PMID- 33112955
OWN - NLM
STAT- MEDLINE
DCOM- 20211005
LR  - 20211005
IS  - 1543-2165 (Electronic)
IS  - 0003-9985 (Linking)
VI  - 145
IP  - 7
DP  - 2021 Jul 1
TI  - HER2 Testing for Breast Cancer in the Genomics Laboratory: A Sea Change for 
      Fluorescence In Situ Hybridization.
PG  - 883-886
LID - 10.5858/arpa.2020-0273-OA [doi]
AB  - CONTEXT.-: Guidelines for HER2 testing in breast cancer have changed over time, 
      from the US Food and Drug Administration guideline to the American Society of 
      Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines 
      published in 2007, 2013, and 2018. OBJECTIVE.-: To investigate the change in 
      assignment of HER2 status in breast cancers with equivocal (2+) 
      immunohistochemistry (IHC) results by fluorescence in situ hybridization (FISH) 
      following implementation of the ASCO/CAP 2018 guideline. DESIGN.-: The study 
      included 3556 invasive breast cancers that were HER2 equivocal (2+) by IHC and 
      were submitted to our FISH laboratory after July 2018. Reflex testing (with 
      repeat IHC staining) was performed on certain categories of FISH results known as 
      groups 2, 3, and 4. Concomitant review of IHC and FISH was performed on these 
      reflex cases per 2018 guideline recommendations. The FISH data were analyzed to 
      compare US Food and Drug Administration and ASCO/CAP 2007, 2013, and 2018 
      interpretations. RESULTS.-: Of 3548 invasive breast cancers with complete data 
      available, the percentage agreement for FISH according to different guidelines 
      was highest for ASCO/CAP 2018 versus US Food and Drug Administration (96.5%), 
      followed by ASCO/CAP 2018 versus 2007 (93.8%), and lowest with ASCO/CAP 2018 
      versus 2013 (83.7%). Per the 2018 guideline, reflex IHC testing was performed on 
      633 breast cancers (17.8%); the majority of reflex testing results were negative 
      (541 of 633; 85.5%). The overall distribution of HER2 FISH results (per the 2018 
      guideline) was 88.5% negative and 11.5% positive. CONCLUSIONS.-: By eliminating 
      the equivocal FISH category, the 2018 ASCO/CAP guideline significantly reduced 
      the HER2 FISH-positive rate in tumors with equivocal (2+) IHC results.
FAU - Geiersbach, Katherine B
AU  - Geiersbach KB
AD  - From the Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, 
      Minnesota.
FAU - Sill, Daniel R
AU  - Sill DR
AD  - From the Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, 
      Minnesota.
FAU - Meyer, Reid G
AU  - Meyer RG
AD  - From the Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, 
      Minnesota.
FAU - Yuhas, Jason A
AU  - Yuhas JA
AD  - From the Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, 
      Minnesota.
FAU - Sukov, William R
AU  - Sukov WR
AD  - From the Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, 
      Minnesota.
FAU - Mounajjed, Taofic
AU  - Mounajjed T
AD  - From the Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, 
      Minnesota.
FAU - Carter, Jodi M
AU  - Carter JM
AD  - From the Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, 
      Minnesota.
FAU - Jenkins, Robert B
AU  - Jenkins RB
AD  - From the Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, 
      Minnesota.
FAU - Chen, Beiyun
AU  - Chen B
AD  - From the Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, 
      Minnesota.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Arch Pathol Lab Med
JT  - Archives of pathology & laboratory medicine
JID - 7607091
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/*genetics
MH  - Breast Neoplasms/*genetics/pathology
MH  - Female
MH  - Humans
MH  - Immunohistochemistry/standards
MH  - In Situ Hybridization, Fluorescence/*standards
MH  - Practice Guidelines as Topic/*standards
MH  - Predictive Value of Tests
MH  - Receptor, ErbB-2/*genetics
MH  - Reproducibility of Results
EDAT- 2020/10/29 06:00
MHDA- 2021/10/06 06:00
CRDT- 2020/10/28 17:17
PHST- 2020/08/09 00:00 [accepted]
PHST- 2020/10/29 06:00 [pubmed]
PHST- 2021/10/06 06:00 [medline]
PHST- 2020/10/28 17:17 [entrez]
AID - 446874 [pii]
AID - 10.5858/arpa.2020-0273-OA [doi]
PST - ppublish
SO  - Arch Pathol Lab Med. 2021 Jul 1;145(7):883-886. doi: 10.5858/arpa.2020-0273-OA.