Determining sensitivity and specificity of HER2 testing in breast cancer using a tissue micro-array approach

Breast Cancer Research

Volumn 14, Issue 3, 2012, Pages

  Dekker, Tim J A ^a   Borg, Susan T ^b   Hooijer, Gerrit K J ^b   Meijer, Sybren L ^b   Wesseling, Jelle ^c   Boers, James E ^d   Schuuring, Ed ^e   Bart, Jos ^e   van Gorp, Joost ^f   Mesker, Wilma E ^a   Kroep, Judith R ^a   Smit, Vincent T H B M ^a   van de Vijver, Marc J ^b  

^a LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^b ACADEMIC MEDICAL CENTER   (Netherlands)

^c NETHERLANDS CANCER INSTITUTE   (Netherlands)

^d ISALA HOSPITAL   (Netherlands)

^e UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^f DEPARTMENT OF SURGERY   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR 2; TRANSCRIPTION FACTOR SP3; 4B5 ANTIGEN; ERBB2 PROTEIN, HUMAN; TUMOR ANTIGEN; TUMOR MARKER;

ARTICLE; BREAST CARCINOMA; CANCER INVASION; CANCER PATIENT; CANCER SCREENING; CLINICAL EVALUATION; CONTROLLED STUDY; DIAGNOSTIC TEST ACCURACY STUDY; FALSE NEGATIVE RESULT; FALSE POSITIVE RESULT; FEASIBILITY STUDY; HUMAN; HUMAN TISSUE; IMMUNOHISTOCHEMISTRY; IN SITU HYBRIDIZATION; INTERMETHOD COMPARISON; QUALITY CONTROL; SENSITIVITY AND SPECIFICITY; STANDARDIZATION; TISSUE MICROARRAY; BREAST TUMOR; FEMALE; FLUORESCENCE IN SITU HYBRIDIZATION; IMMUNOLOGY;

ANTIGENS, NEOPLASM; BREAST NEOPLASMS; FEMALE; HUMANS; IN SITU HYBRIDIZATION, FLUORESCENCE; QUALITY CONTROL; RECEPTOR, ERBB-2; SENSITIVITY AND SPECIFICITY; TISSUE ARRAY ANALYSIS; TUMOR MARKERS, BIOLOGICAL;

EID: 84862201658     PISSN: 14655411     EISSN: 1465542X     Source Type: Journal    
DOI: 10.1186/bcr3208     Document Type: Article

References (29)

1. Yaziji H, Goldstein LC, Barry TS, Werling R, Hwang H, Ellis GK, Gralow JR, Livingston RB, Gown AM. HER-2 testing in breast cancer using parallel tissue-based methods. JAMA 2004, 291:1972-1977. 10.1001/jama.291.16.1972, 15113815.
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. 10.3816/CBC.2004.n.011, 15140287.
3. Sjogren S, Inganas M, Lindgren A, Holmberg L, Bergh J. Prognostic and predictive value of c-erbB-2 overexpression in primary breast cancer, alone and in combination with other prognostic markers. J Clin Oncol 1998, 16:462-469.
4. Carlomagno C, Perrone F, Gallo C, De Laurentiis M, Lauria R, Morabito A, Pettinato G, Panico L, D'Antonio A, Bianco AR, De Placido S. c-erb B2 overexpression decreases the benefit of adjuvant tamoxifen in early-stage breast cancer without axillary lymph node metastases. J Clin Oncol 1996, 14:2702-2708.
5. Thor AD, Berry DA, Budman DR, Muss HB, Kute T, Henderson IC, Barcos M, Cirrincione C, Edgerton S, Allred C, Norton L, Liu ET. erbB-2, p53, and efficacy of adjuvant therapy in lymph node-positive breast cancer. J Natl Cancer Inst 1998, 90:1346-1360. 10.1093/jnci/90.18.1346, 9747866.
6. Pritchard KI, Shepherd LE, O'Malley FP, Andrulis IL, Tu D, Bramwell VH, Levine MN. HER2 and responsiveness of breast cancer to adjuvant chemotherapy. N Engl J Med 2006, 354:2103-2111. 10.1056/NEJMoa054504, 16707747.
7. Sliwkowski MX, Lofgren JA, Lewis GD, Hotaling TE, Fendly BM, Fox JA. Nonclinical studies addressing the mechanism of action of trastuzumab (Herceptin). Semin Oncol 1999, 26:60-70.
8. Clynes RA, Towers TL, Presta LG, Ravetch JV. Inhibitory Fc receptors modulate in vivo cytotoxicity against tumor targets. Nat Med 2000, 6:443-446. 10.1038/74704, 10742152.
9. Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001, 344:783-792. 10.1056/NEJM200103153441101, 11248153.
10. Piccart-Gebhart MJ, Procter M, Leyland-Jones B, Goldhirsch A, Untch M, Smith I, Gianni L, Baselga J, Bell R, Jackisch C, Cameron D, Dowsett M, Barrios CH, Steger G, Huang C, Andersson M, Inbar M, Lichinitser M, Lang I, Nitz U, Iwata H, Thomssen C, Lohrisch C, Suter TM, Rüschoff J, Süto{double acute} T, Greatorex V, Ward C, Straehle C, McFadden E, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005, 353:1659-1672. 10.1056/NEJMoa052306, 16236737.
11. Romond EH, Perez EA, Bryant J, Suman VJ, Geyer CE, Davidson NE, Tan-Chiu E, Martino S, Paik S, Kaufman PA, Swain SM, Pisansky TM, Fehrenbacher L, Kutteh LA, Vogel VG, Visscher DW, Yothers G, Jenkins RB, Brown AM, Dakhil SR, Mamounas EP, Lingle WL, Klein PM, Ingle JN, Wolmark N. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 2005, 353:1673-1684. 10.1056/NEJMoa052122, 16236738.
12. Geyer CE, Forster J, Lindquist D, Chan S, Romieu CG, Pienkowski T, Jagiello-Gruszfeld A, Crown J, Chan A, Kaufman B, Skarlos D, Campone M, Davidson N, Berger M, Oliva C, Rubin SD, Stein S, Cameron D. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 2006, 355:2733-2743. 10.1056/NEJMoa064320, 17192538.
13. Di Leo A, Gomez HL, Aziz Z, Zvirbule Z, Bines J, Arbushites MC, Guerrera SF, Koehler M, Oliva C, Stein S, Williams LS, Dering J, Finn RS, Press MF. Phase III, double-blind, randomized study comparing lapatinib plus paclitaxel with placebo plus paclitaxel as first-line treatment for metastatic breast cancer. J Clin Oncol 2008, 26:5544-5552. 10.1200/JCO.2008.16.2578, 2651098, 18955454.
14. Wolff AC, Hammond ME, Schwartz JN, Hagerty KL, Allred DC, Cote RJ, Dowsett M, Fitzgibbons PL, Hanna WM, Langer A, McShane LM, Paik S, Pegram MD, Perez EA, Press MF, Rhodes A, Sturgeon C, Taube SE, Tubbs R, Vance GH, Van de Vijver MJ, Wheeler TM, Hayes DF. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol 2007, 25:118-145.
15. Paik S, Bryant J, Tan-Chiu E, Romond E, Hiller W, Park K, Brown A, Yothers G, Anderson S, Smith R, Wickerham DL, Wolmark N. Real-world performance of HER2 testing--National Surgical Adjuvant Breast and Bowel Project experience. J Natl Cancer Inst 2002, 94:852-854. 10.1093/jnci/94.11.852, 12048273.
16. Perez EA, Suman VJ, Davidson NE, Martino S, Kaufman PA, Lingle WL, Flynn PJ, Ingle JN, Visscher D, Jenkins RB. 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. 10.1200/JCO.2005.03.4744, 16809727.
17. O'Malley FP, Thomson T, Julian J, Have C, Cosby R, Gelmon K, Andrulis I, Whelan T. HER2 testing in a population-based study of patients with metastatic breast cancer treated with trastuzumab. Arch Pathol Lab Med 2008, 132:61-65.
18. Ferlay J, Parkin DM, Steliarova-Foucher E. Estimates of cancer incidence and mortality in Europe in 2008. Eur J Cancer 2010, 46:765-781. 10.1016/j.ejca.2009.12.014, 20116997.
19. Dowsett M, Hanna WM, Kockx M, Penault-Llorca F, Ruschoff J, Gutjahr T, Habben K, van de Vijver MJ. Standardization of HER2 testing: results of an international proficiency-testing ring study. Mod Pathol 2007, 20:584-591. 10.1038/modpathol.3800774, 17396141.
20. Rhodes A, Jasani B, Couturier J, McKinley MJ, Morgan JM, Dodson AR, Navabi H, Miller KD, Balaton AJ. A formalin-fixed, paraffin-processed cell line standard for quality control of immunohistochemical assay of HER-2/neu expression in breast cancer. Am J Clin Pathol 2002, 117:81-89. 10.1309/4NCM-QJ9W-QM0J-6QJE, 11789735.
21. Rhodes A, Jasani B, Anderson E, Dodson AR, Balaton AJ. Evaluation of HER-2/neu immunohistochemical assay sensitivity and scoring on formalin-fixed and paraffin-processed cell lines and breast tumors: a comparative study involving results from laboratories in 21 countries. Am J Clin Pathol 2002, 118:408-417. 10.1309/97WN-W6UX-XJWT-02H2, 12219783.
22. Camp RL, Charette LA, Rimm DL. Validation of tissue microarray technology in breast carcinoma. Lab Invest 2000, 80:1943-1949. 10.1038/labinvest.3780204, 11140706.
23. Dowsett M, Bartlett J, Ellis IO, Salter J, Hills M, Mallon E, Watters AD, Cooke T, Paish C, Wencyk PM, Pinder SE. Correlation between immunohistochemistry (HercepTest) and fluorescence in situ hybridization (FISH) for HER-2 in 426 breast carcinomas from 37 centres. J Pathol 2003, 199:418-423. 10.1002/path.1313, 12635131.
24. Pauletti G, Godolphin W, Press MF, Slamon DJ. 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.
25. Papouchado BG, Myles J, Lloyd RV, Stoler M, Oliveira AM, Downs-Kelly E, Morey A, Bilous M, Nagle R, Prescott N, Wang L, Dragovich L, McElhinny A, Garcia CF, Ranger-Moore J, Free H, Powell W, Loftus M, Pettay J, Gaire F, Roberts C, Dietel M, Roche P, Grogan T, Tubbs R. Silver in situ hybridization (SISH) for determination of HER2 gene status in breast carcinoma: comparison with FISH and assessment of interobserver reproducibility. Am J Surg Pathol 2010, 34:767-776. 10.1097/PAS.0b013e3181d96231, 20421783.
26. Bartlett JM, Campbell FM, Mallon EA. Determination of HER2 amplification by in situ hybridization: when should chromosome 17 also be determined?. Am J Clin Pathol 2008, 130:920-926. 10.1309/AJCPSDG53BEANCYE, 19019769.
27. Thomson TA, Hayes MM, Spinelli JJ, Hilland E, Sawrenko C, Phillips D, Dupuis B, Parker RL. HER-2/neu in breast cancer: interobserver variability and performance of immunohistochemistry with 4 antibodies compared with fluorescent in situ hybridization. Mod Pathol 2001, 14:1079-1086. 10.1038/modpathol.3880440, 11706067.
28. Ricardo SA, Milanezi F, Carvalho ST, Leitao DR, Schmitt FC. HER2 evaluation using the novel rabbit monoclonal antibody SP3 and CISH in tissue microarrays of invasive breast carcinomas. J Clin Pathol 2007, 60:1001-1005. 1972418, 17158643.
29. Nunes CB, Rocha RM, Reis-Filho JS, Lambros MB, Rocha GF, Sanches FS, Oliveira FN, Gobbi H. Comparative analysis of six different antibodies against Her2 including the novel rabbit monoclonal antibody (SP3) and chromogenic in situ hybridisation in breast carcinomas. J Clin Pathol 2008, 61:934-938. 10.1136/jcp.2007.053892, 18474540.