METHODS: The mean serum concentration of
PIVKA II in HCC patients (784.3 +/- 1364.1 mean +/- s) was higher than that in
cirrhosis patients (16.1 +/- 31.7); this difference was highly significant (P < 0.0001). When the cutoff level of 40 mAU/ml was used as the level of discriminating HCC from
cirrhosis, 51.7% of patients (31/60) with HCC had
PIVKA II values above this level (sensitivity). Only 4 patients with
cirrhosis had such high
PIVKA II levels. Thus, the specificity of this test was 86.7% (26/30). Total accuracy was 62.2% [(31 + 26)/(60 + 30)]. Seven of 19 small HCCs (36.84%) had
PIVKA II values above the cutoff level. Concentrations of AFP above 20 ng/ml were observed in 34 of 60 patients with HCC (56.7%) and in 11 patients with
cirrhosis (36.7%). Eleven of 26 patients with HCC (46.2%) without increased AFP had concentrations of
PIVKA II greater than 40 mAU/ml. No significant correlation was found between serum levels of AFP and
PIVKA II that were measured in 60 HCC patients (rs = 0.101, P = 0.247). Combining the information from
PIVKA II and AFP showed an increase of approximately 21.6% over AFP and 26.7% over
PIVKA II alone. For small HCC patients, combining the information from
PIVKA II and AFP showed an increase of approximately 15.8% over AFP alone and 21.1% over
PIVKA II alone.
CONCLUSION: