title: [Clinical study of serum ErbB-2 protein using sandwich radioimmunometric assay (ErbB-2 IRMA 'Eiken')].
abstract: Sandwich radioimmunometric assay (ErbB-2 IRMA 'Eiken') was developed to determine the levels of c-erbB-2 oncogene product (ErbB-2 protein) in human sera, and a clinical investigation was carried out to evaluate this novel oncogene product. The mean serum concentration of the ErbB-2 protein determined from 364 donors was 4.0 +/- 0.69 ng/ml (mean +/- SD) for females and 4.5 +/- 0.96 ng/ml for males. Cut-off values were set at 5.4 ng/ml for females and 6.5 ng/ml for males. The positivities of serum ErbB-2 protein in patients with breast carcinoma were 13.0% for primary cases and 47.9% for recurrent cases. Patients with hepatic disorders also had positive serum ErbB-2 protein levels, ie, 43.8% (7/16) for hepatocellular carcinoma and 28.9% (11/38) for hepatitis and liver cirrhosis, although the increase was slight and barely exceeded 10 ng/ml. In comparison with the levels of other tumor markers, such as CEA, CA 15-3 and NCC-ST 439, the serum ErbB-2 level was shown to have poor correlations, and was thus assumed to be useful for combination with those tumor markers. In serial determinations of serum ErbB-2 protein in two patients with recurrent breast carcinoma, the antigen increased preceding the increases in the other tumor markers, thereby also showing usefulness as a monitoring marker for breast carcinoma. In conclusion, these results indicated that ErbB-2 measurement improves the assessment of breast cancer in combination with other tumor markers and is useful as a tool for monitoring the clinical condition and the response for treatment in breast cancer.
authors.affiliation: National Cancer Center Hospital, Osaka.
authors.forename: K
authors.initials: K
authors.lastname: Sugano
authors.forename: T
authors.initials: T
authors.lastname: Kawai
authors.forename: M
authors.initials: M
authors.lastname: Ishii
authors.forename: H
authors.initials: H
authors.lastname: Koyama
authors.forename: M
authors.initials: M
authors.lastname: Kitajima
authors.forename: F
authors.initials: F
authors.lastname: Kasumi
authors.forename: R
authors.initials: R
authors.lastname: Demura
authors.forename: T
authors.initials: T
authors.lastname: Nakayama
authors.forename: H
authors.initials: H
authors.lastname: Okabe
authors.forename: S
authors.initials: S
authors.lastname: Mori
mesh_terms: D000368:Aged; D014408:Biomarkers, Tumor / Q000097:blood*; D001943:Breast Neoplasms / Q000175:diagnosis; D003111:Colonic Polyps / Q000175:diagnosis; D066246:ErbB Receptors / Q000097:blood*; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D015592:Immunoradiometric Assay / Q000379:methods*; D008113:Liver Neoplasms / Q000175:diagnosis; D008297:Male; D008875:Middle Aged; D011518:Proto-Oncogene Proteins / Q000097:blood*; D011933:Reagent Kits, Diagnostic / Q000592:standards; D018719:Erb-b2 Receptor Tyrosine Kinases
chemical_list: D014408:Biomarkers, Tumor; D066246:ErbB Receptors; D011518:Proto-Oncogene Proteins; D011933:Reagent Kits, Diagnostic; D018719:Erb-b2 Receptor Tyrosine Kinases