PMID- 12186371
OWN - NLM
STAT- MEDLINE
DCOM- 20030107
LR  - 20190906
IS  - 0167-6806 (Print)
IS  - 0167-6806 (Linking)
VI  - 74
IP  - 2
DP  - 2002 Jul
TI  - Evaluation of HER-2/NEU protein expression in breast cancer by 
      immunohistochemistry: an interlaboratory study assessing the reproducibility of 
      HER-2/NEU testing.
PG  - 113-20
AB  - This study investigated the degree of interlaboratory agreement when HER-2/neu 
      was evaluated by immunohistochemistry (IHC) on archival primary breast cancer 
      samples. IHC for HER-2/neu was performed on the same archival tissue sections 
      from 394 invasive primary breast cancers in two different laboratories. Both 
      laboratories used the primary antibody NCL-CB11; however, different methods of 
      immunostaining (antigen retrieval procedure and manual processing or no antigen 
      retrieval and autostainer processing) as well as different scoring systems were 
      used. Fluorescence in situ hybridization (FISH), considered as the correlation 
      method for HER-2/neu status determination, was performed using the PathVysion kit 
      and compared to the IHC results. Forty-eight of 394 analyzed tumors (12.2%) were 
      scored as HER-2/neu positive in one laboratory, and 109 (27.7%) in the other 
      laboratory where antigen retrieval was performed. Complete concordance in 
      categorization of HER-2/neu status between the two laboratories was achieved in 
      333 of 394 cases (84.5%). FISH performed in 248 formalin-fixed samples revealed 
      HER-2/neu gene amplification in 55/248 (22.2%). Concordance of FISH and IHC was 
      found in 211/248 cases (85.1%) and 220/248 cases (88.7%) when the CB11 antibody 
      was used without and with antigen retrieval, respectively. Both IHC methods 
      generated similar rates of false results, but with different positive predictive 
      values. Our data demonstrate that HER-2/neu evaluation by IHC is not a 
      reproducible technique if there is no standardization of the procedure.
FAU - Gancberg, David
AU  - Gancberg D
AD  - Translational Research Unit of the Chemotherapy Department, Jules Bordet 
      Institute, Brussels, Belgium.
FAU - Jarvinen, Tero
AU  - Jarvinen T
FAU - di Leo, Angelo
AU  - di Leo A
FAU - Rouas, Ghizlane
AU  - Rouas G
FAU - Cardoso, Fatima
AU  - Cardoso F
FAU - Paesmans, Marianne
AU  - Paesmans M
FAU - Verhest, Alain
AU  - Verhest A
FAU - Piccart, Martine J
AU  - Piccart MJ
FAU - Isola, Jorma
AU  - Isola J
FAU - Larsimont, Denis
AU  - Larsimont D
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - Netherlands
TA  - Breast Cancer Res Treat
JT  - Breast cancer research and treatment
JID - 8111104
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Breast Neoplasms/*genetics/*pathology
MH  - Female
MH  - Humans
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence
MH  - Laboratories/standards
MH  - Observer Variation
MH  - Receptor, ErbB-2/*biosynthesis
MH  - Reproducibility of Results
EDAT- 2002/08/21 10:00
MHDA- 2003/01/08 04:00
CRDT- 2002/08/21 10:00
PHST- 2002/08/21 10:00 [pubmed]
PHST- 2003/01/08 04:00 [medline]
PHST- 2002/08/21 10:00 [entrez]
AID - 10.1023/a:1016146130767 [doi]
PST - ppublish
SO  - Breast Cancer Res Treat. 2002 Jul;74(2):113-20. doi: 10.1023/a:1016146130767.