PMID- 28595742
OWN - NLM
STAT- MEDLINE
DCOM- 20170815
LR  - 20220317
IS  - 1769-6917 (Electronic)
IS  - 0007-4551 (Linking)
VI  - 104
IP  - 7-8
DP  - 2017 Jul-Aug
TI  - [Internal quality control on HER2 status determination in breast cancers: 
      Experience of a cancer center].
PG  - 608-617
LID - S0007-4551(17)30128-5 [pii]
LID - 10.1016/j.bulcan.2017.05.002 [doi]
AB  - INTRODUCTION: The implementation of an internal quality control is mandatory to 
      guarantee the accuracy of HER2 status in invasive breast cancers. OBJECTIVES: To 
      evaluate the impact of our quality control assurance on HER2 status results in 
      invasive breast carcinomas from 2008 to 2014. METHODS: HER2 status was determined 
      by immunohistochemistry as the first-line indication, completed by fluorescence 
      in situ hybridization (FISH) for scores 2+ by immunohistochemistry. Internal 
      quality control of HER2 status relied on the standardization of pre-analytical 
      phases, the use of external controls with a known number of HER2 gene copies 
      determined by FISH and continued monitoring of concordance between 
      immunohistochemistry and FISH. RESULTS: The proportion of HER2-positive cases 
      corresponding to scores 3+ by immunohistochemistry and 2+ amplified by FISH 
      varied from 10.6% to 13.8% (median of 11.3%). The proportion of scores 2+ 
      amplified by FISH varied from 13.3% to 32.7% during period of study. The rate of 
      concordance between FISH and immunohistochemistry for score 0/1+ and 3+ cases 
      were>/=97%. Eight among 12 discordant cases were false positive resulting from 
      errors in interpretation of immunohistochemistry (score 2+ instead of 3+). 
      DISCUSSION: Calibration of immunohistochemistry on FISH for HER2 status 
      contributes to limit variability of immunohistochemistry results due to technical 
      issues or interpretation. The implementation of an external control of score 3+ 
      on each slide enables accurate interpretation of score 2+ and 3+ by 
      immunohistochemistry.
CI  - Copyright (c) 2017 Societe Francaise du Cancer. Published by Elsevier Masson SAS. 
      All rights reserved.
FAU - Ngo, Carine
AU  - Ngo C
AD  - Institut Curie, service d'anatomie et de cytologie pathologiques, 26, rue d'Ulm, 
      75005 Paris, France. Electronic address: carine2708@gmail.com.
FAU - Lae, Marick
AU  - Lae M
AD  - Institut Curie, service d'anatomie et de cytologie pathologiques, 26, rue d'Ulm, 
      75005 Paris, France.
FAU - Ratour, Julia
AU  - Ratour J
AD  - Institut Curie, service d'anatomie et de cytologie pathologiques, 26, rue d'Ulm, 
      75005 Paris, France.
FAU - Hamel, Frederique
AU  - Hamel F
AD  - Institut Curie, service d'anatomie et de cytologie pathologiques, 26, rue d'Ulm, 
      75005 Paris, France.
FAU - Taris, Corinne
AU  - Taris C
AD  - Institut Curie, service d'anatomie et de cytologie pathologiques, 26, rue d'Ulm, 
      75005 Paris, France.
FAU - Caly, Martial
AU  - Caly M
AD  - Institut Curie, service d'anatomie et de cytologie pathologiques, 26, rue d'Ulm, 
      75005 Paris, France.
FAU - Le Cunff, Annie
AU  - Le Cunff A
AD  - Institut Curie, service d'anatomie et de cytologie pathologiques, 26, rue d'Ulm, 
      75005 Paris, France.
FAU - Reyal, Fabien
AU  - Reyal F
AD  - Institut Curie, service de chirurgie oncologique, 26, rue d'Ulm, 75005 Paris, 
      France.
FAU - Kirova, Youlia
AU  - Kirova Y
AD  - Institut Curie, service d'oncologie radiotherapie, 26, rue d'Ulm, 75005 Paris, 
      France.
FAU - Pierga, Jean-Yves
AU  - Pierga JY
AD  - Institut Curie, service d'oncologie medicale, 26, rue d'Ulm, 75005 Paris, France.
FAU - Vincent-Salomon, Anne
AU  - Vincent-Salomon A
AD  - Institut Curie, service d'anatomie et de cytologie pathologiques, 26, rue d'Ulm, 
      75005 Paris, France.
LA  - fre
PT  - Comparative Study
PT  - Journal Article
TT  - Controle de qualite interne de la determination du statut HER2 dans les cancers 
      du sein : experience d'un centre de lutte contre le cancer.
DEP - 20170607
PL  - France
TA  - Bull Cancer
JT  - Bulletin du cancer
JID - 0072416
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - *Algorithms
MH  - Breast Neoplasms/chemistry/*genetics
MH  - Carcinoma, Ductal, Breast/chemistry/*genetics
MH  - Decision Support Systems, Clinical
MH  - Female
MH  - *Gene Amplification
MH  - *Genes, erbB-2
MH  - Humans
MH  - Immunohistochemistry/methods/standards/statistics & numerical data
MH  - In Situ Hybridization, Fluorescence/methods/standards/statistics & numerical data
MH  - *Quality Control
MH  - Receptor, ErbB-2/*analysis/metabolism
OTO - NOTNLM
OT  - Breast cancers
OT  - Cancers du sein
OT  - Controle qualite
OT  - Fluorescence in situ hybridization
OT  - HER2
OT  - Hybridation in situ en fluorescence
OT  - Immunohistochemistry
OT  - Immunohistochimie
OT  - Quality control
EDAT- 2017/06/10 06:00
MHDA- 2017/08/16 06:00
CRDT- 2017/06/10 06:00
PHST- 2017/02/26 00:00 [received]
PHST- 2017/04/30 00:00 [revised]
PHST- 2017/05/02 00:00 [accepted]
PHST- 2017/06/10 06:00 [pubmed]
PHST- 2017/08/16 06:00 [medline]
PHST- 2017/06/10 06:00 [entrez]
AID - S0007-4551(17)30128-5 [pii]
AID - 10.1016/j.bulcan.2017.05.002 [doi]
PST - ppublish
SO  - Bull Cancer. 2017 Jul-Aug;104(7-8):608-617. doi: 10.1016/j.bulcan.2017.05.002. 
      Epub 2017 Jun 7.