乳腺癌前哨淋巴结与放疗PPT课件

.,1,保乳手术,breastconservativetreatment(BCT)safe-resultsofrandomizedtrialsinthe1980spatientswithearlybreastcancer,.,2,前哨淋巴结活检,ahighlevelaccuracyfalsenegativeratearound7%equivalentoncologicaloutcomesintermsofdistantdisease-freeandoverallsurvivalsurprisinglylowregionalrecurrencerateoflessthan1%,.,3,前哨淋巴结活检,negativeSN-completionALNDisnotrequired,.,4,前哨淋巴结活检,axillarymetastasisarelimitedtheSNin60-70%overall90%forlowvolumeinvolvement(micrometastasis/isolatedtumourcellsdetectedbyimmunohistochemicalstainingonly),.,5,前哨淋巴结活检,patientswithinvolvedSNomitthecompletionALNDnoapparentdetrimenttooncologicaloutcomes,.,6,ACOSOG-Z0011,AmericanCollegeofSurgeonsOncologyGroup(ACOSOG)-Z0011axillarydissectionvs.noaxillarydissection,.,7,ACOSOG-Z0011,May1999-Dec2004115sites,.,8,ACOSOG-Z0011,Eligibilitycriteriaolderthan18years,T1-2invasivebreastcancer,nopalpableaxillaryadenopathy,and1or2SNmetastasiswithoutextranodalextension,.,9,ACOSOG-Z0011,ExclusioncriteriaClinicallynodepositivediseasemorethan2positivesentinelnodes,mattednodes,grossextranodaldiseasePreoperativesystemictreatmentsisolatedtumourcells(ITC)intheSN,.,10,ACOSOG-Z0011,Stratificationage(youngerorolderthan50years)ERstatustumoursize(2cm),.,11,ACOSOG-Z0011,BCSandSNBSNmetastasisin1or2nodesrandomlyassignedALNDornofurtheraxillaryALNDadissectionofatleast10lymphWBISystemicadjuvanttherapy,.,12,ACOSOG-Z0011,ThemainoutcomemeasureoverallsurvivalSecondaryoutcomemeasurediseasefreesurvival,.,13,ACOSOG-Z0011,noninferioritytrialtheSNB-onlygrouphavinga5-yearOSnotlessthan75%ofALNDgroupTargetedenrolmentwas1900womenwithafinalanalysisafter500deaths.,.,14,ACOSOG-Z0011,Thetrialwasclosed891patientsduetolowerthanexpectedaccrualandeventrates,.,15,ACOSOG-Z0011,445ALND446SNbiopsyalone35patients(25ontheALNDarmand10ontheSNBarm)excludedbecausewithdrewconsent,.,16,ACOSOG-Z0011,.,17,ACOSOG-Z0011,.,18,ACOSOG-Z0011,.,19,ACOSOG-Z0011,.,20,ACOSOG-Z0011,.,21,ACOSOG-Z0011,.,22,ACOSOG-Z0011,limitedSNmetastaticbreastcancerBreastconservationandsystemictherapy,SNBalonecomparedwithALNDdidnotresultininferiorsurvival,.,23,ACOSOG-Z0011,Potentialproblemsstatisticaldesignandinterpretationenrolmentofpatientsimbalancesbetweenthetreatmentgroupsandmissingdata,.,24,ACOSOG-Z0011,Theplannedtargetaccrual1900patients-apredictionofanoverallsurvivalrateof80%at5yearsforwomenwithoptimallytreatednode-positivebreastcancerThestudyhadaslowaccrual(115sitesover4yearsleadingto900patientsesomecentresenteredlessthan3patientswhichisnotmanypersite),wasunabletocompleteenrolment,andthereforeclosedearlywithlessthan50%ofthetargetedaccrualandwithlower-than-expectedeventrates,.,25,ACOSOG-Z0011,asignificantamountofmissingdata98cases(11%)-thenumberoflymphnodemetastaseswasmissing,217cases(32%)-tumourgradewasmissing20cases(2%)-tumoursizewasmissing81cases(9%)-receptorstatuswasmissingThesizeoftheSNmetastasiswasunknownin125cases(15%),33cases(4%)hadnolymphnodemetastases15casesintheSNarmhadmorethan2nodesinvolved,.,26,ACOSOG-Z0011,27%patientsintheALNDarmhadfurtherpositivenodesThus27%ofthe388patientsintheSNBarmmayhavehadundissecteddiseaseMacrometastasesintheSN62.5%ofpatientsintheALNDgroup55.2%ofpatientsintheSNBgroup.,.,27,ACOSOG-Z0011,ThisstatisticallysignificantimbalancebetweenthegroupsraisesthequestiontheSNBgrouphadlesstumourburdenintheirnodesand,consequently,amorefavourableprognosistheaxillaryrecurrenceratewasdoubleintheSNBgroup(0.9%vs.0.5%),.,28,ACOSOG-Z0011,Themostcriticalissue-eligibilitycriteriaincludedpatientsover18yearsoldwithtumour5cmwithmacrometastasesin2sentinelnodesthepatientsrecruitedtothestudyweregenerallylowriskcancersThemajorityofpatientshadsmall(T1)ERpositiveinvasiveductalcarcinomasover50yearsoldraisingthequestionmanypatientswithcancersthatwouldhavemettheeligibilitycriteriabutwerenotrepresentedinthecohortofpatientsinthetrial.,.,29,ACOSOG-Z0011,Anotherconcernthehighproportionofpatientslosttofollow-up21%ALNDand17%SN,.,30,ACOSOG-Z0011,WBIwithopposingstandardtangentialfieldsthefieldswerenotuniformbetweentherandomizationarmstheradiationoncologistsnotblinded,.,31,前哨淋巴结活检微转移,Axillarydissectionversusnoaxillarydissectioninpatientswithsentinel-nodemicrometastases(IBCSG2301)aphase3randomisedcontrolledtrial,.,32,IBCSG2301,noaxillarydissectionnon-inferiortoaxillarydissectiononeormoremicrometastatic(2mm)sentinelnodestumourofmaximum5cmoneormoremicrometastatic(2mm)sentinellymphnodeswithnoextracapsularextension,.,33,IBCSG2301,randomlyassigned(ina1:1ratio)RandomisationwasstratifiedbycentreandmenopausalstatusTreatmentassignmentwasnotmasked,.,34,IBCSG2301,primaryendpointdisease-freesurvivalNon-inferiorityasahazardratio(HR)oflessthan1.25fornoaxillarydissectionversusaxillarydissectionTheanalysis-int