PMID- 26895325
OWN - NLM
STAT- MEDLINE
DCOM- 20161114
LR  - 20220316
IS  - 1573-7217 (Electronic)
IS  - 0167-6806 (Linking)
VI  - 155
IP  - 3
DP  - 2016 Feb
TI  - HER2 FISH classification of equivocal HER2 IHC breast cancers with use of the 
      2013 ASCO/CAP practice guideline.
PG  - 457-62
LID - 10.1007/s10549-016-3717-z [doi]
AB  - The status of human epidermal growth factor receptor 2 (HER2, ERBB2) determines 
      the eligibility of breast cancer patients to receive HER2-targeted therapy. The 
      majority of HER2 testing in the U.S. is performed using a combination of 
      immunohistochemistry (IHC) screening followed by fluorescence in situ 
      hybridization (FISH) for IHC equivocal cases. In 2013, the American Society of 
      Clinical Oncology (ASCO)/College of American Pathologists (CAP) updated the 
      guideline for HER2 testing. This study evaluates the impact of the 2013 ASCO/CAP 
      updated guideline on final HER2 FISH classification of breast cancers with an 
      equivocal IHC result. For each case, we reported a FISH result according to the 
      2013 updated guideline and recorded a separated result using the 2007 guideline 
      for investigational purpose. McNemar's test and Bowker's symmetry test were used 
      to compare the classifications by the two guidelines. Among 172 HER2 IHC 2+ 
      equivocal cases, use of the 2103 guideline changed classifications in 36 cases 
      (21 %) when compared with the results expected by use of the 2007 guideline, and 
      yielded a higher proportion of positive (28.5 vs. 23.3 %) and equivocal (16.3 vs. 
      4.1 %), and a lower proportion of negative (55.2 vs. 72.7 %) cases (p < 0.001). 
      The major classification change with use of the updated guideline is from the 
      HER2 FISH negative to equivocal in 26 cases (15 %). Our study has shown that 
      implementation of the 2013 ASCO/CAP updated guideline has significant impact on 
      HER2 classification for breast cancers with an equivocal HER2 IHC result and 
      therefore increased the use of HER2-targeted therapy. Our data have also shown 
      that reflex FISH is effective for final classification of the IHC equivocal cases 
      and that polysomy 17 (CEP17 copy number >/=3/cell) is present in a significantly 
      higher proportion of cases with an equivocal HER2 FISH classification.
FAU - Fan, Yao-Shan
AU  - Fan YS
AD  - Department of Pathology and Laboratory Medicine, University of Miami Miller 
      School of Medicine, 1601 NW 12th Avenue, Rm 7050, Miami, FL, 33136, USA. 
      yfan@med.miami.edu.
FAU - Casas, Carmen E
AU  - Casas CE
AD  - Department of Pathology and Laboratory Medicine, University of Miami Miller 
      School of Medicine, 1601 NW 12th Avenue, Rm 7050, Miami, FL, 33136, USA.
FAU - Peng, Jinghong
AU  - Peng J
AD  - Department of Pathology and Laboratory Medicine, University of Miami Miller 
      School of Medicine, 1601 NW 12th Avenue, Rm 7050, Miami, FL, 33136, USA.
FAU - Watkins, Melanie
AU  - Watkins M
AD  - Department of Pathology and Laboratory Medicine, University of Miami Miller 
      School of Medicine, 1601 NW 12th Avenue, Rm 7050, Miami, FL, 33136, USA.
FAU - Fan, Lynn
AU  - Fan L
AD  - Department of Pathology and Laboratory Medicine, University of Miami Miller 
      School of Medicine, 1601 NW 12th Avenue, Rm 7050, Miami, FL, 33136, USA.
FAU - Chapman, Jennifer
AU  - Chapman J
AD  - Department of Pathology and Laboratory Medicine, University of Miami Miller 
      School of Medicine, 1601 NW 12th Avenue, Rm 7050, Miami, FL, 33136, USA.
FAU - Ikpatt, Offiong Francis
AU  - Ikpatt OF
AD  - Department of Pathology and Laboratory Medicine, University of Miami Miller 
      School of Medicine, 1601 NW 12th Avenue, Rm 7050, Miami, FL, 33136, USA.
FAU - Gomez, Carmen
AU  - Gomez C
AD  - Department of Pathology and Laboratory Medicine, University of Miami Miller 
      School of Medicine, 1601 NW 12th Avenue, Rm 7050, Miami, FL, 33136, USA.
FAU - Zhao, Wei
AU  - Zhao W
AD  - Biostatistics and Bioinformatics Core Shared Resource, Sylvester Comprehensive 
      Cancer Center, University of Miami School of Medicine, Miami, FL, USA.
FAU - Reis, Isildinha M
AU  - Reis IM
AD  - Department of Public Health Sciences, University of Miami Miller School of 
      Medicine, Miami, FL, USA.
AD  - Biostatistics and Bioinformatics Core Shared Resource, Sylvester Comprehensive 
      Cancer Center, University of Miami School of Medicine, Miami, FL, USA.
LA  - eng
PT  - Journal Article
DEP - 20160219
PL  - Netherlands
TA  - Breast Cancer Res Treat
JT  - Breast cancer research and treatment
JID - 8111104
RN  - 0 (Biomarkers, Tumor)
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Biomarkers, Tumor/*genetics
MH  - Breast Neoplasms/classification/diagnosis/*genetics/pathology
MH  - Chromosome Aberrations
MH  - Chromosomes, Human, Pair 17/genetics
MH  - Female
MH  - Guidelines as Topic
MH  - Humans
MH  - In Situ Hybridization, Fluorescence/*methods
MH  - Receptor, ErbB-2/*genetics
OTO - NOTNLM
OT  - ASCO/CAP practice guideline
OT  - Breast cancer
OT  - Fluorescence in situ hybridization
OT  - HER2
OT  - Immunohistochemistry
OT  - Polysomy 17
EDAT- 2016/02/20 06:00
MHDA- 2016/11/15 06:00
CRDT- 2016/02/20 06:00
PHST- 2016/02/04 00:00 [received]
PHST- 2016/02/08 00:00 [accepted]
PHST- 2016/02/20 06:00 [entrez]
PHST- 2016/02/20 06:00 [pubmed]
PHST- 2016/11/15 06:00 [medline]
AID - 10.1007/s10549-016-3717-z [pii]
AID - 10.1007/s10549-016-3717-z [doi]
PST - ppublish
SO  - Breast Cancer Res Treat. 2016 Feb;155(3):457-62. doi: 10.1007/s10549-016-3717-z. 
      Epub 2016 Feb 19.