PMID- 17721278
OWN - NLM
STAT- MEDLINE
DCOM- 20071107
LR  - 20191210
IS  - 1541-2016 (Print)
IS  - 1533-4058 (Linking)
VI  - 15
IP  - 3
DP  - 2007 Sep
TI  - PGDS, a novel technique combining chromogenic in situ hybridization and 
      immunohistochemistry for the assessment of ErbB2 (HER2/neu) status in breast 
      cancer.
PG  - 316-24
AB  - Given the important prognostic and predictive utility of v-erb-b2 erythroblastic 
      leukemia viral oncogene homolog 2 (ErbB2) [human epidermal growth factor 
      receptor-2 (HER2/neu)] in breast cancer, it is recommended that ErbB2 testing be 
      performed on all invasive breast cancers at the time of diagnosis. A consensus, 
      however, has not yet been reached as to the optimal method of evaluating ErbB2 
      status. Immunohistochemistry to detect protein overexpression and fluorescence in 
      situ hybridization (FISH) to detect ErbB2 gene amplification are the most 
      frequently used methods. As no one detection method fulfills all necessary 
      requirements of reliability, reproducibility, and ease of use, we developed a 
      novel approach in the form of a simple assay we refer to as protein and gene 
      double staining (PGDS) which simultaneously evaluates protein overexpression and 
      gene amplification by combining immunohistochemistry with chromogenic in situ 
      hybridization (CISH). A total of 134 invasive breast carcinomas, including 81 
      cases with a full-face section and 53 cases included in a tissue microarray 
      (TMA), were assessed by PGDS, and the results were correlated with ErbB2 gene 
      amplification status as determined by FISH. ErbB2 gene copy number determined by 
      CISH analysis in the PGDS assay showed excellent concordance with that of FISH 
      (correlation coefficient 0.82; P<0.001 with full-face section cases, and 0.98; 
      P<0.001 with cases in a TMA). The overall concordance rate for gene amplification 
      status between PGDS and FISH was 90.12% in cases with a full-face section and 
      92.45% with TMA cases. Perfect correlation was seen between the PGDS assay and 
      FISH in cases that were considered either nonamplified or highly amplified by the 
      dual assay. Of the 17 cases that showed low amplification by PGDS, 5 were 
      classified as nonamplified by FISH. Correction for chromosome 17 copy number in 
      the FISH assessment contributed to the discordance between CISH and FISH results. 
      This newly developed PGDS method represents a novel approach to ErbB2 status 
      determination that combines the assessment of both protein overexpression and 
      gene amplification in one simple assay. It is likely that this assay will aid in 
      immunohistochemical calibration and will also increase the sensitivity and 
      specificity of ErbB2 testing.
FAU - Ni, Ruoyu
AU  - Ni R
AD  - Department of Pathology and Laboratory Medicine, Mount Sinai Hospital, Toronto, 
      ON, Canada.
FAU - Mulligan, Anna Marie
AU  - Mulligan AM
FAU - Have, Cherry
AU  - Have C
FAU - O'Malley, Frances P
AU  - O'Malley FP
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
PL  - United States
TA  - Appl Immunohistochem Mol Morphol
JT  - Applied immunohistochemistry & molecular morphology : AIMM
JID - 100888796
RN  - 0 (DNA, Neoplasm)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Breast Neoplasms/*diagnosis/pathology
MH  - Carcinoma/*diagnosis/pathology
MH  - Chromosomes, Human, Pair 17/genetics
MH  - DNA, Neoplasm/*analysis
MH  - Female
MH  - Gene Amplification
MH  - Humans
MH  - Immunohistochemistry/*methods
MH  - In Situ Hybridization, Fluorescence/*methods
MH  - Receptor, ErbB-2/*analysis/genetics/metabolism
EDAT- 2007/08/28 09:00
MHDA- 2007/11/08 09:00
CRDT- 2007/08/28 09:00
PHST- 2007/08/28 09:00 [pubmed]
PHST- 2007/11/08 09:00 [medline]
PHST- 2007/08/28 09:00 [entrez]
AID - 00129039-200709000-00014 [pii]
AID - 10.1097/01.pai.0000213138.01536.2e [doi]
PST - ppublish
SO  - Appl Immunohistochem Mol Morphol. 2007 Sep;15(3):316-24. doi: 
      10.1097/01.pai.0000213138.01536.2e.