PMID- 16800975
OWN - NLM
STAT- MEDLINE
DCOM- 20060912
LR  - 20220318
IS  - 1526-8209 (Print)
IS  - 1526-8209 (Linking)
VI  - 7
IP  - 2
DP  - 2006 Jun
TI  - Concordance between central and local laboratory HER2 testing from a 
      community-based clinical study.
PG  - 153-7
AB  - BACKGROUND: Women with HER2-overexpressing breast cancer have an unfavorable 
      prognosis. Trastuzumab improves survival when combined with chemotherapy in the 
      first-line treatment of patients with HER2-overexpressing metastatic breast 
      cancer and decreases the rate of disease relapse by 52% and the rate of death by 
      33% in women with HER2-overexpressing early-stage breast cancer. HER2 testing can 
      be performed using immunohistochemistry (IHC) or fluorescence in situ 
      hybridization (FISH) and can be performed at local pathology laboratories or at 
      central/reference laboratories. Because of the significant benefit seen with 
      trastuzumab, it is critical to accurately identify women most likely to benefit. 
      The method and the location of HER2 testing contribute to the accuracy of test 
      results. PATIENTS AND METHODS: HER-First, a prospective, community-based, phase 
      IV study of first-line trastuzumab/taxane therapy, enrolled patients with 
      HER2-overexpressing metastatic breast cancer. Retesting of all tumor specimens by 
      HER2 IHC and FISH at a high-volume, experienced laboratory was required. RESULTS: 
      Concordance between local and central laboratory HER2 IHC testing was highest for 
      local IHC 3+ samples (n = 377; 77%) and lowest for IHC 2+ samples (n = 184; 26%). 
      Thirty-three percent of samples testing IHC 2+ at a local laboratory tested 
      FISH-positive at the central laboratory. Concordance between HER2 IHC and FISH 
      results was higher when both tests were performed at the central laboratory. 
      CONCLUSION: Accurate HER2 test results are critical to identify patients who are 
      appropriate candidates for trastuzumab, a therapy with significant clinical 
      benefits in HER2-overexpressing breast cancer. These data show that HER2 testing 
      is most accurate when performed at a high-volume reference laboratory.
FAU - Reddy, Josina C
AU  - Reddy JC
AD  - Genentech, Inc, South San Francisco, CA 94080, USA. josina@gene.com
FAU - Reimann, James D
AU  - Reimann JD
FAU - Anderson, Steven M
AU  - Anderson SM
FAU - Klein, Pamela M
AU  - Klein PM
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Clin Breast Cancer
JT  - Clinical breast cancer
JID - 100898731
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antineoplastic Agents)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - P188ANX8CK (Trastuzumab)
SB  - IM
MH  - Antibodies, Monoclonal/therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Agents/therapeutic use
MH  - Breast Neoplasms/*diagnosis/*metabolism/pathology
MH  - Clinical Trials as Topic
MH  - *Community Health Services
MH  - Female
MH  - Humans
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence
MH  - *Laboratories
MH  - Neoplasm Metastasis
MH  - Patient Selection
MH  - Predictive Value of Tests
MH  - Receptor, ErbB-2/*metabolism
MH  - Reproducibility of Results
MH  - Trastuzumab
EDAT- 2006/06/28 09:00
MHDA- 2006/09/13 09:00
CRDT- 2006/06/28 09:00
PHST- 2006/06/28 09:00 [pubmed]
PHST- 2006/09/13 09:00 [medline]
PHST- 2006/06/28 09:00 [entrez]
AID - S1526-8209(11)70884-9 [pii]
AID - 10.3816/CBC.2006.n.025 [doi]
PST - ppublish
SO  - Clin Breast Cancer. 2006 Jun;7(2):153-7. doi: 10.3816/CBC.2006.n.025.