Usefulness of PIVKA-II for diagnosis and evaluation of recurrence of hepatocellular carcinoma

Backgroud: Although alpha-fetoprotein (AFP) is most widely used tumor marker for hepatocellular carcinoma (HCC), the sensitivity is about 60~70% in advanced HCC. Furthermore, the specificity of AFP is relatively low. The aim of this study was to evaluate the usefulness of prothrombin-induced by vitamin K absence or antagonist-II (PIVKA-II) in diagnosis of HCC, and of recurrence after curative surgical resection. Methods: Between April 2001 and March 2004, a total of 245 patients with pathologically confirmed HCC and a total of 267 patients with non-HCC, chronic liver diseases were enrolled. Results: With cutoff-value 20 ng/mL for AFP and 40 mAU/mL for PIVKA-II, the sensitivity of AFP and PIVKA-II was 48.6% (119/245) and 75.1% (184/245), respectively. The specificity of them was 81.3% (217/267) and 94.8% (253/267), respectively. When AFP and PIVKA-II were combined, the sensitivity and specificity was 83.3% (204/245) and 77.2% (206/267), respectively. For HCC 3≤cm, the sensitivity of AFP, PIVKA-II and AFP+PIVKA-II was 42.5% (31/73), 50.7% (37/73), and 68.5% (50/73), respectively. Among the 42 patients with AFP less than 20 ng/mL, whose tumor size was equal to or less than 3 cm, PIVKA-II showed positivity in 19 patients (45.2%). Recurrent HCC developed after curative surgical resection in 27 patients, and the sensitivity of PIVKA-II was 74.1% (20/27). On the contrary, the sensitivity of AFP was 40.7% (16/27). Conclusion : PIVKA-II is a useful tumor marker for HCC, especially in small sized tumor and HCC without AFP elevation. Furthermore, serial measurement of PIVKA-II after surgical resection might be an early indicator for tumor recurrenceope