title: A new approach to the use of α-fetoprotein as surveillance test for hepatocellular carcinoma in patients with cirrhosis.
abstract: BACKGROUND
  Surveillance for hepatocellular carcinoma (HCC) is recommended in patients with cirrhosis. As α-fetoprotein (AFP) is considered a poor surveillance test, we tested the performance of its changes over time.
  
  
  METHODS
  Eighty patients were diagnosed with HCC (cases) during semiannual surveillance with ultrasonography and AFP measurement were recruited and matched for age, gender, etiology and Child-Pugh class with 160 contemporary cancer-free controls undergoing the same surveillance training group (TG). As a validation group (VG) we considered 36 subsequent patients diagnosed with HCC, matched 1 : 3 with contemporary cancer-free controls. α-Fetoprotein values at the time of HCC diagnosis (T0) and its changes over the 12 (Δ12) and 6 months (Δ6) before cancer detection were considered.
  
  
  RESULTS
  In both TG and VG, >80% of HCCs were found at an early stage. In TG, AFP significantly increased over time only in cases. T0 AFP and a positive Δ6 were independently associated with HCC diagnosis (odds ratio: 1.031 and 2.402, respectively). The area under the curve of T0 AFP was 0.76 and its best cutoff (BC) was 10 ng ml(-1) (sensitivity 66.3%, specificity 80.6%). The combination of AFP >10 ng ml(-1) or a positive Δ6 composite α-fetoprotein index (CAI) increased the sensitivity to 80% with a negative predictive value (NPV) of 86.2%. Negative predictive value rose to 99%, considering a cancer prevalence of 3%. In the VG, the AFP-BC was again 10 ng ml(-1) (sensitivity 66.7%, specificity 88.9%), and CAI sensitivity was 80.6% with a NPV value of 90.5%.
  
  
  CONCLUSIONS
  CAI achieves adequate sensitivity and NPV as a surveillance test for the early detection of HCC in cirrhosis.
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Biselli
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Conti
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Gramenzi
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Frigerio
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Cucchetti
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Fatti
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
authors.forename: M
authors.initials: M
authors.lastname: D'Angelo
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Dall'Agata
authors.affiliation: Dipartimento di Medicina Interna, Unità di Gastroenterologia, Università di Genova, Genova, Italy.
authors.forename: E G
authors.initials: EG
authors.lastname: Giannini
authors.affiliation: Dipartimento di Scienze Chirurgiche e Gastroenterologiche, Unità di Gastroenterologia, Università di Padova, Padova, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Farinati
authors.affiliation: Divisione di Chirurgia, Policlinico San Marco, Zingonia, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Ciccarese
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Andreone
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Bernardi
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Trevisani
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006528:Carcinoma, Hepatocellular / Q000737:chemistry* / Q000175:diagnosis; D016022:Case-Control Studies; D005260:Female; D006801:Humans; D008103:Liver Cirrhosis / Q000175:diagnosis*; D008113:Liver Neoplasms / Q000737:chemistry* / Q000175:diagnosis; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012189:Retrospective Studies; D000509:alpha-Fetoproteins / Q000032:analysis*
chemical_list: C097353:AFP protein, human; D000509:alpha-Fetoproteins