Abstract
BACKGROUND: Alpha-fetoprotein (AFP) is a well known widely used biomarker for the detection of hepatocellular carcinoma (HCC); however, it suffers from a low sensitivity and specificity. Protein or prothrombin induced by vitamin K absence or antagonist II (PIVKA-II) is another tumor marker elevated in HCC but not extensively used. AIM: Evaluation of PIVKA-II and AFP in diagnosing HCC in India. PATIENTS AND METHODS: The study group consisted of 70 consecutive HCC patients, 38 patients with cirrhosis, 30 patients with chronic hepatitis, and 30 normal healthy subjects. All patients were evaluated for PIVKA-II and AFP levels by ELISA. RESULT: The mean plasma concentration of PIVKA-II in HCC, cirrhotic, chronic hepatitis patients and healthy controls was 101.07 ± 78.30 ng/ml, 2.45 ± 4.25 ng/ml, 1.50 ± 0.98 ng/ml and 0.79 ± 0.75 ng/ml, respectively. Receiver operating characteristic (ROC) curve was plotted for PIVKA-II and AFP. At a cutoff level of 9.2 ng/ml for PIVKA-II a sensitivity of 80% and a specificity of 92.1% was found, whereas AFP at a cutoff level of 13.02 ng/ml showed 72.9% sensitivity and 65.8% specificity. No significant relationship of plasma levels of PIVKA-II was observed in HCC with HBsAg/antiHCV positivity and associated portal vein thrombosis, but a positive correlation was seen with the tumor size (P = 0.001). However, no such significant association was found with AFP. CONCLUSION: PIVKA-II was more sensitive and specific than AFP for diagnosing HCC in the Indian population.