title: Randomised controlled trial of doxorubicin-eluting beads vs conventional chemoembolisation for hepatocellular carcinoma.
abstract: BACKGROUND
  Transcatheter arterial chemoembolisation (TACE) is the treatment of choice for intermediate stage hepatocellular carcinoma (HCC). Doxorubicin-loaded drug-eluting beads (DEB)-TACE is expected to improve the performance of conventional TACE (cTACE). The aim of this study was to compare DEB-TACE with cTACE in terms of time-to-tumour progression (TTP), adverse events (AEs), and 2-year survival.
  
  
  METHODS
  Patients were randomised one-to-one to undergo cTACE or DEB-TACE and followed-up for at least 2 years or until death. Transcatheter arterial chemoembolisation was repeated 'on-demand'.
  
  
  RESULTS
  We enrolled 177 patients: 89 underwent DEB-TACE and 88 cTACE. The median number of procedures was 2 in each arm, and the in-hospital stay was 3 and 4 days, respectively (P=0.323). No differences were found in local and overall tumour response. The median TTP was 9 months in both arms. The AE incidence and severity did not differ between the arms, except for post-procedural pain, more frequent and severe after cTACE (P<0.001). The 1- and 2-year survival rates were 86.2% and 56.8% after DEB-TACE and 83.5% and 55.4% after cTACE (P=0.949). Eastern Cooperative Oncology Group (ECOG), serum albumin, and tumour number independently predicted survival (P<0.05).
  
  
  CONCLUSIONS
  The DEB-TACE and the cTACE are equally effective and safe, with the only advantage of DEB-TACE being less post-procedural abdominal pain.
authors.affiliation: Radiology Unit, Department of Digestive Disease and Internal Medicine, S. Orsola-Malpighi Hospital, Bologna University, Albertoni Street 15, 40138 Bologna, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Golfieri
authors.affiliation: Radiology Unit, Department of Digestive Disease and Internal Medicine, S. Orsola-Malpighi Hospital, Bologna University, Albertoni Street 15, 40138 Bologna, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Giampalma
authors.affiliation: Radiology Unit, Department of Digestive Disease and Internal Medicine, S. Orsola-Malpighi Hospital, Bologna University, Albertoni Street 15, 40138 Bologna, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Renzulli
authors.affiliation: Diagnostic and Interventional Radiology, Department of Oncology, Transplants and Advanced Technologies in Medicine, University of Pisa, Pisa, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Cioni
authors.affiliation: Diagnostic and Interventional Radiology, Department of Oncology, Transplants and Advanced Technologies in Medicine, University of Pisa, Pisa, Italy.
authors.forename: I
authors.initials: I
authors.lastname: Bargellini
authors.affiliation: Diagnostic and Interventional Radiology, Department of Oncology, Transplants and Advanced Technologies in Medicine, University of Pisa, Pisa, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Bartolozzi
authors.affiliation: Diagnostic Imaging Division, Department of Medical and Surgical Disciplines University of Turin, AOU S. Giovanni Battista, Turin, Italy.
authors.forename: A D
authors.initials: AD
authors.lastname: Breatta
authors.affiliation: Diagnostic Imaging Division, Department of Medical and Surgical Disciplines University of Turin, AOU S. Giovanni Battista, Turin, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Gandini
authors.affiliation: CeLiveR, Ospedali Riuniti di Bergamo, Bergamo, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Nani
authors.affiliation: Department of Radiologic Sciences, University Hospital, S. Maria della Misericordia, Udine, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Gasparini
authors.affiliation: Department of Medical and Surgical Sciences, Alma Mater Studiorum - University of Bologna, Bologna, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Cucchetti
authors.affiliation: Department of Medical and Surgical Sciences, Alma Mater Studiorum - University of Bologna, Bologna, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Bolondi
authors.affiliation: Department of Medical and Surgical Sciences, Alma Mater Studiorum - University of Bologna, Bologna, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Trevisani
mesh_terms: D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage*; D006528:Carcinoma, Hepatocellular / Q000628:therapy*; D016461:Chemoembolization, Therapeutic / Q000379:methods*; D004317:Doxorubicin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000628:therapy*; D008297:Male; D011446:Prospective Studies; D015996:Survival Rate
chemical_list: D000903:Antibiotics, Antineoplastic; D004317:Doxorubicin