PMID- 28967951
OWN - NLM
STAT- MEDLINE
DCOM- 20171020
LR  - 20220316
IS  - 1943-7722 (Electronic)
IS  - 0002-9173 (Linking)
VI  - 148
IP  - 4
DP  - 2017 Oct 1
TI  - Impact of 2013 American Society of Clinical Oncology/College of American 
      Pathologists Guidelines on HER2 Fluorescent In Situ Hybridization Testing in 
      Breast Cancers : Experience From a National Reference Laboratory.
PG  - 308-313
LID - 10.1093/ajcp/aqx079 [doi]
AB  - OBJECTIVES: We compared the impact of 2013 American Society of Clinical 
      Oncology/College of American Pathologists (ASCO/CAP) guidelines on human 
      epidermal growth factor receptor 2 (HER2) fluorescence in situ hybridization 
      (FISH) testing results on breast cancers. METHODS: HER2 FISH testing performed 
      between May 2015 and April 2016 following 2013 ASCO/CAP guidelines was included. 
      HER2 to control probe ratios, mean HER2, and control probe copy numbers were used 
      to reassign HER2 status using 2007 ASCO/CAP and US Food and Drug Administration 
      (FDA) guidelines. RESULTS: HER2 FISH results were available in 2,017 cases. A 
      total of 342 (17.0%) cases were amplified, 301 (14.9%) were equivocal, and 1,374 
      (68.1%) were nonamplified. After additional testing with the alternate probe, 
      amplified cases increased to 21.6%. HER2 positivity rates following the 2013 
      ASCO/CAP guidelines were significantly higher compared with the 2007 ASCO/CAP and 
      FDA guidelines. CONCLUSIONS: The 2013 ASCO/CAP guidelines lead to a higher number 
      of HER2 FISH positive and equivocal cases. In a reference laboratory setting 
      where an alternative control probe was used to resolve equivocal FISH cases, 
      31.2% of patients with initial equivocal results became HER2 positive.
CI  - (c) American Society for Clinical Pathology, 2017. All rights reserved. For 
      permissions, please e-mail: journals.permissions@oup.com
FAU - Gulbahce, H Evin
AU  - Gulbahce HE
AD  - Department of Pathology, University of Utah, Huntsman Cancer Hospital, Salt Lake 
      City.
LA  - eng
PT  - Journal Article
PL  - England
TA  - Am J Clin Pathol
JT  - American journal of clinical pathology
JID - 0370470
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/*analysis
MH  - Breast Neoplasms/*classification
MH  - Female
MH  - Humans
MH  - In Situ Hybridization, Fluorescence/*methods
MH  - Medical Oncology/*standards
MH  - Pathology, Clinical/*standards
MH  - Practice Guidelines as Topic
MH  - Receptor, ErbB-2/*analysis/biosynthesis
MH  - United States
OTO - NOTNLM
OT  - Breast cancer
OT  - FISH
OT  - HER2
EDAT- 2017/10/03 06:00
MHDA- 2017/10/21 06:00
CRDT- 2017/10/03 06:00
PHST- 2017/10/03 06:00 [entrez]
PHST- 2017/10/03 06:00 [pubmed]
PHST- 2017/10/21 06:00 [medline]
AID - 4108065 [pii]
AID - 10.1093/ajcp/aqx079 [doi]
PST - ppublish
SO  - Am J Clin Pathol. 2017 Oct 1;148(4):308-313. doi: 10.1093/ajcp/aqx079.