Analysis of HER2 gene amplification using an automated fluorescence in situ hybridization signal enumeration system

Journal of Molecular Diagnostics

Volumn 9, Issue 2, 2007, Pages 144-150

  Stevens, Rachel ^a   Almanaseer, Imad ^b   Gonzalez, Miguel ^b   Caglar, Derin ^b   Knudson, Ryan A ^c   Ketterling, Rhett P ^c   Schrock, Daniel S ^d   Seemayer, Thomas A ^a   Bridge, Julia A ^a  

^a UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^b ADVOCATE LUTHERAN GENERAL HOSPITAL   (United States)

^c MAYO CLINIC   (United States)

^d ABBOTT LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR 2; FORMALDEHYDE; PARAFFIN;

ARTICLE; AUTOMATION; BREAST CARCINOMA; CALCULATION; CANCER INVASION; CLINICAL ARTICLE; CLINICAL TRIAL; COMPUTER PROGRAM; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DNA PROBE; FLUORESCENCE IN SITU HYBRIDIZATION; GENE AMPLIFICATION; GENETIC ANALYSIS; HUMAN; HUMAN TISSUE; MULTICENTER STUDY; PROGNOSIS; RANDOMIZED CONTROLLED TRIAL; RELIABILITY; SINGLE BLIND PROCEDURE; GENETIC SCREENING; GENETICS; PROTO ONCOGENE; SIGNAL PROCESSING;

AUTOMATION; GENE AMPLIFICATION; GENES, ERBB-2; GENETIC SCREENING; HUMANS; IN SITU HYBRIDIZATION, FLUORESCENCE; SIGNAL PROCESSING, COMPUTER-ASSISTED; SOFTWARE;

EID: 34247843057     PISSN: 15251578     EISSN: None     Source Type: Journal    
DOI: 10.2353/jmoldx.2007.060102     Document Type: Article

References (31)

1. Baselga J: Herceptin alone or in combination with chemotherapy in the treatment of HER2-positive metastatic breast cancer: pivotal trials. Oncology 2001, 61(Suppl 2):14-21
2. Bofin AM, Ytterhus B, Martin C, O'Leary JJ, Hagmar BM: Detection and quantitation of HFR-2 gene amplification and protein expression in breast carcinoma. Am J Olin Pathol 2004, 122:110-119
3. Bloom K, Harrington D: Enhanced accuracy and reliability of HER-2/neu immunohistochemical scoring using digital microscopy. Am J Olin Pathol 2004, 21:620-630
4. Gjerdrum LM, Sorensen BS, Kjeldsen E, Sorensen FB, Nexo E, Hamilton-Dutoit S: Real-time quantitative PCR of microdissected paraffin-embedded breast carcinoma, an alternative method for HER-2 analysis. J Mol Diagn 2004, 6:42-51
5. Ginestier C, Charafe-Jauffret E, Penault-Llorca F, Geneix J, Adelaide J, Chaffanet M, Mozziconacci M, Hassoun J, Viens P, Birnbaum D, Jacquemier J: Comparative multi-methodological measurement of ERBB2 status in breast cancer. J Pathol 2004, 202:286-298
6. Vera-Román JM, Rubio-Martinez LA: Comparative assays for the HER-2/neu oncogene status in breast cancer. Arch Pathol Lab Med 2004, 128:627-633
7. Lehr H, Jacobs TW, Yaziji H, Schnitt SJ, Gown AM: Quantitative evaluation of Her-2/neu status in breast cancer by fluorescence in situ hybridization and by immunohistochemistry with image analysis. Am J Olin Pathol 2001, 115:814-822
8. Hoff ER, Tubbs RR, Myles JL, Procop GW: HER-2/neu amplification in breast cancer, stratification by tumor type and grade. Am J Clin Pathol 2002, 117:916-921
9. Piccart M, Lohrisch C, Di Leo A, Larsimont D: The predictive value of HER2 in breast cancer. Oncology 2001, 61(Suppl 2):73-82
10. Bilous M, Ades C, Armes J, Bishop J, Brown R, Cooke B, Cummings M, Farshid G, Field A, Morey A, McKenzie P, Raymond W, Robbins P, Tan L: Predicting the HER2 status of breast cancer from basic histopathology data: an analysis of 1500 breast cancers as part of the HER2000 International Study. Breast 2003, 12:92-98
11. Pauletti G, Dandekar S, Rong H, Ramos L, Peng H, Seshadri R, Slamon DJ: Assessment of methods for tissue-based detection of the HER-2/neu alteration in human breast cancer: a direct comparison of fluorescence in situ hybridization and immunohistochemistry. J Clin Oncol 2000, 18:3651-3664
12. Press MF, Sauter G, Bernstein L, Villaobos IE, Mirlacher M, Zhou J-Y, Wardeh R, Li Y-T, Guzman R, Ma Y, Sullivan-Halley J, Santiago A, Park JM, Riva A, Slamon DJ: 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
13. EIkin EB, Weinstein MC, Winer EP, Kuntz KM, Schnitt SJ, Weeks JC: HER-2 testing and trastuzumab therapy for metastatic breast cancer: a cost-effectiveness analysis. J Clin Oncol 2004, 22:854-863
14. Perez EA, Roche PC, Jenkins RB, Reynolds CA, Halling KC, Ingle JN, Wold LE: HER2 testing in patients with breast cancer: poor correlation between weak positivity by immunohistochemistry and gene amplification by fluorescence in situ hybridization. Mayo Clin Proc 2002, 77:148-154
15. Schnitt SJ, Jacobs TW: Current status of HER2 testing, caught between a rock and a hard place. Am J Clin Pathol 2001, 116:806-810
16. Cell Markers and Cytogenetics Committees College of American Pathologists: Clinical laboratory assays for HER-2/neu amplification and overexpression: quality assurance, standardization, and proficiency testing. Arch Pathol Lab Med 2002, 126:803-808
17. Dybdal N, Leiberman G, Anderson S, McCune B, Bajamonde A, Cohen R, Mass RD, Saunders Corsee, Press MF: 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
18. Mass R, Press MF, Anderson S, Cobleigh MA, Vogel CL, Dybdal N, Leiberman, Slamon DJ: 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
19. McCormick SR, Lillemoe TJ, Beneke J, Schrauth J, Reinartz J: Her2 assessment by immunohistochemical analysis and fluorescence in situ hybridization, comparison of HercepTest and PathVysion commercial assays. Am J Clin Pathol 2002, 117:935-943
20. Vogel CL, Cobleigh MA, Tripathy D, Gutheil JC, Harris LN, Fehrenbacher L, Slamon DJ, Murphy M, Novotny WF, Burchmore M, Shak S, Stewart SJ: First-line Herceptin monotherapy in metastatic breast cancer. Oncology 2001, 61(Suppl 2):37-42
21. Wiley EL, Diaz LK: High-quality HER-2 testing, setting a standard for oncologic biomarker assessment. JAMA 2004, 291:2019-2020
22. Krouwer JS, Tholen DW, Garber CO, Goldschmidt HMJ, Harris Kroll M, Linnet K, Meier K, Robinowitz M, Kennedy JW: Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline, ed 2, document EP9-A2. Wayne, Clinical and Laboratory Standards Institute, 2002
23. Narath R, Lorch T, Rudas M, Ambros PF: Automatic quantification of gene amplification in clinical samples by IQ-FISH. Cytometry 2004, 57B:15-22
24. Ellis CM, Dyson MJ, Stephenson TJ, Maltby EL: HER2 amplification status in breast cancer: a comparison between immunohistochemical staining and fluorescence in situ hybridization using manual and automated quantitative image analysis scoring techniques. J Clin Pathol 2005, 58:710-714
25. Iourov IY, Soloviev IV, Vorsanova SG, Monakhov VV, Yurov YB: An approach for quantitative assessment of fluorescence in situ hybridization (FISH) signals for applied human molecular cytogenetics. J Histochem Cytochem 2005, 53:401-408
26. Hicks DG, Tubbs RR: Assessment of the HER2 status in breast cancer by fluorescence in situ hybridization: a technical review with interpretive guidelines. Hum Pathol 2005, 36:250-261
27. Hanna W: Testing for HER2 status. Oncology 2001, 61(Suppl 2): 22-30
28. 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
29. Lal P, Salazar PA, Hudis CA, Ladanyi M, Chen B: HER-2 testing in breast cancer using immunohistochemical analysis and fluorescence in situ hybridization. Am J Clin Pathol 2004, 121:631-636
30. 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
31. Levene H: Robust test for the equality of variances. Contributions to Probability and Statistics: Essays in Honor of Harold Hotelling. Edited by I Olkin. Palo Alto, CA, Stanford University Press, 1960, pp 278-292