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Review Article

Pathologic diagnosis, immunohistochemistry, multigene assays and breast cancer treatment: progress toward “precision” cancer therapy

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Pages 81-92 | Accepted 18 Sep 2014, Published online: 01 Dec 2014

References

  • Allison KH, Kandalaft PL, Sitlani CM, Dintzis SM, Gown AM (2012) Routine pathologic parameters can predict Oncotype DX recurrence scores in subsets of ER positive patients: who does not always need testing? Breast Cancer Res. Treat. 131: 413–424.
  • Baak JPA, Gudlaugsson E, Skaland I, Guo L, Klos J, Lende TH, Soiland H, Janssen EAM, Hausen A (2009) Proliferation is the strongest prognosticator in node-negative breast cancer: significance, error sources, alternatives and comparison with molecular prognostic markers. Breast Cancer Res. Treat. 115: 241–254.
  • Bartlett JM, Thomas J, Ross DT, Seitz RS, Ring BZ, Beck RA, Pedersen HC, Munro A, Kunkler IH, Campbell FM, Jack W, Kerr GR, Johnstone L, Cameron DA, Chetty U (2010) Mammostrat as a tool to stratify breast cancer patients at risk of recurrence during endocrine therapy. Breast Cancer Res. 12: R47.
  • Bartlett JM, Bloom KJ, Piper T, Lawton TJ, van de Velde CJ, Ross DT, Ring BZ, Seitz RS, Beck RA, Hasenburg A, Kieback D, Putter H, Markopoulos C, Dirix L, Seynaeve C, Rea D (2012) Mammostrat as an immunohistochemical multigene assay for prediction of early relapse risk in the tamoxifen versus exemestane adjuvant multicenter trial pathology study. J. Clin. Oncol. 30: 4477–4484.
  • Barton S, Zabaglo L, A’Hern R, Turner N, Ferguson T, O’Neill S, Hills M, Smith I, Dowsett M (2012) Assessment of the contribution of the IHC4 + C score to decision making in clinical practice in early breast cancer. Br. J. Cancer 106: 1760–1765.
  • Baselga J, Cortés 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.
  • Bastien RR, Rodríguez-Lescure Á, Ebbert MT, Prat A, Munárriz B, Rowe L, Miller P, Ruiz-Borrego M, Anderson D, Lyons B, Álvarez I, Dowell T, Wall D, Seguí MÁ, Barley L, Boucher KM, Alba E, Pappas L, Davis CA, Aranda I, Fauron C, Stijleman IJ, Palacios J, Antón A, Carrasco E, Caballero R, Ellis MJ, Nielsen TO, Perou CM, Astill M, Bernard PS, Martín M (2012) PAM50 breast cancer subtyping by RT-qPCR and concordance with standard clinical molecular markers. BMC Med. Genom. 5: 44.
  • Bergh J, Holmquist M (2001) Who should not receive adjuvant chemotherapy? J. Natl. Cancer Inst. Monogr. 2001: 103–108.
  • Blows FM, Driver KE, Schmidt MK, Broeks A, van Leeuwen FE, Wesseling J, Cheang MC, Gelmon K, Nielsen TO, Blomqvist C, Heikkilä P, Heikkinen T, Nevanlinna H, Akslen LA, Bégin LR, Foulkes WD, Couch FJ, Wang X, Cafourek V, Olson JE, Baglietto L, Giles GG, Severi G, McLean CA, Southey MC, Rakha E, Green AR, Ellis IO, Sherman ME, Lissowska J, Anderson WF, Cox A, Cross SS, Reed MW, Provenzano E, Dawson SJ, Dunning AM, Humphreys M, Easton DF, García-Closas M, Caldas C, Pharoah PD, Huntsman D (2010) Subtyping of breast cancer by immunohistochemistry to investigate a relationship between subtype and short and long term survival: a collaborative analysis of data for 10,159 cases from 12 studies. PLoS Med. 7: e1000279. doi: 10:1371/journal.1000279.
  • Brunelli M, Manfrin E, Martignoni G, Bersani S, Remo A, Reghellin D, Chilosi M, Bonetti F (2008) HER-2/neu assessment in breast cancer using the original FDA and new ASCO/CAP guideline recommendations: impact on selecting patients for herceptin therapy. Am. J. Clin. Pathol. 129: 907–911.
  • Burstein HJ, Prestrud AA, Seidenfeld J, Anderson H, Buchholz TA, Davidson NE, Gelmon KE, Giordano SH, Hudis CA, Malin J, Mamounas EP, Rowden D, Solky AJ, Sowers MR, Stearns V, Winer EP, Somerfield MR, Griggs JJ (American Society of Clinical Oncology) (2010) American Society of Clinical Oncology clinical practice guideline: update on adjuvant endocrine therapy for women with hormone receptor-positive breast cancer. J. Clin. Oncol. 28: 3784–3796.
  • Buyse M, Loi S, van’t Veer L, Viale G, Delorenzi M, Glas AM, d’Assignies MS, Bergh J, Lidereau R, Ellis P, Harris A, Bogaerts J, Therasse P, Floore A, Amakrane M, Piette F, Rutgers E, Sotiriou C, Cardoso F, Piccart MJ (TRANSBIG Consortium) (2006) Validation and clinical utility of a 70-gene prognostic signature for women with node-negative breast cancer. J. Natl. Cancer Inst. 98: 1183–1192.
  • 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.
  • Cohen DA, Dabbs DJ, Cooper KL, Amin M, Jones TE, Jones MW, Chivukula M, Trucco GA, Bhargava R (2012) Interobserver agreement among pathologists for semiquantitative hormone receptor scoring in breast carcinoma. Am. J. Clin. Pathol. 138: 796–802.
  • Colditz GA, Rosner BA, Chen WY, Holmes MD, Hankinson SE (2004) Risk factors for breast cancer according to estrogen and progesterone receptor status. J. Natl. Cancer Inst. 96: 218–228.
  • Cronin M, Sangli C, Liu ML, Pho M, Dutta D, Nguyen A, Jeong J, Wu J, Langone KC, Watson D (2007) Analytical validation of the Oncotype DX genomic diagnostic test for recurrence prognosis and therapeutic response prediction in node-negative, estrogen receptor-positive breast cancer. Clin. Chem. 53: 1084–1091.
  • Cui X, Schiff R, Arpino G, Osborne CK, Lee AV (2005) Biology of progesterone receptor loss in breast cancer and its implications for endocrine therapy. J. Clin. Oncol. 23: 7721–7735.
  • Cuzick J, Dowsett M, Pineda S, Wale C, Salter J, Quinn E, Zabaglo L, Mallon E, Green AR, Ellis IO, Howell A, Buzdar AU, Forbes JF (2011) Prognostic value of a combined estrogen receptor, progesterone receptor, Ki-67, and human epidermal growth factor receptor 2 immunohistochemical score and comparison with the genomic health recurrence score in early breast cancer. J. Clin. Oncol. 29: 4273–4278.
  • Dent S, Oyan B, Honig A, Mano M, Howell S (2013) HER2-targeted therapy in breast cancer: A systematic review of neoadjuvant trials. Cancer Treat. Rev. 39: 622–631.
  • Desmedt C, Giobbie-Hurder A, Neven P, Paridaens R, Christiaens MR, Smeets A, Lallemand F, Haibe-Kains B, Viale G, Gelber RD, Piccart M, Sotiriou C (2009) The gene expression Grade Index: a potential predictor of relapse for endocrine-treated breast cancer patients in the BIG 1-98 trial. BCM Med. Genom. 2: 40.
  • Dowsett M, Sestak I, Lopez-Knowles E, Sidhu K, Dunbier AK, Cowens JW, Ferree S, Storhoff J, Schaper C, Cuzick J (2013) Comparison of PAM50 risk of recurrence score with Oncotype DX and IHC4 for predicting risk of distant recurrence after endocrine therapy. J. Clin. Oncol. 31: 2783–2790.
  • Early breast cancer trialists’ collaborative group (EBCTCG) (2005) Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomized trials. Lancet 365: 1687–1717.
  • Early breast cancer trialists’ collaborative group (EBCTCG), Peto R, Davies C, Godwin J, Gray R, Pan HC, Clarke M, Cutter D, Darby S, McGale P, Taylor C, Wang YC, Bergh J, Di Leo A, Albain K, Swain S, Piccart M, Pritchard K (2012) Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet 379: 432–444.
  • Ellsworth RE, Hooke JA, Love B, Ellsworth DL, Shriver CD (2009) Molecular changes in primary breast tumors and the Nottingham histologic score. Pathol. Oncol. Res. 15: 541–547.
  • Elston CW, Ellis IO (1991) Pathological prognostic factors in breast cancer. I. The value of histological grade in breast cancer: experience from a large study with long-term follow-up. Histopathology 19: 403–410.
  • Fisher B, Bauer M, Wickerham DL, Redmond CK, Fisher ER, Cruz AB, Foster R, Gardner B, Lerner, H, Margolese R, Poisson R, Shibata H, Volk H (NSABP Investigators) (1983) Relation of the number of positive axillary nodes to the prognosis of patients with primary breast cancer. An NSABP update. Cancer 52: 1551–1557.
  • Fitzgibbons PL, Hicks DG (2014) Progress in implementing HER2 testing guidelines. Arch. Pathol. Lab. Med. 138: 863–864.
  • 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.
  • Glück S, Ross JS, Royce M, McKenna EF Jr, Perou CM, Avisar E, Wu L (2012) TP53 genomics predict higher clinical and pathologic tumor response in operable early-stage breast cancer treated with docetaxel-capecitabine ± trastuzumab. Breast Cancer Res. Treat. 132: 781–791.
  • Goldhirsch A, Wood WC, Coates AS, Gelber RD, Thurlimann B, Senn HJ, Panel members (2011) Strategies for subtypes-dealing with the diversity of breast cancer: highlights of the St. Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2011. Ann. Oncol. 22: 1736–1747.
  • Goldstein NS, Hewitt SM, Taylor CR, Yaziji H, Hicks DG; Members of ad-Hoc Committee on Immunohistochemistry Standardization (2007) Recommendations for improved standardization of immunohistochemistry. Appl. Immunohistochem. Mol. Morphol. 15: 124–133.
  • Gown AM (2008) Current issues in ER and HER2 testing by IHC in breast cancer. Mod. Pathol. 21 (Suppl. 2): S8–S15.
  • 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 (on behalf of the ASCO/CAP Hormone Receptor Testing in Breast Cancer Panel) (2010) American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen/progesterone receptors in breast cancer. J. Clin. Oncol. 28: 2784–2795.
  • Harvey JM, Clark GM, Osborne CK, Allred DC (1999) Estrogen receptor status by immunohistochemistry is superior to the ligand-binding assay for predicting response to adjuvant endocrine therapy in breast cancer. J. Clin. Oncol. 17: 1474–1481.
  • 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) HER2 + breast cancer: review of biologic relevance and optimal use of diagnostic tools. Am. J. Clin. Pathol. 129: 263–273.
  • Hicks DG, Kulkarni S (2008b) Trastuzumab as adjuvant therapy for early breast cancer: the importance of accurate HER2 testing. Arch. Pathol. Lab. Med. 132: 1008–1015.
  • 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, Whitney-Miller CL (2013) The evolving role of HER2 evaluation for diagnosis and clinical decision making for breast and gastric adenocarcinoma. Biotech. & Histochem. 88: 121–131.
  • 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, Janarthanan BR, Vardarajan R, Kulkarni SA, Khoury T, Dim D, Budd GT, Yoder BJ, Tubbs R, Schreeder MT, Estopinal NC, Beck RA, Wang Y, Ring BZ, Seitz RS, Ross DT (2010) The expression of TRMT2A, a novel cell cycle regulated protein, identifies a subset of breast cancer patients with HER2 over- expression that are at an increased risk of recurrence. BMC Cancer 10: 108.
  • 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.
  • Hornberger J, Chien R, Krebs K, Hochheiser L (2011) US insurance program’s experience with a multigene assay for early-stage breast cancer. J. Oncol. Pract. 7 (Suppl. 3): e38–e45.
  • Joensuu H, Kellokumpu-Lehtinen P-L, Bono P, Alandi 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 (FinHer Study Investigators) (2006) Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N. Engl. J. Med. 354: 809–820.
  • Jordan VC (1995) Tamoxifen for breast cancer prevention. Proc. Soc. Exp. Biol. Med. 208: 144–149.
  • Jordan VC (2007) New insights into the metabolism of tamoxifen and its role in the treatment and prevention of breast cancer. Steroids 72: 829–842.
  • Kao KJ, Chang KM, Hsu HC, Huang AT (2011) Correlation of microarray-based breast cancer molecular subtypes and clinical outcomes: implications for treatment optimization. BMC Cancer 11:143. doi: 10.1186/1471-2407-11-143. PubMed PMID: 21501481; PubMed Central PMCID: PMC3094326.
  • Klein ME, Dabbs DJ, Shuai Y, Brufsky AM, Jankowitz R, Puhalla SL, Bhargave R (2013) Prediction of the Oncotype DX recurrence score: use of pathology-generated equations derived by linear regression analysis. Mod. Pathol. 26: 658–664.
  • Knauer M, Mook S, Rutgers EJ, Bender RA, Hauptmann M, van de Vijver MJ, Koornstra RH, Bueno-de-Mesquita JM, Linn SC, van ‘t Veer LJ (2010) The predictive value of the 70-gene signature for adjuvant chemotherapy in early breast cancer. Breast Cancer Res. Treat. 73: 717–722.
  • Koscielny S, Tubiana M, Le MG, Valleron AJ, Mouriesse H, Contesso G, Sarrazin D (1984) Breast cancer: relationship between the size of the primary tumour and the probability of metastatic dissemination. Br. J. Cancer 49: 709–715.
  • Kulkarni SA, Hicks DG, Watroba NL, Murekeyisoni C, Hwang H, Khoury T, Beck RA, Ring BZ, Estopinal NC, Schreeder MT, Seitz RS, Ross DT (2009) TLE3 as a candidate biomarker of response to taxane therapy. Breast Cancer Res. 11: R17.
  • Liedtke C, Hatzis C, Symmans WF, Desmedt C, Haibe-Kains B, Valero V, Kuerer H, Hortobagyi GN, Piccart-Gebhart M, Sotiriou C, Pusztai L (2009) Genomic grade index is associated with response to chemotherapy in patients with breast cancer. J. Clin. Oncol. 73: 3185–3191.
  • Loi S, Haibe-Kains B, Desmedt C, Lallemand F, Tutt AM, Gillet C, Ellis P, Harris A, Bergh J, Foekens JA, Klijn JG, Larsimont D, Buyse M, Bontempi G, Delorenzi M, Piccart MJ, Sotiriou C (2007) Definition of clinically distinct molecular subtypes in estrogen receptor-positive breast carcinomas through genomic grade. J. Clin. Oncol. 25: 1239–1246.
  • Lønning PE, Sørlie T, Perou CM, Brown PO, Botstein D, Børresen-Dale AL (2001) Microarrays in primary breast cancer-lessons from chemotherapy studies. Endocr. Relat. Cancer 8: 259–263.
  • Ma XJ, Salunga R, Dahiya S, Wang W, Carney E, Durbecq V, Harris A, Goss P, Sotiriou C, Erlander M, Sgroi D (2008) A five-gene molecular grade index and HOXB13:IL17BR are complementary prognostic factors in early breast cancer. Clin. Cancer Res. 14: 2601–2608.
  • Markopoulos C (2013) Overview of the use of Oncotype DX as an additional treatment decision tool in early breast cancer. Exp. Rev. Anticancer Ther. 13: 179–194.
  • Metzger Filho O, Ignatiadis M, Sotiriou C (2011) Genomic Grade Index: an important tool for assessing breast cancer tumor grade and prognosis. Crit. Rev. Oncol. Hematol. 77: 20–29.
  • Middleton LP, Price KM, Puig P, Heydon LJ, Tarco E, Sneige N, Barr K, Deavers MT (2009) Implementation of American Society of Clinical Oncology/College of American Pathologists HER2 Guideline Recommendations in a tertiary care facility increases HER2 immunohistochemistry and fluorescence in situ hybridization concordance and decreases the number of inconclusive cases. Arch. Pathol. Lab. Med. 133: 775–780.
  • Naoi Y, Kishi K, Tanei T, Tsunashima R, Tominaga N, Baba Y, Kim SJ, Taguchi T, Tamaki Y, Noguchi S (2011) High genomic grade index associated with poor prognosis for lymph node-negative and estrogen receptor-positive breast cancers and with good response to chemotherapy. Cancer 73: 472–479.
  • Neumeister VM, Anagnostou V, Siddiqui S, England AM, Zarrella ER, Vassilakopoulou M, Parisi F, Kluger Y, Hicks DG, Rimm DL (2012) Quantitative assessment of effect of preanalytic cold ischemic time on protein expression in breast cancer tissues. J. Natl. Cancer Inst. 104: 1815–1824.
  • Nielsen T, Wallden B, Schaper C, Ferree S, Liu S, Gao D, Barry G, Dowidar N, Maysuria M, Storhoff J (2014) Analytical validation of the PAM50-based Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Analysis System using formalin-fixed paraffin-embedded breast tumor specimens. BMC Cancer 14: 177.
  • Owens MA, Horten BC, Da Silve MM (2004) HER2 amplification rates by fluorescence in situ hybridization and correlation with immunohistochemistry in cohort of 6557 breast cancer tissue. Clin. Breast Cancer 5: 63–69.
  • Paik S, Shak S, Tang G, Kim C, Baker J, Cronin M, Baehner FL, Walker MG, Watson D, Park T, Hiller W, Fisher ER, Wickerham DL, Bryant J, Walmart N (2004) A multigene assay to predict recurrence of tamoxifen-treated, node negative breast cancer. N. Engl. J. Med. 351: 2817–2826.
  • Paik S, Tang G, Shak S, Kim C, Baker J, Kim W, Cronin M, Baehner FL, Watson D, Bryant J, Constantine JP, Geyer CE Jr, Wickerham DL, Walmart N (2006) Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J. Clin. Oncol. 24: 3726–3734.
  • Parker JS, Mullins M, Cheang MC, Leung S, Voduc D, Vickery T, Davies S, Fauron C, He X, Hu Z, Quackenbush JF, Stijleman IJ, Palazzo J, Marron JS, Nobel AB, Mardis E, Nielsen TO, Ellis MJ, Perou CM, Bernard PS (2009) Supervised risk predictor of breast cancer based on intrinsic subtypes. J. Clin. Oncol. 27: 1160–1167.
  • Perez EA, Press MF, Dueck AC, Jenkins RB, Kim C, Chen B, Villalobos I, Paik S, Buyse M, Wiktor AE, Meyer R, Finnigan M, Zujewski J, Shing M, Stern HM, Lingle WL, Reinholz MM, Slamon DJ (2013) Immunohistochemistry and fluorescence in situ hybridization assessment of HER2 in clinical trials of adjuvant therapy for breast cancer (NCCTG N9831, BCIRG 006, and BCIRG 005). Breast Cancer Res. Treat. 138: 99–108.
  • Perou CM, Sorlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA, Pollack JR, Ross DT, Johnsen H, Akslen LA, Fluge O, Pergamenschikov A, Williams C, Zhu SX, Lonning PE, Borresen-Dale AL, Brown PO, Botstein D (2000) Molecular portraits of human breast tumours. Nature 406: 747–752.
  • 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 (Herceptin Adjuvant (HERA) Trial Study Team) (2005) Trastuzumab after adjuvant chemotherapy in HER2 positive breast cancer. N. Engl. J. Med. 353: 1659–1672.
  • Rakha EA, El-Sayed ME, Lee AH, Elston CW, Grainge MJ, Hodi Z, Blamey RW, Ellis IO (2008) Prognostic significance of Nottingham histologic grade in invasive breast carcinoma. J. Clin. Oncol. 26: 3153–3158.
  • 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.
  • Ring BZ, Seitz RS, Beck R, Shasteen WJ, Tarr SM, Cheang MC, Yoder BJ, Budd GT, Nielsen TO, Hicks DG, Estopinal NC, Ross DT (2006) Novel prognostic immunohistochemical biomarker panel for estrogen receptor-positive breast cancer. J. Clin. Oncol. 24: 3039–3047.
  • Romond EH, Jeong JH, Rastogi P, Swain SM, Geyer CE Jr, Ewer MS, Rathi V, Fehrenbacher L, Brufsky A, Azar CA, Flynn PJ, Zapas JL, Polikoff J, Gross HM, Biggs DD, Atkins JN, Tan-Chiu E, Zheng P, Yothers G, Mamounas EP, Wolmark N (2012) Seven-year follow-up assessment of cardiac function in NSABP B-31, a randomized trial comparing doxorubicin and cyclophosphamide followed by paclitaxel (ACP) with ACP plus trastuzumab as adjuvant therapy for patients with node-positive, human epidermal growth factor receptor 2-positive breast cancer. J. Clin. Oncol. 30: 3792–3799.
  • 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 DT, Kim CY, Tang G, Bohn OL, Beck RA, Ring BZ, Seitz RS, Paik S, Costantino JP, Wolmark N (2008) Chemosensitivity and stratification by a five monoclonal antibody immunohistochemistry test in the NSABP B14 and B20 trials. Clin. Cancer Res. 14: 6602–6609.
  • Ross JS, Fletcher JA (2008) The HER-2/neu oncogene in breast cancer: prognostic factor, predictive factor, and target for therapy. Oncologist 3: 237–252.
  • 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.
  • Sørlie T, Perou CM, Tibshirani R, Aas T, Geisler S, Johnsen H, Hastie T, Eisen MB, van de Rijn M, Jeffrey SS, Thorsen T, Quist H, Matese JC, Brown PO, Botstein D, Lønning PE, Børresen-Dale AL (2001) Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications. Proc. Natl. Acad. Sci. USA 98: 10869–10874.
  • Sorlie T, Tibshirani R, Parker J, Hastie T, Marron JS, Nobel A, Deng S, Johnsen H, Pesich R, Geisler S, Demeter J, Perou CM, Lønning PE, Brown PO, Børresen-Dale AL, Botstein D (2003) Repeated observation of breast tumor subtypes in independent gene expression data sets. Proc. Natl. Acad. Sci. USA 100: 8418–8423.
  • Sotiriou C, Wirapati P, Loi S, Harris A, Fox S, Smeds J, Nordgren H, Farmer P, Praz V, Haibe-Kains B, Desmedt C, Larsimont D, Cardoso F, Peterse H, Nuyten D, Buyse M, Van de Vijver MJ, Bergh J, Piccart M, Delorenzi M. (2006) Gene expression profiling in breast cancer: understanding the molecular basis of histologic grade to improve prognosis. J. Natl. Cancer Inst. 98: 262–272.
  • Subik K, Lee JF, Baxter L, Strzepek T, Costello D, Crowley P, Xing L, Hung MC, Bonfiglio T, Hicks DG, Tang P (2010) The expression patterns of ER, PR, HER2, CK5/6, EGFR, Ki-67 and AR by immunohistochemical analysis in breast cancer cell lines. Breast Cancer (Auckl.) 4: 35–41.
  • Tang P, Skinner KA, Hicks DG (2009) Molecular classification of breast carcinomas by immunohistochemical analysis: are we ready? Diagn. Mol. Pathol. 18: 125–132.
  • Tang P, Wang J, Hicks DG, Wang X, Schiffhauer L, McMahon L, Yang Q, Shayne M, Huston A, Skinner KA, Griggs J, Lyman G (2010) A lower Allred score for progesterone receptor is strongly associated with a higher recurrence score of 21-gene assay in breast cancer. Cancer Invest. 28: 978–982.
  • Taylor CR (2007) Editorial—a personal perspective. Appl. Immunohistochem. Mol. Morphol. 15: 121–123.
  • Tian S, Roepman P, Van’t Veer LJ, Bernards R, de Snoo F, Glas AM (2010) Biological functions of the genes in the mammaprint breast cancer profile reflect the hallmarks of cancer. Biomark. Insights 5: 129–138.
  • Tischkowitz M, Brunet JS, Bégin LR, Huntsman DG, Cheang MC, Akslen LA, Nielsen TO, Foulkes WD (2007) Use of immunohistochemical markers can refine prognosis in triple negative breast cancer. BMC Cancer 7: 134.
  • Turner BM, Skinner K, Huston A, Schiffhauer L, Shayne M, Ling M, Zhang Z, Jackson M, Tang P, Hicks D (2013) Abstract P2-11-12. Validation of modified Magee equations for predicting the Oncotype DX recurrence score: a cost-effective alternative for estimating the risk of distant recurrence in receptor positive/node negative breast cancer patients. Cancer Res. 73: P2–11–12; doi:10.1158/0008-5472.SABCS13-P2-11-12.
  • van de Vijver MJ, He YD, van't Veer LJ, Dai H, Hart AA, Voskuil DW, Schreiber GJ, Peterse JL, Roberts C, Marton MJ, Parrish M, Atsma D, Witteveen A, Glas A, Delahaye L, van der Velde T, Bartelink H, Rodenhuis S, Rutgers ET, Friend SH, Bernards R (2002) A gene-expression signature as a predictor of survival in breast cancer. N. Engl. J. Med. 347: 1999–2009.
  • van ‘t Veer LJ, Dai H, van de Vijver MJ, He YD, Hart AA, Mao M, Peterse HL, van der Kooy K, Marton MJ, Witteveen AT, Schreiber GJ, Kerkhoven RM, Roberts C, Linsley PS, Bernards R, Friend SH (2002) Gene expression profiling predicts clinical outcome of breast cancer. Nature 415: 530–536.
  • Varga Z, Diebold J, Dommann-Scherrer C, Frick H, Kaup D, Noske A, Obermann E, Ohlschlegel C, Padberg B, Rakozy C, Sancho Oliver S, Schobinger-Clement S, Schreiber-Facklam H, Singer G, Tapia C, Wagner U, Mastropasqua MG, Viale G, Lehr HA (2012) How reliable is Ki-67 immunohistochemistry in grade 2 breast carcinomas? A QA study of the Swiss Working Group of Breast and Gynecopathologists. PLoS One 7: e37379.
  • Vergara-Lluri ME, Moatamed NA, Hong E, Apple SK (2012) High concordance between HercepTest immunohistochemistry and ERBB2 fluorescence in situ hybridization before and after implementation of American Society of Clinical Oncology/College of American Pathology 2007 guidelines. Mod. Pathol. 25: 1326–1332.
  • Verma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, Pegram M, Oh DY, Diéras V, Guardino E, Fang L, Lu MW, Olsen S, Blackwell K; EMILIA Study Group (2012) Trastuzumab emtansine for HER2-positive advanced breast cancer. N. Engl. J. Med. 367: 1783–1791.
  • Viale G, Regan MM, Dell’Orto P, Mastropasqua MG, Maiorano E, Rasmussen BB, MacGrogan G, Forbes JF, Paridaens RJ, Colleoni M, Láng I, Thürlimann B, Mouridsen H, Mauriac L, Gelber RD, Price KN, Goldhirsch A, Gusterson BA, Coates AS (BIG 1-98 Collaborative and International Breast Cancer Study Groups) (2011) Which patients benefit most from adjuvant aromatase inhibitors? Results using a composite measure of prognostic risk in the BIG 1-98 randomized trial. Ann. Oncol. 22: 2201–2207.
  • Voduc KD, Cheang MC, Tyldesley S, Gelmon K, Nielsen TO, Kennecke H (2010) Breast cancer subtypes and the risk of local and regional relapse. J. Clin. Oncol. 28: 1684–1691.
  • 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.
  • Wolff AC, Hammond ME, Hicks DG, Dowsett M, McShane LM, Allison KH, Allred DC, Bartlett JM, Bilous M, Fitzgibbons P, Hanna W, Jenkins RB, Mangu PB, Paik S, Perez EA, Press MF, Spears PA, Vance GH, Viale G, Hayes DF (American Society of Clinical Oncology; College of American Pathologists) (2014) Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. Arch. Pathol. Lab. Med. 138: 241–256.
  • Yarden Y, Baselga J, Miles D (2004) Molecular approach to breast cancer treatment. Semin. Oncol. 31 (Suppl. 10): 6–13.
  • 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. J. Am. Med. Assoc. 291: 1972–1927.
  • 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, Cooper KL, Chivukula M, McManus K, Bhargava R (2012) The effect of 96-hour formalin fixation on the immunohistochemical evaluation of estrogen receptor, progesterone receptor, and HER2 expression in invasive breast carcinoma. Am. J. Clin. Pathol. 137: 691–698.

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