Clinical utility of highly sensitive Lens culinaris agglutinin-reactive alpha-fetoprotein in hepatocellular carcinoma patients with alpha-fetoprotein <20 ng/mL.

The Lens culinaris agglutinin-reactive fraction of alpha-fetoprotein (AFP-L3) has been used as a diagnostic and prognostic marker of hepatocellular carcinoma (HCC). The analytical sensitivity of a conventional method for AFP-L3% is not sufficient in patients with a low AFP level. This study was performed to determine the clinical utility of a newly developed highly sensitive AFP-L3% (hs-AFP-L3%) assay in patients with an AFP level <20 ng/mL. In the cohort study, serum samples obtained from 270 patients with newly diagnosed HCC before treatment and 396 patients with chronic liver disease at Ogaki Municipal Hospital, in both of which the AFP level was <20 ng/mL, were measured for conventional AFP-L3% (c-AFP-L3%), hs-AFP-L3% and des-gamma-carboxy prothrombin (DCP). Diagnostic sensitivity and specificity of hs-AFP-L3% at a cut-off level of 5% were 41.5% and 85.1%, respectively, significantly increasing the sensitivity from 7.0% for c-AFP-L3%. Multivariate analysis identified hs-AFP-L3% as an independent factor associated with reduced long-term survival. The survival rate of patients with high hs-AFP-L3% (≥ 5%) before treatment was significantly poorer than that of patients with low hs-AFP-L3% (<5%) (P < 0.001). In patients with AFP <20 ng/mL, measurements of AFP-L3% by the highly sensitive method before treatment were more useful for diagnosis and prognosis of HCC than by the conventional method.