SCI
21July
SafetybutLimitedEfficacyofEnsartinibinROS1-PositiveNon-smallCellLungCancer:ASingle-arm,MulticenterPhaseIIstudy
AiX,WangQ,ChengY,LiuX,CaoL,ChenJ,DongX,ZhouJ,FanY,HuangC,CuiJ,WangY,ChenG,DingC,GaoB,LiX,WangZ,ZhangH,DingL,WangY,YuanX,ChengH,WangT,LuS,SafetybutLimitedEfficacyofEnsartinibinROS1-PositiveNon-smallCellLungCancer:ASingle-arm,MulticenterPhaseIIstudy,JournalofThoracicOncology(),doi:10./j.jtho..06..
Introduction引言SomeAnaplasticlymphomakinase(ALK)inhibitorswithgoodinhibitionofROS1inpreclinicalstudieshasbeenreportedpossiblybeneficialinROS1-positivenon-smallcelllungcancer(NSCLC).Inthiswork,westudiedtheefficacyandsafetyofensartinibinthetreatmentofpatientswithROS1-positiveNSCLC.
一些在临床前研究中对ROS1有良好抑制作用的间变性淋巴瘤激酶(ALK)抑制剂已被报道可能对ROS1阳性的非小细胞肺癌(NSCLC)有益。在本研究中，我们研究了恩沙替尼治疗ROS1阳性NSCLC患者的有效性和安全性。
Methods方法TheexploratorystudywasaphaseIIsingle-arm,multicenterdesign(NCT).ROS1-positiveNSCLCpatientswithapriorchemotherapylinenumberof≤1whoreceivedensartinibatthedoseofmgoncedailywereenrolled.Theprimaryendpointwasobjectiveresponserate(ORR)evaluatedbyinvestigatorperResponseEvaluationCriteriainSolidTumorsversion1.1.
探索性研究为II期单臂多中心设计(NCT)。纳入既往化疗线数≤1、接受恩沙替尼mg每日一次剂量的ROS1阳性NSCLC患者。主要终点是研究者根据实体肿瘤疗效评价标准1.1版评估的客观缓解率(ORR)。
Results结果FromJunetoJuly,59patientswereenrolledat23centersinChina.Atthetimeofdatacutoff,themedianfollow-upwas19.8months(range0.8-22.5).ThemedianORRwas27.0%(95%CI13.8,44.1)with10partialresponses.Mediandurationofresponse(DoR)was4.8months(95%CI1.8-10.8).Themedianprogression-freesurvival(PFS)was4.6months(95%CI4.0-6.4).Themedianoverallsurvival(OS)wasnotestimable(95%CI14.9-notestimable).Of4patientswithbrainmetastases,intracranialdiseasecontrolwasreportedin3(75.0%;95%CI19.4-99.4).Themost