PMID- 19019764
OWN - NLM
STAT- MEDLINE
DCOM- 20081229
LR  - 20220318
IS  - 1943-7722 (Electronic)
IS  - 0002-9173 (Linking)
VI  - 130
IP  - 6
DP  - 2008 Dec
TI  - What causes discrepancies in HER2 testing for breast cancer? A Japanese ring 
      study in conjunction with the global standard.
PG  - 883-91
LID - 10.1309/AJCP5UUMFMA5ZKII [doi]
AB  - We assessed interinstitutional and interobserver consistency of human epidermal 
      growth factor receptor type-2 (HER2) testing using immunohistochemical analysis 
      and fluorescence in situ hybridization (FISH) in a set of 20 breast cancer 
      samples among 10 institutions in Japan and a Herceptin adjuvant study 
      participating laboratory in Germany and identified factors that may lead to 
      discordant results.We found a good agreement in immunohistochemical HER2 scoring 
      between the coordinating institution and 10 participating laboratories (kappa = 
      0.718) and excellent agreement for FISH (kappa = 0.900). The results of a 
      comparison between 10 Japanese laboratories and the German laboratory was good 
      for immunohistochemical studies (kappa = 0.713) and excellent for FISH (kappa = 
      0.887). FISH retesting of equivocal samples (2+ immunohistochemically) improved 
      agreement. Discrepancies between results were attributed to the evaluation 
      process in 33.0% of the samples, staining procedures in 25.0%, and a combination 
      of the two in 41.7%. Evaluation of samples according to the American Society of 
      Clinical Oncology/College of American Pathologists guideline increased the number 
      of 2+ immunohistochemical scores. By performing FISH retesting for these samples, 
      consistency among multiple institutions could be archived. The quality of the 
      staining procedures performed and the consistency of evaluations require regular 
      assessment.
FAU - Umemura, Shinobu
AU  - Umemura S
AD  - Department of Pathology, Tokai University School of Medicine, Isehara, Japan.
FAU - Osamura, R Yoshiyuki
AU  - Osamura RY
FAU - Akiyama, Futoshi
AU  - Akiyama F
FAU - Honma, Keiichi
AU  - Honma K
FAU - Kurosumi, Masafumi
AU  - Kurosumi M
FAU - Sasano, Hironobu
AU  - Sasano H
FAU - Toyoshima, Satoshi
AU  - Toyoshima S
FAU - Tsuda, Hitoshi
AU  - Tsuda H
FAU - Ruschoff, Josef
AU  - Ruschoff J
FAU - Sakamoto, Goi
AU  - Sakamoto G
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
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  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - P188ANX8CK (Trastuzumab)
SB  - IM
MH  - Antibodies, Monoclonal/therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Breast Neoplasms/*diagnosis/drug therapy
MH  - Female
MH  - Genes, erbB-2
MH  - Humans
MH  - Immunohistochemistry/methods
MH  - In Situ Hybridization, Fluorescence/methods/standards
MH  - Japan
MH  - Observer Variation
MH  - Practice Guidelines as Topic
MH  - Receptor, ErbB-2/*analysis/biosynthesis
MH  - Reproducibility of Results
MH  - Trastuzumab
EDAT- 2008/11/21 09:00
MHDA- 2008/12/30 09:00
CRDT- 2008/11/21 09:00
PHST- 2008/11/21 09:00 [pubmed]
PHST- 2008/12/30 09:00 [medline]
PHST- 2008/11/21 09:00 [entrez]
AID - M1774462325V0258 [pii]
AID - 10.1309/AJCP5UUMFMA5ZKII [doi]
PST - ppublish
SO  - Am J Clin Pathol. 2008 Dec;130(6):883-91. doi: 10.1309/AJCP5UUMFMA5ZKII.