title: Safety profile of sequential transcatheter chemoembolization with DC Bead™: results of 237 hepatocellular carcinoma (HCC) patients.
abstract: BACKGROUND
  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.
authors.affiliation: Imaging and Research Unit, Evgenidion University Hospital, 20 Papadiamandopoulou Street, Ilisia 11528, Athens, Greece. kmalag@otenet.gr
authors.forename: Katerina
authors.initials: K
authors.lastname: Malagari
authors.forename: Mary
authors.initials: M
authors.lastname: Pomoni
authors.forename: Themistoklis N
authors.initials: TN
authors.lastname: Spyridopoulos
authors.forename: Hippokratis
authors.initials: H
authors.lastname: Moschouris
authors.forename: Alexis
authors.initials: A
authors.lastname: Kelekis
authors.forename: Spyros
authors.initials: S
authors.lastname: Dourakis
authors.forename: Efthymia
authors.initials: E
authors.lastname: Alexopoulou
authors.forename: John
authors.initials: J
authors.lastname: Koskinas
authors.forename: Michalis
authors.initials: M
authors.lastname: Angelopoulos
authors.forename: John
authors.initials: J
authors.lastname: Kornezos
authors.forename: Anastasia
authors.initials: A
authors.lastname: Pomoni
authors.forename: Savvas
authors.initials: S
authors.lastname: Tandeles
authors.forename: Athanasios
authors.initials: A
authors.lastname: Marinis
authors.forename: Spyros
authors.initials: S
authors.lastname: Rizos
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Kelekis
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D006528:Carcinoma, Hepatocellular / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D016461:Chemoembolization, Therapeutic / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D004317:Doxorubicin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006115:Greece; D006801:Humans; D008111:Liver Function Tests; D008113:Liver Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging
chemical_list: D000903:Antibiotics, Antineoplastic; D004317:Doxorubicin