Background背景
DualblockadeoftheEGFRandVEGFpathwaysinEGFR-mutatedmetastaticnon-small-celllungcancer(NSCLC)issupportedbypreclinicalandclinicaldata,yettheapproachisnotwidelyimplemented.RELAYassessederlotinib,anEGFRtyrosinekinaseinhibitor(TKI)standardofcare,plusramucirumab,ahumanIgG1VEGFR2antagonist,orplaceboinpatientswithuntreatedEGFR-mutatedmetastaticNSCLC.
EGFR突变的转移性非小细胞肺癌(NSCLC)中表皮生长因子和血管内皮生长因子通路的双重阻断得到了临床前和临床数据的支持,但该方法尚未广泛实施。RELAY方案对未治疗的EGFR突变转移性非小细胞肺癌患者进行了厄洛替尼,一种EGFR酪氨酸激酶抑制剂(TKI)标准治疗,加雷莫芦单抗(一种人IgG1VEGFR2拮抗剂)或安慰剂的疗效评估。Method方法
Thisisaworldwide,double-blind,phase3trialdoneinhospitals,clinics,andmedicalcentresin13countries.Eligiblepatientswereaged18yearsorolder(20yearsorolderinJapanandTaiwan)atthetimeofstudyentry,hadstageIVNSCLC,withanEGFRexon19deletion(ex19del)orexon21substitution(LeuArg)mutation,anEasternCooperativeOncologyGroupperformancestatusof0or1,andnoCNSmetastases.Werandomlyassignedeligiblepatientsina1:1ratiotoreceiveoralerlotinib(mg/day)pluseitherintravenousramucirumab(10mg/kg)ormatchingplaceboonceevery2weeks.Randomisationwasdonebyaninteractivewebresponsesystemwitha