PMID- 12955036
OWN - NLM
STAT- MEDLINE
DCOM- 20040115
LR  - 20191210
IS  - 1340-6868 (Print)
IS  - 1340-6868 (Linking)
VI  - 10
IP  - 3
DP  - 2003
TI  - Evaluation of HER-2 status in breast carcinoma by fluorescence in situ 
      hybridization and immunohistochemistry.
PG  - 234-40
AB  - BACKGROUND: Evaluation of HER-2 status is essential for selecting appropriate 
      candidates for treatment with trastuzumab, a recombinant humanized monoclonal 
      antibody active against human epidermal growth factor receptor-2 (HER-2) protein. 
      METHODS: To standardize a HER-2 diagnostic system for breast cancer tissue, we 
      compared immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) 
      results. We studied specimens from 110 patients with invasive ductal breast 
      cancer who underwent operation. IHC analysis was performed using HercepTestTM 
      (Dako A/S), and results assessed according to the HercepTestTM criteria. FISH was 
      performed using a PathVysionTM HER-2 DNA probe kit (Vysis Inc.), with specimens 
      considered HER-2 positive if the ratio of the total HER-2 signals to chromosome 
      17 centromere (CEP17) signals was greater than 2. RESULTS: FISH results were 
      indefinite in 3 patients and positive in 24 patients (22%). IHC scores were 0 in 
      27 patients (25%), 1+ in 53 patients (48%), 2+ in 10 patients (9%), and 3+ in 20 
      patients (18%). All 20 patients with a score of 3+ by IHC were positive by FISH, 
      with only 1 (10%) of 10 patients with an IHC score of 2+ positive by FISH. 
      CONCLUSIONS: Our results indicated that an IHC score of 3+ is equivalent to 
      FISH-positivity for HER-2 diagnosis, while patients with an IHC score of 2+ 
      should undergo FISH testing.
FAU - Ogura, Hiroyuki
AU  - Ogura H
AD  - Department of Breast Pathology, The Cancer Institute of the Japanese Foundation 
      for Cancer Research, 1-37-1, Kami-Ikebukuro, Toshima-ku, Tokyo 170-8455, Japan.
FAU - Akiyama, Futoshi
AU  - Akiyama F
FAU - Kasumi, Fujio
AU  - Kasumi F
FAU - Kazui, Teruhisa
AU  - Kazui T
FAU - Sakamoto, Goi
AU  - Sakamoto G
LA  - eng
PT  - Comparative Study
PT  - Evaluation Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - Japan
TA  - Breast Cancer
JT  - Breast cancer (Tokyo, Japan)
JID - 100888201
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Biomarkers, Tumor)
RN  - 0 (Recombinant Proteins)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - P188ANX8CK (Trastuzumab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal/therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Agents/therapeutic use
MH  - Biomarkers, Tumor/*metabolism
MH  - Breast Neoplasms/drug therapy/*metabolism/pathology
MH  - Female
MH  - Humans
MH  - Immunohistochemistry/standards
MH  - In Situ Hybridization, Fluorescence/standards
MH  - Middle Aged
MH  - Predictive Value of Tests
MH  - Receptor, ErbB-2/*metabolism
MH  - Recombinant Proteins/therapeutic use
MH  - Trastuzumab
EDAT- 2003/09/05 05:00
MHDA- 2004/01/16 05:00
CRDT- 2003/09/05 05:00
PHST- 2003/09/05 05:00 [pubmed]
PHST- 2004/01/16 05:00 [medline]
PHST- 2003/09/05 05:00 [entrez]
AID - 10.1007/BF02966723 [doi]
PST - ppublish
SO  - Breast Cancer. 2003;10(3):234-40. doi: 10.1007/BF02966723.