Chromogenic in situ hybridisation for the assessment of HER2 status in breast cancer: an international validation ring study.
Breast Cancer Res
; 9(5): R68, 2007.
Article
em En
| MEDLINE
| ID: mdl-17922920
ABSTRACT
INTRODUCTION:
Before any new methodology can be introduced into the routine diagnostic setting it must be technically validated against the established standards. To this end, a ring study involving five international pathology laboratories was initiated to validate chromogenic in situ hybridisation (CISH) against fluorescence in situ hybridisation (FISH) and immunohistochemistry (IHC) as a test for assessing human epidermal growth factor receptor 2 (HER2) status in breast cancer.METHODS:
Each laboratory performed CISH, FISH and IHC on its own samples. Unstained sections from each case were also sent to another participating laboratory for blinded retesting by CISH ('outside CISH').RESULTS:
A total of 211 invasive breast carcinoma cases were tested. In 76 cases with high amplification (HER2/CEP17 ratio >4.0) by FISH, 73 cases (96%) scored positive (scores >or= 6) by 'outside CISH'. For FISH-negative cases (HER2/CEP17 ratio <2.0), 94 of 100 cases (94%) had CISH scores indicating no amplification (scoreCONCLUSION:
These results show that CISH inter- and intra-laboratory concordance to FISH and IHC is very high, even in equivocal IHC 2+ cases. Therefore, we conclude that CISH is a methodology that is a viable alternative to FISH in the HER2 testing algorithm.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias da Mama
/
Compostos Cromogênicos
/
Hibridização in Situ Fluorescente
/
Receptor ErbB-2
Tipo de estudo:
Clinical_trials
/
Guideline
Limite:
Female
/
Humans
Idioma:
En
Ano de publicação:
2007
Tipo de documento:
Article