PMID- 30095467
OWN - NLM
STAT- MEDLINE
DCOM- 20190919
LR  - 20190919
IS  - 1533-4058 (Electronic)
IS  - 1533-4058 (Linking)
VI  - 26
IP  - 10
DP  - 2018 Nov/Dec
TI  - High Fidelity of Breast Biomarker Metrics: A 10-Year Experience in a Single, 
      Large Academic Institution.
PG  - 697-700
LID - 10.1097/PAI.0000000000000697 [doi]
AB  - PURPOSE: Recommendations for standardization of breast biomarkers including 
      estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth 
      factor 2 (HER2) led to the creation of American Society of Clinical Oncology 
      (ASCO)/College of American Pathologists (CAP) guidelines to provide continuous 
      guidance. Included in these recommendations is the "ongoing assay assessment 
      procedures." We report these biomarker metrics as there is a dearth of published 
      information on this topic. MATERIALS AND METHODS: ER, PR, and HER2 positivity 
      rates of all newly diagnosed, recurrent, and metastatic invasive breast cancers 
      on core biopsies, and repeated testing on resection specimen by 
      immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH) were 
      collected from April 1, 2008 to December 31, 2017. RESULTS: The positivity rates 
      of ER, PR, and HER2 over almost 10 years of monitoring showed high fidelity. 
      Total ER-positive rate was 83.6% (81.4% to 86.8%), ER+/PR+ was 71.7% (68.6% to 
      75.5%), ER+/PR- was 17.6% (11.0% to 15.0%), ER-/PR- was 16.0% (13.5% to 18.2%), 
      and ER-/PR+ was 0.6% (0.2% to 1.0%). The HER2-positive rate was 13.7% (10.2% to 
      17.4%) including 9.9% (7.3% to 11.9%) by IHC and 3.8% (1.9% to 5.9%) by FISH 
      reflexed from IHC 2+ results. FISH amplification rate of HER2 IHC 2+ cases was 
      11.0% (5.8% to 19.2%). Annual quality-assurance check for HER2 IHC/FISH percent 
      positive and percent negative agreement (as defined by Food and Drug 
      Administration) was 96% to 100%. CONCLUSIONS: This longitudinal active assessment 
      of 9564 breast biomarker cases shows the achievement of high fidelity of breast 
      biomarker results when following the ASCO/CAP guidelines. Continuous monitoring 
      of breast biomarkers may minimize assay analytical drift and assure quality 
      clinically relevant results.
FAU - Zhang, Huina
AU  - Zhang H
AD  - Department of Pathology, Magee-Womens Hospital, University of Pittsburgh Medical 
      Center, Pittsburgh, PA.
FAU - Han, Min
AU  - Han M
FAU - Varma, Kavita R
AU  - Varma KR
FAU - Clark, Beth Z
AU  - Clark BZ
FAU - Bhargava, Rohit
AU  - Bhargava R
FAU - Dabbs, David J
AU  - Dabbs DJ
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Appl Immunohistochem Mol Morphol
JT  - Applied immunohistochemistry & molecular morphology : AIMM
JID - 100888796
RN  - 0 (Biomarkers, Tumor)
RN  - 0 (Neoplasm Proteins)
SB  - IM
MH  - Biomarkers, Tumor/*metabolism
MH  - *Breast Neoplasms/epidemiology/metabolism/pathology
MH  - Female
MH  - Humans
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence
MH  - Neoplasm Proteins/*metabolism
MH  - Retrospective Studies
EDAT- 2018/08/11 06:00
MHDA- 2019/09/20 06:00
CRDT- 2018/08/11 06:00
PHST- 2018/08/11 06:00 [pubmed]
PHST- 2019/09/20 06:00 [medline]
PHST- 2018/08/11 06:00 [entrez]
AID - 10.1097/PAI.0000000000000697 [doi]
PST - ppublish
SO  - Appl Immunohistochem Mol Morphol. 2018 Nov/Dec;26(10):697-700. doi: 
      10.1097/PAI.0000000000000697.