Authors: | Schwartz, M. K.; Smith, C.; Schwartz, D. C.; Dnistrian, A.; Neiman, I. |
Title: | Monitoring therapy by serum HER-2/neu |
Conference Title: | 5th Specialist Workshop on Blood Tumor Markers |
Abstract: | We have evaluated the performance of the Bayer Immuno 1™ serum HER-2/neu assay. The precision is excellent and varied between 1.7% and 2.1% at values of HER-2/neu ranging from 16.8 ng/mL to 108.6 ng/mL. In normal women who were followed on a monthly basis the average deviation was 6%. The concentration (mean ± SD) in normal women was 8.7 ± 3.2 ng/mL. There was no difference between pre and postmenopausal women. The normal/abnormal cutoff was defined as greater than 15 ng/mL. In normal women and those with benign disease the specificity varied between 95% and 100%. In women with breast cancer the sensitivity was 1.7% in stage I disease, 3.0% in stage II, 16.7 in stage III and 35.5% in stage IV. There were 56 elevations (14.7%) in the total group of 285 women with breast cancer. There was an excellent correlation with a microtitre plate method (r=0.9944). Longitudinal studies showed clearly that women who expressed HER-2/neu in their tissue had elevated serum levels and these levels reflected the clinical course of the patient. More extensive control studies are required to establish the role of HER-2/neu assays in the management of women with breast cancer. |
Keywords: | controlled study; treatment outcome; retrospective studies; disease course; antineoplastic agents; conference paper; disease marker; comparative study; neoplasm staging; diagnostic accuracy; sensitivity and specificity; reproducibility of results; breast cancer; carcinoembryonic antigen; tumor markers, biological; patient monitoring; breast neoplasms; automation; enzyme immunoassay; antibodies, monoclonal; longitudinal studies; neoplasm metastasis; outcomes research; receptor, erbb-2; drug monitoring; trastuzumab; longitudinal study; oncogene neu; growth factor receptor; her-2/neu; ca-15-3 antigen; reagent kits, diagnostic; herceptin; humans; human; female; bayer immuno 1 |
Journal Title | International Journal of Biological Markers |
Volume: | 15 |
Issue: | 4 |
Conference Dates: | 1999 Sep 21 |
Conference Location: | Nottingham, U.K. |
ISBN: | 0393-6155 |
Publisher: | Wichtig Editore |
Date Published: | 2000-10-01 |
Start Page: | 324 |
End Page: | 329 |
Language: | English |
PUBMED: | 11192828 |
PROVIDER: | scopus |
DOI/URL: | |
Notes: | Export Date: 18 November 2015 -- Source: Scopus |