Everolimus(Afinitor,Novartis)isnowapprovedintheUnitedStatesforuseinadultswithneuroendocrinetumors(NETs)ofgastrointestinal(GI)orlungoriginthatareunresectable,locallyadvanced,ormetastatic.ThedrugisalreadyapprovedforuseinpancreaticNETsandforuseinthetreatmentofbreastandkidneycancer.Everolimusisthefirsttreatmentapprovedforprogressive,nonfunctionalNETsoflungorigin,andoneofveryfewoptionsavailableforprogressive,nonfunctionalGINETs,representingashiftinthetreatmentparadigmforthesecancers,accordingtothemanufacturer.Thisindicationwasapprovedonthebasisofefficacyandsafetydatafromapivotal302-patientstudy(RADIANT-4),whichshowedbettermedianprogression-freesurvival(assessedbycentralreview)witheverolimusthanwithplacebo(11.0vs3.9months;
hazardratio,0.48;
P.00001).InRADIANT-4,themostcommontreatment-relatedgrade3/4adverseeventsthatoccurredinatleast5%ofpatientsintheeverolimusgroup,comparedwiththeplacebogroup,wereinfections(11%vs2%),diarrhea(9%vs2%),stomatitis(9%vs0%),fatigue(5%vs1%),andhyperglycemia(5%vs0%).TheseresultswerefirstpresentedattheEuropeanCancerCongress2015,asreportedbyMedscapeMedicalNews.AlthoughweknewfrompreviousstudiesthateverolimuscoulddelaythegrowthofpancreaticNETs,thisisthefirsttimewehavebeenabletoconclusivelyshowthatitiseffectiveinotherNETsites,saidleadinvestigatorJamesYao,MD,chairofgastrointestinalmedicaloncologyattheUniversityofTexasM.D.AndersonCancerCenterinHouston,atthattime.Thesearerareandaggressivecancers,withlimitedtreatmentoptions,headded.ThepatientsinRADIANT-4hadpreviouslybeentreatedwithsomatostatinanalogues,suchasoctreotide(in53%ofeverolimuspatientsand56%ofplacebopatients),chemotherapy(26%and24%),andradiotherapy(22%and20%).RADIANT-4waspublishedonlineDecember15intheLancet,aswasanaccompanyingcomment.Additionalworldwideregulatoryfilingsforthisindicationareunderway,accordingtothecompany,andadecisionisanticipatedinEuropein2016.
标签：飞尼妥
