Background & aims: Prothrombin induced by vitamin K absence-II (PIVKA II) is a diagnostic marker and a major prognostic factor for hepatocellular carcinoma (HCC) with limited experience in European patients.
The aim of this study was to investigate the clinical utility of simultaneous measurement of alphafetoprotein (AFP) and PIVKA II for hepatocellular carcinoma (HCC) diagnosis.
Methods: In a Romanian cohort, we performed a case-control study to compare the performances of AFP and PIVKA-II serum levels for HCC diagnosis. To determine the diagnostic value of both biomarkers in distinguishing HCC from liver cirrhosis, receiver operating characteristic (ROC) curves were constructed for each biomarker and their combination.
Results: From January 2016 to December 2017, 54 cirrhotic patients and 59 HCC cases were prospectively included. ROC curve analysis showed that 63 mAU mL and 6 ng mL were the optimal cut-off values for PIVKA-II and AFP respectively for diagnosis of HCC in our cohort.
For HCC diagnosis in patients with AFP levels <20 ng mL, the combination of AFP and PIVKA II had a specificity of 93.8% vs. 68.8 for AFP (AUC 0.846 vs. 0.732 respectively) (p=0.03). For the diagnosis of early HCC, the combination of AFP and PIVKA-II had a sensitivity of 72.7% and a specificity of 90.9% vs. 69% and 75% for AFP (AUC 0.867 vs. 0.825, respectively).
Conclusion: The diagnostic performance of a combination of AFP and PIVKA II is better to that of either marker alone, in the diagnosis of HCC especially in patients with AFP levels <20 ng mL and in patients with early tumors.
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