CLINICAL-EVALUATION OF A MONOCLONAL-ANTIBODY TO SERUM KM01 FOR THE DIAGNOSIS OF HEPATOCELLULAR-CARCINOMA

In order to evaluate a monoclonal antibody KM01 which was developed in mice immunized against a human colon carcinoma cell line, serum level s of KM01 and other tumor markers were studied in patients with both h epatocellular carcinoma and liver cirrhosis and in patients with liver cirrhosis alone. The KM01 levels in the sera of 50 patients with hepa tocellular carcinoma plus liver cirrhosis and 50 patients with liver c irrhosis were measured using an enzyme immunoassay method and compared with various tumor markers including alpha-fetoprotein (AFP), DUPAN-2 , and protein induced vitamin K absence or antagonist-II (PIVKA-II). T he mean serum level (+/- S.D.) and sensitivity of KM01 in patients wit h hepatocellular carcinoma plus liver cirrhosis were 734(+/- 716) unit s/ml and 64%, respectively, and they were significantly higher than th ose of liver cirrhosis patients (P < 0.001). Three out of 9 cases show ing negative serum AFP levels had positive serum KM01 levels. Although the sensitivity of serum KM01 level for hepatocellular carcinoma was inferior to serum AFP and plasma PIVKA-II values, the sensitivity of a combination assay of serum KM01 or AFP was increased to 88%. Clinical data of the patients with markedly elevated serum KM01 levels (more t han 1000 units/ml) were compared with patients with moderately elevate d levels (530-1000 units/ml); serum bilirubin and alkaline-phosphatase were statistically higher in the former group (P < 0.01). These data suggest that the serum KM01 assay is a useful tumor marker for patient s with hepatocellular carcinoma, especially in AFP negative hepatocell ular carcinoma patients, and that biliary tract involvement may contri bute to increased serum KM01 value.