PMID- 16809727
OWN - NLM
STAT- MEDLINE
DCOM- 20060719
LR  - 20220408
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 24
IP  - 19
DP  - 2006 Jul 1
TI  - HER2 testing by local, central, and reference laboratories in specimens from the 
      North Central Cancer Treatment Group N9831 intergroup adjuvant trial.
PG  - 3032-8
AB  - PURPOSE: To evaluate concordance between local and central laboratory HER2 
      testing results in patients from the North Central Cancer Treatment Group (NCCTG) 
      N9831 adjuvant trial of trastuzumab. PATIENTS AND METHODS: NCCTG N9831 is a 
      randomized, phase III clinical trial comparing three drug regimens: 
      doxorubicin/cyclophosphamide followed by paclitaxel with trastuzumab added 
      concurrently, sequentially, or not at all as adjuvant therapy for women with 
      HER2-positive resected breast cancer. Originally, patients were eligible if their 
      tumors were HER2 positive by either local laboratory immunohistochemistry (IHC) 
      or fluorescence in situ hybridization (FISH). A protocol modification in 2002 
      made central laboratory testing mandatory, with additional testing of discordant 
      cases conducted by a reference laboratory. Concordance between local and central 
      laboratory, and level of agreement between central and reference laboratory HER2 
      findings in discordant cases were examined. RESULTS: HER2 positivity was 
      confirmed in 85.8% of 2,535 patients registered since March 2002. When local and 
      central evaluation used the same methodology, concordance was 88.1% for FISH and 
      81.6% for a diagnostic test for presence of the HER2 protein. Among discordant 
      cases examined at the reference laboratory, there was 94.3% agreement for IHC (0, 
      1+, 2+) and 95.2% agreement for FISH (not gene amplified). CONCLUSION: There was 
      a high degree of discordance between local and central testing for IHC and FISH, 
      but a high degree of agreement between central and reference laboratories. These 
      findings support the importance of using high-volume, experienced laboratories 
      for HER2 testing to improve the process of selecting patients likely to benefit 
      from trastuzumab therapy.
FAU - Perez, Edith A
AU  - Perez EA
AD  - Mayo Clinic, 4500 San Pablo Rd, Jacksonville, FL 32224, USA. perez.edith@mayo.edu
FAU - Suman, Vera J
AU  - Suman VJ
FAU - Davidson, Nancy E
AU  - Davidson NE
FAU - Martino, Silvana
AU  - Martino S
FAU - Kaufman, Peter A
AU  - Kaufman PA
FAU - Lingle, Wilma L
AU  - Lingle WL
FAU - Flynn, Patrick J
AU  - Flynn PJ
FAU - Ingle, James N
AU  - Ingle JN
FAU - Visscher, Daniel
AU  - Visscher D
FAU - Jenkins, Robert B
AU  - Jenkins RB
LA  - eng
GR  - CA25224/CA/NCI NIH HHS/United States
PT  - Evaluation Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
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 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Biomarkers, Tumor)
RN  - P188ANX8CK (Trastuzumab)
SB  - IM
CIN - J Clin Oncol. 2007 Aug 1;25(22):e27-8. PMID: 17664462
MH  - Antibodies, Monoclonal/therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Biomarkers, Tumor/analysis
MH  - Breast Neoplasms/drug therapy/*genetics/pathology
MH  - Chemotherapy, Adjuvant
MH  - Female
MH  - *Genes, erbB-2
MH  - Humans
MH  - Immunohistochemistry/*standards
MH  - In Situ Hybridization, Fluorescence/*standards
MH  - Laboratories/standards
MH  - Patient Selection
MH  - Predictive Value of Tests
MH  - Reproducibility of Results
MH  - Trastuzumab
EDAT- 2006/07/01 09:00
MHDA- 2006/07/20 09:00
CRDT- 2006/07/01 09:00
PHST- 2006/07/01 09:00 [pubmed]
PHST- 2006/07/20 09:00 [medline]
PHST- 2006/07/01 09:00 [entrez]
AID - 24/19/3032 [pii]
AID - 10.1200/JCO.2005.03.4744 [doi]
PST - ppublish
SO  - J Clin Oncol. 2006 Jul 1;24(19):3032-8. doi: 10.1200/JCO.2005.03.4744.