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保乳手术 breastconservativetreatment BCT safe resultsofrandomizedtrialsinthe1980 spatientswithearlybreastcancer 前哨淋巴结活检 ahighlevelaccuracyfalsenegativeratearound7 equivalentoncologicaloutcomesintermsofdistantdisease freeandoverallsurvivalsurprisinglylowregionalrecurrencerateoflessthan1 前哨淋巴结活检 negativeSN completionALNDisnotrequired 前哨淋巴结活检 axillarymetastasisarelimitedtheSNin60 70 overall90 forlowvolumeinvolvement micrometastasis isolatedtumourcellsdetectedbyimmunohistochemicalstainingonly 前哨淋巴结活检 patientswithinvolvedSNomitthecompletionALNDnoapparentdetrimenttooncologicaloutcomes ACOSOG Z0011 AmericanCollegeofSurgeonsOncologyGroup ACOSOG Z0011axillarydissectionvs noaxillarydissection ACOSOG Z0011 May1999 Dec2004115sites ACOSOG Z0011 Eligibilitycriteriaolderthan18years T1 2invasivebreastcancer nopalpableaxillaryadenopathy and1or2SNmetastasiswithoutextranodalextension ACOSOG Z0011 ExclusioncriteriaClinicallynodepositivediseasemorethan2positivesentinelnodes mattednodes grossextranodaldiseasePreoperativesystemictreatmentsisolatedtumourcells ITC intheSN ACOSOG Z0011 Stratificationage youngerorolderthan50years ERstatustumoursize 2cm ACOSOG Z0011 BCSandSNBSNmetastasisin1or2nodesrandomlyassignedALNDornofurtheraxillaryALNDadissectionofatleast10lymphWBISystemicadjuvanttherapy ACOSOG Z0011 ThemainoutcomemeasureoverallsurvivalSecondaryoutcomemeasurediseasefreesurvival ACOSOG Z0011 noninferioritytrialtheSNB onlygrouphavinga5 yearOSnotlessthan75 ofALNDgroupTargetedenrolmentwas1900womenwithafinalanalysisafter500deaths ACOSOG Z0011 Thetrialwasclosed891patientsduetolowerthanexpectedaccrualandeventrates ACOSOG Z0011 445ALND446SNbiopsyalone35patients 25ontheALNDarmand10ontheSNBarm excludedbecausewithdrewconsent ACOSOG Z0011 ACOSOG Z0011 ACOSOG Z0011 ACOSOG Z0011 ACOSOG Z0011 ACOSOG Z0011 ACOSOG Z0011 limitedSNmetastaticbreastcancerBreastconservationandsystemictherapy SNBalonecomparedwithALNDdidnotresultininferiorsurvival ACOSOG Z0011 Potentialproblemsstatisticaldesignandinterpretationenrolmentofpatientsimbalancesbetweenthetreatmentgroupsandmissingdata ACOSOG Z0011 Theplannedtargetaccrual1900patients apredictionofanoverallsurvivalrateof80 at5yearsforwomenwithoptimallytreatednode positivebreastcancerThestudyhadaslowaccrual 115sitesover4yearsleadingto 900patientsesomecentresenteredlessthan3patientswhichisnotmanypersite wasunabletocompleteenrolment andthereforeclosedearlywithlessthan50 ofthetargetedaccrualandwithlower than expectedeventrates ACOSOG Z0011 asignificantamountofmissingdata98cases 11 thenumberoflymphnodemetastaseswasmissing 217cases 32 tumourgradewasmissing20cases 2 tumoursizewasmissing81cases 9 receptorstatuswasmissingThesizeoftheSNmetastasiswasunknownin125cases 15 33cases 4 hadnolymphnodemetastases15casesintheSNarmhadmorethan2nodesinvolved ACOSOG Z0011 27 patientsintheALNDarmhadfurtherpositivenodesThus27 ofthe388patientsintheSNBarmmayhavehadundissecteddiseaseMacrometastasesintheSN62 5 ofpatientsintheALNDgroup55 2 ofpatientsintheSNBgroup ACOSOG Z0011 ThisstatisticallysignificantimbalancebetweenthegroupsraisesthequestiontheSNBgrouphadlesstumourburdenintheirnodesand consequently amorefavourableprognosistheaxillaryrecurrenceratewasdoubleintheSNBgroup 0 9 vs 0 5 ACOSOG Z0011 Themostcriticalissue eligibilitycriteriaincludedpatientsover18yearsoldwithtumour5cmwithmacrometastasesin2sentinelnodesthepatientsrecruitedtothestudyweregenerallylowriskcancersThemajorityofpatientshadsmall T1 ERpositiveinvasiveductalcarcinomasover50yearsoldraisingthequestionmanypatientswithcancersthatwouldhavemettheeligibilitycriteriabutwerenotrepresentedinthecohortofpatientsinthetrial ACOSOG Z0011 Anotherconcernthehighproportionofpatientslosttofollow up21 ALNDand17 SN ACOSOG Z0011 WBIwithopposingstandardtangentialfieldsthefieldswerenotuniformbetweentherandomizationarmstheradiationoncologistsnotblinded 前哨淋巴结活检微转移 Axillarydissectionversusnoaxillarydissectioninpatientswithsentinel nodemicrometastases IBCSG23 01 aphase3randomisedcontrolledtrial IBCSG23 01 noaxillarydissectionnon inferiortoaxillarydissectiononeormoremicrometastatic 2mm sentinelnodestumourofmaximum5cmoneormoremicrometastatic 2mm sentinellymphnodeswithnoextracapsularextension IBCSG23 01 randomlyassigned ina1 1ratio RandomisationwasstratifiedbycentreandmenopausalstatusTreatmentassignmentwasnotmasked IBCSG23 01 primaryendpointdisease freesurvivalNon inferiorityasahazardratio HR oflessthan1 25fornoaxillarydissectionvers
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