PMID- 19415952
OWN - NLM
STAT- MEDLINE
DCOM- 20090519
LR  - 20220317
IS  - 1543-2165 (Electronic)
IS  - 0003-9985 (Linking)
VI  - 133
IP  - 5
DP  - 2009 May
TI  - Implementation of American Society of Clinical Oncology/College of American 
      Pathologists HER2 Guideline Recommendations in a tertiary care facility increases 
      HER2 immunohistochemistry and fluorescence in situ hybridization concordance and 
      decreases the number of inconclusive cases.
PG  - 775-80
AB  - CONTEXT: The American Society of Clinical Oncology/ College of American 
      Pathologists (ASCO/CAP) guideline recommendations from January 2007 identified 
      many sources of immunohistochemistry (IHC) testing variation. OBJECTIVE: In this 
      current study, we implemented the guidelines and addressed our institution's 
      preanalytic, analytic, and postanalytic variables relating to HER2 testing to 
      improve clinical outcomes. DESIGN: We evaluated core biopsies performed on breast 
      lesions from 2006 through 2007. Prognostic/predictive markers obtained by IHC 
      were correlated with HER2 fluorescence in situ hybridization (FISH). Preanalytic 
      sources of biopsy testing variation were studied by collecting data on the number 
      of biopsies that needed repeat testing because of inconclusive FISH results. 
      RESULTS: In the year preceding implementation of the guidelines, the HER2 IHC and 
      FISH concordance was 98%. In an additional 10.8% of cases, the FISH results were 
      inconclusive. When additional material became available to retest the 
      inconclusive cases, the results were informative. Further evaluation of the 
      inconclusive cases revealed that the core needle biopsies received, on average, 4 
      hours of formalin fixation. After implementation of a minimum 6 hours of fixation 
      and the ASCO/CAP guideline recommendations, the HER2 IHC and FISH concordance was 
      98.5%. The number of FISH inconclusive cases decreased from 10.8% to 3.4% (a 64% 
      reduction). Repeat estrogen-receptor IHC requests decreased by 40% from 38 in 
      2006 to 23 in 2007. CONCLUSIONS: We have shown that standardized fixation and 
      adherence to the ASCO/CAP guidelines for HER2 testing has resulted in a greater 
      HER2 IHC and HER2 FISH correlation, decreased numbers of inconclusive FISH cases, 
      decreased repeat estrogen-receptor requests, and financial savings to the 
      Department of Pathology.
FAU - Middleton, Lavinia P
AU  - Middleton LP
AD  - Departments of Pathology, The University of Texas M. D. Anderson Cancer Center, 
      Houston, USA. lpmiddleton@mdanderson.org
FAU - Price, Kathy M
AU  - Price KM
FAU - Puig, Pamela
AU  - Puig P
FAU - Heydon, Lori J
AU  - Heydon LJ
FAU - Tarco, Emily
AU  - Tarco E
FAU - Sneige, Nour
AU  - Sneige N
FAU - Barr, Kaye
AU  - Barr K
FAU - Deavers, Michael T
AU  - Deavers MT
LA  - eng
PT  - Comparative Study
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 (Receptor, ErbB-2)
SB  - IM
MH  - Biomarkers, Tumor/genetics/metabolism
MH  - Breast Neoplasms/genetics/metabolism/*pathology
MH  - Female
MH  - Gene Amplification
MH  - *Genes, erbB-2
MH  - *Guidelines as Topic
MH  - Humans
MH  - Immunohistochemistry/*methods/standards
MH  - In Situ Hybridization, Fluorescence/*methods/standards
MH  - *Receptor, ErbB-2/genetics/metabolism
MH  - Reproducibility of Results
MH  - Societies, Medical
EDAT- 2009/05/07 09:00
MHDA- 2009/05/20 09:00
CRDT- 2009/05/07 09:00
PHST- 2008/09/12 00:00 [accepted]
PHST- 2009/05/07 09:00 [entrez]
PHST- 2009/05/07 09:00 [pubmed]
PHST- 2009/05/20 09:00 [medline]
AID - 2008-0316-OA [pii]
AID - 10.5858/133.5.775 [doi]
PST - ppublish
SO  - Arch Pathol Lab Med. 2009 May;133(5):775-80. doi: 10.5858/133.5.775.