摘要
Objective:SHR-1210isanewandpromisinganti-PD-1agentforsolidtumors.DuringthephaseIstudyofSHR-1210,weencounteredanovelbutprevalentimmune-relateddermatologictoxicity:reactivecapillaryhemangiomas(RCHs).ThuswetriedtosummarizethefeaturesofRCHsandestimatetheirrelationshipwithtumorresponse.Methods:Thisprospectiveobservationalstudysystematicallyenrolled98patientswithadvancedsolidtumorsfromApril27th,2016toJune8th,2017inthecontextofthephaseIclinicalstudyofSHR-1210.Thisreportfocusedontheskintoxicities.Patientsunderwententireskininspectioneverytwoweekswhiletakingmedication.TheclinicalcourseofRCHswasrecordedandtheirassociationwithtumorresponsewasestimated.Thedatacut-offdatewasNovember15th,2017.Results:Afteramedianfollow-upof242(range,29–567)days,RCHswereobservedin85.7%(84/98)ofpatientsoncutaneous/mucosalsurfaces;84.5%(71/84)oftheRCHswereevaluatedasgrade1adverseevents.Nograde3or4RCHswereobserved.ThetimeofonsetofRCHswasdosedependentandshortestinthe400mg-dosecohort(P<0.001).SpontaneousandcompleteregressionofRCHswasobservedbothduringandaftertreatment.TheobjectiveresponserateoftumorsforpatientswithRCHswas28.9%(24/83).However,noresponderswereobservedamongthepatientswithoutRCHs.Conclusions:RCHswereprevalentbutmanageableduringtreatmentwithSHR-1210.Itmightaddtotheexpandingliteratureregardingimmune-relateddermatologicadverseevents.
出版日期
2019年01月11日(中国期刊网平台首次上网日期,不代表论文的发表时间)