PMID- 28192599
OWN - NLM
STAT- MEDLINE
DCOM- 20170828
LR  - 20170828
IS  - 1097-0142 (Electronic)
IS  - 0008-543X (Linking)
VI  - 123
IP  - 12
DP  - 2017 Jun 15
TI  - Impact of an alternative chromosome 17 probe and the 2013 American Society of 
      Clinical Oncology and College of American Pathologists guidelines on fluorescence 
      in situ hybridization for the determination of HER2 gene amplification in breast 
      cancer.
PG  - 2230-2239
LID - 10.1002/cncr.30592 [doi]
AB  - BACKGROUND: The dual-probe fluorescence in situ hybridization (FISH) assay for 
      human epidermal growth factor receptor 2 (HER2) gene amplification in breast 
      cancer provides an HER2:CEP17 (centromere enumeration probe for chromosome 17) 
      ratio. Copy number alteration (CNA) in CEP17 may skew this ratio. The authors 
      analyzed the impact of the 2013 American Society of Oncology/College of American 
      Pathologists (ASCO/CAP) guidelines and an alternative chromosome 17 probe on HER2 
      status in tumor specimens with CEP17 CNA. METHODS: Specimens with CEP17 CNA (n = 
      310) were selected from 3048 tumor samples that were received from January 2013 
      to June 2015 for testing with the alternative chromosome 17 probe D17S122. 
      Reclassification of HER2 status was assessed using the 2007 and 2013 ASCO/CAP 
      guidelines. RESULTS: The alternative chromosome 17 probe reclassified 82 of 310 
      (26.5%) and 87 of 310 (28.1%) tumors using the 2007 and 2013 guidelines, 
      respectively. Of the 41 of 310 tumors (13.2%) that were reclassified from 
      nonamplified to amplified according to 2007 guidelines, 28 of 41 (68.3%) had an 
      average HER2 copy number >/=4.0 and <6.0. The 39 of 310 tumors (12.6%) that were 
      reclassified from equivocal to amplified according to 2013 guidelines had a mean 
      HER2 copy number between >/=4.0 and <6.0. Most of these patients had stage I, 
      hormone receptor-positive, lymph node-negative tumors, which is an unusual 
      clinicopathologic profile for HER2-amplified tumors, and most received 
      HER2-targeted therapy in addition to endocrine therapy. CONCLUSIONS: Reflex 
      testing with an alternative chromosome 17 probe using the 2013 ASCO/CAP 
      guidelines reclassified 28.1% of tumor samples that had CEP17 CNA, converting 
      nearly one-half from equivocal to amplified. The benefit of HER2-targeted therapy 
      in this patient population requires further study. Cancer 2017;123:2230-2239. (c) 
      2017 American Cancer Society.
CI  - (c) 2017 American Cancer Society.
FAU - Donaldson, Alana R
AU  - Donaldson AR
AD  - Department of Pathology, Robert J. Tomsich Institute of Pathology and Laboratory 
      Medicine, Cleveland Clinic, Cleveland, Ohio.
FAU - Shetty, Shashirekha
AU  - Shetty S
AD  - Department of Laboratory Medicine, Robert J. Tomsich Institute of Pathology and 
      Laboratory Medicine, Cleveland Clinic, Cleveland, Ohio.
FAU - Wang, Zhen
AU  - Wang Z
AD  - Department of Pathology, Robert J. Tomsich Institute of Pathology and Laboratory 
      Medicine, Cleveland Clinic, Cleveland, Ohio.
FAU - Rivera, Christine L
AU  - Rivera CL
AD  - Department of Laboratory Medicine, Robert J. Tomsich Institute of Pathology and 
      Laboratory Medicine, Cleveland Clinic, Cleveland, Ohio.
FAU - Portier, Bryce P
AU  - Portier BP
AD  - Department of Pathology, Robert J. Tomsich Institute of Pathology and Laboratory 
      Medicine, Cleveland Clinic, Cleveland, Ohio.
FAU - Budd, G Thomas
AU  - Budd GT
AD  - Department of Hematology and Oncology, Taussig Cancer Institute, Cleveland 
      Clinic, Cleveland, Ohio.
FAU - Downs-Kelly, Erinn
AU  - Downs-Kelly E
AD  - Department of Pathology, Huntsman Cancer Hospital, University of Utah, Salt Lake 
      City, Utah.
FAU - Lanigan, Christopher P
AU  - Lanigan CP
AD  - Department of Pathology, Robert J. Tomsich Institute of Pathology and Laboratory 
      Medicine, Cleveland Clinic, Cleveland, Ohio.
FAU - Calhoun, Benjamin C
AU  - Calhoun BC
AD  - Department of Pathology, Robert J. Tomsich Institute of Pathology and Laboratory 
      Medicine, Cleveland Clinic, Cleveland, Ohio.
LA  - eng
PT  - Journal Article
DEP - 20170213
PL  - United States
TA  - Cancer
JT  - Cancer
JID - 0374236
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Antineoplastic Agents, Hormonal)
RN  - 0 (Molecular Probes)
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Antineoplastic Agents/therapeutic use
MH  - Antineoplastic Agents, Hormonal/therapeutic use
MH  - Breast Neoplasms/classification/drug therapy/*genetics
MH  - Carcinoma/classification/drug therapy/*genetics
MH  - Chromosomes, Human, Pair 17/*genetics
MH  - Disease Progression
MH  - Female
MH  - Humans
MH  - In Situ Hybridization, Fluorescence/*methods
MH  - Medical Oncology
MH  - Molecular Probes/*genetics
MH  - Molecular Targeted Therapy
MH  - Neoplasm Recurrence, Local/epidemiology
MH  - Pathology, Clinical
MH  - Practice Guidelines as Topic
MH  - Receptor, ErbB-2/*genetics
MH  - Retrospective Studies
OTO - NOTNLM
OT  - Erb-B2 receptor tyrosine kinase 2 (ERBB2)
OT  - breast cancer
OT  - diagnosis
OT  - human epidermal growth factor receptor 2 (HER2)
OT  - in situ hybridization
OT  - pathology
OT  - prognosis
EDAT- 2017/02/14 06:00
MHDA- 2017/08/29 06:00
CRDT- 2017/02/14 06:00
PHST- 2016/11/07 00:00 [received]
PHST- 2016/12/21 00:00 [revised]
PHST- 2017/01/06 00:00 [accepted]
PHST- 2017/02/14 06:00 [pubmed]
PHST- 2017/08/29 06:00 [medline]
PHST- 2017/02/14 06:00 [entrez]
AID - 10.1002/cncr.30592 [doi]
PST - ppublish
SO  - Cancer. 2017 Jun 15;123(12):2230-2239. doi: 10.1002/cncr.30592. Epub 2017 Feb 13.