Diagnostic accuracy of serum protein induced by vitamin K absence (PIVKA‐II), serum a‐fetoprotein and their combination for hepatocellular carcinoma among Caucasian cirrhotic patients with diagnostic or non‐diagnostic serum a‐fetoprotein levels

Abstract

AbstractAimThe aim of our study was to evaluate the accuracy of serum biomarkers (AFP/PIVKA‐II) and their combination in HCC diagnosis among Caucasian cirrhotic patients.MethodsSerum AFP/PIVKA‐II levels were evaluated in 218 cirrhotics (163 males, 118 CTP‐A, 66 ALBI‐I, 111 with varices, 63 with diabetes) with (n = 90) or without (n = 128) HCC. Patients with HCC were categorized to BCLC Stage 0/A (n = 12), B (n = 21), C (n = 48), and D (n = 9).ResultsThe two groups were comparable for all baseline parameters except for age, platelets, and diabetes presence. Median levels of AFP (239.1 vs. 4.0 ng/mL) and PIVKA‐II (4082.7 vs. 45.8 mAU/mL) were both significantly higher in HCC group compared to controls (p < 0.001). AUROC and cutoff value for HCC diagnosis were 88%/12.35 ng/mL (AFP) and 84.4%/677.13 mAU/mL (PIVKA‐II), whereas their combination showed better diagnostic accuracy (AUROC = 90.2%). The diagnostic accuracy of each biomarker separately was moderate or good in BCLC‐0/A/B and was excellent only for BCLC‐C patients (AFP: AUROC = 94.3%, cutoff = 12.35 ng/mL and PIVKA‐II: 91.3%, 253.51 mAU/mL) whereas their combination presented quite acceptable results in BCLC‐B (AUROC = 92.4%) and BCLC‐C (AUROC = 95.7%). Excluding HCC patients with high AFP (above 400 ng/mL), the diagnostic accuracy of each biomarker separately and their combination was moderate/good in all groups, except for their combination in BCLC‐C (AUROC = 90.5%).ConclusionsEach biomarker separately showed acceptable accuracy for detecting HCC in cirrhotic patients and excellent for those in BCLC‐C stage. The combination of the biomarkers presented excellent results in BCLC‐B/C patients. The diagnostic accuracy of PIVKA‐II and the combination of the two biomarkers in patients expressing low/non‐diagnostic AFP levels was good in BCLC‐B and excellent in BCLC‐C patients.