NSABPPROTOCOLB32临床试验课件

NSABPPROTOCOLB-32ARandomized,PhaseIIIClinicalTrialtoCompareSentinelNodeResectiontoAxillaryDissectioninClinicallyNode-NegativeBreastCancerPatients10yearUpdateTBJulian,SJAnderson,DNKrag,SPHarlow,JPCostantino,TAshikaga,DWeaver,EPMamounas,NWolmarkAbstract#1000Presentedatthe2013ASCOAnnualMeeting.Dataisthepropertyoftheauthor.ClinicallyNegativeAxillaryNodesGROUP1SN+AD(2807)SNNeg(SNonly)

StratificationAgeClinicalTumorSizeTypeofSurgeryNSABPB-32SNPos+ADSNPosSNNeg(SN+AD)Intraopcytology&postopHE

FUFU1,975pts2,011ptsRandomizationKragDetal:ASCO2010Abstr.LBA505LancetOncology,2010829pts793ptsGROUP2SN(2804)SNDetectionMethodsBluedye(5.1%cases)Technetiumsulfurcolloid(24.1%cases)Palpation(~4%cases)Colloidanddye(65.1%)NSABPB-32

UpdatedthroughDecember31,20123,989–SNneg(71%of5611)3,986(99.9%)–follow-upinformation131.1months–mediantimeonstudy121.8months–medianfollow-uptimeofpatientswhoarestillaliveEvenlyBalancedEntryCharacteristicsAge:75%>49Race:90%CaucasianTumorsize:16%>2cmHormonestatus:80%positiveSurgicaltreatmentplan:87%BCSAssociatedTreatmentsSystemicTherapy:85%&84%RadiationTherapy:82%

NSABPB-32SentinelNodeNegativePatientsSurvivalTrt

N

DeathsSNR+AD 1975 228SNR 2011 252 HR=1.09p=0.35DataasofDec31,2012NSABPB-32SentinelNodeNegativePatientsDisease-FreeSurvivalTrt

N

EventsSNR+AD 1975 455SNR 2011 475 HR=1.02p=0.72DataasofDec31,2012NSABPB-32SentinelNodeNegativePatientsDistantDisease-FreeSurvivalTrt

N

EventsSNR+AD 1975 293SNR 2011 325 HR=1.09p=0.29DataasofDec31,2012AsofDec31,20120.20.61.01.41.82.2Allpatientswithfollow-upPatients<50atentryPatients50+atentryTumorsize≤2cmTumorsize>2cmPlannedLumpectomyPlannedMastectomySNR+ADbetterHR=1.08SNRbetterHazardRatioB-32SNNegativePatients:HazardRatiosofOSBetweenGroupsAccordingtoStratificationVariables0.20.40.60.81.01.21.41.61.8Allpatientswithfollow-upPatients<50atentryPatients50+atentryTumorsize≤2cmTumorsize>2cmPlannedLumpectomyPlannedMastectomySNRbetterHR=1.02SNR+ADbetterHazardRatioB-32SNNegativePatients:HazardRatiosofDFSBetweenGroupsAccordingtoStratificationVariablesAsofDec31,2012NSABPB-32CumulativeIncidenceLocal-RegionalRecurrencesDataasofDec31,2012SNR+AD

1975pts., 84Local-RegionaleventsSNR 2011pts., 81Local-RegionaleventsHR=0.96p=0.77Group1(SN+AND)

10y

8y

Group2(SN)

10y

8yLocal

75(3.8%)54(2.7%)

66(3.3%)49(2.4%)Axillary

3(0.2%)2(0.1%)9(0.4%)8(0.3%)Extra-axillary

6(0.3%)5(0.25%)

6(0.3%)6(0.3%)LocalandRegionalRecurrencesasFirstEventsUpdatedthroughDec31,2012ClinicallyNegativeAxillaryNodesGROUP1SentinelNodeBiopsyAxillaryDissectionGROUP2SentinelNodeBiopsy*Randomization*AxillarynodedissectiononlyiftheSNispositiveNSABPB-32:OccultMetastasesIHCanddetailedpathologicexaminationoftheSNsperformedcentrallyandresultswerenotdisclosedWeaverDetal:NEnglJMed2011NSABPB-32

SentinelNodeStatusVariableCategory#ofPatients#ofPatientswithF/UpSentinelnode(SN)statusSNNegative39893986SNPositive13901390NoSNremoved209206Unknown235NSABPB-32

OccultMetastasesDetectionMethod3989SNBnegativepatients2mmtissueblocks(UofVermont)Additionalsectionsobtainedat0.5and1mmRoutineH&EandIHCstainsITCs:≤0.2mmMicrometastases:>0.2mm&≤2.0mmMacrometastases:>2.0mmNSABPB-32:RandomizationandResultsofEvaluationforOccultMetastases5611PatientsRandomlyAssigned2807assignedtoSLNbiopsy+AxDiss2804assignedtoSLNbiopsyonly1978wereSLNNegative2011wereSLNNegative1927hadSLNblocksavailable1960hadSLNblocksavailable1924hadfollow-updataavailable1960hadfollow-updataavailable1608negativeforoccultmetastases316positiveforoccultmetastases1660negativeforoccultmetastases300positiveforoccultmetastases

3268NegativeforOccultMetastases 616PositiveforOccultMetastases-15.9% 430IsolatedTumor-CellClusters-11.1% 172HadMicrometastases-4.4% 14HadMacrometastases–0.4%WeaverDL,etal.NEJM364(5):412-21,2011NSABPB-32SentinelNodeNegativePatientsOverallSurvivalbyAbsenceorPresenceofOccultMetastasesDataasofDec31,2012HR=1.26Adjustedp=0.063.1%8yearsp=0.03HR=1.37AD=1.2%OccultMetsAbsent 3268pts.,378deathsOccultMetsPresent 616pts.,90deathsNSABPB-32SentinelNodeNegativePatientsDisease-FreeSurvivalbyAbsenceorPresenceofOccultMetastasesDataasofDec31,20124.7%8yearsp=0.02HR=1.27AD=2.8%OccultMetsAbsent 3268pts.,738eventsOccultMetsPresent 616pts.,170eventsHR=1.25Adjustedp=0.01NSABPB-32SentinelNodeNegativePatientsOverallSurvivalbyStatuswithinOccultMetastasesDataasofDec31,2012NoOccultMets

3268pts.,378deathsITC

431pts.,61deaths,HR=1.22Micromets 171pts.,28deaths,HR=1.43DataasofDec31,2012NSABPB-32SentinelNodeNegativePatientsDisease-FreeSurvivalbyStatuswithinOccultMetastasesNoOccultMets

3268pts.,738eventsITC

431pts.,122events,HR=1.29Micromets 171pts.,46events,HR=1.23NSABPB-32

ConclusionsAttenyearstherecontinuestobenodifferenceinOS,DFS,DDFS,orRegionalControlforpatientswithclinicallynodenegativedisease.SNBaloneforclinicallynodenegativepatientscontinuestobeasafeandeffectivemethodforaxillarystagingasvalidatedisthisverylargecohortofpatients.NSABPB-32

OccultMetastasesConclusionsAttenyears,foroccultmetastasesthereisnolongerasignificantdifferenceinOSdesp