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1、Watch-and-waitapproachversussurgicalresectionafterchemoradiotherapyforpatientswithrectalcancer(theOnCoReproject):apropensity-scorematchedcohortanalysisLancetOncolPublishedOnlineDecember16,2015v2004.10,AnnalsofSurgery,Habr-Gama.egv265patientswithdistalrectalweretreatedbyCRTwith5-FU,Leucovorinand5040c
2、GyvFive-yearOSandDFSrateswere88%and83%inResectionGroup,100%and92%inObservationGroupPurposevoncologicaloutcomesbetweenwatchandwaitandsurgicalresectionvthesafetyofthewatch-and-waitThedefinitionofacCRv(1)substantialdownsizingwithnoresidualtumororresidualfibrosisonlyv(2)nosuspiciouslymphnodesonMRIv(3)no
3、residualtumoratendoscopyoronlyasmallresidualerythematousulcerorscarv(4)negativebiopsiesfromthescar,ulcer,orformertumorlocationv(5)nopalpabletumor,wheninitiallypalpablewithdigitalrectalexaminationMethodsvone-to-onepairedcohortsofwatchandwaitversussurgicalresectionusingpropensity-scorematching(Tstage,
4、age,andperformancestatus)vprimaryendpointwasDFSvsecondaryendpointswasOSandcolostomy-freesurvivalMethodsvCCRstandard: after CRT 8 weeks or morevabsence of residual ulceration, stenosis, or mass within the rectum during digital rectal examination and endoscopic examinationMethodsv259patientsfromaterti
5、arycancercentreinManchester,UKbetweenJan14,2011andApril15,2013vCCR-wait-and-seepolicygroup(31)vNCCR-surgicalresection(228)MethodsvthreeneighbouringUKregionalcancercentres(LancashireandSouthCumbria,MerseysideandCheshire,andnorthWales)March10,2005,andJan21,2015-wait-and-seepolicygroup(98)Methodsvpreop
6、erativechemoradiotherapy:45Gyin25dailyfractionswithconcurrentfluoropyrimidine-basedchemotherapyfor34daysMethodsvDatainclude:vTandNstages(MRI)vSex,age,BMIvSmokingstatus,performancestatusvBaselineCEAvHistologicalgradevHeightfromanalvergeMethodsvStatisticalanalysisvcontinuousvariables-Kruskal-Wallisand
7、Wilcoxonsigned-ranktestsvcategoricalvariables-andMcNamaratestsvPvalueResultsvMedianfollow-upof33months(IQR1943)v44/129patientshadlocalregrowths(42patientshadmucosallesions,2patienthadsubmucosalormesorectallesions)ResultsResultsv31underwentsubsequentsalvagesurgeryTandNstages5ypT1,10ypT2,16ypT324ypN0,
8、6ypN1,1ypN2ResultsResultsResultsDiscussionvanewoncologicalendpoint-non-regrowthdisease-freesurvivalvthefirsttime-colostomy-freesurvival(1/4CCRavoidcolostomy)DiscussionvTwoadditionalfindingvabout2/3nodepositiveassessedbyMRI,butdidnotaffectsubsequentendpointsv9%(CCR)didnotreceivepreoperativechemothera
9、pyanditsabsencedidnotaffectstudyendpointsDiscussionvlimitations1.follow-upwasrelativelyshort2.notrepresentativeofreal-worldoff-trialclinicalpractice3.isariskinpatientswithCCRmanagedbywatchandwaitDiscussionvStrengths1.largestreportedcohortoutside2.fromseveraltreatmentcentres3.astandardiseddefinitionCCRFuturePerspectivesvNeedaprospectiverandomizedcontrolledtrialvuniformstandardsforthedefinitionofacCRvTheproposedselectioncriteriaandfollow-upcanbeusedinfuturetrialsaimedatprovidingmoreevidenceonthewait-and-seepolicy