Phase II Trial of Goserelin and Exemestane Combination Therapy in Premenopausal Women With Locally Advanced or Metastatic Breast Cancer

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1、Medicine®OBSERVATIONALSTUDYPhaseIITrialofGoserelinandExemestaneCombinationTherapyinPremenopausalWomenWithLocallyAdvancedorMetastaticBreastCancerJiayuWang,MD,BingheXu,MD,PengYuan,MD,FeiMa,MD,QingLi,MD,PinZhang,MD,RuigangCai,MD,YingFan,MD,YangLuo,MD,andQiaoLi,MDA

2、bstract:Apromisingoptionasthetreatmentofchoiceforpre-cancer,ORR=objectiveresponserate,OS=overallsurvival,PD=menopausalpatientswithlocallyadvancedormetastaticbreastcancerprogressivedisease,PFS=progression-freesurvival,PgR=(MBC)couldbethecombinationofaluteinizing

3、hormone-releasingprogesteronereceptor,PR=partialresponse,RECIST=hormoneanalogandanaromataseinhibitor.However,noprospectiveResponseEvaluationCriteriainSolidTumors,SD=stabledisease.studiesontheefficacyofgoserelinwithexemestaneinlocallyadvancedorMBCpremenopausalbre

4、astcancerpatientshavebeenreported.WepresentthephaseIItrialofgoserelinplusexemestaneinatotalINTRODUCTIONof44premenopausalwomenwithlocallyadvancedorMBC.Allreastcancerisoneofthemostcommonmalignancies,patientsreceivedasubcutaneousinjectionof3.6mggoserelineveryBacco

5、untingforapproximately21%ofthecancerincidences1,24weeksalongwith25mgexemestanedaily.Theprimaryendpointwasworldwidefrom1995to2009.Previousstudieshaveshownprogression-freesurvival(PFS).ThesecondendpointincludedoverallthattherateofbreastcanceramongChinesewomenislo

6、wer3–6survival(OS),objectiveresponserate(ORR),durationofresponsethanthoseinmanyWesterncountries.However,recent(DOR),andclinicalbenefitrate(CBR)basedoncompleteresponsestudieshaveshownthattherateofbreastcancerisrapidly1,7,8(CR),partialresponse(PR),orstabledisease(

7、SD)for6months.increasinginChina,especiallyamongwomenages20to45ThemedianPFSwas13months(range:2–42months).Themedianyears,andbreastcancerisnowthemostcommonmalignancy7,9DORwas8months(range:2–40months).TwopatientsachievedCRamongChinesewomen.(4.5%),and15patientsexpe

8、riencedPR(34.1%).FifteenpatientsNumerouscase-controlandcohortstudieshavereportedthat(34.1%)hadSD6months.TheORRwas38.6%,andtheCBR39%to87%ofwomenwithbreastcancerhavetumorsexp