乳腺癌摘要和讨论-Kwong.ppt

NSABPPROTOCOLB-32ARandomized,PhaseIIIClinicalTrialtoCompareSentinelNodeResectiontoAxillaryDissectioninClinicallyNode-NegativeBreastCancerPatientsDefinitiveAnalysisofthePrimaryOutcomesDNKrag,SJAnderson,TBJulian,ABrown,SPHarlow,JPCostantino,TAshikaga,DWeaver,EPMamounas,NWolmarkASCOAbstractLBA505

ADvs.noADRandomizedTrialsOrrRK.AnnSurgOncol1999;6(1):109-16SurvivalAlltrialsreportedhighersurvivalintheADgroup

Fewvs.Somevs.Manynodes15nodesAllnodesnegative?Survival0102030405

ClinicallyNegativeAxillaryNodesGROUP1SN+ADSNNeg(SNonly)GROUP2SNStratificationAgeClinicalTumorSizeTypeofSurgeryB-32SNpos+ADSNPosSNNeg(SN+AD)IntraopcytologypostopHEFUFU1,975patients2,011patientsRandomization

SNDetectionMethodsBluedyeTechnetiumsulfurcolloidPalpation(~2%cases)B-32Surgery

Intraop-CytologyPostop-HEStandardizedPathProtocolB-32Pathology

SurgeonPerformanceCoretrainingcenters224surgeonsauditedforstandardSupportsaccuracyandconclusionsoftheB-32trial.B-32QCSNSurgeryiscomplex-expectvariation

3,989-SNneg(71%of5611)9%-follow-upinformationmonths-averagetimeonstudyPrimaryendpointsOS,DFS,RegionalControlStudypoweredtodetect2%differenceOS0302010405B-32AnalysisPlan

AgeRaceTumorsizeSurgicaltreatmentplanEntryCharacteristics01RadiationTherapy85%84%SystemicTherapy82%AssociatedTreatments02EvenlyBalanced

B-32OS*300deathstriggeredthedefinitiveanalysis*309reportedasof12/31/2009NSABPProtocolB-32YearsAfterEntry%Surviving02468020406080100Trt N DeathsSNR+AD 1975 140SNR 2011 169HR=1.20p=0.117OverallSurvivalforSentinelNodeNegativePatientsDataasofDecember31,2009

B-32SNNegativePatients:HazardRatiosofOSAccordingtoStratificationVariablesB-32OSHazardRatio0.20.61.01.41.82.22.6Allpatientswithfollow-upHR=1.2Patients50atentryPatients50+atentryTumorsize≤2cmTumorsize2cmPlannedLump