The clinical significance of the measurement of c-erbB-2 oncogene prod
uct was evaluated. The subjects consisted of 404 patients, including 2
48 with cancer of the digestive organs and 128 with benign digestive d
iseases. Serum c-erbB-2 protein levels were measured by sandwich immun
oenzyme assay. The positive rates of c-erbB-2 protein, at a cut-off va
lue of 17.0U/ml, were, for cancers: hepatocellular carcinoma 61.6%, bi
liary tract cancer 54.8%, pancreatic cancer 25.0%, esophageal cancer 3
3.3%, gastric cancer 16.9%, and colorectal cancer 5.0%. For benign dig
estive diseases, the rates were: liver cirrhosis 63.3%, chronic hepati
tis 43.2%, acute hepatitis 42.9%, other liver diseases 42.8%, cholelit
hiasis 30.0%, and chronic pancreatitis 0%. Serum c-erbB-2 protein leve
ls were significantly correlated with the markers of hepatic functiona
l reserve, the indocyanine green retention rate and the hepaplastin te
st. These findings suggest that serum c-erbB-2 protein levels are grea
tly influenced by liver dysfunction and that their clinical usefulness
as a serum tumor marker is questionable.