CapOX as neoadjuvant chemotherapy for locally advanced operable colon cancer patients: a prospective single-arm phase Ⅱ trial

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摘要 Objective:Theaimofthisprospective,single-armphaseIItrialwastoconfirmthesafetyandefficacyofneoadjuvantchemotherapy(NAC)usingoxaliplatinpluscapecitabine(CapOX)forpatientswithoperablelocallyadvancedcoloncancer(CC).Methods:Patientswithcomputedtomography-definedT4orlymphnode-positiveCCswereenrolled.Afterradiologicalstaging,patientsweretreatedwithatleast2cyclesofNACconsistingof130mg/m2oxaliplatinond1,plus1,000mg/m2capecitabinetwicedailyfor14devery3weeks,followedbysurgery,andthenwiththerestcyclesofadjuvantchemotherapy.Radiologicalresponsewasevaluatedafter2cyclesofNAC.Tumorresponse,treatmenttoxicity,andsurgicalcomplicationswererecorded.Thepathologicalresponsetotherapywasevaluatedaccordingtothetumorregressiongrade(TRG)score.Theprimaryendpointwaspathologictumorresponse.ThistrialisregisteredinClinicalTrials.gov(No:NCT02415829).Results:Forty-sevenpatientswereenrolledinthestudy.Forty-twopatientscompletedtheplannedtreatments.Thetotalradiologicalresponseratewas68%(32/47),includingcompleteandpartialresponseratesof2%(1/47)and66%(31/47),respectively.Stablediseasewasobservedin32%(15/47)andprogressivediseasewasobservedinnone.Completepathologicresponse,majorregression,andatleastmoderateregressionwereachievedin1(2%),2(4%),and29(62%)patients,respectively.Fourpatientsdevelopedgrade3treatmenttoxicities.Onepatientwithwoundinfectionoccurredafteroperation(1/47,2%).Therewasnotreatment-relateddeath.Conclusions:OurresultssuggestthatNACwithCapOXisaneffectiveandsafetreatmentoptionforpatientswithlocallyadvancedCCs.
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出版日期 2016年06月16日(中国期刊网平台首次上网日期,不代表论文的发表时间)
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