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Watch-and-waitapproachversussurgicalresectionafterchemoradiotherapyforpatientswithrectalcancer(theOnCoReproject):apropensity-scorematchedcohortanalysisLancetOncolPublishedOnlineDecember16,20151.Watch-and-waitapproachversusv2004.10,AnnalsofSurgery,Habr-Gama.egv265patientswithdistalrectalweretreatedbyCRTwith5-FU,Leucovorinand5040cGyvFive-yearOSandDFSrateswere88%and83%inResectionGroup,100%and92%inObservationGroup2.2004.10,AnnalsofSurgery,HabPurposevoncologicaloutcomesbetweenwatchandwaitandsurgicalresectionvthesafetyofthewatch-and-wait3.PurposeoncologicaloutcomesbeThedefinitionofacCRv(1)substantialdownsizingwithnoresidualtumororresidualfibrosisonlyv(2)nosuspiciouslymphnodesonMRIv(3)noresidualtumoratendoscopyoronlyasmallresidualerythematousulcerorscarv(4)negativebiopsiesfromthescar,ulcer,orformertumorlocationv(5)nopalpabletumor,wheninitiallypalpablewithdigitalrectalexamination4.ThedefinitionofacCR(1)sMethodsvone-to-onepairedcohortsofwatchandwaitversussurgicalresectionusingpropensity-scorematching(Tstage,age,andperformancestatus)vprimaryendpointwasDFSvsecondaryendpointswasOSandcolostomy-freesurvival5.Methodsone-to-onepairedcohorMethodsvCCRstandard:after CRT 8 weeks or morevabsence of residual ulceration,stenosis,or mass within the rectum during digital rectal examination and endoscopic examination6.MethodsCCRstandard:afterCRTMethodsv259patientsfromatertiarycancercentreinManchester,UKbetweenJan14,2011andApril15,2013vCCR-wait-and-seepolicygroup(31)vNCCR-surgicalresection(228)7.Methods259patientsfromaterMethodsvthreeneighbouringUKregionalcancercentres(LancashireandSouthCumbria,MerseysideandCheshire,andnorthWales)March10,2005,andJan21,2015-wait-and-seepolicygroup(98)8.MethodsthreeneighbouringUKMethodsvpreoperativechemoradiotherapy:45Gyin25dailyfractionswithconcurrentfluoropyrimidine-basedchemotherapyfor34days9.MethodspreoperativechemoradiMethodsvDatainclude:vTandNstages(MRI)vSex,age,BMIvSmokingstatus,performancestatusvBaselineCEAvHistologicalgradevHeightfromanalverge10.MethodsDatainclude:10.MethodsvStatisticalanalysisvcontinuousvariables-Kruskal-WallisandWilcoxonsigned-ranktestsvcategoricalvariables-andMcNamaratestsvPvalue11.MethodsStatisticalanalysis11.12.12.13.13.14.14.ResultsvMedianfollow-upof33months(IQR1943)v44/129patientshadlocalregrowths(42patientshadmucosallesions,2patienthadsubmucosalormesorectallesions)15.ResultsMedianfollow-upof33Results16.Results16.Resultsv31underwentsubsequentsalvagesurgeryTandNstages5ypT1,10ypT2,16ypT324ypN0,6ypN1,1ypN217.Results31underwentsubsequenResults18.Results18.Results19.Results19.Results20.Results20.Discussionvanewoncologicalendpoint-non-regrowthdisease-freesurvivalvthefirsttime-colostomy-freesurvival(1/4CCRavoidcolostomy)21.DiscussionanewoncologicalenDiscussionvTwoadditionalfindingvabout2/3nodepositiveassessedbyMRI,butdidnotaffectsubsequentendpointsv9%(CCR)didnotreceivepreoperativechemotherapyanditsabsencedidnotaffectstudyendpoints22.DiscussionTwoadditionalfindiDiscussionvlimitations1.follow-upwasrelativelyshort2.notrepresentativeofreal-worldoff-trialclinicalpractice3.isariskinpatientswithCCRmanagedbywatchandwait23.Discussionlimitations23.DiscussionvStrengths1.largestreportedcohortoutside2.fromseveraltreatmentcentres3.astandardiseddefinitionCCR24.DiscussionStrengths24.FuturePerspectivesvNeedaprospectiverandomizedcontrolledtrialvuniformstandardsforthedefinitionofacCRvTheproposedselectioncriteriaandfollow-upcanbeusedinfuturetrialsaimedatprovidingmoreevidenceonthewait-and-seepolicy25.FuturePerspectivesNeedapro
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