Hepatocellular carcinoma: PIVKA-II may be unsuitable for Indian patients

Abstract Introduction Hepatocellular carcinoma (HCC) diagnosis requires a combination of elevated ɑ-fetoprotein (AFP) levels and liver imaging. We evaluated the role of prothrombin induced by vitamin K antagonist-II (PIVKA-II) in patients with suspected HCC. Methods A retrospective analysis was conducted on adult Indian patients with suspected HCC who had elevated AFP and PIVKA-II levels and had undergone radiologic investigation. Results Among 178 suspected cases, 144 (80.99%) were diagnosed with HCC; the median age of these 144 patients was 62 years (IQR, 54-68 years). The median AFP and PIVKA-II levels were 14.68 ng/mL (IQR, 3.83-146.50 ng/mL) and 354.50 ng/mL (IQR, 49.41-4293.40 ng/mL), respectively. The sensitivity and specificity were 52.08% and 88.24% for AFP (≥10 ng/mL) and 80.56% and 32.35% for PIVKA-II (≥40 ng/mL). The false positivity rate of PIVKA-II was 67.60%. PIVKA-II showed moderate correlation (r = 0.413) with HCC size and was more reliable than AFP for HCC lesions larger than 5 cm (area under the curve = 0.731 vs 0.627). PIVKA-II levels were lower following therapy for HCC (682.98-122.50 ng/mL; P < .001) than AFP levels (15.05-6.50 ng/mL; P = .30). Among AFP-negative patients with HCC, 68.10% had elevated PIVKA-II levels. Discussion With its higher false positivity rate, PIVKA-II may not be a reliable marker for HCC, although it may be useful in larger HCC lesions and in AFP-negative patients. Establishing a newer cutoff value for PIVKA-II among the Indian population may improve its specificity in the diagnosis and management of HCC.