BACKGROUND AND AIMS: Lens culinaris agglutinin-reactive fraction of alpha-fetoprotein (AFP-L3%) has been reported to be useful in the early detection of hepatocellular carcinoma (HCC) in Japan. The aim of this prospective study was to compare the clinical utility of AFP-L3% with that of total AFP in North American patients. METHODS: Patients with chronic hepatitis (CH) C virus-related cirrhosis from 7 clinical sites were prospectively followed every 3-6 months for 2 yr. RESULTS: Of the 372 patients evaluated, 40 had hepatitis C virus-related HCC at entry and 332 entered the prospective trial. Of the latter, 34 developed HCC and 298 remained free of HCC. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for AFP were 60.8%, 71.1%, 34.4%, and 88.0% with a cutoff of 20 ng/mL and 21.6%, 98.7%, 80.0%, and 83.5% with a cutoff of 200 ng/mL, compared to 36.5%, 91.6%, 51.9%, and 85.3% for AFP-L3% with a cutoff of 10%. In those with an elevated AFP (20-200 ng/mL), AFP-L3% had a specificity of 86.6% and an NPV of 80.7%. Multivariate analysis identified AFP, AFP-L3%, and age as independent predictors of HCC. Elevated AFP-L3% was associated with a lower cumulative HCC-free rate at 2 yr (58.9%) than was AFP (82.0%, P = 0.01). CONCLUSIONS: The incidence of HCC was significantly higher in patients with elevated AFP-L3% than in those with elevated AFP. The high specificity of AFP-L3% persisted among patients with elevated AFP (20-200 ng/mL) and suggests that AFP-L3% has clinical utility in HCV patients with AFP of 20-200 ng/mL.
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