PMID- 33813685
OWN - NLM
STAT- MEDLINE
DCOM- 20210623
LR  - 20210623
IS  - 1573-7217 (Electronic)
IS  - 0167-6806 (Linking)
VI  - 187
IP  - 1
DP  - 2021 May
TI  - HER2 testing in breast cancers: comparison of assays and interpretation using 
      ASCO/CAP 2013 and 2018 guidelines.
PG  - 95-104
LID - 10.1007/s10549-021-06208-5 [doi]
AB  - PURPOSE: HER2 overexpression and gene amplification are routinely tested by 
      immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH), 
      respectively. In addition, HER2 mRNA expression is also tested by the Oncotype DX 
      assay. Discordance between laboratories among the different assays remains a 
      problem. To improve the routine HER2 reporting, the American Society of Clinical 
      Oncology (ASCO) and the College of American Pathologists (CAP) updated their 
      guidelines in 2018. Our study will compare concordance of HER2 status by IHC and 
      FISH using ASCO/CAP 2013 and 2018 guidelines with Oncotype DX. METHODS: We 
      retrospectively reviewed 657 estrogen receptor positive primary breast cancer 
      cases with available Oncotype DX tests between 2011 and 2018. Medical records 
      were reviewed for HER2 results by IHC, FISH, and Oncotype DX. The HER2 results by 
      different assays and between 2013 and 2018 guidelines were compared. RESULTS: Of 
      the 657 cases, 280 were tested by IHC, FISH, and Oncotype DX. HER2-equivocal 
      cases by IHC 2013 guidelines were all negative (67/67, 100%) by FISH 2018 
      guidelines and by Oncotype DX. HER2-equivocal cases by FISH 2013 guidelines were 
      all negative (16/16, 100%) by FISH 2018 guidelines, while 15/16 (93.8%) negative 
      and 1/16 (6.2%) equivocal by Oncotype DX. The HER2-equivocal and HER2-negative 
      groups were similar in age, gender, histology, grade, and Ki67 score. 
      CONCLUSIONS: HER2 concordance was highest between Oncotype DX (99.6%) and FISH 
      per 2018 guidelines. This suggests that the ASCO/CAP 2018 guidelines improved the 
      accurate stratification of HER2-equivocal cases.
FAU - McLemore, Lauren E
AU  - McLemore LE
AD  - Department of Pathology, The University of Texas MD Anderson Cancer Center, 1515 
      Holcombe Blvd., Unit 085, G1.3617B, Houston, TX, 77030, USA.
AD  - Department of Pathology, University of Colorado, Denver, CO, USA.
FAU - Albarracin, Constance T
AU  - Albarracin CT
AD  - Department of Pathology, The University of Texas MD Anderson Cancer Center, 1515 
      Holcombe Blvd., Unit 085, G1.3617B, Houston, TX, 77030, USA.
FAU - Gruschkus, Stephen K
AU  - Gruschkus SK
AD  - Department of Biostatistics, The University of Texas MD Anderson Cancer Center, 
      Houston, TX, USA.
FAU - Bassett, Roland L Jr
AU  - Bassett RL Jr
AD  - Department of Biostatistics, The University of Texas MD Anderson Cancer Center, 
      Houston, TX, USA.
FAU - Wu, Yun
AU  - Wu Y
AD  - Department of Pathology, The University of Texas MD Anderson Cancer Center, 1515 
      Holcombe Blvd., Unit 085, G1.3617B, Houston, TX, 77030, USA.
FAU - Dhamne, Sagar
AU  - Dhamne S
AD  - Department of Pathology & Immunology, Baylor College of Medicine, Houston, TX, 
      USA.
FAU - Yim, Isaiah
AU  - Yim I
AD  - Department of Pathology, The University of Texas MD Anderson Cancer Center, 1515 
      Holcombe Blvd., Unit 085, G1.3617B, Houston, TX, 77030, USA.
FAU - Lin, Kevin
AU  - Lin K
AD  - Department of Pathology, The University of Texas MD Anderson Cancer Center, 1515 
      Holcombe Blvd., Unit 085, G1.3617B, Houston, TX, 77030, USA.
FAU - Bedrosian, Isabelle
AU  - Bedrosian I
AD  - Department of Breast Surgical Oncology, The University of Texas MD Anderson 
      Cancer Center, Houston, TX, USA.
FAU - Sneige, Nour
AU  - Sneige N
AD  - Department of Pathology, The University of Texas MD Anderson Cancer Center, 1515 
      Holcombe Blvd., Unit 085, G1.3617B, Houston, TX, 77030, USA.
FAU - Chen, Hui
AU  - Chen H
AUID- ORCID: 0000-0002-5847-0561
AD  - Department of Pathology, The University of Texas MD Anderson Cancer Center, 1515 
      Holcombe Blvd., Unit 085, G1.3617B, Houston, TX, 77030, USA. 
      hchen7@mdanderson.org.
LA  - eng
GR  - P30 CA016672/CA/NCI NIH HHS/United States
GR  - P30 CA016672/CA/NCI NIH HHS/United States
GR  - P30 CA016672/CA/NCI NIH HHS/United States
PT  - Journal Article
DEP - 20210403
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 (Receptor, ErbB-2)
SB  - IM
MH  - Biomarkers, Tumor/genetics
MH  - *Breast Neoplasms/diagnosis/genetics
MH  - Female
MH  - Humans
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence
MH  - Receptor, ErbB-2/genetics
MH  - Retrospective Studies
OTO - NOTNLM
OT  - ASCO/CAP guidelines
OT  - Breast cancer
OT  - FISH
OT  - HER2 amplification
OT  - HER2 overexpression
OT  - Oncotype DX
EDAT- 2021/04/05 06:00
MHDA- 2021/06/24 06:00
CRDT- 2021/04/04 21:04
PHST- 2021/01/08 00:00 [received]
PHST- 2021/03/20 00:00 [accepted]
PHST- 2021/04/05 06:00 [pubmed]
PHST- 2021/06/24 06:00 [medline]
PHST- 2021/04/04 21:04 [entrez]
AID - 10.1007/s10549-021-06208-5 [pii]
AID - 10.1007/s10549-021-06208-5 [doi]
PST - ppublish
SO  - Breast Cancer Res Treat. 2021 May;187(1):95-104. doi: 10.1007/s10549-021-06208-5. 
      Epub 2021 Apr 3.