晚期肠癌靶向治疗进展-徐瑞华教授

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1、晚期肠癌靶向治疗进展徐瑞华MD&PhD中山大学肿瘤医院内科xurh@mail.sysu.edu.cn主要内容以分子指标为指导的靶向治疗时代的来临多个靶向药物联合的重新定位靶向药物治疗的广泛研究ERBITUXinfirst-linetreatmentofmCRCPhaseIIICRYSTALstudy:StudydesignStratificationfactors:RegionECOGperformancestatusPopulations:Randomizedpatients(n=1217)Safetypopulation(n

2、=1202)ITTpopulation(n=1198)FOLFIRIIrinotecan(180mg/m2)+5-FU(400mg/m2bolus+2400mg/m2as46-hcontinuousinfusion)+LV(every2weeks)ERBITUX+FOLFIRIERBITUX(IV400mg/m2onday1,then250mg/m2weekly)+irinotecan(180mg/m2)+5-FU(400mg/m2bolus+2400mg/m2as46-hcontinuousinfusion)+LV(every

3、2weeks)REGFR-expressingmCRCVanCutsemE,etal.ASCO2007(AbstractNo.4000)1.00.80.90.00.10.20.30.40.50.60.702468101214161820Primaryendpoint:PFS(ITTpopulation)PFSestimateVanCutsemE,etal.ASCO2007(AbstractNo.4000)PFStime(months)1-yearPFSrate:23%vs34%FOLFIRI(n=599)ERBITUX+FOL

4、FIRI(n=599)PFSITT:HR=0.85;p=0.048mPFSERBITUX+FOLFIRI:8.9monthsmPFSFOLFIRI:8.0monthsIndependentassessmentofresponseOutcomeFOLFIRI(n=599)(%)ERBITUX+FOLFIRI(n=599)(%)CRPRSDPD0.338.446.79.00.546.437.48.8ORR[95%CI]38.7[34.8–42.8]46.9[42.9–51.0]DCR85.484.3VanCutsemE,

5、etal.ECCO2007(AbstractNo.3001)39%47%Responserate(%)p=0.0038aaCochran–Mantel–HaenszeltestKRASanalysis:ObjectiveandmethodologyToretrospectivelyinvestigatetheimpactoftheKRASmutationstatusoftumorsonPFSandRRinthefirst-linetreatmentofmCRCwithFOLFIRI±ERBITUXEfficacyanalyses

6、repeatedonKRASevaluablepopulationGenomicDNAisolatedfromarchivedtumormaterialParaffin-embedded,formalin-fixedtissueKRASmutationstatusofcodons12/13determinedusingquantitativePCR-basedassayVanCutsemE,etal.JClinOncol2008;26(Suppl.abstract2)KRASevaluablepopulation587subje

7、ctsanalysedforKRASmutationstatus540(45%)subjects:KRASevaluablepopulation348(64.4%)KRASwild-type192(35.6%)KRASmutant171subjectswithevents(49.1%)GroupA:105(54.7%)GroupB:87(45.3%)101subjectswithevents(52.6%)1198subjects(ITT)GroupA:172(49.4%)GroupB:176(50.6%)FOLFIRIERBIT

8、UX+FOLFIRIVanCutsemE,etal.JClinOncol2008;26(Suppl.abstract2)RelatingKRASstatustoefficacyPrimaryendpoint:PFS–KRASwild-type0.00.10.2