospholipids; D011108:Polymers; D011446:Prospective Studies; D013459:Sulfur Hexafluoride; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D003287:Contrast Media; D004337:Drug Carriers; D010743:Phospholipids; D011108:Polymers; C420843:contrast agent BR1; D004998:Ethiodized Oil; D004317:Doxorubicin; D013459:Sulfur Hexafluoride