Spotlight on the utility of the Oncotype DX^® breast cancer assay

References

• GLOBOCAN 2012 [webpage on the Internet]Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 20122012 Available from: http://globocan.iarc.fr/Pages/fact_sheets_population.aspxAccessed May 31, 2017
   Google Scholar
• BerryDACroninKAPlevritisSKEffect of screening and adjuvant therapy on mortality from breast cancerN Engl J Med2005353171784179216251534
   PubMed Web of Science ®Google Scholar
• Early Breast Cancer Trialists’ Collaborative Group (EBCTCG)Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trialsLancet200536594721687171715894097
   PubMed Web of Science ®Google Scholar
• DignamJJDukicVMAndersonSJMamounasEPWickerhamDLWolmarkNHazard of recurrence and adjuvant treatment effects over time in lymph node-negative breast cancerBreast Cancer Res Treat2009116359560218830816
   PubMed Web of Science ®Google Scholar
• SparanoJAGrayRJMakowerDFProspective validation of a 21-gene expression assay in breast cancerN Engl J Med2015373212005201426412349
   PubMed Web of Science ®Google Scholar
• HarbeckNThomssenCA new look at node-negative breast cancerOncologist201116suppl 1516021278441
   PubMed Web of Science ®Google Scholar
• GriggsJHawleySGraffJFactors associated with receipt of breast cancer adjuvant chemotherapy in a diverse population-based sampleJ Clin Oncol201230253058306422869890
   PubMed Web of Science ®Google Scholar
• GaßPFaschingPAFehmTFactors influencing decision-making for or against adjuvant and neoadjuvant chemotherapy in postmenopausal hormone receptor-positive breast cancer patients in the Evaluate-TM studyBreast Care201611531532227920623
   PubMed Web of Science ®Google Scholar
• BaumMRavdinPMDecision-making in early breast cancer: guidelines and decision toolsEur J Cancer200238674574911937306
   PubMed Web of Science ®Google Scholar
• ScholzenTGerdesJThe Ki-67 protein: from the known and the unknownJ Cell Physiol2000182331132210653597
   PubMed Web of Science ®Google Scholar
• InwaldECKlinkhammer-SchalkeMHofstädterFKi-67 is a prognostic parameter in breast cancer patients: results of a large population-based cohort of a cancer registryBreast Cancer Res Treat2013139253955223674192
   PubMed Web of Science ®Google Scholar
• RavdinPMSiminoffLADavisGJComputer program to assist in making decisions about adjuvant therapy for women with early breast cancerJ Clin Oncol200119498099111181660
   PubMed Web of Science ®Google Scholar
• OlivottoIABajdikCDRavdinPMPopulation-based validation of the prognostic model ADJUVANT! for early breast cancerJ Clin Oncol200523122716272515837986
   PubMed Web of Science ®Google Scholar
• GoldsteinLJGrayRBadveSPrognostic utility of the 21-gene assay in hormone receptor–positive operable breast cancer compared with classical clinicopathologic featuresJ Clin Oncol200826254063407118678838
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• De SchutterHVan DammeNColpaertCQuality of pathology reporting is crucial for cancer care and registration: a baseline assessment for breast cancers diagnosed in Belgium in 2008Breast201524214315225572136
   PubMed Web of Science ®Google Scholar
• PolleyMYLeungSCMcShaneLMAn international Ki67 reproducibility studyJ Natl Cancer Inst2013105241897190624203987
   PubMedGoogle Scholar
• AlbainKSPaikSvan’t VeerLPrediction of adjuvant chemotherapy benefit in endocrine responsive, early breast cancer using multigene assaysBreast200918S141S14519914534
   PubMed Web of Science ®Google Scholar
• PaikSIs gene array testing to be considered routine now?Breast201120suppl 3S87S9122015300
   PubMed Web of Science ®Google Scholar
• BartlettJBayaniJMarshallAComparing breast cancer multiparameter tests in the OPTIMA prelim trial: no test is more equal than the othersJ Natl Cancer Inst20161089djw05027130929
   PubMedGoogle Scholar
• VargaZSinnPFritzscheFComparison of EndoPredict and Oncotype DX Test results in hormone receptor positive invasive breast cancerPLoS One201383e5848323505515
   PubMed Web of Science ®Google Scholar
• FilipitsMRudasMJakeszREP InvestigatorsA new molecular predictor of distant recurrence in ER-positive, HER2-negative breast cancer adds independent information to conventional clinical risk factorsClin Cancer Res201117186012602021807638
   PubMed Web of Science ®Google Scholar
• DubskyPFilipitsMJakeszRAustrian Breast and Colorectal Cancer Study Group (ABCSG)EndoPredict improves the prognostic classification derived from common clinical guidelines in ER-positive, HER2-negative early breast cancerAnn Oncol201324364064723035151
   PubMed Web of Science ®Google Scholar
• BuusRSestakIKronenwettRComparison of EndoPredict and EPclin with Oncotype DX Recurrence Score for prediction of risk of distant recurrence after endocrine therapyJ Natl Cancer Inst201610811djw149
   PubMedGoogle Scholar
• JankowitzRCCooperKErlanderMGPrognostic utility of the breast cancer index and comparison to Adjuvant! Online in a clinical case series of early breast cancerBreast Cancer Res2011135R9821999244
   PubMed Web of Science ®Google Scholar
• SgroiDCSestakICuzickJPrediction of late distant recurrence in patients with oestrogen-receptor-positive breast cancer: a prospective comparison of the breast-cancer index (BCI) assay, 21-gene recurrence score, and IHC4 in the TransATAC study populationLancet Oncol201314111067107624035531
   PubMed Web of Science ®Google Scholar
• ParkerJSMullinsMCheangMCUSupervised risk predictor of breast cancer based on intrinsic subtypesJ Clin Oncol20092781160116719204204
   PubMed Web of Science ®Google Scholar
• CardosoFvan’t VeerLJBogaertsJ70-gene signature as an aid to treatment decisions in early-stage breast cancerN Engl J Med2016375871772927557300
   PubMed Web of Science ®Google Scholar
• PaikSShakSTangGA multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancerN Engl J Med2004351272817282615591335
   PubMed Web of Science ®Google Scholar
• HarrisLNIsmailaNMcShaneLMUse of biomarkers to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer: American Society of Clinical Oncology Clinical Practice GuidelineJ Clin Oncol201634101134115026858339
   PubMed Web of Science ®Google Scholar
• National Comprehensive Cancer NetworkNCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) – Breast Cancer, Version 2. 20172017 Available from: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdfAccessed July 4, 2017
   Google Scholar
• SenkusEKyriakidesSOhnoSPrimary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-upAnn Oncol201526suppl_5v8v3026314782
   PubMed Web of Science ®Google Scholar
• GnantMHarbeckNThomssenCSt. Gallen/Vienna 2017: a brief summary of the consensus discussion about escalation and de-escalation of primary breast cancer treatmentBreast Care (Basel)201712210210728559767
   PubMed Web of Science ®Google Scholar
• NICE [webpage on the Internet]Gene Expression Profiling and Expanded Immunohistochemistry Tests for Guiding Adjuvant Chemotherapy Decisions in Early Breast Cancer Management: MammaPrint, Oncotype DX, IHC4 and Mammostrat2013 Available from: https://www.nice.org.uk/guidance/dg10Accessed July 4, 2017
   Google Scholar
• PaikSTangGShakSGene expression and benefit of chemotherapy in women with node-negative, estrogen receptor–positive breast cancerJ Clin Oncol200624233726373416720680
   PubMed Web of Science ®Google Scholar
• MamounasEPBryantJLemberskyBPaclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: results from NSABP B-28J Clin Oncol200523163686369615897552
   PubMed Web of Science ®Google Scholar
• FisherBBrownAMDimitrovNVTwo months of doxorubicin-cyclophosphamide with and without interval reinduction therapy compared with 6 months of cyclophosphamide, methotrexate, and fluorouracil in positive-node breast cancer patients with tamoxifen-nonresponsive tumors: results from the National Surgical Adjuvant Breast and Bowel Project B-15J Clin Oncol199089148314962202791
   PubMed Web of Science ®Google Scholar
• GluzONitzUAChristgenMWest German Study Group Phase III PlanB Trial: first prospective outcome data for the 21-gene recurrence score assay and concordance of prognostic markers by central and local pathology assessmentJ Clin Oncol201634202341234926926676
   PubMed Web of Science ®Google Scholar
• European Cancer Organisation [webpage on the Internet]EBCC-10 NEWS: Five-Year Result Show 21-Gene Test Successfully Identifies Early Breast Cancer Patients Who Can Be Spared Chemotherapy2017 Available from: http://www.ecco-org.eu/Global/News/EBCC/EBCC10-PR/2016/03/Five-year-results-identifies-early-breast-cancer-patients-who-can-be-spared-chemoAccessed June 9, 2017
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• KalinskyKTamoxifen citrate, letrozole, anastrozole, or exemestane with or without chemotherapy in treating patients with invasive RxPONDER breast cancer2017 Available from: https://clinicaltrials.gov/ct2/show/NCT01272037. NLM identifier: NCT01272037Accessed July 5, 2017
   Google Scholar
• ShacharSSMussHBInternet tools to enhance breast cancer careNPJ Breast Cancer201621601128721377
   PubMedGoogle Scholar
• TangGCuzickJCostantinoJPRisk of recurrence and chemotherapy benefit for patients with node-negative, estrogen receptor–positive breast cancer: recurrence score alone and integrated with pathologic and clinical factorsJ Clin Oncol201129334365437222010013
   PubMed Web of Science ®Google Scholar
• Oncotype DX toolsOncotype DX tools® User Guide2013 Available from: http://www.genomichealth.com/-/media/ODX-Breast/Files/Downloads/GHI10203_0313_Oncotype_DX_tools_Guide.pdfAccessed July 4, 2017
   Google Scholar
• CortazarPZhangLUntchMPathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysisLancet2014384993816417224529560
   PubMed Web of Science ®Google Scholar
• GuarneriVBroglioKKauSWPrognostic value of pathologic complete response after primary chemotherapy in relation to hormone receptor status and other factorsJ Clin Oncol20062471037104416505422
   PubMed Web of Science ®Google Scholar
• YardleyDAPeacockNWShastryMA phase II trial of ixabepilone and cyclophosphamide as neoadjuvant therapy for patients with HER2-negative breast cancer: correlation of pathologic complete response with the 21-gene recurrence scoreBreast Cancer Res Treat2015154229930826507191
   PubMed Web of Science ®Google Scholar
• BrownJRDiGiovannaMPKilleleaBLanninDRRimmDLQuantitative assessment Ki-67 score for prediction of response to neoadjuvant chemotherapy in breast cancerLab Invest20149419810624189270
   PubMed Web of Science ®Google Scholar
• SahebjamSAloyzRPilavdzicDKi 67 is a major, but not the sole determinant of Oncotype Dx Recurrence ScoreBr J Cancer201110591342134521970880
   PubMed Web of Science ®Google Scholar
• BearHDWanWRobidouxAUsing the 21-gene assay from core needle biopsies to choose neoadjuvant therapy for breast cancer: a multicenter trialJ Surg Oncol2017115891792328407247
   PubMed Web of Science ®Google Scholar
• RobidouxAMcCulloughDLauAStöpplerMChaoCUse of the 21-gene Oncotype DX® Breast Recurrence Score™ (RS) assay in the neoadjuvant treatment settingBreast201732suppl 1S80
   Web of Science ®Google Scholar
• webpage on the Internet10-K: Genomic Health2017 Available from: http://www.marketwatch.com/story/10-k-genomic-health-inc-2017-03-15Accessed June 1, 2017
   Google Scholar
• LamondNWSkedgelCRaysonDLethbridgeLYounisTCost-utility of the 21-gene recurrence score assay in node-negative and node-positive breast cancerBreast Cancer Res Treat201213331115112322361999
   PubMed Web of Science ®Google Scholar
• YamauchiHNakagawaCYamashigeSSocietal cost-effectiveness analysis of the 21-gene assay in estrogen-receptor-positive, lymph-node-negative early-stage breast cancer in JapanBMC Health Serv Res2014514372
   Web of Science ®Google Scholar
• Bargallo-RochaJELara-MedinaFPerez-SanchezVCost-effectiveness of the 21-gene breast cancer assay in MexicoAdv Ther201532323925325740550
   PubMed Web of Science ®Google Scholar
• KatzGRomanoOFoaCEconomic impact of gene expression profiling in patients with early-stage breast cancer in FrancePLoS One2015106e012888026086912
   PubMed Web of Science ®Google Scholar
• TsoiDTInoueMKellyCMVermaSPritchardKICost-effectiveness analysis of recurrence score-guided treatment using a 21-gene assay in early breast cancerOncologist201015545746520421264
   PubMed Web of Science ®Google Scholar
• MSAC Public Summary DocumentApplication No. 1342.1 – Gene Expression Profiling of 21 genEs in Breast Cancer to Quantify the Risk of Disease Recurrence and Predict Adjuvant Chemotherapy Benefit2014 Available from: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/D4EF97AE878785FDCA25801000123BEE/$File/13421-PSD-MSACPSD-OncotypeDX(D14-1184441).PDFAccessed July 4, 2017
   Google Scholar
• Specialised Therapeutics [webpage on the Internet]Press Release – Cutting Edge Breast Cancer Test ‘Should be Reimbursed’ – Medical Experts2015 Available from: https://www.stabiopharma.com/index.php?q=cutting-edge-breast-cancer-test-should-be-reimbursed-medical-experts.htmlAccessed June 1, 2017
   Google Scholar
• Genomic Health [webpage on the Internet]Following NICE’s Exclusive Recommendation, NHS England Agrees to Access Program for Oncotype DX® Breast Cancer Test2015 Available from: http://investor.genomichealth.com/releasedetail.cfm?releaseid=894895Accessed June 1, 2017
   Google Scholar
• Genomic HealthOncotype DX® Breast Cancer Test Achieves Positive Reimbursement in Switzerland2014 Available from: https://www.bioalps.org/data/documents/suggesteventsnews/genomic-health-breast-cancer-test-obtains-1426.pdfAccessed July 4, 2017
   Google Scholar
• Genomic Health [webpage on the Internet]Oncotype DX for Breast Cancer – Tailoring Treatment for Individual Patients with Early-Stage Breast Cancer2017 Available from: http://www.genomichealth.com/en-US/oncotype_iq_products/oncotype_dx/oncotype_dx_breast_cancerAccessed June 1, 2017
   Google Scholar
• LoSSMumbyPNortonJProspective multicenter study of the impact of the 21-gene recurrence score assay on medical oncologist and patient adjuvant breast cancer treatment selectionJ Clin Oncol201028101671167620065191
   PubMed Web of Science ®Google Scholar
• de BoerRBakerCSpeakmanDChaoCYoshizawaCMannGBThe impact of a genomic assay (Oncotype DX) on adjuvant treatment recommendations in early breast cancerMed J Aust2013199320520823909545
   PubMed Web of Science ®Google Scholar
• PestalozziBCTauschCDedesKJAdjuvant treatment recommendations for patients with ER-positive/HER2-negative early breast cancer by Swiss tumor boards using the 21-gene recurrence score (SAKK 26/10)BMC Cancer201717126528407750
   PubMed Web of Science ®Google Scholar
• OratzRPaulDCohnALSedlacekSMImpact of a commercial reference laboratory test recurrence score on decision making in early-stage breast cancerJ Oncol Pract20073418218620859407
   PubMedGoogle Scholar
• KuchelARobinsonTCominsCThe impact of the 21-gene assay on adjuvant treatment decisions in oestrogen receptor-positive early breast cancer: a prospective studyBr J Cancer2016114773173626954715
   PubMed Web of Science ®Google Scholar
• AlbanellJSvedmanCGligorovJPooled analysis of prospective European studies assessing the impact of using the 21-gene recurrence score assay on clinical decision making in women with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative early-stage breast cancerEur J Cancer1990201666104113
   Google Scholar
• LoncasterJArmstrongAHowellSImpact of Oncotype DX breast Recurrence Score testing on adjuvant chemotherapy use in early breast cancer: real world experience in Greater Manchester, UKEur J Surg Oncol201743593193728111076
   PubMed Web of Science ®Google Scholar
• OzmenVAtasoyAGokmenEImpact of Oncotype DX Recurrence Score on treatment decisions: results of a prospective multicenter study in TurkeyCureus201683e52227081583
   PubMedGoogle Scholar
• LeungRCYauTCChanMCThe impact of the Oncotype DX breast cancer assay on treatment decisions for women with estrogen receptor-positive, node-negative breast carcinoma in Hong KongClin Breast Cancer201616537237827105769
   PubMed Web of Science ®Google Scholar
• LeeMHHanWLeeJEThe clinical impact of 21-gene recurrence score on treatment decisions for patients with hormone receptor-positive early breast cancer in KoreaCancer Res Treat201547220821425381828
   PubMed Web of Science ®Google Scholar
• DavidsonJACromwellIEllardSLA prospective clinical utility and pharmacoeconomic study of the impact of the 21-gene Recurrence Score® assay in oestrogen receptor positive node negative breast cancerEur J Cancer201349112469247523611660
   PubMed Web of Science ®Google Scholar
• GligorovJPivotXBJacotWProspective clinical utility study of the use of the 21-Gene assay in adjuvant clinical decision making in women with estrogen receptor-positive early invasive breast cancer: results from the SWITCH StudyOncologist201520887387926112003
   PubMed Web of Science ®Google Scholar
• BargalloJELaraFShaw-DulinRA study of the impact of the 21-gene breast cancer assay on the use of adjuvant chemotherapy in women with breast cancer in a Mexican public hospitalJ Surg Oncol2015111220320725288020
   PubMed Web of Science ®Google Scholar
• EiermannWRezaiMKümmelSThe 21-gene recurrence score assay impacts adjuvant therapy recommendations for ER-positive, node-negative and node-positive early breast cancer resulting in a risk-adapted change in chemotherapy useAnn Oncol201324361862423136233
   PubMed Web of Science ®Google Scholar
• HoltSBertelliGHumphreysIA decision impact, decision conflict and economic assessment of routine Oncotype DX testing of 146 women with node-negative or pNImi, ER-positive breast cancer in the UKBr J Cancer2013108112250225823695023
   PubMed Web of Science ®Google Scholar
• HassettMJSilverSHughesMAdoption of gene expression profile testing and association with use of chemotherapy among women with breast cancerJ Clin Oncol201230182218222622585699
   PubMed Web of Science ®Google Scholar