Validation of the 4B5 rabbit monoclonal antibody in determining Her2/neu status in breast cancer

Modern Pathology

Volumn 22, Issue 7, 2009, Pages 879-886

  Van Der Vegt, Bert ^a   De Bock, Geertruida H ^a   Bart, Joost ^a   Zwartjes, Nick G ^a   Wesseling, Jelle ^a,b  

^a UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^b ANTONI VAN LEEUWENHOEK HOSPITAL   (Netherlands)

Author keywords

Breast carcinoma; Her2 neu; Immunohistochemistry; Rabbit monoclonal antibody; Validation study

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR 2; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY 4B5; MONOCLONAL ANTIBODY CB11; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; BREAST ADENOCARCINOMA; BREAST CANCER; CHROMOGENIC IN SITU HYBRIDIZATION; FEMALE; FLUORESCENCE IN SITU HYBRIDIZATION; GENE AMPLIFICATION; GENE OVEREXPRESSION; HUMAN; HUMAN TISSUE; IMMUNOHISTOCHEMISTRY; MAJOR CLINICAL STUDY; OBSERVER VARIATION; ONCOGENE NEU; PRIORITY JOURNAL; SENSITIVITY AND SPECIFICITY; TISSUE MICROARRAY; VALIDATION PROCESS;

ADENOCARCINOMA; ADULT; AGED; AGED, 80 AND OVER; ANIMALS; ANTIBODIES, MONOCLONAL; BREAST NEOPLASMS; FEMALE; HUMANS; IMMUNOHISTOCHEMISTRY; IN SITU HYBRIDIZATION; MENOPAUSE; MICE; MIDDLE AGED; OBSERVER VARIATION; PREDICTIVE VALUE OF TESTS; RABBITS; RECEPTOR, ERBB-2; REPRODUCIBILITY OF RESULTS; TISSUE ARRAY ANALYSIS; TUMOR MARKERS, BIOLOGICAL;

EID: 67650696577     PISSN: 08933952     EISSN: 15300285     Source Type: Journal    
DOI: 10.1038/modpathol.2009.37     Document Type: Article

References (31)

1. Goldhirsch A, Glick JH, Gelber RD, et al. Meeting highlights: international expert consensus on the primary therapy of early breast cancer 2005. Ann Oncol 2005));16:1569-1583.
2. 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.
3. Joensuu H, Kellokumpu-Lehtinen P, Bono P, et al. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med 2006;354: 809-820.
4. Robert N, Leyland-Jones B, Asmar L, et al. Randomized phase III study of trastuzumab, paclitaxel, and carboplatin compared with trastuzumab and paclitaxel in women with HER-2-overexpressing metastatic breast cancer. J Clin Oncol 2006;24:2786-2792.
5. 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.
6. Bird BRJH, Swain SM. Cardiac toxicity in breast cancer survivors: review of potential cardiac problems. Clin Cancer Res 2008;14:14-24.
7. Dowsett M, Bartlett J, Ellis IO, et al. 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.
8. Yaziji H, Goldstein LC, Barry TS, et al. Her-2 testing in breast cancer using parallel tissue-based methods. JAMA 2004;291:1972-1977.
9. Press MF, Slamon DJ, Flom KJ, et al. Evaluation of her-2/neu gene amplification and overexpression: comparison of frequently used assay methods in a molecularly characterized cohort of breast cancer specimens. J Clin Oncol 2002;20:3095-3105.
10. Wolff AC, Hammond MEH, 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.
11. Lebeau A, Deimling D, Kaltz C, et al. Her-2/neu analysis in archival tissue samples of human breast cancer: comparison of immunohistochemistry and fluorescence in situ hybridization. J Clin Oncol 2001;19:354-363.
12. Fornier M, Risio M, Van Poznak C, et al. Her2 testing and correlation with efficacy of trastuzumab therapy. Oncology (Williston Park) 2002;16:1340-1348, 1351-2; discussion 1352, 1355-8.
13. Bartlett JM, Going JJ, Mallon EA, et al. Evaluating her2 amplification and overexpression in breast cancer. J Pathol 2001;195:422-428.
14. Gancberg D, Järvinen T, di Leo A, et al. Evaluation of her-2/neu protein expression in breast cancer by immunohistochemistry: an interlaboratory study assessing the reproducibility of her-2/neu testing. Breast Cancer Res Treat 2002;74:113-120.
15. Thomson TA, Hayes MM, Spinelli JJ, et al. 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.
16. Tsuda H, Sasano H, Akiyama F, 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. Pathol Int 2002;52:126-134.
17. Gouvêa AP, Milanezi F, Olson SJ, et al. Selecting antibodies to detect her2 overexpression by immunohistochemistry in invasive mammary carcinomas. Appl Immunohistochem Mol Morphol 2006;14:103-108.
18. Rossi S, Laurino L, Furlanetto A, et al. Rabbit monoclonal antibodies: a comparative study between a novel category of immunoreagents and the corresponding mouse monoclonal antibodies. Am J Clin Pathol 2005;124:295-302.
19. Kononen J, Bubendorf L, Kallioniemi A, et al. Tissue microarrays for high-throughput molecular profiling of tumor specimens. Nat Med 1998;4:844-847.
20. Camp R, Charette L, Rimm D. Validation of tissue microarray technology in breast carcinoma. Lab Invest 2000;80:1943-1949.
21. Press MF, Sauter G, Bernstein L, et al. Diagnostic evaluation of her-2 as a molecular target: an assessment of accuracy and reproducibility of laboratory testing in large, prospective, randomized clinical trials. Clin Cancer Res 2005;11:6598-6607.
22. Dybdal N, Leiberman G, Anderson S, et al. Determination of her2 gene amplification by fluorescence in situ hybridization and concordance with the clinical trials immunohistochemical assay in women with metastatic breast cancer evaluated for treatment with trastuzumab. Breast Cancer Res Treat 2005;93:3-11.
23. Bartlett JMS. Fluorescence in situ hybridization: technical overview. Methods Mol Med 2004;97:77-87.
24. Lambros MBK, Natrajan R, Reis-Filho JS. Chromogenic and fluorescent in situ hybridization in breast cancer. Hum Pathol 2007;38:1105-1122.
25. van de Vijver M, Bilous M, Hanna W, et al. Chromogenic in situ hybridisation for the assessment of her2 status in breast cancer: an international validation ring study. Breast Cancer Res 2007;9:R68.
26. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977;33: 159-174.
27. Powell WC, Hicks DG, Prescott N, et al. A new rabbit monoclonal antibody (4b5) for the immunohistochemical (ihc) determination of the her2 status in breast cancer: comparison with cb11, fluorescence in situ hybridization (fish), and interlaboratory reproducibility. Appl Immunohistochem Mol Morphol 2007;15:94-102.
28. Dendukuri N, Khetani K, McIsaac M, et al. Testing for her2-positive breast cancer: a systematic review and cost-effectiveness analysis. CMAJ 2007;176:1429-1434.
29. Egervari K, Szollosi Z, Nemes Z. Immunohistochemical antibodies in breast cancer her2 diagnostics. a comparative immunohistochemical and fluorescence in situ hybridization study. Tumour Biol 2008;29:18-27.
30. Kakar S, Puangsuvan N, Stevens JM, et al. Her-2/neu assessment in breast cancer by immunohistochemistry and fluorescence in situ hybridization: comparison of results and correlation with survival. Mol Diagn 2000;5:199-207.
31. Ricardo SAV, Milanezi F, Carvalho ST, et al. 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.