PMID- 26125432
OWN - NLM
STAT- MEDLINE
DCOM- 20150910
LR  - 20150701
IS  - 1543-2165 (Electronic)
IS  - 0003-9985 (Linking)
VI  - 139
IP  - 7
DP  - 2015 Jul
TI  - Evaluation of HER2/neu Status by Immunohistochemistry Using Computer-Based Image 
      Analysis and Correlation With Gene Amplification by Fluorescence In Situ 
      Hybridization Assay: A 10-Year Experience and Impact of Test Standardization on 
      Concordance Rate.
PG  - 922-8
LID - 10.5858/arpa.2014-0127-OA [doi]
AB  - CONTEXT: The American Society of Clinical Oncology/College of American 
      Pathologists proposed several recommendations for human epidermal growth factor 
      receptor 2 (HER2) test standardization. One suggestion was that image analysis 
      (IA) could be useful for scoring of HER2/neu immunohistochemistry. The 
      utilization of IA in a real-world practice in a large cohort of cases has not 
      been previously reported. OBJECTIVES: To compare HER2/neu quantification by IA 
      with gene amplification by fluorescence in situ hybridization (FISH); to 
      determine sensitivity, specificity, and concordance rates with the FISH assay; 
      and to determine association between HER2 status with estrogen receptor (ER), 
      progesterone receptor (PR), and Ki-67 expression. DESIGN: We evaluated HER2 
      results performed by immunohistochemistry and FISH in conjunction with ER, PR, 
      and Ki-67 in 3093 invasive breast cancer cases from 2002 to 2011. RESULTS: The 
      overall concordance between immunohistochemistry and FISH was 87.3% (1768 of 
      2026). When analyzed by year, there was an improvement in the positive 
      concordance rate from 49.4% (44 of 89) to 95.0% (57 of 60) (P < .001). The 
      negative concordance rate was at least 95% with a median false-negative rate of 
      1.5%. In the FISH+ group, amplification ratio showed significant correlation with 
      IA scores (P < .001). Positive versus negative HER2 status was associated with 
      lower ER and PR levels (P < .001) and higher Ki-67 expression (P < .001). 
      CONCLUSION: Scoring of HER2/neu by IA was associated with high false-positive 
      rates before 2008. Improvement in concordance rate after 2008 may be due to 
      proper tissue handling, improved HER2/neu scoring by IA, and assay 
      standardization.
FAU - Sarode, Venetia R
AU  - Sarode VR
FAU - Xiang, Qun Diane
AU  - Xiang QD
FAU - Christie, Alana
AU  - Christie A
FAU - Collins, Rebecca
AU  - Collins R
FAU - Rao, Roshni
AU  - Rao R
FAU - Leitch, A Marilyn
AU  - Leitch AM
FAU - Euhus, David
AU  - Euhus D
FAU - Haley, Barbara
AU  - Haley B
AD  - From the Departments of Pathology (Drs Sarode, Xiang, and Collins).
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Arch Pathol Lab Med
JT  - Archives of pathology & laboratory medicine
JID - 7607091
RN  - 0 (Receptors, Estrogen)
RN  - 0 (Receptors, Progesterone)
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Breast Neoplasms/*diagnosis/genetics/metabolism
MH  - Female
MH  - Humans
MH  - Image Processing, Computer-Assisted/methods/*standards
MH  - Immunohistochemistry/methods/*standards
MH  - In Situ Hybridization, Fluorescence/methods/*standards
MH  - Middle Aged
MH  - Nucleic Acid Amplification Techniques/methods/*standards
MH  - Receptor, ErbB-2/genetics/*metabolism
MH  - Receptors, Estrogen/metabolism
MH  - Receptors, Progesterone/metabolism
MH  - Sensitivity and Specificity
MH  - Young Adult
EDAT- 2015/07/01 06:00
MHDA- 2015/09/12 06:00
CRDT- 2015/07/01 06:00
PHST- 2015/07/01 06:00 [entrez]
PHST- 2015/07/01 06:00 [pubmed]
PHST- 2015/09/12 06:00 [medline]
AID - 10.5858/arpa.2014-0127-OA [doi]
PST - ppublish
SO  - Arch Pathol Lab Med. 2015 Jul;139(7):922-8. doi: 10.5858/arpa.2014-0127-OA.