HER2 Testing: How to Reach a High Concordance Rate between Immunohistochemistry and Fluorescence in Situ Hybridization

Applied Immunohistochemistry and Molecular Morphology

Volumn 19, Issue 5, 2011, Pages 424-430

  Khoury, Thaer ^a   Kulkarni, Swati ^a   Morrison, Carl ^a   Bshara, Wiam ^a   Zakharia, Yousef ^b   Edge, Stephen ^a  

^a ROSWELL PARK CANCER INSTITUTE   (United States)

^b Department of Medicine   (United States)

Author keywords

concordance; fluorescence in situ hybridization; immunohistochemistry

Indexed keywords

ANASTROZOLE; CYCLOPHOSPHAMIDE; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; FULVESTRANT; PACLITAXEL; TAXANE DERIVATIVE; TRASTUZUMAB;

ADULT; ARTICLE; BREAST CARCINOMA; FEMALE; FLUORESCENCE IN SITU HYBRIDIZATION; HUMAN; HUMAN CELL; IMMUNOHISTOCHEMISTRY; INVASIVE CARCINOMA; MAJOR CLINICAL STUDY; PARTIAL MASTECTOMY; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUALITY CONTROL; SCORING SYSTEM; SENTINEL LYMPH NODE BIOPSY; TUMOR CELL;

DIAGNOSTIC TECHNIQUES AND PROCEDURES; FALSE NEGATIVE REACTIONS; FALSE POSITIVE REACTIONS; FEMALE; HUMANS; IMMUNOHISTOCHEMISTRY; IN SITU HYBRIDIZATION, FLUORESCENCE; MIDDLE AGED; RECEPTOR, ERBB-2; RESEARCH DESIGN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 80052756434     PISSN: 15412016     EISSN: 15334058     Source Type: Journal    
DOI: 10.1097/PAI.0b013e31820b62be     Document Type: Article

References (34)

1. Yarden Y, Sliwkowski MX. Untangling the ErbB signalling network. Nat Rev Mol Cell Biol. 2001;2:127-137. (Pubitemid 33674041)
2. 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)
3. 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. (Pubitemid 38821193)
4. 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. (Pubitemid 17231334)
5. Bast RC Jr, Ravdin P, Hayes DF, et al. 2000 update of recommendations for the use of tumor markers in breast and colorectal cancer: clinical practice guidelines of the American Society of Clinical Oncology. J Clin Oncol. 2001;19:1865-1878. (Pubitemid 32230890)
6. Vogel CL, Franco SX. Clinical experience with trastuzumab (Herceptin). Breast J. 2003;9:452-462. (Pubitemid 37433210)
7. 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. (Pubitemid 46174133)
8. 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. (Pubitemid 34705058)
9. Perez EA, Suman VJ, Davidson NE, et al. HER2 testing by local, central, and reference laboratories in the NCCTG N9831 Intergroup adjuvant trial. J Clin Oncol. 2004;22:567.
10. Perez EA, Suman VJ, Davidson NE, et al. HER2 testing by local, central, and reference laboratories in specimens from the North Central Cancer Treatment Group N9831 Intergroup adjuvant trial. J Clin Oncol. 2006;24:3032-3038. (Pubitemid 46638937)
11. Baselga J, Norton L, Albanell J, et al. Recombinant humanized anti-HER2 antibody (Herceptin) enhances the antitumor activity of paclitaxel and doxorubicin against HER2/neu overexpressing human breast cancer xenografts. Cancer Res. 1998;58:2825-2831. (Pubitemid 28311914)
12. Pegram MD, Slamon DJ. Combination therapy with Trastuzumab (Herceptins) and cisplatin for chemoresistant metastatic breast cancer: evidence for receptor-enhanced chemosensitivity. Semin Oncol. 1999;26:89-95. (Pubitemid 29411438)
13. 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. (Pubitemid 19147683)
14. Borg A, Tandon AK, Sigurdsson H, et al. HER-2/neu amplification predicts poor survival in node-positive breast cancer. Cancer Res. 1990;50:4332-4337. (Pubitemid 20225674)
15. Parkes HC, Lillycrop K, Howell A, et al. C-erbB2 mRNA expression in human breast tumours: comparison with c-erbB2 DNA amplification and correlation with prognosis. Br J Cancer. 1990;61:39-45. (Pubitemid 20043541)
16. Telli ML, Hunt SA, Carlson RW, et al. Trastuzumab-related cardiotoxicity: calling into question the concept of reversibility. J Clin Oncol. 2007;25:3525-3533. (Pubitemid 47310891)
17. Tan-Chiu E, Yothers G, Romond E, et al. Assessment of cardiac dysfunction in a randomized trial comparing doxorubicin and cyclophosphamide followed by paclitaxel, with or without trastuzumab as adjuvant therapy in node-positive, human epidermal growth factor receptor 2-overexpressing breast cancer: NSABP B-31 J Clin Oncol. 2005;23:7811-7819. (Pubitemid 46657378)
18. Hillner BE, Smith TJ. Do the large benefits justify the large costs of adjuvant breast cancer trastuzumab?. J Clin Oncol. 2007;25: 611-613. (Pubitemid 350002913)
19. Shah SS, Ketterling RP, Goetz MP, et al. Impact of American Society of Clinical Oncology/College of American Pathologists guideline recommendations on HER2 interpretation in breast cancer. Hum Pathol. 2010;41:103-106.
20. Mass RD, Press MF, Anderson S, et al. Evaluation of clinical outcomes according to HER2 detection by fluorescence in situ hybridization in women with metastatic breast cancer treated with trastuzumab. Clin Breast Cancer. 2005;6:240-246. (Pubitemid 47050800)
21. Wang S, Saboorian MH, Frenkel E, et al. Laboratory assessment of the status of Her-2/neu protein and oncogene in breast cancer specimens: comparison of immunohistochemistry assay with fluorescence in situ hybridisation assays. J Clin Pathol. 2000;53:374-381. (Pubitemid 30256906)
22. Jacobs TW, Gown AM, Yaziji H, et al. Comparison of fluorescence in situ hybridization and immunohistochemistry for the evaluation of HER-2/neu in breast cancer. J Clin Oncol. 1999;17:1974-1982. (Pubitemid 29318824)
23. Persons DL, Borelli KA, Hsu PH. Quantitation of HER-2/neu and c-myc gene amplification in breast carcinoma using fluorescence in situ hybridization. Mod Pathol. 1997;10:720-727. (Pubitemid 27321765)
24. 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. (Pubitemid 26248546)
25. Hoang MP, Sahin AA, Ordò ñ ez NG, et al. HER-2/neu gene amplification compared with HER-2/neu protein overexpression and interobserver reproducibility in invasive breast carcinoma. Am J Clin Pathol. 2000;113:852-859. (Pubitemid 33051521)
26. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353:1673-1684. (Pubitemid 41464706)
27. Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353:1659-1672. (Pubitemid 41464705)
28. Smith I, Procter M, Gelber RD, et al. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet. 2007;369: 29-36. (Pubitemid 46039831)
29. Slamon D, Eiermann W, Robert N, et al. Phase III trial comparing AC-T with AC-TH and with TCH in the adjuvant treatment of HER2-positive early breast cancer patients: second interim efficacy analysis. Breast Cancer Res Treat. 2006;100(suppl 1):53.
30. Press M, Pike M, Chazin V, et al. Her-2/neu expression in node-negative breast cancer: Direct tissue quantitation by computerized image analysis and association of overexpression with increased risk of recurrent disease. Cancer Res. 1993;53: 4960-4970. (Pubitemid 23326194)
31. Press MF, Bernstein L, Thomas PA, et al. HER-2/neu gene amplification characterized by fluorescence in situ hybridization: Poor prognosis in node-negative breast carcinomas. J Clin Oncol. 1997;15:2894-2904. (Pubitemid 27330017)
32. Yamauchi H, Stearns V, Hayes DF. When is a tumor marker ready for prime time? a case study of c-erbB-2 as a predictive factor in breast cancer. J Clin Oncol. 2001;19:2334-2356. (Pubitemid 32366985)
33. Sauter G, Lee J, Bartlett JM, et al. Guidelines for human epidermal growth factor receptor 2 testing: biologic and methodologic considerations. J Clin Oncol. 2009;27:1323-1333.
34. Bartlett JMS, Reeves J, Stanton P, et al. Evaluating HER2 amplification and overexpression in breast cancer. J Pathol. 2001;195:422-428. (Pubitemid 33069666)