PMID- 20697093
OWN - NLM
STAT- MEDLINE
DCOM- 20101102
LR  - 20220415
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 28
IP  - 28
DP  - 2010 Oct 1
TI  - Human epidermal growth factor receptor 2 assessment in a case-control study: 
      comparison of fluorescence in situ hybridization and quantitative reverse 
      transcription polymerase chain reaction performed by central laboratories.
PG  - 4300-6
LID - 10.1200/JCO.2009.24.8211 [doi]
AB  - PURPOSE: The optimal method to assess human epidermal growth factor receptor 2 
      (HER2) status remains highly controversial. Before reporting patient HER2 
      results, American Society of Clinical Oncology (ASCO)/College of American 
      Pathologists (CAP) guidelines mandate that laboratories demonstrate >/= 95% 
      concordance to another approved laboratory or methodology. Here, we compare 
      central laboratory HER2 assessed by fluorescence in situ hybridization (FISH) and 
      quantitative reverse transcriptase polymerase chain reaction (RT-PCR) using 
      Oncotype DX in lymph node-negative, chemotherapy-untreated patients from a large 
      Kaiser Permanente case-control study. PATIENTS AND METHODS: Breast cancer 
      specimens from the Kaiser-Genomic Health study were examined. Central FISH 
      assessment of HER2 amplification and polysomy 17 was conducted by PhenoPath 
      Laboratories (ratios > 2.2, 1.8 to 2.2, and < 1.8 define HER2 positive, HER2 
      equivocal, and HER2 negative, respectively). HER2 expression by RT-PCR was 
      conducted using Oncotype DX by Genomic Health (normalized expression units >/= 
      11.5, 10.7 to < 11.5, and < 10.7 define HER2 positive, HER2 equivocal, and HER2 
      negative, respectively). Concordance analyses followed ASCO/CAP guidelines. 
      RESULTS: HER2 concordance by central FISH and central RT-PCR was 97% (95% CI, 96% 
      to 99%). Twelve percent (67 of 568 patients) and 11% (60 of 568 patients) of 
      patients were HER2 positive by RT-PCR and FISH, respectively. HER2-positive 
      patients had increased odds of dying from breast cancer compared with 
      HER2-negative patients. Polysomy 17 was demonstrated in 12.5% of all patients and 
      33% of FISH-positive patients. Nineteen of 20 FISH-positive patients with 
      polysomy 17 were also RT-PCR HER2 positive. Although not statistically 
      significantly different, HER2-positive/polysomy 17 patients tended to have the 
      worst prognosis, followed by HER2-positive/eusomic, HER2-negative/polysomy 17, 
      and HER2-negative/eusomic patients. CONCLUSION: There is a high degree of 
      concordance between central FISH and quantitative RT-PCR using Oncotype DX for 
      HER2 status, and the assay warrants additional study in a trastuzumab-treated 
      population.
FAU - Baehner, Frederick L
AU  - Baehner FL
AD  - University of California, San Francisco, 1600 Divisadero St, Rm R200, San 
      Francisco, CA 94063, USA. rbaehner@genomichealth.com
FAU - Achacoso, Ninah
AU  - Achacoso N
FAU - Maddala, Tara
AU  - Maddala T
FAU - Shak, Steve
AU  - Shak S
FAU - Quesenberry, Charles P Jr
AU  - Quesenberry CP Jr
FAU - Goldstein, Lynn C
AU  - Goldstein LC
FAU - Gown, Allen M
AU  - Gown AM
FAU - Habel, Laurel A
AU  - Habel LA
LA  - eng
PT  - Comparative Study
PT  - Journal Article
DEP - 20100809
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Biomarkers, Tumor)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
CIN - J Clin Oncol. 2010 Oct 1;28(28):4289-92. PMID: 20697080
CIN - J Clin Oncol. 2010 Oct 1;28(28):4293-5. PMID: 20697085
CIN - J Clin Oncol. 2012 Feb 10;30(5):570-1. PMID: 22231038
MH  - Adult
MH  - Biomarkers, Tumor/metabolism
MH  - Breast Neoplasms/*diagnosis/genetics/metabolism/mortality
MH  - California/epidemiology
MH  - Case-Control Studies
MH  - Chromosomes, Human, Pair 17
MH  - False Negative Reactions
MH  - False Positive Reactions
MH  - Female
MH  - Humans
MH  - In Situ Hybridization, Fluorescence/*methods
MH  - Laboratories
MH  - Logistic Models
MH  - Middle Aged
MH  - Pathology, Clinical
MH  - Prognosis
MH  - Receptor, ErbB-2/*metabolism
MH  - Registries
MH  - Reverse Transcriptase Polymerase Chain Reaction/*methods
MH  - Sensitivity and Specificity
EDAT- 2010/08/11 06:00
MHDA- 2010/11/03 06:00
CRDT- 2010/08/11 06:00
PHST- 2010/08/11 06:00 [entrez]
PHST- 2010/08/11 06:00 [pubmed]
PHST- 2010/11/03 06:00 [medline]
AID - JCO.2009.24.8211 [pii]
AID - 10.1200/JCO.2009.24.8211 [doi]
PST - ppublish
SO  - J Clin Oncol. 2010 Oct 1;28(28):4300-6. doi: 10.1200/JCO.2009.24.8211. Epub 2010 
      Aug 9.