直肠癌放化疗后等待观察策略

直肠癌放化疗后等待观察策略第1页/共26页2004.10,AnnalsofSurgery,Habr-Gama.eg265patientswithdistalrectalweretreatedbyCRTwith5-FU,Leucovorinand5040cGyFive-yearOSandDFSrateswere88%and83%inResectionGroup,100%and92%inObservationGroup第2页/共26页Purposeoncologicaloutcomesbetweenwatchandwaitandsurgicalresectionthesafetyofthewatch-and-wait第3页/共26页ThedefinitionofacCR(1)substantialdownsizingwithnoresidualtumororresidualfibrosisonly(2)nosuspiciouslymphnodesonMRI(3)noresidualtumoratendoscopyoronlyasmallresidualerythematousulcerorscar(4)negativebiopsiesfromthescar,ulcer,orformertumorlocation(5)nopalpabletumor,wheninitiallypalpablewithdigitalrectalexamination第4页/共26页Methodsone-to-onepairedcohortsofwatchandwaitversussurgicalresectionusingpropensity-scorematching（Tstage,age,andperformancestatus）primaryendpointwasDFSsecondaryendpointswasOSandcolostomy-freesurvival第5页/共26页MethodsCCRstandard:afterCRT8weeksormoreabsenceofresidualulceration,stenosis,ormasswithintherectumduringdigitalrectalexaminationandendoscopicexamination第6页/共26页Methods259patientsfromatertiarycancercentreinManchester,UKbetweenJan14,2011andApril15,2013CCR--wait-and-seepolicygroup(31)NCCR--surgicalresection(228)第7页/共26页MethodsthreeneighbouringUKregionalcancercentres(LancashireandSouthCumbria,MerseysideandCheshire,andnorthWales)March10,2005,andJan21,2015--wait-and-seepolicygroup(98)第8页/共26页Methodspreoperativechemoradiotherapy:45Gyin25dailyfractionswithconcurrentfluoropyrimidine-basedchemotherapyfor34days第9页/共26页MethodsDatainclude:TandNstages(MRI)Sex,age,BMISmokingstatus,performancestatusBaselineCEAHistologicalgradeHeightfromanalverge第10页/共26页MethodsStatisticalanalysiscontinuousvariables--Kruskal-WallisandWilcoxonsigned-ranktestscategoricalvariables--χ²andMcNamaratestsPvalue第11页/共26页第12页/共26页第13页/共26页第14页/共26页ResultsMedianfollow-upof33months(IQR19–43)44/129patientshadlocalregrowths(42patientshadmucosallesions,2patienthadsubmucosalormesorectallesions)第15页/共26页Results第16页/共26页Results31underwentsubsequentsalvage

surgeryTandNstages5ypT1,10ypT2,16ypT324ypN0,6ypN1,1ypN2第17页/共26页Results第18页/共26页Results第19页/共26页Results第20页/共26页Discussionanewoncologicalendpoint--non-regrowthdisease-freesurvivalthefirsttime--colostomy-freesurvival(1/4CCRavoidcolostomy)第21页/共26页DiscussionTwoadditionalfindingabout2/3nodepositiveassessedbyMRI,butdidnotaffectsubsequentendpoints9%(CCR)didnotreceivepreoperativechemotherapyanditsabsencedidnotaffectstudyendpoints第22页/共26页Discussionlimitations1.follow-upwasrelativelyshort2.notrepresentativeofreal-worldoff-trialclinicalpractice3.isariskinpatientswithCCRmanagedbywatchandwait第23页/共26页DiscussionStrengths1.largestreportedcohortoutside2.fromseveraltreatmentcentres3.astandardiseddefinition—CCR

第24页/共26页FuturePerspectivesNeedaprospectiverandomizedcontrolledtrialuniform

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