PMID- 15151202
OWN - NLM
STAT- MEDLINE
DCOM- 20040603
LR  - 20220316
IS  - 0002-9173 (Print)
IS  - 0002-9173 (Linking)
VI  - 121
IP  - 5
DP  - 2004 May
TI  - HER-2 testing in breast cancer using immunohistochemical analysis and 
      fluorescence in situ hybridization: a single-institution experience of 2,279 
      cases and comparison of dual-color and single-color scoring.
PG  - 631-6
AB  - We analyzed concordance between immunohistochemical analysis and fluorescence in 
      situ hybridization (FISH) in HER-2 status and studied the effect of dual-color 
      (D-FISH) vs single-color FISH (S-FISH) scoring on the assignment of tumors to 
      amplified or nonamplified categories. The assays were performed on 
      formalin-fixed, paraffin-embedded sections of 2,279 invasive breast carcinomas. 
      Immunohistochemical results were interpreted as negative (0, 1+) or positive (2+, 
      3+). For FISH analyses, a ratio for HER-2/chromosome 17 of 2.0 or more (D-FISH) 
      or an absolute HER-2 copy number per nucleus of more than 4.0 (S-FISH) were 
      interpreted as positive gene amplification. We found 547 (24.0%) cases positive 
      immunohistochemically, 326 (14.3%) by D-FISH, and 351 (15.4%) by S-FISH. Overall 
      concordance in HER-2 status with immunohistochemical analysis was 87% for D-FISH 
      and 86% for S-FISH. Excellent concordance was found among groups scored 
      immunohistochemically as 0, 1+, and 3+ (with D-FISH, 97%; with S-FISH, 96%). The 
      most discordant category was the group scored 2+ immunohistochemically, in which 
      only a quarter of the 2+ tumors were FISH(+). D-FISH and S-FISH scoring results 
      were discordant in 89 tumors (4%), of which 8 (9%) had 3+ immunohistochemical 
      staining and none showed high-level HER-2 amplification. Among all FISH(+) 
      tumors, 10% were negative by immunohistochemical analysis, and notably almost 
      half (47%) showed borderline to low HER-2 amplification (D-FISH score, 2.0-3.9); 
      the clinical significance of these findings warrants further investigation.
FAU - Lal, Priti
AU  - Lal P
AD  - Department of Pathology, Memorial Sloan-Kettering Cancer Center, New York, NY 
      10021, USA.
FAU - Salazar, Paulo A
AU  - Salazar PA
FAU - Hudis, Clifford A
AU  - Hudis CA
FAU - Ladanyi, Marc
AU  - Ladanyi M
FAU - Chen, Beiyun
AU  - Chen B
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PL  - England
TA  - Am J Clin Pathol
JT  - American journal of clinical pathology
JID - 0370470
RN  - 0 (DNA, Neoplasm)
RN  - 0 (Reagent Kits, Diagnostic)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
EIN - Am J Clin Pathol. 2004 Feb;6(1):58
MH  - Adenocarcinoma/*chemistry/pathology
MH  - Breast Neoplasms/*chemistry/pathology
MH  - DNA, Neoplasm/analysis
MH  - Female
MH  - Gene Amplification
MH  - Gene Dosage
MH  - Genes, erbB-2/genetics
MH  - Humans
MH  - Immunohistochemistry/methods
MH  - In Situ Hybridization, Fluorescence
MH  - Reagent Kits, Diagnostic
MH  - Receptor, ErbB-2/*analysis
MH  - Reproducibility of Results
EDAT- 2004/05/21 05:00
MHDA- 2004/06/04 05:00
CRDT- 2004/05/21 05:00
PHST- 2004/05/21 05:00 [pubmed]
PHST- 2004/06/04 05:00 [medline]
PHST- 2004/05/21 05:00 [entrez]
AID - 10.1309/VE78-62V2-646B-R6EX [doi]
PST - ppublish
SO  - Am J Clin Pathol. 2004 May;121(5):631-6. doi: 10.1309/VE78-62V2-646B-R6EX.