334
Views
13
CrossRef citations to date
0
Altmetric
Review Article

The evolving role of HER2 evaluation for diagnosis and clinical decision making for breast and gastric adenocarcinoma

&
Pages 121-131 | Accepted 17 Nov 2012, Published online: 07 Jan 2013

References

  • AJCC Cancer Staging Manual, 7th ed. (2010). Springer, New York.
  • Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK, ToGA Trial Investigators (2010) Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet 376: 687–697.
  • Bartlett JM, Campbell FM, Ibrahim M, O’Grady A, Kay E, Faulkes C, Collins N, Starczynski J, Morgan JM, Jasani B, Miller K (2011) A UK NEQAS ISH multicenter ring study using the Ventana HER2 dual-color ISH assay. Am. J. Clin. Pathol. 135: 157–162.
  • 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.
  • 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 efficacy 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: 2639–2648.
  • Downs-Kelly E, Yoder BJ, Stoler M, Tubbs RR, Skacel M, Grogan T, Roche P, Hicks DG (2005) The influence of polysomy 17 on HER2 gene and protein expression in adenocarcinoma of the breast: a fluorescent in situ hybridization, immunohistochemical, and isotopic mRNA in situ hybridization study. Am. J. Surg. Pathol. 29: 1221–1227.
  • Eifel P, Axelson JA, Costa J, Crowley J, Curran WJ Jr, Deshler A, Fulton S, Hendricks CB, Kemeny M, Kornblith AB, Louis TA, Markman M, Mayer R, Roter D (2001) National Institutes of Health Consensus Development Conference Statement: adjuvant therapy for breast cancer, November 1-3, 2000. J. Natl. Cancer Inst. 93: 979–989.
  • 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.
  • Globocan 2008 Cancer Fact Sheet (2010) International Agency for Research on Cancer, World Health Organization http://globocan.iarc.fr/factsheets/cancers/stomach.asp.
  • Gravalos C, Jimeno A (2008) HER2 in gastric cancer: a new prognostic factor and a novel therapeutic target. Ann. Oncol. 19: 1523–1529.
  • Hammond ME, Hayes DF, Dowsett M, Allred DC, Hagerty KL, Badve S, Fitzgibbons PL, Francis G, Goldstein NS, Hayes M, Hicks DG, Lester S, Love R, Mangu PB, McShane L, Miller K, Osborne CK, Paik S, Perlmutter J, Rhodes A, Sasano H, Schwartz JN, Sweep FC, Taube S, Torlakovic EE, Valenstein P, Viale G, Visscher D, Wheeler T, Williams RB, Wittliff JL, Wolff AC (2010) American Society of Clinical Oncology/College Of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. J. Clin. Oncol. 28: 2784–2795.
  • Hicks DG (2011) Standardized assessment of the HER2 status in breast cancer by immunohistochemistry. Lab. Med. 42: 450–467.
  • Hicks DG, Boyce BF (2012) The challenge and importance of standardizing pre-analytical variables in surgical pathology specimens for clinical care and translational research. Biotech. & Histochem. 87: 14–17.
  • Hicks DG, Kulkarni S (2008a) Trastuzumab as adjuvant therapy for early breast cancer: the importance of accurate human epidermal growth factor receptor 2 testing. Arch. Pathol. Lab. Med. 132: 1008–1015.
  • Hicks DG, Kulkarni S (2008b) HER2 + breast cancer: review of biologic relevance and optimal use of diagnostic tools. Am. J. Clin. Pathol. 129: 263–273.
  • Hicks DG, Tubbs RR (2005) Assessment of the HER2 status in breast cancer by fluorescence in situ hybridization: a technical review with interpretive guidelines. Hum. Pathol. 36: 250–261.
  • Hicks DG, Whitney-Miller C (2011) HER2 testing in gastric and gastroesophageal junction cancers: a new therapeutic target and diagnostic challenge. Appl. Immunohistochem. Mol. Morphol. 19: 506–508.
  • Hicks DG, Short SM, Prescott NL, Tarr SM, Coleman KA, Yoder BJ, Crowe JP, Choueiri TK, Dawson AE, Budd GT, Tubbs RR, Casey G, Weil RJ (2006) Breast cancers with brain metastases are more likely to be estrogen receptor negative, express the basal cytokeratin CK5/6, and overexpress HER2 or EGFR. Am. J. Surg. Pathol. 30: 1097–1104.
  • Hicks DG, Kushner L, McCarthy K (2011) Breast cancer predictive factor testing: the challenges and importance of standardizing tissue handling. J. Natl. Cancer. Inst. Monogr. 2011: 43–45.
  • Hofmann M, Stoss O, Shi D, Buttner R, van de Vijver M, Kim W, Ochiai A, Ruschoff J, Henkel T (2008) Assessment of a HER2 scoring system for gastric cancer: results from a validation study. Histopathology 52: 797–805.
  • Joensuu H, Kellokumpu-Lehtinen PL, Bono P, Alanko T, Kataja V, Asola R, Utriainen T, Kokko R, Hemminki A, Tarkkanen M, Turpeenniemi-Hujanen T, Jyrkkio S, Flander M, Helle L, Ingalsuo S, Johansson K, Jaaskelainen AS, Pajunen M, Rauhala M, Kaleva-Kerola J, Salminen T, Leinonen M, Elomaa I, Isola J, (2006) Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N. Engl. J. Med. 354: 809–820.
  • Khoury T, Mojica W, Hicks D, Starostik P, Ademuyiwa F, Janarthanan B, Cheney RT (2011) ERBB2 juxtamembrane domain (trastuzumab binding site) gene mutation is a rare event in invasive breast cancers overexpressing the ERBB2 gene. Mod. Pathol. 24: 1055–1059.
  • Koltz BR, Hicks DG, Whitney-Miller CL (2012) HER2 testing in gastric and esophageal adenocarcinoma: new diagnostic challenges arising from new therapeutic options. Biotech. & Histochem. 87: 40–45.
  • Mollerup J, Henriksen U, Muller S, Schonau A (2012) Dual color chromogenic in situ hybridization for determination of HER2 status in breast cancer: a large comparative study to current state of the art fluorescence in situ hybridization. BMC Clin. Pathol. 12: 3.
  • National Cancer Institute (2012a) Surveillance Epidemiology and End Results, Seer Stat Fact Sheets: Esophagus http://seer.cancer.gov/statfacts/html/esoph.html#incidence-mortality.
  • National Cancer Institute (2012b) Surveillance Epidemiology and End Results, Seer Stat Fact Sheets: Stomach http://seer.cancer.gov/statfacts/html/stomach.html.
  • Owens MA, Horten BC, Da Silva MM (2004) HER2 amplification ratios by fluorescence in situ hybridization and correlation with immunohistochemistry in a cohort of 6556 breast cancer tissues. Clin. Breast Cancer 5: 63–69.
  • Penault-Llorca F, Bilous M, Dowsett M, Hanna W, Osamura RY, Ruschoff J, van de Vijver M (2009) Emerging technologies for assessing HER2 amplification. Am. J. Clin. Pathol. 132: 539–548.
  • 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.
  • 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.
  • Powell WC, Hicks DG, Prescott N, Tarr SM, Laniauskas S, Williams T, Short S, Pettay J, Nagle RB, Dabbs DJ, Scott KM, Brown RW, Grogan T, Roche PC, Tubbs RR (2007) 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. 15: 94–102.
  • Ravdin PM, Siminoff LA, Davis GJ, Mercer MB, Hewlett J, Gerson N, Parker HL (2001) Computer program to assist in making decisions about adjuvant therapy for women with early breast cancer. J. Clin. Oncol. 19: 980–991.
  • Romond EH, Perez EA, Bryant J, Suman VJ, Geyer CE, Jr, 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 (2005) Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N. Engl. J. Med. 353: 1673–1684.
  • Ross JS, Fletcher JA, Linette GP, Stec J, Clark E, Ayers M, Symmans WF, Pusztai L, Bloom KJ (2003) The Her-2/neu gene and protein in breast cancer 2003: biomarker and target of therapy. Oncologist 8: 307–325.
  • Ross JS, Slodkowska EA, Symmans WF, Pusztai L, Ravdin PM, Hortobagyi GN (2009) The HER-2 receptor and breast cancer: ten years of targeted anti-HER-2 therapy and personalized medicine. Oncologist 14: 320–368.
  • Ruschoff J, Hanna W, Bilous M, Hofmann M, Osamura RY, Penault-Llorca F, van de Vijver M, Viale G (2012) HER2 testing in gastric cancer: a practical approach. Mod. Pathol. 25: 637–650.
  • Sherman ME, Howatt W, Blows FM, Pharoah P, Hewitt SM, Garcia-Closas M (2010) Molecular pathology in epidemiologic studies: a primer on key considerations. Cancer Epidemiol. Biomarkers Prev. 19: 966–972.
  • Simpson PT, Reis-Filho JS, Gale T, Lakhani SR (2005) Molecular evolution of breast cancer. J. Pathol. 205: 248–254.
  • 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.
  • Slamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Pawlicki M, Chan A, Smylie M, Liu M, Falkson C, Pinter T, Fornander T, Shiftan T, Valero V, Von Minckwitz G, Mackey J, Tabah-Fisch I, Buyse M, Lindsay MA, Riva A, Bee V, Pegram M, Press M, Crown J (2005) Phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (ACT) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (ACTH) with docetaxel, carboplatin and trastuzumab (TCH) in HER2 positive early breast cancer patients: BCIRG 006 study. Breast Cancer Res. Treat. 94 Suppl. 1:S5, Abstract 1.
  • Tse CH, Hwang HC, Goldstein LC, Kandalaft PL, Wiley JC, Kussick SJ, Gown AM (2011) Determining true HER2 gene status in breast cancers with polysomy by using alternative chromosome 17 reference genes: implications for anti-HER2 targeted therapy. J. Clin. Oncol. 29: 4168–4174.
  • Tubbs RR, Hicks DG, Cook J, Downs-Kelly E, Pettay J, Hartke MB, Hood L, Neelon R, Myles J, Budd GT, Moore HC, Andresen S, Crowe JP (2007) Fluorescence in situ hybridization (FISH) as primary methodology for the assessment of HER2 Status in adenocarcinoma of the breast: a single institution experience. Diagn. Mol. Pathol. 16: 207–210.
  • Vance GH, Barry TS, Bloom KJ, Fitzgibbons PL, Hicks DG, Jenkins RB, Persons DL, Tubbs RR, Hammond ME, College of American Pathologists (2009) Genetic heterogeneity in HER2 testing in breast cancer: panel summary and guidelines. Arch. Pathol. Lab. Med. 133: 611–612.
  • 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 (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.
  • Yaziji H, Goldstein LC, Barry TS, Werling R, Hwang H, Ellis GK, Gralow JR, Livingston RB, Gown AM (2004) HER-2 testing in breast cancer using parallel tissue-based methods. JAMA 291: 1972–1977.
  • Yaziji H, Taylor CR, Goldstein NS, Dabbs DJ, Hammond EH, Hewlett B, Floyd AD, Barry TS, Martin AW, Badve S, Baehner F, Cartun RW, Eisen RN, Swanson PE, Hewitt SM, Vyberg M, Hicks DG, Members of the Standardization Ad-Hoc Consensus Committee (2008) Consensus recommendations on estrogen receptor testing in breast cancer by immunohistochemistry. Appl. Immunohistochem. Mol. Morphol. 16: 513–520.
  • Yildiz-Aktas IZ, Dabbs DJ, Bhargava R (2012) The effect of cold ischemic time on the immunohistochemical evaluation of estrogen receptor, progesterone receptor, and HER2 expression in invasive breast carcinoma. Mod. Pathol. 25: 1098–1205.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.