PMID- 10678582
OWN - NLM
STAT- MEDLINE
DCOM- 20000316
LR  - 20141120
IS  - 0091-7370 (Print)
IS  - 0091-7370 (Linking)
VI  - 30
IP  - 1
DP  - 2000 Jan
TI  - Fluorescence in situ hybridization (FISH) for detection of HER-2/neu 
      amplification in breast cancer: a multicenter portability study.
PG  - 41-8
AB  - Amplification and/or overexpression of HER-2/neu has been shown to be both a 
      prognostic and predictive marker in breast cancer. Recent studies have also 
      confirmed the efficacy of Herceptin (trastuzumab) as adjuvant therapy for 
      patients with overexpression of HER-2/neu. Therefore, it is critical that precise 
      and reproducible assays be used in the clinical laboratory setting for 
      determination of the HER-2/neu status in patients with breast cancer. The 
      objective of this study was to determine the portability (reproducibility between 
      different institutions) of the PathVysion HER-2 fluorescence in situ 
      hybridization (FISH) assay used for detection of amplification of the HER-2/neu 
      gene in formalin-fixed, paraffin-embedded tissue sections of invasive ductal 
      carcinoma of the breast. Study specimens consisted of one breast tumor with a 
      normal HER-2/neu copy number, two tumors with a low level, and one tumor with a 
      high level of HER-2/neu amplification. The PathVysion HER-2 assay was shown to be 
      highly reproducible on different assay days (n = 3) and between different 
      institutions (n = 5) in the detection of amplification of the HER-2/neu gene in 
      routinely processed clinical specimens of breast carcinoma. In addition, this 
      study examined the feasibility of enumerating FISH signals in 20 nuclei in 
      contrast to 60 nuclei per specimen. Although a modest increase in variation was 
      observed when analyzing 20 compared to 60 nuclei, the mean ratios were similar. 
      Therefore, analysis of as few as 20 nuclei with this FISH HER-2/neu assay may be 
      sufficient for determining the amplification level of the HER-2/neu gene.
FAU - Persons, D L
AU  - Persons DL
AD  - Department of Pathology and Laboratory Medicine, University of Kansas Medical 
      Center, Kansas City 66160, USA. dpersons@kumc.edu
FAU - Bui, M M
AU  - Bui MM
FAU - Lowery, M C
AU  - Lowery MC
FAU - Mark, H F
AU  - Mark HF
FAU - Yung, J F
AU  - Yung JF
FAU - Birkmeier, J M
AU  - Birkmeier JM
FAU - Wong, E Y
AU  - Wong EY
FAU - Yang, S J
AU  - Yang SJ
FAU - Masood, S
AU  - Masood S
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Ann Clin Lab Sci
JT  - Annals of clinical and laboratory science
JID - 0410247
RN  - 0 (Antimetabolites, Antineoplastic)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Antineoplastic Agents, Alkylating)
RN  - 0 (DNA, Neoplasm)
RN  - 80168379AG (Doxorubicin)
RN  - 8N3DW7272P (Cyclophosphamide)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - Antimetabolites, Antineoplastic/administration & dosage
MH  - Antineoplastic Agents/administration & dosage
MH  - Antineoplastic Agents, Alkylating/administration & dosage
MH  - Breast Neoplasms/*diagnosis/drug therapy/*genetics
MH  - Cell Nucleus/genetics
MH  - Cyclophosphamide/administration & dosage
MH  - DNA, Neoplasm/analysis
MH  - Double-Blind Method
MH  - Doxorubicin/administration & dosage
MH  - Female
MH  - Fluorouracil/administration & dosage
MH  - Gene Amplification
MH  - Gene Expression Regulation, Neoplastic
MH  - Humans
MH  - In Situ Hybridization, Fluorescence/*standards
MH  - Receptor, ErbB-2/*genetics
MH  - Reproducibility of Results
EDAT- 2000/03/18 00:00
MHDA- 2000/03/18 00:01
CRDT- 2000/03/18 00:00
PHST- 2000/03/18 00:00 [pubmed]
PHST- 2000/03/18 00:01 [medline]
PHST- 2000/03/18 00:00 [entrez]
PST - ppublish
SO  - Ann Clin Lab Sci. 2000 Jan;30(1):41-8.