PMID- 11410505
OWN - NLM
STAT- MEDLINE
DCOM- 20010920
LR  - 20141120
IS  - 1078-0432 (Print)
IS  - 1078-0432 (Linking)
VI  - 7
IP  - 6
DP  - 2001 Jun
TI  - Evaluation of the United States Food and Drug Administration-approved scoring and 
      test system of HER-2 protein expression in breast cancer.
PG  - 1669-75
AB  - PURPOSE: The purpose of this study was to investigate the prognostic significance 
      of assessment of human epidermal growth factor receptor (HER)-2 oncogene protein 
      overexpression of breast cancer tissue by the United States Food and Drug 
      Administration (FDA)-approved HercepTest and grading system (negative, 0 or 1+; 
      weakly positive, 2+; strongly positive, 3+). Furthermore, results of the 
      HercepTest were correlated with immunohistochemical results obtained using 
      different antibodies and protocols and with HER-2 oncogene gene amplification 
      assessed by fluorescence in situ hybridization (FISH). EXPERIMENTAL DESIGN: HER-2 
      status in 303 patients with lymph node-positive breast cancer was investigated by 
      using a rabbit polyclonal antibody (DAKO) by conventional immunohistochemistry 
      and by applying the HercepTest. Furthermore, the monoclonal antibody CB-11 was 
      used in conventional immunohistochemistry and with the NexES automatic stainer, 
      which is also under consideration for FDA approval for determination of 
      eligibility for Herceptin therapy. Results were compared with FISH analysis 
      performed in all 2+ and 3+ specimens (103 cases) and 104 HER-2-negative 
      specimens. RESULTS: 3+ positive carcinomas were found in 8.9-15.7% of specimens. 
      FISH revealed that almost exclusively 3+ positive cases were amplified, with the 
      HercepTest and the NexES automatic stainer giving the best results. In univariate 
      analysis, staining with the HercepTest revealed a significantly worse prognosis 
      in 3+ cases. Also, 3+ cases were significantly associated with lower estrogen 
      receptor levels and histological grade III tumors. CONCLUSIONS: This study shows 
      that the results of the FDA-approved HER-2 grading and test system correlated 
      strongly with findings in FISH. Furthermore, HercepTest proved to be of 
      prognostic relevance. Strict adherence to the given protocols is critical.
FAU - Birner, P
AU  - Birner P
AD  - The Institute of Clinical Pathology, University of Vienna Medical School, A-1090 
      Vienna, Austria. peter.birner@akh-wien.ac.at
FAU - Oberhuber, G
AU  - Oberhuber G
FAU - Stani, J
AU  - Stani J
FAU - Reithofer, C
AU  - Reithofer C
FAU - Samonigg, H
AU  - Samonigg H
FAU - Hausmaninger, H
AU  - Hausmaninger H
FAU - Kubista, E
AU  - Kubista E
FAU - Kwasny, W
AU  - Kwasny W
FAU - Kandioler-Eckersberger, D
AU  - Kandioler-Eckersberger D
FAU - Gnant, M
AU  - Gnant M
FAU - Jakesz, R
AU  - Jakesz R
CN  - Austrian Breast & Colorectal Cancer Study Group
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Clin Cancer Res
JT  - Clinical cancer research : an official journal of the American Association for 
      Cancer Research
JID - 9502500
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Receptors, Estrogen)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal/metabolism
MH  - Breast Neoplasms/*diagnosis/*metabolism/mortality
MH  - Carcinoma/metabolism
MH  - Disease-Free Survival
MH  - Female
MH  - Humans
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence
MH  - Medical Oncology/*methods/*standards
MH  - Middle Aged
MH  - *Prognosis
MH  - Receptor, ErbB-2/*biosynthesis
MH  - Receptors, Estrogen/metabolism
MH  - Time Factors
MH  - United States
MH  - United States Food and Drug Administration
EDAT- 2001/06/19 10:00
MHDA- 2001/09/21 10:01
CRDT- 2001/06/19 10:00
PHST- 2001/06/19 10:00 [pubmed]
PHST- 2001/09/21 10:01 [medline]
PHST- 2001/06/19 10:00 [entrez]
PST - ppublish
SO  - Clin Cancer Res. 2001 Jun;7(6):1669-75.