R Lamerz1, M Runge, P Stieber, E Meissner. 1. Department of Internal Medicine II, Ludwig-Maximilians-University, Munich, Germany. lamerz@med2.med.uni-muenchen.de
Abstract
BACKGROUND: The concentration of Des-gamma-carboxy-prothrombin (DCP) or PIVKA-II has been described to be increased in patients with hepatocellular cancer, 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: Measurements were performed in duplicate in serum of 87 patients with benign (acute/chronic hepatitis B/C/autoimmune, liver cirrhosis B/C/alcoholic) and 154 patients with highly probable (CT, MRT imaging) or histologically proven HCC. Two commercial or research ELISA tests (1: Eitest MonoP-II, Eisai, Tokyo, Japan; 2: Asserachrom PIVKA-II, Stago, France) using murine monoclonal anti-PIVKA-II antibodies were used comparatively and compared with a laboratory-developed conventional AFP-RIA. RESULTS: By ROC analysis, a highly significant discrimination (p < 0.0001) was found at cutoffs of 0.09 AU/ml (Eisai) or 0.8 ng/ml (Stago) at a specificity of about 90% (Eisai: s = 78.6%, ppv = 0.92, npv = 0.70; Stago: 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 (rS = 0.89, p < 0.0001) than benign groups (rS = 0.41, p < 0.001) and a lower correlation between the AFP and Eisai (rS = 0.27/0.36, p < 0.01) and Stago test for the malignant group (0.16; p < 0.05). CONCLUSION: DCP determination in serum/plasma adds significantly in the discrimination between benign and malignant liver diseases.
BACKGROUND: The concentration of Des-gamma-carboxy-prothrombin (DCP) or PIVKA-II has been described to be increased in patients with hepatocellular cancer, 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: Measurements were performed in duplicate in serum of 87 patients with benign (acute/chronic hepatitis B/C/autoimmune, liver cirrhosis B/C/alcoholic) and 154 patients with highly probable (CT, MRT imaging) or histologically proven HCC. Two commercial or research ELISA tests (1: Eitest MonoP-II, Eisai, Tokyo, Japan; 2: Asserachrom PIVKA-II, Stago, France) using murine monoclonal anti-PIVKA-II antibodies were used comparatively and compared with a laboratory-developed conventional AFP-RIA. RESULTS: By ROC analysis, a highly significant discrimination (p < 0.0001) was found at cutoffs of 0.09 AU/ml (Eisai) or 0.8 ng/ml (Stago) at a specificity of about 90% (Eisai: s = 78.6%, ppv = 0.92, npv = 0.70; Stago: 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 (rS = 0.89, p < 0.0001) than benign groups (rS = 0.41, p < 0.001) and a lower correlation between the AFP and Eisai (rS = 0.27/0.36, p < 0.01) and Stago test for the malignant group (0.16; p < 0.05). CONCLUSION: DCP determination in serum/plasma adds significantly in the discrimination between benign and malignant liver diseases.
Authors: Anna S Lok; Richard K Sterling; James E Everhart; Elizabeth C Wright; John C Hoefs; Adrian M Di Bisceglie; Timothy R Morgan; Hae-Young Kim; William M Lee; Herbert L Bonkovsky; Jules L Dienstag Journal: Gastroenterology Date: 2009-10-20 Impact factor: 22.682