【文档说明】同步放化疗及辅助化疗治疗局部晚期宫颈癌II期临床研究课件.ppt，共(19)页，130.501 KB，由小橙橙上传

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同步放化疗及辅助化疗治疗局部晚期宫颈癌：II期临床研究报告复旦大学附属肿瘤医院妇科张美琴IB2-IVA期宫颈癌的标准治疗5PhaseIIIRCTs+2largemetaanalysesCisplatin-b

asedconcurrentchemoradiotherapy(CCRT)最近meta分析结果:◼Asignificantbenefitwithnon-platinumregimenswasalsoobserved.◼CCRT:5yOS6%CCRT+adj

uvantchemo:5yOS19%?◼IA-IIAIIBIII-IVA5yOS10%7%3%JClinOncol,2008;26:5802-5811目前存在的问题◼铂类为基础的CCRT与非铂类为基础的CCRT◼CCR

T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胃肠道反应大研究设计◼药物选择◼RTOG9001◼GOG:II、III期宫颈癌隐匿性主动脉旁淋巴结转移率为16％，25％◼Choi等：CCRT后辅助化疗可以增强放疗的延迟效应入组标准◼IIB-IIIB期宫

颈鳞癌◼18-65岁◼ECOG0-2◼CT/MRI：主动脉旁淋巴结（－）◼血生化指标、EKG、胸片正常治疗计划HDRintracavitarybrachytherapyExternalbeamradiationtherapyDay18152229364350A

fterCCRTDay30517293TN1TN1TN1TN1TN1TN1TN2TN2TN2TN2TN1:TXL35mg/m2+NDP20mg/m2TN2:TXL135mg/m2+NDP60mg/m2研究终点和治疗评估◼Prim

aryendpoints:responserate,acutetoxicity(NCI-CTCV2.0)◼Secondaryendpoints:failures,OS,PFS,latetoxicity(RTOGcriteria)◼Responserate:RECISTcriteria◼L

ocoregionalfailure:inthepelvisorbothwithinandoutsidepelvis◼Distantfailure:onlyoutsidepelvis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例患者特征(n=34)characte

risticsNo.ofpts(%)Medianage(range)47(35-64)ECOG0-125(73)29(27)StageIIB10(29)IIIA3(9)IIIB21(62)PelvicLNMpos

itive5(15)negative29(85)MedianbaselineHemoglobin(range)114g/L(90-146)患者接受化疗情况◼Concurrentchemo:allptsreceived6cycles◼Adjuvantchemo:28p

ts----4cycles3pts------3cycles2pts------2cycles1pt-------refuse◼Reasons:2pts-----G3vomiting1pt--------severeabdominal

pain3pts------nonmedicalreasons急性毒性反应toxicityConcurrentchemo(199cycles)Consolidationchemo(119cycles)G0-2G3-4G0

-2G3-4hematologicLeukopenia193(96.9)6(3.1)106(89.1)13(10.9)Neutropenia199(100)0(0)106(90.1)13(9.9)Thrombocytopenia199(100)0(0)119

(100)0(0)Anemia199(100)0(0)119(100)0(0)NonhematologicNausea/vomiting195(98)4(2)118(99.2)1(0.8)GI199(100)0(0)

119(100)0(0)GU199(100)0(0)119(100)0(0)Liverdamage199(100)0(0)119(100)0(0)neuropathy199(100)0(0)119(100)0(0)skin199(100)0(0

)119(100)0(0)晚期毒性反应SiteofsideeffectNo.ofpts(%)G0G1G2G3G4GI23(67.6)5(14.7)4(11.8)2(5.9)0(0.0)GU30(88.2)3(8.8)0(0)1(3

.0)0(0)治疗结果◼1-monthafterCCRT:27pts(79%)CR;7pts(21%)PR◼1-monthafteradjuvantchemo:30pts(88%)CR◼Medianfollow-upof23months(14-30)◼28pts:alivewith

outdisease◼5pts:locoregionalfailure◼1pt:distantmetastasesN=34(Progression6)2-yrPFS82%(95%CI,68-95%)2年无瘤生存率82

％N=34(Death2)2-yrOS93%(95%CI,83-100%)2年总生存率93％StudiesonCCRTplusadjuvantchemotherapyinLACCReferenceNoStageradiotherapyConcurrentchemoConsolidationchem

oCRMedianFollowupSurvivalrate3yPFSOSWongetal1999110I-IIIPelvicEBRT+LDRICBTEpi60mg/m2q4w90mg/m2q4w×59296m(16-130)8385Vrdoljaketal200544IB2~IVAP

elvicEBRT+LDRICBTDDP75mg/m2d11IFO2g/m2d11q3w×2DDP75mg/m2d1IFO2g/m2d1-3q3w×410034m(20-54)8491Choietal200732IB2~IVAPelvicEBRT+HD

RICBTDDP60mg/m2d15-Fu1g/m2d1-5q3w×3DDP60mg/m2d15-Fu1g/m2d1-5q3w×38727m(6-58)8391结论◼本研究治疗方法有效，可以耐受.◼Paclitaxel+n

edaplatin可以替代cisplatin.◼CCRT后辅助化疗可以降低局部复发率，提高生存率.◼有必要与标准治疗方案进行对比研究，得出肯定结论。谢谢!