Main Article Content
Objectives: To determine the status of the HER2 amplification in Breast cancer performed in peripheral laboratories in Colombia by immunohistochemistry and its comparison with central laboratories and the FISH status.
Methods: Four thousand one hundred and five cases referred for the determination of the HER2 status by FISH and/or IHQ to the Department of Pathology of the Fundacion Santa Fe were studied. The analysis included correlation between the IHQ HER2 score submitted by the peripheral laboratory (PL), the HER2 score emitted in the LC and the FISH studies performed in the central laboratory (CL).
Results: two thousand five hundred and eight HER2 IHQ studies were performed in the (CL), using the Dako Herceptest. With the following results: 68.2 % negative (0-1+); 16.4% indeterminate (2+); 15.3% 3+ and 2.3 % not adequate. 1360/ 1719 cases studied by FISH came from the (PL), and 329 (19.1%) from the (Lc). Comparing the IHQ score emitted by the PL and the positive FISH status showed: 6/28 0+ were positive (21.4%); 7/31 1+ (22.5%); 397/1.240 2+ (32.8%) and 74/91 3+ (81.3%). In the CL the results were 1/9 0+ (11.1%); 3/18 1+ (16.7%); 154/292 2+ (53.0%); and 9/9 3+ (100%). Only 1/4 negative cases (0/1+) was in house.
Conclusion: The false negative rate (22.0%), and false positive results (18.7%), of the HER2 status performed by IHQ in peripheral laboratories in Colombia is unacceptable high as well as the inadequacy of tissue indicating that pre-analytical factors have to be improved in Colombia in order to get optimal results
1. GLOBOCAN 2008: Cancer Incidence and Mortality Worldwide: International Agency for Research on Cancer IARC Cancer Base No.10. 2da ed. Lyon, France. 2010.
2. Tavassoli FA, Devilee P. WHO Classification of Tumours. Pathology and Genetics of Tumours of the Breast and Female Genital Organs. 1a ed. Lyon, France: IARC; 2003.
3. Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987; 235(4785): 177-82.
4. Yarden Y. Biology of HER2 and its importance in breast cancer. Oncology. 2001; 61(Suppl 2): 1-13.
5. Wieduwilt MJ, Moasser MM. The epidermal growth factor receptor family: biology driving targeted therapeutics. Cell Mol Life. 2008; 65(10): 1566-84.
6. Owens MA, Horten BC, Da Silva MM. HER2 Amplification ratios by fluorescence in situ hybridization and correlation with immunohistochemistry in a cohort of 6,556 breast cancer tissues. Clin Breast Cancer. 2004; 5(1): 63-9.
7. Smith I, Procter M, Gelber RD, Guillaume S, Feyereislova A, Dowsett M, et al. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet. 2007; 369(9555): 29-36.
8. Sparano JA, Paik S. Development of the 21-gene assay and its application in clinical practice and clinical trials. J Clin Oncol. 2008; 26(5): 721-8.
9. Cardoso F, Van’t Veer, L, , Rutgers E, Loi S, Mook S, PiccartGebhart, MJ. Clinical Application of the 70-Gene Profile: The MINDACT Trial. J Clin Oncol. 2008; 26(5): 729-35.
10. Harris L, Fritsche H, Mennel R, Norton L, Ravdin P, Taube S. American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. J Clin Oncol. 2007; 25(33): 5287-312.
11. Wolff AC, Hammond MEH, Schwartz JN, Hagerty KL, Allred DC, Cote RJ, et al. 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(1): 118-45.
12. Tubbs RR, Pettay JD, Roche PC, Stoler MH, Jenkins RB, Grogan TM. Discrepancies in clinical laboratory testing of eligibility for trastuzumab therapy: apparent immunohistochemical falsepositives do not get the message. J Clin Oncol. 2001; 19(10): 2714-21.
13. Press MF, Hung G, Godolphin W, Slamon DJ. Sensitivity of HER-2/neu antibodies in archival tissue samples: potential source of error in immunohistochemical studies of oncogene expression. Cancer Res. 1994; 54(10): 2771-7.
14. Persons DL, Tubbs RR, Cooley LD, Dewald GW, Dowling PK, Du E, et al. HER-2 fluorescence in situ hybridization: results from the survey program of the College of American Pathologists. Arch Pathol Lab Med. 2006; 130(3): 325-31.
15. Roche PC, Suman VJ, Jenkins RB, Davidson NE, Martino S, Kaufman PA, et al. Concordance between local and central laboratory HER2 testing in the breast intergroup trial N9831. J Natl Cancer Inst. 2002; 94(11): 855-7.
16. Perez EA, Suman VJ, Davidson NE, Martino S, Kaufman PA, Lingle WL, 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(19): 3032-8.
17. Reddy JC, Reimann JD, Anderson SM, Klein PM. Concordance between central and local laboratory HER2 testing from a community-based clinical study. Clin Breast Cancer. 2006; 7(2): 153-7.
18. Wludarski SC, Lopes LF, Berto E Silva TR , Carvalho FM, Weiss LM, et al. HER2 testing in breast carcinoma: very low concordance rate between reference and local laboratories in Brazil. Appl Immunohistochem Mol Morphol. 2011; 12(2): 112-8.
19. Ghaffari SR, Sabokbar T, Dastan J, Rafati M, Moossavi S. Her2 amplification status in Iranian breast cancer patients: comparison of immunohistochemistry (IHC) and fluorescence in situ hybridisation (FISH). Asian Pac J Cancer Prev. 2011; 12(4): 1031-4.
20. O’ Malley FP, Thomson T, Julian J, Have C, Cosby R, Gelmon K, et al. HER2 testing in a population based study of patients with metastatic breast cancer treated with trastuzumab. Arch Pathol Lab Med. 2008; 132(1): 61-5.
21. Papadopoulos S, Kouvatseas G, Skarlos D, Malamos N, Delliou E, Saratsiotou I, et al. Comparison of HER2 detection methods between central and regional laboratories in Greece. J Natl Cancer Inst. 2002; 94(10): 852-4.
- Luz F Sua, Nhora M Silva, Martha Vidaurreta, Virginia de la Orden, Silvia Veganzones, Sara Rafael, María L Maestro de las Casas, Rapid detection of sentinel lymph node metastases in different techniques and comparison in low-grade breast carcinomas , Colombia Medica: Vol. 43 No. 1 (2012)
You may also start an advanced similarity search for this article.
The copy rights of the articles published in Colombia Médica belong to the Universidad del Valle. The contents of the articles that appear in the Journal are exclusively the responsibility of the authors and do not necessarily reflect the opinions of the Editorial Committee of the Journal. It is allowed to reproduce the material published in Colombia Médica without prior authorization for non-commercial use