title: Clinical significance of the highly sensitive fucosylated fraction of α-fetoprotein in patients with chronic liver disease.
abstract: OBJECTIVE
  The purpose of the present study was to investigate the clinical significance of the highly sensitive fucosylated fraction of α-fetoprotein (hs-AFP-L3) in patients with chronic liver disease (CLD) and low serum α-fetoprotein (AFP) concentration.
  
  
  METHODS
  A total of 241 patients being treated at our institute with CLD and low serum AFP concentration (3-10 ng/mL) were investigated retrospectively. We measured total AFP and the percentage of AFP-L3 using a µTAS Wako i30 device. The possible presence of hepatocellular carcinoma (HCC) was thoroughly investigated by various examinations carried out from 1 month before to 1 month after measurements. In addition, hs-AFP-L3 elevated and non-elevated groups, divided by the cut-off value based on a receiver-operator characteristic (ROC) curve, were followed for possible future development of HCC.
  
  
  RESULTS
  hs-AFP-L3 was above the detectable range in 60 patients (24.9%). Among those AFP-L3 positive cases, 20 (33.3%) were found to be HCC prevalent, whereas HCC was found in just 16 patients (8.8%) with undetectable hs-AFP-L3 levels. We determined the cut-off value of hs-AFP-L3%, which shows the proportion of AFP L3 in total AFP, to be 5.75%. During the follow-up period, HCC was newly detected in six patients (22.2%) in the hs-AFP-L3% elevated group and in 10 (5.6%) in the non-elevated group. Analysis using the Kaplan-Meier method showed the HCC-free rate of the hs-AFP-L3% elevated group was significantly lower than that of the non-elevated group (P=0.0038). Independent predicting variants were female sex (P=0.0024) and hs-AFP-L3% elevation (P=0.0036).
  
  
  CONCLUSIONS
  Our results suggest hs-AFP-L3 level is a useful tumor marker for HCC in patients with CLD and low serum AFP concentration.
authors.affiliation: Department of Gastroenterology and Hepatology, Shimane University, Faculty of Medicine, Izumo, Japan.
authors.forename: Takuya
authors.initials: T
authors.lastname: Hanaoka
authors.forename: Shuichi
authors.initials: S
authors.lastname: Sato
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Tobita
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Miyake
authors.forename: Shunji
authors.initials: S
authors.lastname: Ishihara
authors.forename: Shuji
authors.initials: S
authors.lastname: Akagi
authors.forename: Yuji
authors.initials: Y
authors.lastname: Amano
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Kinoshita
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor / Q000097:blood*; D006528:Carcinoma, Hepatocellular / Q000097:blood / Q000175:diagnosis* / Q000453:epidemiology; D016009:Chi-Square Distribution; D002908:Chronic Disease; D005260:Female; D005643:Fucose / Q000031:analogs & derivatives / Q000378:metabolism*; D006801:Humans; D007118:Immunoassay; D015994:Incidence; D007564:Japan / Q000453:epidemiology; D053208:Kaplan-Meier Estimate; D008107:Liver Diseases / Q000097:blood / Q000175:diagnosis* / Q000453:epidemiology; D008113:Liver Neoplasms / Q000097:blood / Q000175:diagnosis* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D015995:Prevalence; D011379:Prognosis; D016016:Proportional Hazards Models; D011499:Protein Processing, Post-Translational; D012372:ROC Curve; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D000509:alpha-Fetoproteins / Q000378:metabolism*
chemical_list: C097353:AFP protein, human; D014408:Biomarkers, Tumor; D000509:alpha-Fetoproteins; D005643:Fucose