PMID- 12118023
OWN - NLM
STAT- MEDLINE
DCOM- 20020808
LR  - 20170210
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 20
IP  - 14
DP  - 2002 Jul 15
TI  - Evaluation of HER-2/neu gene amplification and overexpression: comparison of 
      frequently used assay methods in a molecularly characterized cohort of breast 
      cancer specimens.
PG  - 3095-105
AB  - PURPOSE: To compare and evaluate HER-2/neu clinical assay methods. MATERIALS AND 
      METHODS: One hundred seventeen breast cancer specimens with known HER-2/neu 
      amplification and overexpression status were assayed with four different 
      immunohistochemical assays and two different fluorescence in situ hybridization 
      (FISH) assays. RESULTS: The accuracy of the FISH assays for HER-2/neu gene 
      amplification was high, 97.4% for the Vysis PathVision assay (Vysis, Inc, Downers 
      Grove, IL) and 95.7% for the the Ventana INFORM assay (Ventana, Medical Systems, 
      Inc, Tucson, AZ). The immunohistochemical assay with the highest accuracy for 
      HER-2/neu overexpression was obtained with R60 polyclonal antibody (96.6%), 
      followed by immunohistochemical assays performed with 10H8 monoclonal antibody 
      (95.7%), the Ventana CB11 monoclonal antibody (89.7%), and the DAKO HercepTest 
      (88.9%; Dako, Corp, Carpinteria, CA). Only the sensitivities, and therefore, 
      overall accuracy, of the DAKO Herceptest and Ventana CB11 immunohistochemical 
      assays were significantly different from the more sensitive FISH assay. 
      CONCLUSION: Based on these findings, the FISH assays were highly accurate, with 
      immunohistochemical assays performed with R60 and 10H8 nearly as accurate. The 
      DAKO HercepTest and the Ventana CB11 immunohistochemical assay were statistically 
      significantly different from the Vysis FISH assay in evaluating these previously 
      molecularly characterized breast cancer specimens.
FAU - Press, Michael F
AU  - Press MF
AD  - Breast Cancer Research Program of the Lee Breast Center, Department of Pathology, 
      University of Southern California, Los Angeles, USA. press@hsc.usc.edu
FAU - Slamon, Dennis J
AU  - Slamon DJ
FAU - Flom, Kerry J
AU  - Flom KJ
FAU - Park, Jinha
AU  - Park J
FAU - Zhou, Jian-Yuan
AU  - Zhou JY
FAU - Bernstein, Leslie
AU  - Bernstein L
LA  - eng
GR  - CA48780/CA/NCI NIH HHS/United States
GR  - N01-HD-3-3175/HD/NICHD NIH HHS/United States
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, Non-P.H.S.
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Biomarkers, Tumor)
SB  - IM
CIN - J Clin Oncol. 2002 Dec 1;20(23):4607; author reply 4607-9. PMID: 12454125
MH  - Antibodies, Monoclonal
MH  - Biomarkers, Tumor/*genetics
MH  - Breast Neoplasms/chemistry/*genetics
MH  - Cohort Studies
MH  - Evaluation Studies as Topic
MH  - Female
MH  - Gene Amplification
MH  - Gene Expression Regulation, Neoplastic
MH  - Genes, erbB-2/*genetics
MH  - Humans
MH  - Immunoenzyme Techniques
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence
MH  - Up-Regulation
EDAT- 2002/07/16 10:00
MHDA- 2002/08/09 10:01
CRDT- 2002/07/16 10:00
PHST- 2002/07/16 10:00 [pubmed]
PHST- 2002/08/09 10:01 [medline]
PHST- 2002/07/16 10:00 [entrez]
AID - 10.1200/JCO.2002.09.094 [doi]
PST - ppublish
SO  - J Clin Oncol. 2002 Jul 15;20(14):3095-105. doi: 10.1200/JCO.2002.09.094.