A quality assurance exercise to evaluate the accuracy and reproducibility of chromogenic in situ hybridisation for HER2 analysis in breast cancer

Background: Chromogenic in situ hybridisation (CISH) is an alternative to immunohistochemistry or FISH for the assessment of HER2 oncogene status in breast cancer. Although CISH is being used increasingly in routine diagnostics, there are no established inter-laboratory quality assurance programmes for this test. Methods: The reproducibility of HER2 CISH analysis was assessed when performed by seven different centres that use the test routinely in diagnostic service. Results: The results from 28 cases showed overall concordance of 98.5% (192/195 tests; κ coefficient 0.91). One of the discrepancies was due to the invasive carcinoma having been cut out in the sections received by two of the centres, and the other two were in the non-amplified/equivocal/low-amplified category. Conclusion: This is believed to be the first report of a quality assurance study assessing laboratories that use HER2 CISH routinely in clinical diagnostics. The results show that CISH is a robust technique providing a suitable assay for the frontline testing of HER2 status in breast cancer.

[1]  F. Penault-Llorca,et al.  Pathologic Complete Response to Trastuzumab-Based Neoadjuvant Therapy Is Related to the Level of HER-2 Amplification , 2007, Clinical Cancer Research.

[2]  M. J. van de Vijver,et al.  Chromogenic in situ hybridisation for the assessment of HER2 status in breast cancer: an international validation ring study , 2007, Breast Cancer Research.

[3]  R. Tuma.  Inconsistency of HER2 test raises questions. , 2007, Journal of the National Cancer Institute.

[4]  S. Paik,et al.  Benefit from adjuvant trastuzumab may not be confined to patients with IHC 3+ and/or FISH-positive tumors: Central testing results from NSABP B-31 , 2007 .

[5]  M. Kissin,et al.  Chromogenic in situ hybridisation (CISH) should be an accepted method in the routine diagnostic evaluation of HER2 status in breast cancer , 2006, Journal of Clinical Pathology.

[6]  I. Ellis,et al.  External quality assurance of HER2 fluorescence in situ hybridisation testing: results of a UK NEQAS pilot scheme , 2006, Journal of Clinical Pathology.

[7]  F. Marandino,et al.  Chromogenic in situ hybridization to detect HER-2/neu gene amplification in histological and ThinPrep-processed breast cancer fine-needle aspirates: a sensitive and practical method in the trastuzumab era. , 2006, The oncologist.

[8]  M. A. Seguí,et al.  HER-2 gene amplification by chromogenic in situ hybridisation (CISH) compared with fluorescence in situ hybridisation (FISH) in breast cancer-A study of two hundred cases. , 2006, Breast.

[9]  K. Kwok,et al.  Chromogenic in-situ hybridization: a viable alternative to fluorescence in-situ hybridization in the HER2 testing algorithm , 2006, Modern Pathology.

[10]  M. Cummings,et al.  Chromogenic in situ hybridisation testing for HER2 gene amplification in breast cancer produces highly reproducible results concordant with fluorescence in situ hybridisation and immunohistochemistry , 2006, Pathology.

[11]  Jorma Isola,et al.  Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. , 2006, The New England journal of medicine.

[12]  Anthony Rhodes,et al.  American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. , 2006, Archives of pathology & laboratory medicine.

[13]  C. Vogel,et al.  Evaluation of clinical outcomes according to HER2 detection by fluorescence in situ hybridization in women with metastatic breast cancer treated with trastuzumab. , 2005, Clinical breast cancer.

[14]  N. Sneige,et al.  Reliability of chromogenic in situ hybridization for detecting HER-2 gene status in breast cancer: comparison with fluorescence in situ hybridization and assessment of interobserver reproducibility , 2005, Modern Pathology.

[15]  P. Lal,et al.  Chromogenic in situ hybridization for the detection of HER-2/neu gene amplification in breast cancer with an emphasis on tumors with borderline and low-level amplification: does it measure up to fluorescence in situ hybridization? , 2005, American journal of clinical pathology.

[16]  N. Dandachi,et al.  Comparison of chromogenic in situ hybridization with other methodologies for HER2 status assesment in breast cancer , 2004, Journal of Molecular Histology.

[17]  J. Isola,et al.  Interlaboratory Comparison of HER-2 Oncogene Amplification as Detected by Chromogenic and Fluorescence in situ Hybridization , 2004, Clinical Cancer Research.

[18]  I. Ellis,et al.  Best Practice No 176 , 2004, Journal of Clinical Pathology.

[19]  A. Vincent-Salomon,et al.  Agreement between chromogenic in situ hybridisation (CISH) and FISH in the determination of HER2 status in breast cancer , 2003, British Journal of Cancer.

[20]  M. Dowsett,et al.  Current Perspectives on HER2 Testing: A Review of National Testing Guidelines , 2003, Modern Pathology.

[21]  O. Dietze,et al.  Chromogenic In Situ Hybridization: A Novel Approach to a Practical and Sensitive Method for the Detection of HER2 Oncogene in Archival Human Breast Carcinoma , 2002, Laboratory Investigation.

[22]  H. Tsuda,et al.  Evaluation of interobserver agreement in scoring immunohistochemical results of HER‐2/neu (c‐erbB‐2) expression detected by HercepTest, Nichirei polyclonal antibody, CB11 and TAB250 in breast carcinoma , 2002, Pathology international.

[23]  John J Spinelli,et al.  HER-2/neu in Breast Cancer: Interobserver Variability and Performance of Immunohistochemistry with 4 Antibodies Compared with Fluorescent In Situ Hybridization , 2001, Modern Pathology.

[24]  T. Grogan,et al.  Discrepancies in clinical laboratory testing of eligibility for trastuzumab therapy: apparent immunohistochemical false-positives do not get the message. , 2001, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[25]  A. Gown,et al.  Specificity of HercepTest in determining HER-2/neu status of breast cancers using the United States Food and Drug Administration-approved scoring system. , 1999, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[26]  J. R. Landis,et al.  The measurement of observer agreement for categorical data. , 1977, Biometrics.

[27]  M. Cummings,et al.  HER2 TESTING RECOMMENDATIONS IN AUSTRALIA , 2001, Pathology.

[28]  J. Fleiss.  Measuring nominal scale agreement among many raters. , 1971 .