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DrugTreatmentofMetastaticBreastCancerFDAApprovalOverviewPatriciaCortazar,MD微快车微信营销Methotrexate1953Cyclophosphamide1959Thiotepa1959Vinblastine19615-Fluorouracil1962Doxorubicin1974Paclitaxel1994Docetaxel1996Trastuzumab1998Capecitabine1998Capecitabine+Docetaxel2001Abraxane2005Lapatinib2006Ixabepilone2007Drugsapprovedin2nd-3rdlineMetastaticBreastCancerPaclitaxelTAXOL®isindicatedforthetreatmentofbreastcancerafterfailureofcombinationchemotherapyformetastaticdiseaseorrelapsewithin6monthsofadjuvantchemotherapy.PriortherapyshouldhaveincludedananthracyclineunlessclinicallycontraindicatedPaclitaxel135mg/m23-hourinfusionTAXOLStudyDesignPaclitaxel175mg/m23-hourinfusion471Patientswhofailedoneortworegimensofchemotherapy67%previousanthracyclinesTAXOLEfficacyResultsFullApprovalPaclitaxel175235Paclitaxel135236Response(months)28%22%P-value(logrank)p=0.135TTPmedian(months)4.23.0P-value(logrank)p=0.027Survival(months)11.710.5P-value(logrank)p=0.321DocetaxelTAXOTERE®forInjectionindicatedforthetreatmentofpatientswithlocallyadvancedormetastaticbreastcancerafterfailureofpriorchemotherapyDocetaxelAcceleratedApproval19963PhaseIIstudiesintotal134patientsDose100mg/m2q3weeksEndpoint:OverallRR41%(95%CI:33-49)PMC:Submitdatafromcontrolledclinicalstudies(TAX311,TAX304)Mytomicin12mg/m2Q6weeksVinblastine6mg/m2Q3weeksTAX304StudyDesignDocetaxel100mg/m2Q3weeks392PatientswithPrioranthracyclineregimensTAX304EfficacyResultsFullApprovalDocetaxel203Myt+Vinblastine189TTP(months)4.32.5RiskRatio95%CI(RR)0.750.61-0.94P-value(logrank)p=0.01Survival(months)11.48.7RiskRatio*95%CI(RR)0.730.58-0.93P-value(logrank)p=0.01TrastuzumabHerceptin®isindicatedfortreatmentofpatientswithmetastaticbreastcancerwhosetumorsoverexpresstheHER2proteinandwhohavereceivedoneormorechemotherapyregimensfortheirmetastaticdisease.Trastuzumab4mg/kgloadingdose2mg/kgwklymaintenanceHerceptinMBCStudyDesign222PatientswithMBCHER2overexpression2+3+1or2priorCTforMBCAnthracyclineandTaxaneHerceptinmonotherapyFullApprovalResponseRate14%CR2%PR12%ResponseDurationmedian(months)9Survivalmedian(months)12.8CapecitabineXeloda®isindicatedforthetreatmentofpatientswithmetastaticbreastcancerresistanttobothpaclitaxelandananthracycline-containingchemotherapyregimenorresistanttopaclitaxelandforwhomfurtheranthracyclinetherapymaybecontraindicated,e.g.,patientswhohavereceivedcumulativedosesof400mg/m2ofdoxorubicinordoxorubicinequivalents.CapecitabinemonotherapyAcceleratedApprovalPatientsresistanttopaclitaxelandanthracycline43CR0PR11ResponseRate95%CI25.6%(13.5,41.2)ResponseDurationmedian(days)Range154(63-233)CapecitabineXeloda®isindicatedincombinationwithTaxotere(docetaxel)forthetreatmentofpatientswithlocallyadvancedormetastaticbreastcancerafterfailureofprioranthracyclinecontainingchemotherapy.Docetaxel100mg/m2Q3weeksStudyDesignCapecitabine1250mg/m2twicedailyfor14daysDocetaxel75mg/m2Q3weeks511metastaticbreastcancerresistanttoAnthracycline30%1stlineCapecitabineEfficacyResultsFullApprovalCapeciabine+DocetaxelDocetaxelTTP(mediandays)18612895%CI(165-198)(105-136)HazardRatio0.643P-value(logrank)p=0.01Survival(mediandays)44235295%CI(375-497)(298-387)HazardRatio0.775P-value(logrank)0.0126OverallSurvivalmediandaysDocetaxel----352Capecitabine+Doc----442Logrankp=0.0126LapatinibTYKERB®incombinationwithcapecitabineforthetreatmentofpatientswithadvancedormetastaticbreastcancerwhosetumorsover-expressHER2(ErbB2)whohavereceivedpriortherapyincludingananthracycline,ataxaneandtrastuzumab.Capecitabine2500mg/m2dailyfor14daysStudyDesignLapatinib1250mg/m2continuouslyCapecitabine2000mg/m2dailyfor14days399LocallyadvancedormetastaticbreastcancerHER2+prioranthracycline,TaxaneandHerceptin.LapatinibEfficacyResultsFullApprovalIndependentradiologyReviewInvestigatorLap+CapCapLap+CapCapTTP#events82102121126Median(weeks)27.118.623.918.3Hazardratio95%CI0.57(0.43,0.77)0.72(0.56,0.92)P-value0.000130.00762ORR%23.713.931.817.4EfficacyofCombinationTherapy:Kaplan-MeierCurvesofTTPLapatinib+Capecitabine-----------Capecitabine---------p=0.00013IxabepiloneCombinationTherapy:Ixempraisindicatedincombinationwithcapecitabineforthetreatmentofpatientswithmetastaticorlocallyadvancedbreastcancerresistanttotreatmentwithananthracyclineandataxane,orwhosecanceristaxaneresistantorforwhomfurtheranthracyclinetherapyiscontraindicated.Capecitabine1250mg/m2BIDDays1to14q21daysStudyDesignIxabepilone40mg/m2Days1q21daysCapecitabine1000mg/m2BIDDays1to14q21days752ResistanttoTaxaneandanthracyclineIxabepiloneEfficacyResultsFullApprovalIxa+Cape375Capecitabine377PFS(months)5.74.1HazardRatio95%CI0.690.58-0.83P-value(logrank)p0.0001EfficacyofCombinationTherapy:Kaplan-MeierCurvesofPFSlogrankp0.0001IxabepiloneMonotherapy:Ixempraisindicatedasmonotherapyforthetreatmentofmetastaticorlocallyadvancedbreastcancerinpatientswhosetumorsareresistantorrefractorytoanthracyclines,taxanes,andcapecitabine.Single-armMonotherapyStudies(n=126)IndependentradiologyReviewInvestigatorORR(%)12.418.395%CI6.9,19.911.9,26.1ResponseDurat