PMID- 26185309
OWN - NLM
STAT- MEDLINE
DCOM- 20150930
LR  - 20220316
IS  - 1943-7722 (Electronic)
IS  - 0002-9173 (Linking)
VI  - 144
IP  - 2
DP  - 2015 Aug
TI  - Impact of the 2013 ASCO/CAP HER2 Guideline Updates at an Academic Medical Center 
      That Performs Primary HER2 FISH Testing: Increase in Equivocal Results and 
      Utility of Reflex Immunohistochemistry.
PG  - 247-52
LID - 10.1309/AJCPE5NCHWPSMR5D [doi]
AB  - OBJECTIVES: The 2013 American Society of Clinical Oncology (ASCO)/College of 
      American Pathologists (CAP) guideline updates lowered the threshold for HER2 
      positivity and altered the equivocal category. The goal of this study was to 
      evaluate the impact of these changes on the distribution of HER2 fluorescence in 
      situ hybridization (FISH) status. The utility of reflex HER2 immunohistochemistry 
      (IHC) for FISH equivocal cases was also examined. METHODS: We retrospectively 
      reviewed all invasive breast cancers analyzed for HER2 via dual-probe FISH 
      (PathVysion; Abbott Laboratories. Abbott Park, IL) 12 months before and after the 
      HER2 guidelines updates were implemented. Reflex HER2 IHC results were recorded 
      for HER2 FISH equivocal cases. RESULTS: There was a significant increase in the 
      number of HER2 FISH equivocal results after the guideline updates (4.9% vs 1.4%, 
      P = .0087) that was independent of specimen type (core vs surgical, P = .6). All 
      17 FISH equivocal cases after the updates had reflex HER2 IHC: two (12%) of 17 
      were positive, 12 (71%) of 17 remained equivocal, and three (18%) of 17 were 
      negative. CONCLUSIONS: Implementation of the 2013 ASCO/CAP HER2 guideline updates 
      resulted in an increase in HER2 FISH equivocal results, which can be attributed 
      to HER2 copy number, regardless of the HER2/CEP17 ratio. Reflex IHC for FISH 
      equivocal cases is of limited utility; however, IHC does assign HER2 positivity 
      or negativity in a small percentage of cases.
CI  - Copyright(c) by the American Society for Clinical Pathology.
FAU - Muller, Kristen E
AU  - Muller KE
AD  - From Department of Pathology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, 
      and Geisel School of Medicine at Dartmouth, Hanover, NH.
FAU - Marotti, Jonathan D
AU  - Marotti JD
AD  - From Department of Pathology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, 
      and Geisel School of Medicine at Dartmouth, Hanover, NH.
FAU - Memoli, Vincent A
AU  - Memoli VA
AD  - From Department of Pathology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, 
      and Geisel School of Medicine at Dartmouth, Hanover, NH.
FAU - Wells, Wendy A
AU  - Wells WA
AD  - From Department of Pathology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, 
      and Geisel School of Medicine at Dartmouth, Hanover, NH.
FAU - Tafe, Laura J
AU  - Tafe LJ
AD  - From Department of Pathology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, 
      and Geisel School of Medicine at Dartmouth, Hanover, NH. 
      Laura.J.Tafe@Hitchcock.org.
LA  - eng
GR  - P30 CA023108/CA/NCI NIH HHS/United States
PT  - Journal Article
PL  - England
TA  - Am J Clin Pathol
JT  - American journal of clinical pathology
JID - 0370470
RN  - 0 (Biomarkers, Tumor)
SB  - IM
MH  - Academic Medical Centers
MH  - Biomarkers, Tumor/analysis
MH  - Breast Neoplasms/*genetics
MH  - Female
MH  - Genes, erbB-2/*genetics
MH  - Humans
MH  - Immunohistochemistry/*methods
MH  - In Situ Hybridization, Fluorescence/*methods
MH  - Practice Guidelines as Topic/*standards
MH  - Retrospective Studies
OTO - NOTNLM
OT  - ASCO/CAP HER2 guidelines
OT  - Breast cancer
OT  - HER2 FISH
OT  - HER2 IHC
EDAT- 2015/07/18 06:00
MHDA- 2015/10/01 06:00
CRDT- 2015/07/18 06:00
PHST- 2015/07/18 06:00 [entrez]
PHST- 2015/07/18 06:00 [pubmed]
PHST- 2015/10/01 06:00 [medline]
AID - 144/2/247 [pii]
AID - 10.1309/AJCPE5NCHWPSMR5D [doi]
PST - ppublish
SO  - Am J Clin Pathol. 2015 Aug;144(2):247-52. doi: 10.1309/AJCPE5NCHWPSMR5D.