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Central retesting of breast cancer with HER2 immunohistochemistry score of 0 or 1+ using silver-enhanced in situ hybridisation: a multicentre, prospective study in Greece Cover

Central retesting of breast cancer with HER2 immunohistochemistry score of 0 or 1+ using silver-enhanced in situ hybridisation: a multicentre, prospective study in Greece

Open Access
|Aug 2014

References

  1. [1] 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 M, Wheeler TM, Hayes DF, American Society of Clinical Oncology, College of American Pathologists (2007) 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 25:118–145. doi: 10.1200/JCO.2006.09.277510.1200/JCO.2006.09.2775
  2. [2] 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 (2001) Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 344:783–792. doi: 10.1056/NEJM20010315344110110.1056/NEJM200103153441101
  3. [3] 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 CS, Andersson M, Inbar M, Lichinitser M, Lang I, Nitz U, Iwata H, Thomssen C, Lohrisch C, Suter TM, Ruschoff J, Suto T, Greatorex V, Ward C, Straehle C, McFadden E, Dolci MS, Gelber RD (2005) Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 353:1659–1672. doi: 10.1056/ NEJMoa05230610.1056/NEJMoa052306
  4. [4] Marty M, Cognetti F, Maraninchi D, Snyder R, Mauriac L, Tubiana-Hulin M, Chan S, Grimes D, Anton A, Lluch A, Kennedy J, O’Byrne K, Conte P, Green M, Ward C, Mayne K, Extra JM (2005) Randomized phase II trial of the effcacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as frst-line treatment: the M77001 study group. J Clin Oncol 23:4265–4274. doi: 10.1200/ JCO.2005.04.173
  5. [5] Gianni L, Eiermann W, Semiglazov V, Manikhas A, Lluch A, Tjulandin S, Zambetti M, Vazquez F, Byakhow M, Lichinitser M, Climent MA, Ciruelos E, Ojeda B, Mansutti M, Bozhok A, Baronio R, Feyereislova A, Barton C, Valagussa P, Baselga J (2010) Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet 375:377–384. doi: 10.1016/S0140-6736(09)61964-410.1016/S0140-6736(09)61964-4
  6. [6] Cobleigh MA, Vogel CL, Tripathy D, Robert NJ, Scholl S, Fehrenbacher L, Wolter JM, Paton V, Shak S, Lieberman G, Slamon DJ (1999) Multinational study of the effcacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol 17:2639–264810.1200/JCO.1999.17.9.263910561337
  7. [7] Vogel CL, Cobleigh MA, Tripathy D, Gutheil JC, Harris LN, Fehrenbacher L, Slamon DJ, Murphy M, Novotny WF, Burchmore M, Shak S, Stewart SJ, Press M (2002) Effcacy and safety of trastuzumab as a single agent in frst-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol 20:719–726. doi: 10.1200/JCO.20.3.71910.1200/JCO.20.3.719
  8. [8] Boekhout AH, Beijnen JH, Schellens JH (2011) Trastuzumab. Oncologist 16:800–810. doi: 10.1634/theoncologist.2010-003510.1634/theoncologist.2010-0035322821321632460
  9. [9] Jackisch C (2006) HER-2-positive metastatic breast cancer: optimizing trastuzumab-based therapy. Oncologist 11 (Suppl 1):34–41. doi: 10.1634/theoncologist.11-90001-3410.1634/theoncologist.11-90001-3416971738
  10. [10] National Comprehensive Cancer Network (2013) NCCN Clinical Practice Guidelines in Oncology: Breast Cancer, Version 1
  11. [11] Mass RD, Press MF, Anderson S, Cobleigh MA, Vogel CL, Dybdal N, Leiberman G, Slamon DJ (2005) Evaluation of clinical outcomes according to HER2 detection by fuorescence in situ hybridization in women with metastatic breast cancer treated with trastuzumab. Clin Breast Cancer 6:240–246. doi: 10.3816/CBC.2005.n.02610.3816/CBC.2005.n.02616137435
  12. [12] Baselga J, Cortes J, Kim SB, Im SA, Hegg R, Im YH, Roman L, Pedrini JL, Pienkowski T, Knott A, Clark E, Benyunes MC, Ross G, Swain SM, CLEOPATRA Study Group (2012) Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med 366:109–119. doi: 10.1056/ NEJMoa111321610.1056/NEJMoa1113216570520222149875
  13. [13] Verma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, Pegram M, Oh D-Y, Diéras V, Guardino E, Fang L, Lu M, Olsen S and Blakwell K (2012) Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med 2012;367:1783-91. doi:10.1056/ NEJMoa120912410.1056/NEJMoa1209124512525023020162
  14. [14] 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 (2006) Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 355:2733–2743. doi: 10.1056/NEJMoa06432010.1056/NEJMoa06432017192538
  15. [15] Yamauchi H, Stearns V, Hayes DF (2001) When is a tumor marker ready for prime time? A case study of c-erb B-2 as a predictive factor in breast cancer. J Clin Oncol 19:2334–235610.1200/JCO.2001.19.8.233411304787
  16. [16] Penault-Llorca F, Bilous M, Dowsett M, Hanna W, Osamura RY, Rüschoff J, van de Vijver M (2009) Emerging technologies for assessing HER2 amplifcation. Am J Clin Pathol 132:539–548. doi: 10.1309/AJCPV2I0HGPMGBSQ10.1309/AJCPV2I0HGPMGBSQ19762531
  17. [17] Dietel M, Ellis IO, Höfer H, Kreipe H, Moch H, Dankof A, Kölble K, Kristiansen G (2007) Comparison of automated silver enhanced in situ hybridisation (SISH) and fuorescence ISH (FISH) for the validation of HER2 gene status in breast carcinoma according to the guidelines of the American Society of Clinical Oncology and the College of American Pathologists. Virchows Arch 451:19–25. doi: 10.1007/s00428-007-0424-510.1007/s00428-007-0424-517562074
  18. [18] Bartlett JM, Campbell FM, Ibrahim M, Wencyk P, Ellis I, Kay E, Connolly Y, O’Grady A, Di Palma S, Starczynski J, Morgan JM, Jasani B, Miller K (2009) Chromogenic in situ hybridization: a multicenter study comparing silver in situ hybridization with FISH. Am J Clin Pathol 132:514–520. doi: 10.1309/ AJCPXY3MJ6GSRCYP10.1309/AJCPXY3MJ6GSRCYP19762528
  19. [19] Ross JS (2011) Point: Fluorescence in situ hybridization is the preferred approach over immunohistochemistry for determining HER2 status. Clin Chem 57:980–982. doi: 10.1373/ clinchem.2010.16076210.1373/clinchem.2010.16076221558455
  20. [20] Cuadros M, Villegas R (2009) Systematic review of HER2 breast cancer testing. Appl Immunohistochem Mol Morphol 17:1–7. doi: 10.1097/PAI.0b013e318169fc1c10.1097/PAI.0b013e318169fc1c18685491
  21. [21] Papadopoulos S, Kouvatseas G, Skarlos D, Malamos N, Delliou E, Saratsiotou I, Ardavanis A, Mavroudis D, Skarpidi E, Arapantoni P, Karyda I, Patakioyta F, Aravantinos G, Razis E, Fountzilas G, Kosmidis P (2007) Comparison of HER2 detection methods between central and regional laboratories in Greece. Clin Breast Cancer 7:784–790. doi: 10.3816/CBC.2007.n.04010.3816/CBC.2007.n.04018021480
  22. [22] Vergara-Lluri ME, Moatamed NA, Hong E, Apple SK (2012) High concordance between HercepTest immunohistochemistry and ERBB2 fuorescence in situ hybridization before and after implementation of American Society of Clinical Oncology/College of American Pathology 2007 guidelines. Mod Pathol 25:1326–1332. doi: 10.1038/modpathol.2012.9310.1038/modpathol.2012.9322699517
  23. [23] Agresti A, Coull BA (1998) Approximate is better than “exact” for interval estimation of binomial proportions. Am Stat 52:119–126
  24. [24] Press MF, Slamon DJ, Flom KJ, Park J, Zhou JY, Bernstein L (2002) Evaluation of HER-2/neu gene amplifcation and overexpression: comparison of frequently used assay methods in a molecularly characterized cohort of breast cancer specimens. J Clin Oncol 20:3095–3105. doi: 10.120/ JCO.2002.09.094
  25. [25] Lal P, Salazar PA, Hudis CA, Ladanyi M, Chen B (2004) HER-2 testing in breast cancer using immunohistochemical analysis and fuorescence in situ hybridization: a single-institution experience of 2,279 cases and comparison of dual-color and single-color scoring. Am J Clin Pathol 121:631– 636. doi: 10.1309/VE78-62V2-646B-R6EX10.1309/VE78-62V2-646B-R6EX15151202
  26. [26] Perez EA, Suman VJ, Davidson NE, Martino S, Kaufman PA, Lingle WL, Flynn PJ, Ingle JN, Visscher D, Jenkins RB (2006) HER2 testing by local, central, and reference laboratories in specimens from the North Central Cancer Treatment Group N9831 intergroup adjuvant trial. J Clin Oncol 24:3032–3038. doi: 10.1200/JCO.2005.03.474410.1200/JCO.2005.03.474416809727
  27. [27] 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 (2002) Real-world performance of HER2 testing-National Surgical Adjuvant Breast and Bowel Project experience. J Natl Cancer Inst 94:852–854. doi: 10.1093/ jnci/94.11.85210.1093/jnci/94.11.85212048273
  28. [28] Roche PC, Suman VJ, Jenkins RB, Davidson NE, Martino S, Kaufman PA, Addo FK, Murphy B, Ingle JN, Perez EA (2002) Concordance between local and central laboratory HER2 testing in the Breast Intergroup trial N9831. J Natl Cancer Inst 94:855–857. doi: 10.1093/jnci/94.11.85510.1093/jnci/94.11.85512048274
  29. [29] Reddy JC, Reimann JD, Anderson SM, Klein PM (2006) Concordance between central and local laboratory HER2 testing from a community-based clinical study. Clin Breast Cancer 7:153–157. doi: 10.3816/CBC.2006.n.02510.3816/CBC.2006.n.02516800975
  30. [30] Larsimont D, Colpaert C, Salgado R, Vermeesen N, D’hondt V, De Celle T (2011) Results of a Belgian multicenter retrospective study to determine the incidence of HER2 gene amplifcation in patients scored as immunohistochemistry 0 or 1+. J Clin Oncol 29:abstr 549
  31. [31] Reiner-Concin AM, Lax S, Regitnig P, Kronberger C, Jasarevic Z, Bogner S (2011) Should HER-2 score 0/1+ breast cancer cases be retested by in-situ hybridisation? Results of a multicenter retesting study. Cancer Res 71:P5-11-15. doi: 10.1158/0008-5472.SABCS11-P5-11-1510.1158/0008-5472.SABCS11-P5-11-15
  32. [32] Hanna W, Barnes PJ, Chang MC, Gilks B, Magliocco A, Rees H, Robertson S, SenGupta SK, Nofech-Mozes S (2012) The incidence of false negative of HER2/Neu status in primary breast cancer in the era of standardized testing: a Canadian prospective study. Cancer Res 72:P2-10-09. doi: 10.1158/0008-5472. SABCS12-P2-10-09
  33. [33] Lee M, Cho S, Kim D, Lee K, Lee J, Kwon H, Lee H, Lee S (2012) Concordance between immunohistochemistry and FISH (fuorescence in situ hybridization) & SISH (silver in situ hybridization) for assessment of the HER2. Cancer Res 72:PD02-06. doi: 10.1158/0008-5472.SABCS12-PD02-0610.1158/0008-5472.SABCS12-PD02-06
  34. [34] Slamon DJ, Godolphin W, Jones LA, Holt JA, Wong SG, Keith DE, Levin WJ, Stuart SG, Udove J, Ullrich A (1989) Studies of the HER-2/ neu proto-oncogene in human breast and ovarian cancer. Science 244:707–712. doi: 10.1126/ science.247015210.1126/science.24701522470152
  35. [35] Press MF, Hung G, Godolphin W, Slamon DJ (1994) Sensitivity of HER-2/neu antibodies in archival tissue samples: potential source of error in immunohistochemical studies of oncogene expression. Cancer Res 54:2771–2777
  36. [36] van der Vegt B, de Bock GH, Bart J, Zwartjes NG, Wesseling J (2009) Validation of the 4B5 rabbit monoclonal antibody in determining Her2/neu status in breast cancer. Mod Pathol 22:879-886. doi: 10.1038/modpathol.2009.3710.1038/modpathol.2009.3719305385
  37. [37] Marchiò C, Lambros MB, Gugliotta P, Di Cantogno LV, Botta C, Pasini B, Tan DS, Mackay A, Fenwick K, Tamber N, Bussolati G, Ashworth A, Reis-Filho JS, Sapino A (2009) Does chromosome 17 centromere copy number predict polysomy in breast cancer? A fuorescence in situ hybridization and microarray-based CGH analysis. J Pathol 219:16–24. doi: 10.1002/path.257410.1002/path.257419670217
  38. [38] Grimm EE, Schmidt RA, Swanson PE, Dintzis SM, Allison KH (2010) Achieving 95% cross-methodological concordance in HER2 testing: causes and implications of discordant cases. Am J Clin Pathol 134:284–292. doi: 10.1309/ AJCPUQB18XZOHHBJ10.1309/AJCPUQB18XZOHHBJ20660333
  39. [39] Paik S, Kim C, Wolmark N (2008) HER2 status and beneft from adjuvant trastuzumab in breast cancer. N Engl J Med 358:1409–1411. doi: 10.1056/ NEJMc0801440
  40. [40] Perez EA, Reinholz MM, Hillman DW, Tenner KS, Schroeder MJ, Davidson NE, Martino S, Sledge GW, Harris LN, Gralow JR, Dueck AC, Ketterling RP, Ingle JN, Lingle WL, Kaufman PA, Visscher DW, Jenkins RB (2010) HER2 and chromosome 17 effect on patient outcome in the N9831 adjuvant trastuzumab trial. J Clin Oncol 28:4307–4315. doi: 10.1200/JCO.2009.26.215410.1200/JCO.2009.26.2154295413220697084
  41. [41] Rossi V, Sarotto I, Maggiorotto F, Berchialla P, Kubatzki F, Tomasi N, Redana S, Martinello R, Valabrega G, Aglietta M, Ponzone R, Montemurro F (2012) Moderate immunohistochemical expression of HER-2 (2+) without HER-2 gene amplifcation is a negative prognostic factor in early breast cancer. Oncologist 17:1418–1425. doi: 10.1634/ theoncologist.2012-0194
  42. [42] Nitta H, Kelly BD, Padilla M, Wick N, Brunhoeber P, Bai I, Singh S, Ranger-Moore J, Bieniarz C, Tsuda H, Grogan TM (2012) A gene-protein assay for human epidermal growth factor receptor 2 (HER2): brightfeld tricolor visualization of HER2 protein, the HER2 gene, and chromosome 17 centromere (CEN17) in formalin-fxed, paraffn-embedded breast cancer tissue sections. Diagn Pathol 7:60-1596-7-60. doi: 10.1186/1746-1596-7-6010.1186/1746-1596-7-60348781022647525
DOI: https://doi.org/10.2478/fco-2014-0004 | Journal eISSN: 1792-362X | Journal ISSN: 1792-345X
Language: English
Page range: 20 - 28
Published on: Aug 14, 2014
In partnership with: Paradigm Publishing Services
Publication frequency: 2 issues per year

© 2014 Savvas Papadopoulos, Petroula Arapantoni-Dadioti, Konstantinos Sfikas, Artemis Stylianidou, Helen Trichia, Eleftheria Katsamagou, Vaia Baleki, Johannes Noe, published by Helenic Society of Medical Oncology
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