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Review

Targeted therapies with companion diagnostics in the management of breast cancer: current perspectives

Pages 7-16 | Published online: 22 Jan 2016

References

  • Breast Cancer2015 Available from: http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-key-statisticsAccessed May 11, 2015
  • US Food Drug AdministrationIn Vitro Companion Diagnostic DevicesUS Food and Drug Administration2014
  • LernerHJBandPRIsraelLLeungBSPhase II study of tamoxifen: report of 74 patients with stage IV breast cancerCancer Treat Rep1976601014311435798626
  • FisherBCostantinoJRedmondCA randomized clinical trial evaluating tamoxifen in the treatment of patients with node-negative breast cancer who have estrogen-receptor-positive tumorsN Engl J Med198932084794842644532
  • FisherBRedmondCBrownAInfluence of tumor estrogen and progesterone receptor levels on the response to tamoxifen and chemotherapy in primary breast cancerJ Clin Oncol1983142272416366135
  • FisherBRedmondCBrownATreatment of primary breast cancer with chemotherapy and tamoxifenN Engl J Med19813051167015139
  • LymanGHTeminSEdgeSBSentinel lymph node biopsy for patients with early-stage breast cancer: American Society of Clinical Oncology clinical practice guideline updateJ Clin Oncol201432131365138324663048
  • CaudleASHuntKKTuckerSLAmerican College of Surgeons Oncology Group (ACOSOG) Z0011: impact on surgeon practice patternsAnn Surg Oncol201219103144315122847123
  • GalimbertiVColeBFZurridaSAxillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trialLancet Oncol201314429730523491275
  • VoutsadakisIASpadaforaSAxillary lymph node management in breast cancer with positive sentinel lymph node biopsyWorld J Clin Oncol2015611625667909
  • CoatesASWinerEPGoldhirschATailoring therapies – improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015Ann Oncol20152681533154625939896
  • RakhaEAEl-SayedMELeeAHPrognostic significance of Nottingham histologic grade in invasive breast carcinomaJ Clin Oncol200826193153315818490649
  • CarlsonRWBrownEBursteinHJNCCN Task Force Report: adjuvant therapy for breast cancerJ Natl Compr Canc Netw200641S1S26
  • Van BelleVVan CalsterBBrouckaertOQualitative assessment of the progesterone receptor and HER2 improves the Nottingham Prognostic Index up to 5 years after breast cancer diagnosisJ Clin Oncol201028274129413420713855
  • PerouCMSorlieTEisenMBMolecular portraits of human breast tumoursNature2000406679774775210963602
  • SorlieTPerouCMTibshiraniRGene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implicationsProc Natl Acad Sci U S A20019819108691087411553815
  • GoldhirschAWinerEPCoatesASPersonalizing the treatment of women with early breast cancer: highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2013Ann Oncol20132492206222323917950
  • CheangMCChiaSKVoducDKi67 index, HER2 status, and prognosis of patients with luminal B breast cancerJ Natl Cancer Inst20091011073675019436038
  • HuZFanCOhDSThe molecular portraits of breast tumors are conserved across microarray platformsBMC Genomics200679616643655
  • RouzierRPerouCMSymmansWFBreast cancer molecular subtypes respond differently to preoperative chemotherapyClin Cancer Res200511165678568516115903
  • SotiriouCNeoSYMcShaneLMBreast cancer classification and prognosis based on gene expression profiles from a population-based studyProc Natl Acad Sci U S A200310018103931039812917485
  • BursteinHJTeminSAndersonHAdjuvant endocrine therapy for women with hormone receptor-positive breast cancer: American Society of Clinical Oncology clinical practice guideline focused updateJ Clin Oncol201432212255226924868023
  • DaviesCPanHGodwinJLong-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trialLancet2013381986980581623219286
  • TormeyDCGrayRFalksonHCPostchemotherapy adjuvant tamoxifen therapy beyond five years in patients with lymph node-positive breast cancer. Eastern Cooperative Oncology GroupJ Natl Cancer Inst19968824182818338961972
  • McArthurHLMahoneyKMMorrisPGAdjuvant trastuzumab with chemotherapy is effective in women with small, node-negative, HER2-positive breast cancerCancer2011117245461546821681735
  • Piccart-GebhartMJProcterMLeyland-JonesBTrastuzumab after adjuvant chemotherapy in HER2-positive breast cancerN Engl J Med2005353161659167216236737
  • RodriguesMJPeronJFrenelJSBenefit of adjuvant trastuzumab-based chemotherapy in T1ab node-negative HER2-overexpressing breast carcinomas: a multicenter retrospective seriesAnn Oncol201324491692423104720
  • SlamonDEiermannWRobertNAdjuvant trastuzumab in HER2-positive breast cancerN Engl J Med2011365141273128321991949
  • SlamonDJLeyland-JonesBShakSUse of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2N Engl J Med20013441178379211248153
  • BaselgaJCortesJKimSBPertuzumab plus trastuzumab plus docetaxel for metastatic breast cancerN Engl J Med2012366210911922149875
  • GeyerCEForsterJLindquistDLapatinib plus capecitabine for HER2-positive advanced breast cancerN Engl J Med2006355262733274317192538
  • VermaSMilesDGianniLTrastuzumab emtansine for HER2-positive advanced breast cancerN Engl J Med2012367191783179123020162
  • ClarkGMOsborneCKMcGuireWLCorrelations between estrogen receptor, progesterone receptor, and patient characteristics in human breast cancerJ Clin Oncol1984210110211096491696
  • HarveyJMClarkGMOsborneCKAllredDCEstrogen receptor status by immunohistochemistry is superior to the ligand-binding assay for predicting response to adjuvant endocrine therapy in breast cancerJ Clin Oncol19991751474148110334533
  • AllredDCCarlsonRWBerryDANCCN Task Force Report: Estrogen receptor and progesterone receptor testing in breast cancer by immunohistochemistryJ Natl Compr Canc Netw200976S1S21 uiz S22–S2319755043
  • HammondMEHayesDFDowsettMAmerican Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancerJ Clin Oncol201028162784279520404251
  • YardenYSliwkowskiMXUntangling the ErbB signalling networkNat Rev Mol Cell Biol20012212713711252954
  • RubinIYardenYThe basic biology of HER2Ann Oncol2001121S3S811521719
  • SlamonDJClarkGMWongSGLevinWJUllrichAMcGuireWLHuman breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogeneScience198723547851771823798106
  • PaulettiGGodolphinWPressMFSlamonDJDetection and quantitation of HER-2/neu gene amplification in human breast cancer archival material using fluorescence in situ hybridizationOncogene199613163728700555
  • BoseRKavuriSMSearlemanACActivating HER2 mutations in HER2 gene amplification negative breast cancerCancer Discov20133222423723220880
  • NelsonELHER2/neu: an increasingly important therapeutic target. Part 1: basic biology and therapeutic armamentariumClin Investig201447649671
  • LandgrafRHER2 therapy. HER2 (ERBB2): functional diversity from structurally conserved building blocksBreast Cancer Res20079120217274834
  • WolffACHammondMEHicksDGRecommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline updateJ Clin Oncol201331313997401324101045
  • Gonzalez-AnguloAMLittonJKBroglioKRHigh risk of recurrence for patients with breast cancer who have human epidermal growth factor receptor 2-positive, node-negative tumors 1 cm or smallerJ Clin Oncol200927345700570619884543
  • GianniLEiermannWSemiglazovVNeoadjuvant and adjuvant trastuzumab in patients with HER2-positive locally advanced breast cancer (NOAH): follow-up of a randomised controlled superiority trial with a parallel HER2-negative cohortLancet Oncol201415664064724657003
  • HudisCATrastuzumab – mechanism of action and use in clinical practiceN Engl J Med20073571395117611206
  • SpectorNLBlackwellKLUnderstanding the mechanisms behind trastuzumab therapy for human epidermal growth factor receptor 2-positive breast cancerJ Clin Oncol200927345838584719884552
  • ValabregaGMontemurroFAgliettaMTrastuzumab: mechanism of action, resistance and future perspectives in HER2-overexpressing breast cancerAnn Oncol200718697798417229773
  • WolffACHammondMEHicksDGRecommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline updateArch Pathol Lab Med2014138224125624099077
  • Early Breast Cancer Trialists’ Collaborative GroupPetoRDaviesCComparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trialsLancet2012379981443244422152853
  • PaikSDevelopment and clinical utility of a 21-gene recurrence score prognostic assay in patients with early breast cancer treated with tamoxifenOncologist200712663163517602054
  • PaikSShakSTangGA multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancerN Engl J Med2004351272817282615591335
  • PaikSTangGShakSGene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancerJ Clin Oncol200624233726373416720680
  • AlbainKSBarlowWEShakSPrognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trialLancet Oncol2010111556520005174
  • DowsettMCuzickJWaleCPrediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC studyJ Clin Oncol201028111829183420212256
  • MamounasEPTangGFisherBAssociation between the 21-gene recurrence score assay and risk of locoregional recurrence in node-negative, estrogen receptor-positive breast cancer: results from NSABP B-14 and NSABP B-20J Clin Oncol201028101677168320065188
  • TangGShakSPaikSComparison of the prognostic and predictive utilities of the 21-gene Recurrence Score assay and Adjuvant! for women with node-negative, ER-positive breast cancer: results from NSABP B-14 and NSABP B-20Breast Cancer Res Treat2011127113314221221771
  • SparanoJAGrayRJMakowerDFProspective validation of a 21-gene expression assay in breast cancerN Engl J Med2015373212005201426412349
  • HornbergerJAlvaradoMDRebeccaCGutierrezHRYuTMGradisharWJClinical validity/utility, change in practice patterns, and economic implications of risk stratifiers to predict outcomes for early-stage breast cancer: a systematic reviewJ Natl Cancer Inst2012104141068107922767204
  • National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: Breast Cancer, version 3; 2015.
  • HarrisLFritscheHMennelRAmerican Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancerJ Clin Oncol200725335287531217954709
  • US Food Drug AdministrationDraft Guidance for Industry, Clinical Laboratories, and Staff: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)US Food and Drug Administration2014 Available from: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm416685.pdfAccessed January 8, 2016
  • US Food Drug AdministrationDraft Guidance for Industry, Clinical Laboratories, and Staff: In Vitro Diagnostic Multivariate Index AssaysUS Food and Drug Administration2007 Available from: http://www.fda.gov/downloads/MedicalDevices/…/ucm071455.pdfAccessed January 8, 2016
  • van’t VeerLJDaiHvan de VijverMJGene expression profiling predicts clinical outcome of breast cancerNature2002415687153053611823860
  • van de VijverMJHeYDvan’t VeerLJA gene-expression signature as a predictor of survival in breast cancerN Engl J Med2002347251999200912490681
  • BuyseMLoiSvan’t VeerLValidation and clinical utility of a 70-gene prognostic signature for women with node-negative breast cancerJ Natl Cancer Inst200698171183119216954471
  • Bueno-de-MesquitaJMvan HartenWHRetelVPUse of 70-gene signature to predict prognosis of patients with node-negative breast cancer: a prospective community-based feasibility study (RASTER)Lancet Oncol20078121079108718042430
  • DrukkerCABueno-de-MesquitaJMRetelVPA prospective evaluation of a breast cancer prognosis signature in the observational RASTER studyInt J Cancer2013133492993623371464
  • MookSSchmidtMKVialeGThe 70-gene prognosis-signature predicts disease outcome in breast cancer patients with 1–3 positive lymph nodes in an independent validation studyBreast Cancer Res Treat2009116229530218661261
  • ParkerJSMullinsMCheangMCSupervised risk predictor of breast cancer based on intrinsic subtypesJ Clin Oncol20092781160116719204204
  • NielsenTOParkerJSLeungSA comparison of PAM50 intrinsic subtyping with immunohistochemistry and clinical prognostic factors in tamoxifen-treated estrogen receptor-positive breast cancerClin Cancer Res201016215222523220837693
  • DowsettMSestakILopez-KnowlesEComparison of PAM50 risk of recurrence score with oncotype DX and IHC4 for predicting risk of distant recurrence after endocrine therapyJ Clin Oncol201331222783279023816962
  • FilipitsMNielsenTORudasMThe PAM50 risk-of-recurrence score predicts risk for late distant recurrence after endocrine therapy in postmenopausal women with endocrine-responsive early breast cancerClin Cancer Res20142051298130524520097
  • GnantMFilipitsMGreilRPredicting distant recurrence in receptor-positive breast cancer patients with limited clinicopathological risk: using the PAM50 Risk of Recurrence score in 1478 postmenopausal patients of the ABCSG-8 trial treated with adjuvant endocrine therapy aloneAnn Oncol201425233934524347518
  • SestakICuzickJDowsettMPrediction of late distant recurrence after 5 years of endocrine treatment: a combined analysis of patients from the Austrian breast and colorectal cancer study group 8 and arimidex, tamoxifen alone or in combination randomized trials using the PAM50 risk of recurrence scoreJ Clin Oncol201533891692225332252
  • NielsenTWalldenBSchaperCAnalytical validation of the PAM50-based Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Analysis System using formalin-fixed paraffin-embedded breast tumor specimensBMC Cancer201414117724625003
  • US Food Drug Administration. [webpage on the Internet]List of cleared or approved companion diagnostic devices (in vitro and imaging tools) Available from: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htmAccessed December 22, 2015