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时间:2019-08-08
《Neoadjuvant Therapy as a Platform for Drug Developmentand Approval in Breast Cancer新辅助治疗作为药物开发的平台 乳腺癌的批准》由会员上传分享,免费在线阅读,更多相关内容在学术论文-天天文库。
1、CCRFOCUSNeoadjuvantTherapyasaPlatformforDrugDevelopmentandApprovalinBreastCancer12AdityaBardiaandJoseBaselgaAbstractThetraditionaldrugdevelopmentprocessinbreastcancerbasedonlargephaseIIIstudieshasseriouslimitationsandneedsamajoroverhaul.Searchingfornewapproaches,thetestingofnovelagen
2、tsinthepreoperative(neoadjuvant)settingapproachoffersapotentiallyrapidandefficientstrategyfordrugdev-elopmentutilizingpathologiccompleteresponse(pathCR),asurrogatemarkerforsurvival,astheprimaryendpoint.Inaddition,neoadjuvantstudiesallowtheassessmentofdrugeffectsonthetarget(pharmaco-dyn
3、amicresponse)andthedevelopmentofpredictivebiomarkersofresponse.Molecularprofilingoftheresidualtumorinthesurgicalspecimenmayalsoprovideinsightsintoactionablemechanismsofresistance.Recognizingthepotentialofneoadjuvanttrialsfordrugdevelopment,theU.S.FoodandDrugAdminis-tration(FDA)recently
4、announcedconsiderationofneoadjuvanttrialsforaccelerateddrugapprovalinearlybreastcancer,particularlyfortumorswithhighriskofrecurrenceandunfavorableprognosis,andprovidedacceleratedapprovaltoneoadjuvantpertuzumabinSeptember2013.TheFDAhasemphasizedthatwhileimprovementinpathCRcouldbeutiliz
5、edfor"accelerated"approval,improvementinsurvivalwillstillneedtobedemonstratedfor"regular"approval.Keyconsiderationsinconductofsuchneoadjuvantdrugdevelopmenttrialsinclude(i)studydesignsuchasutilizationofbiomarkerstratifieddesigntoevaluateabiomarkerthatcouldenrichresponse,(ii)definitionof
6、pathCR,(iii)distributionoffactorsthatinfluencepathCRbetweenthetreatmentarms,(iv)prespecifiedplanforfollow-uptoobtaindataonsurvival,and(v)safetyasitinvolvesapatientpopulationwithcurabledisease.Intheyearstocome,weanticipateanincreaseinthenumberofneoadjuvanttrialstestingnoveltherapiesthath
7、opefullywillopenanewpathinbringingefficaciousnewtherapiestopatientswithbreastcancer.ClinCancerRes;19(23);636070.Ó2013AACR.IntroductionInthisreview,weprovideanoverviewoftheongoinginitiativesintheneoadjuvantspaceandanalyzethekeyNeoadjuvanttherapy,alsoknownaspreoperativether-consideration
8、sandc
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