Achieving 95% cross-methodological concordance in HER2 testing: Causes and implications of discordant cases

American Journal of Clinical Pathology

Volumn 134, Issue 2, 2010, Pages 284-292

  Grimm, Erin E ^a   Schmidt, Rodney A ^a   Swanson, Paul E ^a   Dintzis, Suzanne M ^a   Allison, Kimberly H ^a  

^a UNIVERSITY OF WASHINGTON MEDICAL CENTER   (United States)

Author keywords

ASCO CAP guidelines; Breast cancer; FISH; Fluorescence in situ hybridization; HER2 discordance; HER2 testing; HER2 validation

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR 2; TRASTUZUMAB;

ARTICLE; ARTIFACT; BREAST BIOPSY; BREAST CARCINOMA; CONTROLLED STUDY; DIAGNOSTIC ERROR; FLUORESCENCE IN SITU HYBRIDIZATION; HUMAN; HUMAN TISSUE; IMMUNOHISTOCHEMISTRY; PRIORITY JOURNAL; TUMOR BIOPSY; VALIDATION PROCESS;

ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; FEMALE; HUMANS; IMMUNOHISTOCHEMISTRY; IN SITU HYBRIDIZATION, FLUORESCENCE; PRACTICE GUIDELINES AS TOPIC; RECEPTOR, ERBB-2; REPRODUCIBILITY OF RESULTS; TUMOR MARKERS, BIOLOGICAL;

EID: 77955610459     PISSN: 00029173     EISSN: 19437722     Source Type: Journal    
DOI: 10.1309/AJCPUQB18XZOHHBJ     Document Type: Article

References (20)

1. Lal P, Salazar PA, Hudis CA, et al. HER-2 testing in breast cancer using immunohistochemical analysis and fluorescence in situ hybridization: a single-institution experience of 2,279 cases and comparison of dual-color and single-color scoring. Am J Clin Pathol. 2004;121:631-636. (Pubitemid 38533994)
2. Owens MA, Horten BC, Da Silva MM. HER2 amplification ratios by fluorescence in situ hybridization and correlation with immunohistochemistry in a cohort of 6556 breast cancer tissues. Clin Breast Cancer. 2004;5:63-69.
3. Slamon DJ, Clark GM, Wong SG, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987;235:177-182.
4. Yaziji H, Goldstein LC, Barry TS, et al. HER-2 testing in breast cancer using parallel tissue-based methods. JAMA. 2004;291:1972-1977. (Pubitemid 38544278)
5. Ross JS, Slodkowska EA, Symmans WF, et al. The HER-2 receptor and breast cancer: ten years of targeted anti-HER-2 therapy and personalized medicine. Oncologist. 2009;14:320-368.
6. Bartlett JM, Going JJ, Mallon EA, et al. Evaluating HER2 amplification and overexpression in breast cancer. J Pathol. 2001;195:422-428. (Pubitemid 33069666)
7. Pauletti G, Godolphin W, Press MF, et al. Detection and quantitation of HER-2/neu gene amplification in human breast cancer archival material using fluorescence in situ hybridization. Oncogene. 1996;13:63-72.
8. Slamon DJ, Godolphin W, Jones LA, et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science. 1989;244:707-712.
9. Wolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Arch Pathol Lab Med. 2007;131:18-43.
10. Konecny G, Pauletti G, Pegram M, et al. Quantitative association between HER-2/neu and steroid hormone receptors in hormone receptor-positive primary breast cancer. J Natl Cancer Inst. 2003;95:142-153. (Pubitemid 36193263)
11. Paik S, Bryant J, Tan-Chiu E, et al. Real-world performance of HER2 testing: National Surgical Adjuvant Breast and Bowel Project experience. J Natl Cancer Inst. 2002;94:852-854.
12. Roche PC, Suman VJ, Jenkins RB, et al. Concordance between local and central laboratory HER2 testing in the Breast Intergroup Trial N9831. J Natl Cancer Inst. 2002;94:855-857.
13. Gown AM, Goldstein LC, Barry TS, et al. High concordance between immunohistochemistry and fluorescence in situ hybridization testing for HER2 status in breast cancer requires a normalized IHC scoring system. Mod Pathol. 2008;21:1271-1277.
14. Hameed O, Adams AL, Baker AC, et al. Using a higher cutoff for the percentage of HER2+ cells decreases interobserver variability in the interpretation of HER2 immunohistochemical analysis. Am J Clin Pathol. 2008;130:425-427.
15. Hameed O, Chhieng DC, Adams AL. Does using a higher cutoff for the percentage of positive cells improve the specificity of HER-2 immunohistochemical analysis in breast carcinoma? Am J Clin Pathol. 2007;128:825-829.
16. Yaziji H, Taylor CR. Begin at the beginning, with the tissue! the key message underlying the ASCO/CAP task-force guideline recommendations for HER2 testing. Appl Immunohistochem Mol Morphol. 2007;15:239-241.
17. Middleton LP, Price KM, Puig P, et al. Implementation of American Society of Clinical Oncology/College of American Pathologists HER2 guideline recommendations in a tertiary care facility increases HER2 immunohistochemistry and fluorescence in situ hybridization concordance and decreases the number of inconclusive cases. Arch Pathol Lab Med. 2009;133:775-780.
18. Moelans CB, de Weger RA, van Diest PJ. Absence of chromosome 17 polysomy in breast cancer: analysis by CEP17 chromogenic in situ hybridization and multiplex ligation-dependent probe amplification [published online ahead of print May 14, 2010]. Breast Cancer Res Treat. doi:10.1038/modpathol.2010.84.
19. Marchio C, Lambros MB, Gugliotta P, et al. Does chromosome 17 centromere copy number predict polysomy in breast cancer? a fluorescence in situ hybridization and microarray-based CGH analysis. J Pathol. 2009;219:16-24.
20. Yeh IT, Martin MA, Robetorye RS, et al. Clinical validation of an array CGH test for HER2 status in breast cancer reveals that polysomy 17 is a rare event. Mod Pathol. 2009;22:1169-1175.