替吉奥同步放疗治疗局部晚期和复发性胰腺癌的Ⅱ期临床试验

吴莉莉楼文晖曾昭冲曾蒙苏李婷婷姬巍16,15MV,(GTV),(CTV)=GTV,(PTV)=GTV+1.0cm,95%PTV50.4Gy28-15.5-1(1.8Gy)40mg/,1,2.5~3.5h(3h),15d4CT,,(responseevaluationcriteriainsolidtumors,RECIST),(NCICTCAE3.0)16,3/16,12/16(13/16)3,,,;;;PhasetrialoflowdosageS1concurrentwithradiotherapyinpatientswithlocallyadvancedorrecurrentpancreaticcancer*WULili,LOUWenhui,ZENGZhaochong,ZENGMengsu,LITingting,JIWei.*DepartmentofRadiationOncology,ZhongshanHospital,FudanUniversity,Shanghai200032,ChinaCorrespondingauthor:LOUWenhui.Email:[e-mail];ZENGZhaochong,Email:[e-mail]luatetheefficacyandsafetyoflowdosageS1concurrentwithradiotherapyfortreatmentofpatientswithlocallyadvancedorrecurrentpancreaticcancer.MethodsEligibilitycriteriawerepathologicallyconfirmedorclinicallydiagnosedlocallyadvancedorrecurrentpancreaticcancer.S1wasadministeredorallyatadoseof40mgoncedaily3hbeforeradiotherapy(5daysperweek).Atotaldoseof50.4Gywasappliedbydailyfractionsof1.8Gy,5daysperweekusinga15MVlinearaccelerator.Thegrosstumorvolume(GTV)wasconfinedtotheprimarytumorandmetastaticlymphnodes.Clinicaltargetvolume(CTV)=GTV,noprophylacticnodalirradiated,PTV=CTV+1.0cm,and95%PTVwasencompassedwithintheisodoseline.ToxicitieswereevaluatedusingtheNCICTCAE3.0(responseevaluationcriteriainsolidtumors).TumorresponsewasassessedusingmultidetectorCTaccordingtoRECIST4weeksaftertreatment.ResultsAtotalof16patientswereincludedforevaluationofefficacyandtoxicity.Theresponserateanddiseasecontrolratewere3/16and12/16,respectively.Themostcommontoxicreactionduringconcurrentradiotherapywasnausea(13/16).Therewasnograde3orabovemyelosuppression,andalltoxicitiesweretolerableandtransient.ConclusionsLowdoseS1concurrentwithradiotherapyshowsfavorableefficacyagainstlocallyadvancedorrecurrencepancreaticcancer,anditiswelltolerated,butthelongtermresultsstillneedtobefurtherobserved.(ShanghaiMedJ,2011,34:367370)KeywordsPancreaticcancer;Concurrentchemoradiotherapy;S1;Localadvanced:200032,(),(),():,[e-mail];,[e-mail],95%,55%,40%[1],3672011345,50%,[23],,[46],,,(NCCN)(),[710],,5(5FU),11.1研究对象:2010520112[:(AJCC)6,T4N0~1M0,],18~75,(karnofskyperformancestatus,KPS)70,(),CT,2,,4:,,;CA199;CTMRI;(PETCT)(standarduptakevalue,SUV),:,,,6,,,(ChiCTRTNC10000929)1.2治疗方案:,,CT,3mm,L4,50(internationalcommissiononradiationunitsandmeasurements,ICRU50)(GTV)(PTV),CTPETCTGTV(1cm),(CTV)=GTV,PTVCTV1.0cm,0.7cm195%PTV50.4Gy28-15.5-1(1.8Gy):1/350Gy,2/335Gy,25Gy:1/335Gy,20Gy:40Gy:40mg/,1,2.5~3.5h(3h),15d:,2,,,3,,12,1.3疗效和毒性评价4,,XCT()MRI,1(responseevaluationcriteriainsolidtumors,RECIST)(NCICTCAE3.0):,:1.4统计学处理SPSS,,KaplanMeier122.1一般资料16,10,17(7/16),9(9/16);43~74,65,4(4/16)70KPS702(2/16),804(4/16),90~10010(10/16)1.3~10.0cm,368ShanghaiMedJ,2011,Vol.34,No.53.8cm6(6/16)8(8/16),2(2/16):1(1/16)T3N1M0,10(10/16)T4N0M0,3(3/16)T4N1M0,2(2/16)15(15/16)1(1/16)34,2.2毒副反应1(1/16)2,,121(1/16)2,113(13/16),8(8/16),11(11/16),1(1/16)2d,3,11(N=16,n)1234410020004000300010300521083008200400000105200310010001.3治疗效果1(CR),(PR)3(3/16),(SD)9(9/16),(PD)4(4/16)(CR+PR)3/16,(CR+PR+SD)12/162(2/16),1(1/16),()1(1/16)16CA19916~1419U/mL,182.1U/mL,14(14/16)CA199(37U/mL),10(10/16)4CA199,7(7/16)50%,1(1/16)3,,,,,KPS80,,[8],[1011],,,2~4h,[9]3h(2.5~3.5h),21,[7,1011],,,,,,213416,704,Auprin[8],,34,1CRANECH,VARADHACHARYG,PISTERSPW,etal.Futurechemoradiationstrategiesinpancreaticcancer[J].SeminOncol,2007,34:335346.2.[J].,2008,28:9092.3,,,.[J].,2009,19:580584.4GastrointestinalTumorStudyGroup.Treatmentoflocallyunresectablecarcinomaofthepancreas:comparisonofcombinedmodalitytherapy(chemotherapyplusradiotherapy)tochemotherapyalone[J].JNatlCancerInst,1988,80:751755.5REGINEWF,WINTERKW,ABRAMSR,etal.RTOG9704aphaseIIIstudyofadjuvantpreandpostchemoradiation(CRT)5FUvs.gemcitabine(G)forresectedpancreaticadenocarcinoma[J].JClinOncol,2006,369201134524:4007.6MOERTELCG,FRYTAKS,HAHNRG,etal.Therapyoflocallyunresectablepancreaticcarcinoma:arandomizedcomparisonofhighdose(6000rads)radiationalone,moderatedoseradiation(4000rads+5fluorouracil),andhighdoseradiation+5fluorouracil:TheGastrointestinalTumorStudyGroup[J].Cancer,1981,48:17051710.7KIMHM,BANGS,PARKJY,etal.PhaseIItrialofS1andconcurrentradiotherapyinpatientswithlocallyadvancedpancreaticcancer[J].CancerChemotherPharmacol,2009,63:535541.8AUPRINA,LEPCHOUXC,ROLLANDE,etal.Metaanalysisofconcomitantversussequentialradiochemotherapyinlocallyadvancednonsmallcelllungcancer[J].JClinOncol,2010,28:21812190.9FUJITAK,NAKAYAMAH,ICHIKAWAW,etal.Pharmacokineticsof5fluorouracilinelderlyJapanesepatientswithcancertreatedwithS1(acombinationoftegafuranddihydropyrimidinedehydrogenaseinhibitor5chloro2,4dihydroxypyridine)[J].DrugMetabDispos,2009,37:13751377.10SUDOK,YAMAGUCHIT,ISHIHARAT,etal.PhaseStudyofOralS1andConcurrentRadiotherapyinPatientsWithUnresectableLocallyAdvancedPancreaticCancer[J].IntJRadiatOncolBiolPhys,2011,80:119125.11BJERREGAARDJK,MORTENSENMB,JENSENHA,etal.LongtermresultsofconcurrentradiotherapyandUFTinpatientswithlocallyadvancedpancreaticcancer[J].RadiotherOncol,2009,92:226230.(