伊立替康DEBTACE与FOLFIRI治
Intra-arterialInfusionofIrinotecan-loadedDrug-elutingBeads(DEBIRI)versusIntravenousTherapy(FOLFIRI)forHepaticMetastasesfromColorectalCancer:FinalResultsofaPhaseIIIStudy
Abstract.
Background:Metastasestotheliverreceivemostoftheirbloodsupplyfromthearterialroute,thereforeforpatientswithhepaticmetastasesfromlargebowelcancer,hepaticarterialinfusionadoptingdrug-elutingbeadspreloadedwithirinotecan(DEBIRI)mayofferachanceofcure.
PatientsandMethods:Inamulti-institutionalstudy,74patientswererandomlyassignedtoreceiveDEBIRI(36)versussystemicirinotecan,fluorouracilandleucovorin(FOLFIRI,38).Theprimaryend-pointwassurvival;secondaryendpointswereresponse,recurrence,toxicity,qualityoflife,costandinfluenceofmolecularmarkers.
Results:At50months,overallsurvivalwassignificantlylongerforpatientstreatedwithDEBIRIthanforthosetreatedwithFOLFIRI(p=0.,log-rank).Mediansurvivalwas22(95%ConfidenceIntervalCI=21-23)months,forDEBIRIand15(95%CI=12-18)monthsforFOLFIRI.Progression-freesurvivalwas7(95%CI=3-11)monthsintheDEBIRIgroup