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1、JNeurooncolDOI10.1007/s11060-013-1303-3CLINICALSTUDYAphaseIstudyofnel?navirconcurrentwithtemozolomideandradiotherapyinpatientswithglioblastomamultiformeMichelleAlonso-Basanta?PennyFang?AmitMaity?StephenM.Hahn?RobertA.Lustig?JayF.DorseyReceived:10May2013/Accepted:21October2013óSpring
2、erScience+BusinessMediaNewYork2013AbstractWeconductedaphaseItrialtoexaminethe1,250mgbiddoselevel,patientsshouldbemonitoredformaximallytolerateddose(MTD)oftheoralproteasehepatotoxicityandGIsideeffects.inhibitornel?navir(NFV)incombinationwithtemozolo-mideandconcurrentradiotherapyinpat
3、ientswithglio-KeywordsNel?navirGlioblastomaMalignantblastomaandtogatherpreliminarydataforresponse.ThegliomaRadiationtherapyRadiosensitizerstudywasconductedinpatientswithnewlydiagnosedglioblastomaaftersurgicalresection.Patientsweretreatedwithstandardradiotherapy(6,000cGytothegros
4、stumorIntroduction2volume),temozolomide(75mg/mdaily)togetherwithdailyoralNFVstarting7–10dayspriortochemoradio-Glioblastomamultiforme(GBM)isthemostfrequentpri-therapycontinuingforthedurationofchemoradiationformarymalignantbraintumorinadults.Thestandardofcare26weeks.Temozolomide(150–2
5、00mg/m)wasresumedofnewlydiagnosedglioblastomafollowingsurgical4weeksaftercompletionofchemoradiotherapy.Twodoseresectiontotheextentsafelyfeasibleisconcurrenttem-levelsofNFVwereinvestigated:625mgtwicedaily(bid)ozolomidewithradiotherapyfollowedbymonthlytem-and1,250mgbidinacohortescalat
6、iondesign.Atotalofozolomidefor5dayseachmonthforatleast6cycles[1].21patientswereenrolled.Atthemaximumtolerateddose,Thiscourseoftherapyresultsinamediansurvivalof18subjectswereenrolledtofurtherevaluatetoxicityand14.6monthsandaprogression-freesurvivalofaboutforpreliminaryestimateofef?ca
7、cyforfurtherphaseII6.9monthsascomparedwithmediansurvivalofstudy.Nodose-limitingtoxicitywasnotedat625mgbid.12.1monthswithradiotherapyalone[1].However,thisAt1,250mgbid,3dose-limitingepisodesofhepatotox-standardtherapystillonlyresultsinamodestsurvivalicitywerenotedandonedose-limitingep
8、isodeofdiarrhea.ben
