同步放化疗及辅助化疗治疗局部晚期宫颈癌II期临床研究精品课件.ppt

同步放化疗及辅助化疗治疗局部晚期宫颈癌：II期临床研究报告,1,.,IB2-IVA期宫颈癌的标准治疗,5PhaseIIIRCTs+2largemetaanalysesCisplatin-basedconcurrentchemoradiotherapy(CCRT),2,最近meta分析结果:,Asignificantbenefitwithnon-platinumregimenswasalsoobserved.CCRT:5yOS6%CCRT+adjuvantchemo:5yOS19%?IA-IIAIIBIII-IVA5yOS10%7%3%JClinOncol,2008;26:5802-5811,3,目前存在的问题,铂类为基础的CCRT与非铂类为基础的CCRTCCRT后辅助化疗的作用晚期宫颈癌应用CCRT生存获益小铂类为基础的CCRT胃肠道反应大,4,研究设计,药物选择RTOG9001GOG:II、III期宫颈癌隐匿性主动脉旁淋巴结转移率为16，25Choi等：CCRT后辅助化疗可以增强放疗的延迟效应,5,入组标准,IIB-IIIB期宫颈鳞癌18-65岁ECOG0-2CT/MRI：主动脉旁淋巴结（）血生化指标、EKG、胸片正常,6,治疗计划,HDRintracavitarybrachytherapy,Externalbeamradiationtherapy,Day18152229364350,AfterCCRTDay30517293,TN1TN1TN1TN1TN1TN1,TN2TN2TN2TN2,TN1:TXL35mg/m2+NDP20mg/m2TN2:TXL135mg/m2+NDP60mg/m2,7,研究终点和治疗评估,Primaryendpoints:responserate,acutetoxicity(NCI-CTCV2.0)Secondaryendpoints:failures,OS,PFS,latetoxicity(RTOGcriteria)Responserate:RECISTcriteriaLocoregionalfailure:inthepelvisorbothwithinandoutsidepelvisDistantfailure:onlyoutsidepelvis,8,入组病例数,II期临床研究Simon二阶段法：第一阶段：13例第二阶段：30例,9,患者特征(n=34),10,患者接受化疗情况,Concurrentchemo:allptsreceived6cyclesAdjuvantchemo:28pts-4cycles3pts-3cycles2pts-2cycles1pt-refuseReasons:2pts-G3vomiting1pt-severeabdominalpain3pts-nonmedicalreasons,11,急性毒性反应,12,晚期毒性反应,13,治疗结果,1-monthafterCCRT:27pts(79%)CR;7pts(21%)PR1-monthafteradjuvantchemo:30pts(88%)CRMedianfollow-upof23months(14-30)28pts:alivewithoutdisease5pts:locoregionalfailure1pt:distantmetastases,14,N=34(Progression6)2-yrPFS82%(95%CI,68-95%),2年无瘤生存率82,15,N=34(Death2)2-yrOS93%(95%CI,83-100%),2年总生存率93,16,StudiesonCCRTplusadjuvantchemotherapyinLACC,17,结论,本研究治疗方法有效，可以耐受.Paclitaxel+n