title: Transarterial chemoembolization in very early and early-stage hepatocellular carcinoma patients excluded from curative treatment: a prospective cohort study.
abstract: OBJECTIVE
  To assess clinical outcome of transarterial chemoembolization (TACE) in a series of patients with early-stage hepatocellular carcinoma (HCC), within Milan criteria, but clinically unfit for liver transplantation (OLT).
  
  
  METHODS
  From January 2006 to May 2009, 67 patients (43 males, mean age 70 ± 7.6 years) with very early or early-stage unresectable HCC, within Milan selection criteria but clinically unfit for OLT, underwent TACE. The primary endpoint of the study was overall survival. Secondary endpoints were: safety, liver toxicity, 1-month tumour response according to the amended RECIST criteria, time to local and distant intrahepatic tumour recurrence and time to radiological progression.
  
  
  RESULTS
  Two major periprocedural complications occurred (3%), consisting of liver failure. Periprocedural mortality rate was 1.5% (1 patient). A significant increase in ALT and bilirubin levels 24h after treatment was reported, with progressive decrease at discharge. At 1-month follow-up, complete and partial tumour response rates were 67.2% and 29.8%, respectively, with two cases of progressive disease. Mean follow-up was 37.3 ± 15 months. The 1-, 2-, and 3-year overall survival rates were 90.9%, 86.1%, and 80.5%, respectively. Median expected time to local tumour recurrence and intrahepatic tumour recurrence were 7.9 and 13.8 months, respectively. Radiological disease progression was observed in 12 patients (17.9%) with a mean expected time of 26.5 months.
  
  
  CONCLUSIONS
  In patients with early-stage HCC, clinically excluded from OLT and unfit for surgery or percutaneous ablation, TACE is a safe and effective option, with favourable long-term survival.
authors.affiliation: Diagnostic and Interventional Radiology, Pisa University Hospital, Via Paradisa 2, 56124 Pisa, Italy. irenebargellini@hotmail.com
authors.forename: Irene
authors.initials: I
authors.lastname: Bargellini
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Sacco
authors.forename: Elena
authors.initials: E
authors.lastname: Bozzi
authors.forename: Marco
authors.initials: M
authors.lastname: Bertini
authors.forename: Barbara
authors.initials: B
authors.lastname: Ginanni
authors.forename: Antonio
authors.initials: A
authors.lastname: Romano
authors.forename: Antonio
authors.initials: A
authors.lastname: Cicorelli
authors.forename: Emanuele
authors.initials: E
authors.lastname: Tumino
authors.forename: Graziana
authors.initials: G
authors.lastname: Federici
authors.forename: Roberto
authors.initials: R
authors.lastname: Cioni
authors.forename: Salvatore
authors.initials: S
authors.lastname: Metrangolo
authors.forename: Michele
authors.initials: M
authors.lastname: Bertoni
authors.forename: Giampaolo
authors.initials: G
authors.lastname: Bresci
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Parisi
authors.forename: Emanuele
authors.initials: E
authors.lastname: Altomare
authors.forename: Alfonso
authors.initials: A
authors.lastname: Capria
authors.forename: Carlo
authors.initials: C
authors.lastname: Bartolozzi
mesh_terms: D000368:Aged; D006528:Carcinoma, Hepatocellular / Q000401:mortality / Q000628:therapy*; D016461:Chemoembolization, Therapeutic / Q000379:methods* / Q000401:mortality; D016009:Chi-Square Distribution; D018450:Disease Progression; D015251:Epirubicin / Q000008:administration & dosage; D004998:Ethiodized Oil / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008111:Liver Function Tests; D008113:Liver Neoplasms / Q000401:mortality / Q000628:therapy*; D008279:Magnetic Resonance Imaging; D008297:Male; D009364:Neoplasm Recurrence, Local; D018579:Patient Selection; D011446:Prospective Studies; D015996:Survival Rate; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D015251:Epirubicin; D004998:Ethiodized Oil