胃癌辅助化疗临床试验解读.ppt

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1、AdjuvantChemotherapyforGastricCancerwithS-1,anOralFluoropyrimidine--ACTS-GCIntroductionMeta-analyseshaveshownthatadjuvantchemotherapyiseffectiveintreatinggastriccancer.However,theeffectivenessofspecificregimenshasnotbeenverifiedinlargeclinicaltrials.BackgroundAdvancedgastriccancercanres

2、pondtoS-1,anoralfluoropyrimidine.WetestedS-1asadjuvantchemotherapyinpatientswithcurativelyresectedgastriccancer.METHODSPatientsinJapanwithstageIIorIIIgastriccancerwhounderwentgastrectomywithextended(D2)lymph-nodedissectionwererandomlyassignedtoundergosurgeryfollowedbyadjuvanttherapywithS

3、-1ortoundergosurgeryonly.METHODSIntheS-1group,administrationofS-1wasstartedwithin6weeksaftersurgeryandcontinuedfor1year.Thetreatmentregimenconsistedof6-weekcyclesinwhich,inprinciple,80mgoforalS-1persquaremeterofbody-surfaceareaperdaywasgivenfor4weeksandnochemotherapywasgivenforthefollowi

4、ng2weeks.Theprimaryendpointwasoverallsurvival.EligibilityCriteriaThecriteriaforeligibilitywerehistologicallyprovengastriccancerofstageII,IIIA,orIIIB;D2ormoreextensivelymph-nodedissectionwithR0surgery;nohepatic,peritoneal,ordistantmetastasis;notumorcellsinperitonealfluidoncytologicanalysi

5、s;anageof20to80years;noprevioustreatmentforcancerexceptfortheinitialgastricresectionfortheprimarylesion;andadequateorganfunction.StudyDesignandTreatmentTheprimaryendpointwasoverallsurvival;secondaryendpointswererelapse-freesurvivalandthedegreeofsafetyofS-1.Patientswereenrolled,within6wee

6、ksaftersurgeryandrandomlyassignedtoeithertheS-1grouporthesurgery-onlygroup.StudyDesignandTreatmentPatientsassignedtotheS-1groupreceivedtwooraldosesof40mgofS-1persquaremeterofbody-surfaceareaperday,for4weeks,followedby2weeksofnochemotherapy.This6-weekcyclewasrepeatedduringthefirstyearafte

7、rsurgery.Thesurgery-onlygroupreceivednoanticancertreatmentaftersurgery,unlesstherewasaconfirmedrelapse.Patientsinbothgroupsweretobefollowedupfor5yearspostoperatively.RESULTSWerandomlyassigned529patientstotheS-1groupand530patientstothesurgeryonlygroupbetweenOctober2001andD