PMID- 18208807
OWN - NLM
STAT- MEDLINE
DCOM- 20080311
LR  - 20151119
IS  - 0002-9173 (Print)
IS  - 0002-9173 (Linking)
VI  - 129
IP  - 2
DP  - 2008 Feb
TI  - HER2+ breast cancer: review of biologic relevance and optimal use of diagnostic 
      tools.
PG  - 263-73
LID - 10.1309/99AE032R9FM8WND1 [doi]
AB  - Clinical laboratory testing for human epidermal growth factor receptor 2 (HER2) 
      status in newly diagnosed breast cancer is critically important for therapeutic 
      decision making. Unlike most pathologic testing, which serves as an adjunct to 
      establishing a diagnosis, the results of HER2 testing stand alone in determining 
      which patients are likely to respond to trastuzumab, a monoclonal antibody 
      against HER2. Given the significant clinical impact of the testing results on 
      subsequent patient management, the accuracy, precision, and reproducibility of 
      HER2 testing are critical. At present, several preanalytic factors, including the 
      time from tissue removal to tissue fixation, are underappreciated as important 
      variables that have the potential to negatively impact the consistency and 
      reliability of HER2 testing. Rigorous quality control and standardization of the 
      testing process, from the handling of tissue samples to interpretation and 
      reporting of results, are essential for achieving accurate and reproducible assay 
      results.
FAU - Hicks, David G
AU  - Hicks DG
AD  - Department of Pathology and Laboratory Medicine, Roswell Park Cancer Institute, 
      Buffalo, NY 14263, USA.
FAU - Kulkarni, Swati
AU  - Kulkarni S
LA  - eng
PT  - Journal Article
PT  - Review
PL  - England
TA  - Am J Clin Pathol
JT  - American journal of clinical pathology
JID - 0370470
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antineoplastic Agents)
RN  - P188ANX8CK (Trastuzumab)
SB  - IM
CIN - Am J Clin Pathol. 2009 Jun;131(6):897-8; author reply 898-900. PMID: 19461099
MH  - Adenocarcinoma/*diagnosis/*genetics
MH  - Algorithms
MH  - Antibodies, Monoclonal/therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Agents/therapeutic use
MH  - Breast Neoplasms/*diagnosis/*genetics
MH  - Clinical Trials as Topic
MH  - *Genes, erbB-2
MH  - Guidelines as Topic
MH  - Humans
MH  - Immunohistochemistry/standards
MH  - In Situ Hybridization, Fluorescence/standards
MH  - Laboratories/standards
MH  - Quality Control
MH  - Sensitivity and Specificity
MH  - Trastuzumab
RF  - 62
EDAT- 2008/01/23 09:00
MHDA- 2008/03/12 09:00
CRDT- 2008/01/23 09:00
PHST- 2008/01/23 09:00 [pubmed]
PHST- 2008/03/12 09:00 [medline]
PHST- 2008/01/23 09:00 [entrez]
AID - 77H4611LN62414P0 [pii]
AID - 10.1309/99AE032R9FM8WND1 [doi]
PST - ppublish
SO  - Am J Clin Pathol. 2008 Feb;129(2):263-73. doi: 10.1309/99AE032R9FM8WND1.