PMID- 20925963
OWN - NLM
STAT- MEDLINE
DCOM- 20110321
LR  - 20220318
IS  - 1471-2407 (Electronic)
IS  - 1471-2407 (Linking)
VI  - 10
DP  - 2010 Oct 7
TI  - HER2 testing on core needle biopsy specimens from primary breast cancers: 
      interobserver reproducibility and concordance with surgically resected specimens.
PG  - 534
LID - 10.1186/1471-2407-10-534 [doi]
AB  - BACKGROUND: Accurate evaluation of human epidermal growth factor receptor type-2 
      (HER2) status based on core needle biopsy (CNB) specimens is mandatory for 
      identification of patients with primary breast cancer who will benefit from 
      primary systemic therapy with trastuzumab. The aim of the present study was to 
      validate the application of HER2 testing with CNB specimens from primary breast 
      cancers in terms of interobserver reproducibility and comparison with surgically 
      resected specimens. METHODS: A total of 100 pairs of archival formalin-fixed 
      paraffin-embedded CNB and surgically resected specimens of invasive breast 
      carcinomas were cut into sections. All 100 paired sections were subjected to HER2 
      testing by immunohistochemistry (IHC) and 27 paired sections were subjected to 
      that by fluorescence in situ hybridization (FISH), the results being evaluated by 
      three and two observers, respectively. Interobserver agreement levels in terms of 
      judgment and the concordance of consensus scores between CNB samples and the 
      corresponding surgically resected specimens were estimated as the percentage 
      agreement and kappa statistic. RESULTS: In CNB specimens, the percentage 
      interobserver agreement of HER2 scoring by IHC was 76% (kappa = 0.71) for 3 x 3 
      categories (0-1+ versus 2+ versus 3+) and 90% (kappa = 0.80) for 2 x 2 categories 
      (0-2+ versus 3+). These levels were close to the corresponding ones for the 
      surgically resected specimens: 80% (kappa = 0.77) for 3 x 3 categories and 92% (kappa = 
      0.88) for 2 x 2 categories. Concordance of consensus for HER2 scores determined 
      by IHC between CNB and the corresponding surgical specimens was 87% (kappa = 0.77) 
      for 3 x 3 categories, and 94% (kappa = 0.83) for 2 x 2 categories. Among the 13 
      tumors showing discordance in the mean IHC scores between the CNB and surgical 
      specimens, the results of consensus for FISH results were concordant in 11. The 
      rate of successful FISH analysis and the FISH positivity rate in cases with a 
      HER2 IHC score of 2+ differed among specimens processed at different 
      institutions. CONCLUSION: It is mandatory to study HER2 on breast cancers, and 
      either CNB or surgical specimen can be used.
FAU - Tsuda, Hitoshi
AU  - Tsuda H
AD  - Diagnostic Pathology Section, Clinical Laboratory Division, National Cancer 
      Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. hstsuda@ncc.go.jp
FAU - Kurosumi, Masafumi
AU  - Kurosumi M
FAU - Umemura, Shinobu
AU  - Umemura S
FAU - Yamamoto, Sohei
AU  - Yamamoto S
FAU - Kobayashi, Takayuki
AU  - Kobayashi T
FAU - Osamura, Robert Yoshiyuki
AU  - Osamura RY
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20101007
PL  - England
TA  - BMC Cancer
JT  - BMC cancer
JID - 100967800
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/pharmacology
MH  - Antibodies, Monoclonal, Humanized
MH  - Biopsy, Needle/*methods
MH  - Breast Neoplasms/*diagnosis/genetics/*metabolism/surgery
MH  - Female
MH  - Humans
MH  - Immunohistochemistry/methods
MH  - In Situ Hybridization, Fluorescence
MH  - Medical Oncology/methods
MH  - Observer Variation
MH  - Receptor, ErbB-2/*metabolism
MH  - Reproducibility of Results
MH  - Trastuzumab
PMC - PMC2958945
EDAT- 2010/10/12 06:00
MHDA- 2011/03/22 06:00
PMCR- 2010/10/07
CRDT- 2010/10/08 06:00
PHST- 2010/02/20 00:00 [received]
PHST- 2010/10/07 00:00 [accepted]
PHST- 2010/10/08 06:00 [entrez]
PHST- 2010/10/12 06:00 [pubmed]
PHST- 2011/03/22 06:00 [medline]
PHST- 2010/10/07 00:00 [pmc-release]
AID - 1471-2407-10-534 [pii]
AID - 10.1186/1471-2407-10-534 [doi]
PST - epublish
SO  - BMC Cancer. 2010 Oct 7;10:534. doi: 10.1186/1471-2407-10-534.