The clinical application of PIVKA‐II in hepatocellular carcinoma and chronic liver diseases: A multi‐center study in China

BACKGROUND: Due to the absence of specific symptoms and low survival rate, efficient biomarkers for hepatocellular carcinoma (HCC) diagnosis are urgently required. The purpose of this study was to evaluate the diagnostic performance of protein induced by vitamin K absence or antagonist‐II (PIVKA‐II) and to determine the optimal cutoff values for HBV infection‐related HCC. METHODS: We conducted a cross‐sectional, multi‐center study in China to ascertain the cutoff value for HCC patients in the context of CHB‐ and HBV‐related cirrhosis. The receiver operating characteristic curve (ROC) and the area under the curve (AUC) were used to evaluate the diagnostic performance of PIVKA‐II. RESULTS: This study enrolled 784 subjects and demonstrated that PIVKA‐II had a sensitivity of 84.08% and a specificity of 90.43% in diagnosis HCC from chronic liver diseases. PIVKA‐II at a cutoff of 37.5 mAU/mL yielded an AUC of 0.9737 (sensitivity 91.78% and specificity 96.30%) in discriminating HCC from chronic hepatitis B (CHB) patients. PIVKA‐II at a cutoff of 45 mAU/mL yielded an AUC of 0.9419 (sensitivity 77.46% and specificity 95.12%) in discriminating HCC‐ from HBV‐related cirrhosis patients. Furthermore, using a cutoff value of 40 mAU/mL for PIVKA‐II as an HCC marker, only 4.81% (15/312) was positive in chronic hepatitis and 12.80% (37/289) in cirrhosis patients, revealing the satisfactory specificity of PIVKA‐II in chronic liver disease of different etiologies. CONCLUSION: Our data indicated that PIVKA‐II had satisfactory diagnostic efficiencies and could be used as a screening or surveillance biomarker in HCC high‐risk population.