Nab-paclitaxel （abraxane）-based chemotherapy to treat elderly patients with advanced non-small-cell lung cancer： a single center, randomized and open-label clinical trial.pdfVIP

Nab·paclitaxel(abraxane)一basedchemotherapytotreatelderly patientswithadvancednon—·small--celllungcancer：asingle center,random izedandopen-labelclinicaltrial HanruiChen，XuewuHuang，ShutangWang，XinfingZheng，JietaoLin，PengLi，LizhuLin DepartmentofOncology,TheFirstAffiliatedHospitalofGuangzhouUniversityofChineseMedicine，Guangzhou510407，China Correspondenceto：LizhuLin．DepartmentofOncology,TheFirstAffiliatedHospitalofGuangzhouUniversiytofChineseMedicine，16Jichang Road，Guangzhou510407，China．Email：lizhu12241@sohu．corn． Background：Thepurposeofthisstudyistoevaluatetheclinicalefficaw andsafetyofabraxane．based chemotherapywiht／wihtoutnedaplatininelderlypatientswihtnon—small—celllungcancer(NSCLC)． Materialsandmethods：From October2009toJanuary2013，48elderlypatients(65years)with NSCLCwereinvestigatedinthisclinicaItria1．Thepatientswererandomizedandequallyallocatedinto armsAandAP：(A)abraxane(130mg／m ，daysl，8)；(B)abraxane+nedaplatin(20mg／m days1-3，q3W)． Theparametersofobjectiveresponserate(0RR)，diseasecontrolrate(DcR)，progression—freesurvival(PFS)， overallsurvival(0S)andsideeffectswereevaluatedbetweentwoarms． Results：0ver80％ ofthepatientscompletedfourcyclesofchemotherapy．Thetota1ORRwas21．3％． DCRwas55．3％．PFS4．5mOBthSandOS12．6monhts．Nosignificantdifferencewasfoundbewt eenarmsA andAPintermsofORR(16．7％us．26．1％，P=0．665)orDCR(55．3％us．56．5％，P：0．871)．ThemedianPFS inarmAwas3．3months2【5—75％confidenceinterval(CI)：3．1—7．21and5．5monhts(25—75％CI：3．2—7．0)in armAPwiht nostatisticalsingificance(P=0．640)．ThemedianOSinarmAwas12．6monthsf25-75％CI： 5．7—26．2)andl5．1months(25-75％CI：6．4—35．3)inarmAPwithnostatisticalsignificance(P：0．770)．The sideeffectsweremainlygrade1—2．Theincidenceofgrade3-斗toxicitieswas29．1％ inarm A and62．5％ in armApwi出astatisticalsingificancefp：0．020)．