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简介：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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简介：PURPOSE:Todeterminethesafetyandefficacyofgefitinib,anepidermalgrowthfactorreceptor(EGFR)tyrosinekinaseinhibitor,incombinationwithradiationfornewlydiagnosedglioblastoma(GBM)patients.METHODSANDMATERIALS:BetweenMarch21,2002,andMay3,2004,RadiationTherapyOncologyGroup(RTOG)0211enrolled31and147GBMpatientsinthephase1and2arms,respectively.Treatmentconsistedofdailyoralgefinitnibstartedatthetimeofconventionalcranialradiationtherapy(RT)andcontinuedpostRTfor18monthsoruntilprogression.Tissuemicroarraysfrom68caseswereanalyzedforEGFRexpression.RESULTS:Themaximumtolerateddose(MTD)ofgefitinibwasdeterminedtobe500mginpatientsonnon-enzyme-inducinganticonvulsantdrugs(non-EIAEDs).Allpatientsinthephase2componentweretreatedatagefitinibdoseof500mg;patientsreceivingEIADSscouldbeescalatedto750mg.Themostcommonsideeffectsofgefitinibincombinationwithradiationweredermatologicandgastrointestinal.Mediansurvivalwas11.5monthsforpatientstreatedperprotocol.Therewasnooverallsurvivalbenefitforpatientstreatedwithgefitinib+RTwhencomparedwithahistoricalcohortofpatientstreatedwithRTalone,matchedbyRTOGrecursivepartitioninganalysis(RPA)classdistribution.Youngeragewassignificantlyassociatedwithbetteroutcome.Perprotocolstratification,EGFRexpressionwasnotfoundtobeofprognosticvalueforgefitinib+RT-treatedpatients.CONCLUSIONS:TheadditionofgefitinibtoRTiswelltolerated.MediansurvivalofRTOG0211patientstreatedwithRTwithconcurrentandadjuvantgefitinibwassimilartothatinahistoricalcontrolcohorttreatedwithradiationalone.

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