PMID- 17536315
OWN - NLM
STAT- MEDLINE
DCOM- 20070725
LR  - 20220408
IS  - 1541-2016 (Print)
IS  - 1533-4058 (Linking)
VI  - 15
IP  - 1
DP  - 2007 Mar
TI  - A new rabbit monoclonal antibody (4B5) for the immunohistochemical (IHC) 
      determination of the HER2 status in breast cancer: comparison with CB11, 
      fluorescence in situ hybridization (FISH), and interlaboratory reproducibility.
PG  - 94-102
AB  - The 2 methodologies in current clinical use to assess HER2 status in breast 
      cancer are: fluorescence in situ hybridization (FISH) (gene amplification) and 
      immunohistochemistry (protein over-expression). A consistent finding has been 
      that 3% to 15% of breast cancers over-express HER2 protein without evidence for 
      gene amplification. Accurate determination of the HER2 status has implications 
      for selecting patients most likely to respond to trastuzumab. We report here our 
      preliminary experience with a new anti-HER2 rabbit monoclonal antibody, 4B5. The 
      evaluation of HER2 status in 2 different cohorts of breast cancer cases (Single 
      Institution (SI) and Multinational (MN)) with a total of 322 breast cancer cases 
      was performed on an automated staining system (Ventana Medical Systems, Inc, 
      Tucson, AZ) and scored by 3 pathologists (0-3+), for comparison with CB11 
      staining results (PATHWAY) and FISH (PathVysion). Interlaboratory reproducibility 
      of automated staining results and interpretation was determined on a subset of 
      the SI cohort at 3 separate laboratories. Rabbit monoclonal 4B5 demonstrated 
      sharper membrane staining with less cytoplasmic and stromal background staining 
      than CB11. In the SI cohort, the staining results for 4B5 were highly comparable 
      with those obtained for CB11 with an overall concordance of 93.3%. In the 
      multinational cohort, the overall concordance with CB11 was 84.7%. This lower 
      level of concordance was associated with a much higher overall agreement of 4B5 
      with FISH (89.5%), compared with agreement of CB11 with FISH (81.2%). The 
      difference in the performance of CB11 in the MN cohort versus the SI cohort may 
      be due to differences in tissue fixation and processing in a centralized, high 
      volume laboratory in an academic medical center versus multiple sites in the 
      international community with potentially nonstandardized techniques. The staining 
      results with 4B5 indicate that it has a more robust performance than CB11 because 
      the correlation of 4B5 with FISH was nearly equivalent (88.2% MN; 89.3% SI) in 
      both cohorts. Interlaboratory reproducibility was also excellent (kappa 1.0). 
      RMoAb 4B5 provides excellent sensitivity, specificity, and interlaboratory 
      reproducibility for the detection of HER2 status in breast cancer.
FAU - Powell, William C
AU  - Powell WC
AD  - Ventana Medical Systems Inc,; Tucson, AZ, USA.
FAU - Hicks, David G
AU  - Hicks DG
FAU - Prescott, Nichole
AU  - Prescott N
FAU - Tarr, Shannon M
AU  - Tarr SM
FAU - Laniauskas, Simas
AU  - Laniauskas S
FAU - Williams, Tristin
AU  - Williams T
FAU - Short, Sarah
AU  - Short S
FAU - Pettay, James
AU  - Pettay J
FAU - Nagle, Raymond B
AU  - Nagle RB
FAU - Dabbs, David J
AU  - Dabbs DJ
FAU - Scott, Katherine M
AU  - Scott KM
FAU - Brown, Richard W
AU  - Brown RW
FAU - Grogan, Thomas
AU  - Grogan T
FAU - Roche, Patrick C
AU  - Roche PC
FAU - Tubbs, Raymond R
AU  - Tubbs RR
LA  - eng
PT  - Comparative Study
PT  - Evaluation Study
PT  - Journal Article
PL  - United States
TA  - Appl Immunohistochem Mol Morphol
JT  - Applied immunohistochemistry & molecular morphology : AIMM
JID - 100888796
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Coloring Agents)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
CIN - Appl Immunohistochem Mol Morphol. 2008 Oct;16(5):510-1. PMID: 18580496
MH  - Animals
MH  - Antibodies, Monoclonal/*biosynthesis
MH  - Breast Neoplasms/*diagnosis
MH  - Coloring Agents
MH  - Female
MH  - Humans
MH  - Immunohistochemistry/methods/standards
MH  - In Situ Hybridization, Fluorescence/standards
MH  - Methods
MH  - Rabbits
MH  - Receptor, ErbB-2/*analysis/immunology
MH  - Reproducibility of Results
MH  - Sensitivity and Specificity
EDAT- 2007/06/01 09:00
MHDA- 2007/07/26 09:00
CRDT- 2007/06/01 09:00
PHST- 2007/06/01 09:00 [pubmed]
PHST- 2007/07/26 09:00 [medline]
PHST- 2007/06/01 09:00 [entrez]
AID - 10.1097/pai.0b013e31802ced25 [doi]
PST - ppublish
SO  - Appl Immunohistochem Mol Morphol. 2007 Mar;15(1):94-102. doi: 
      10.1097/pai.0b013e31802ced25.