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Slideseton:ThatcherN,HirschFR,LuftAV,etal.Necitumumabplusgemcitabineandcisplatinversusgemcitabineandcisplatinaloneasfirst-linetherapyinpatientswithstageIVsquamousnon-small-celllungcancer(SQUIRE):anopen-label,randomized,controlledphase3trial.LancetOncol.2015;16:763-774.SQUIRE:ImprovedSurvivalWithNecitumumab+Gemcitabine/CisplatinvsGemcitabine/CisplatinasFirst-lineTreatmentinPatientsWithSquamousNSCLCThisactivityissupportedbyeducationalgrantsfromGenentech,Lilly,andNovartisPharmaceuticalsCorporation.AboutTheseSlidesUsersareencouragedtousetheseslidesintheirownnoncommercialpresentations,butweaskthatcontentandattributionnotbechanged.UsersareaskedtohonorthisintentTheseslidesmaynotbepublishedorpostedonlinewithoutpermissionfromClinicalCareOptions(emailpermissions@clinicaloptions.com)DisclaimerThematerialspublishedontheClinicalCareOptionsWebsitereflecttheviewsoftheauthorsoftheCCOmaterial,notthoseofClinicalCareOptions,LLC,theCMEproviders,orthecompaniesprovidingeducationalgrants.ThematerialsmaydiscussusesanddosagesfortherapeuticproductsthathavenotbeenapprovedbytheUnitedStatesFoodandDrugAdministration.Aqualifiedhealthcareprofessionalshouldbeconsultedbeforeusinganytherapeuticproductdiscussed.Readersshouldverifyallinformationanddatabeforetreatingpatientsorusinganytherapiesdescribedinthesematerials.Background:NecitumumabinAdvancedSquamousNSCLCPlatinum-baseddoubletchemotherapylongtimestandardfirst-linetreatmentoptionforthe~30%ofptswithsquamousNSCLC[1]Necitumumab:fullyhumanIgG1anti–EGFRmAb–Additiontogemcitabine/cisplatinincreasedantitumoractivityinmousexenograftmodelsofNSCLC[2]–FailedtoimproveOSwhenaddedtopemetrexed/cisplatininptswithadvancednonsquamousNSCLCinphaseIIIINSPIREtrial[3]PhaseIIISQUIREtrialevaluatedsafety,efficacyofnecitumumab+gemcitabine/cisplatinvsgemcitabine/cisplatininchemotherapy-naiveptswithstageIVsquamousNSCLC[1]1.ThatcherN,etal.LancetOncol.2015;16:763-774.2.SamakogluS,etal.CancerGenomicProteomics.2012;9:77-92.3.Paz-AresL,etal.LancetOncol.2015;16:328-337.Slidecredit:clinicaloptions.comSQUIRE:PhaseIIIStudySchemaPrimaryendpoint:OS(ITT)Secondaryendpoints:PFS,ORR,TTF,safetyThatcherN,etal.LancetOncol.2015;16:763-774.StratifiedbyECOGPS(0-1vs2)andgeographicregion(NorthAmerica/Europe/AustraliavsSouthAmerica/SouthAfrica/IndiavseasternAsia)Chemotherapy-naiveptswithstageIVsquamousNSCLC,ECOGPS0-2,adequateorganfunction(N=1093)Slidecredit:clinicaloptions.comNecitumumab800mgIVonDays1,8+Gemcitabine1250mg/m2IVonDays1,8+Cisplatin75mg/m2IVonDay1Q3W(n=545)Gemcitabine1250mg/m2IVonDays1,8+Cisplatin75mg/m2IVonDay1Q3W(n=548)Maximum6cyclesPtswithoutPDreceivingnecitumumabcouldcontinueonsingle-agentnecitumumabuntilPDorunacceptabletoxicityPDOSsignificantlyimprovedwithnecitumumab+gemcitabine/cisplatinvsgemcitabine/cisplatinaloneSQUIRE:OSThatcherN,etal.LancetOncol.2015;16:763-774.Slidecredit:clinicaloptions.com0204060801000246810121416182022242628303234363840MosOS(%)N+G/CCensoredptsG/CCensoredptsN+G/C(n=545)G/C(n=548)HR:0.84(95%CI:0.74-0.96;P=.01)MedianOS,Mos(95%CI)11.5(10.4-12.6)9.9(8.9-11.1)1-YrOS,%(95%CI)48(43-52)43(39-47)2-YrOS,%(95%CI)20(16-24)17(13-20)Necitumumab+Gemcitabine/Cisplatin,n/EventsGemcitabine/Cisplatin,n/EventsHR(95%CI)Agegroup,yrs<65≥65to<70≥70332/258105/79108/81340/277111/9497/710.88(0.74-1.04)0.63(0.46-0.85)1.03(0.75-1.42)SexWomenMen95/77450/34190/72458/3700.8...