Use of serum PIVKA-II (DCP) determination for differentiation between benign and malignant liver diseases

Background: The concentration of Des-gamma-carboxy-prothrombin (DCP) or PIV KA-II has been described to be increased in patients with hepatocellular ca ncer, along with its elevation in vitamin K deficient states by warfarin or dicoumarol treatment. The aim of the study was to investigate its clinical value in HCC in comparison with alpha-fetoprotein. Patients and Methods: M easurements were performed in duplicate in serum of 87 patients with benign (acute/chronic hepatitis B/C/autoimmune, liver cirrhosis B/C/alcoholic) an d 154 patients with highly probable (CT, MRT imaging) or histologically pro ven HCC. Two commercial or research ELISA tests (1:: Eitest MonoP-II, Eisai , Tokyo, Japan; 2: Asserachrom PIVKA-II, Stage, France) using murine monocl onal anti-PIVKA-II antibodies were used comparatively and compared with a l aboratory-developed conventional AFP-RIA. Results: By ROC analysis, a highl y significant discrimination (p<0.0001) was found at cutoffs of 0.09 A U/ml (Eisai) or 0.8 ng/ml (Stago) at a specificity of about 90% (Eisai:s 78.6%, ppv=0.92, npv=0.70; Stage,s=77.9% ppv=0.93, npv=0.70) compared with the AFP -test at a cutoff of 45 ng/ml (sp=91% s=58.4% ppv=0.92, npv=0.55). A higher significant correlation was seen between both DCP tests in malignant (r(S) =0.89, p<0.0001) than benign groups (r(S)=0.41, p<0.001) and a lower correl ation between the AFP and Eisai (r(S)=0.27/0.36, p<0.01) and Stage test for the malignant group (0.16; p<0.05). Conclusion: DCP determination in serum /plasma adds significantly in the discrimination between benign and maligna nt liver diseases.