胃癌治療指南解讀

NCCN胃癌治療指南的解讀

——內(nèi)科治療局部(2021V.2)1精品課件2023/11/9中國胃癌的發(fā)病率和死亡率世界范圍內(nèi)，中國是胃癌發(fā)病率最高的國家之一總數(shù):934000,其中42%發(fā)生在中國(2021)疾病部位胃竇仍然是最常見部位胃食管結(jié)合部發(fā)病率升高的趨勢多數(shù)患者確診時(shí)已為進(jìn)展期胃癌，且約70％需要化療#Kamangaretal,JClinOncol24:2137-50;20212精品課件上海(2021-2021):發(fā)病率仍高:惡性腫瘤中，男性占第二位，女性占第三位疾病部位:胃竇最常見,為39.88%,小彎為12.68%中國大城市中胃癌的發(fā)病率Jsurconcepts＆practice2021,vol13,No124-29北京(2021-2021)3精品課件

年度年齡201920192019MFtotalMFtotalMFtotal11~2001100001121~30325448691531~4011122316132910213141~50491665362965614110251~60892711669411101275217961~701021812088391271043614071~80681987802310368249281~9070710212761391~100000000101total32995424303151454384190574≤5094/424(22.2%)102/454(22.5%)149/574(26.0%)近3年來收入院胃癌病例北京大學(xué)臨床腫瘤學(xué)院(2019~2019)4精品課件AJCC分期 美國 日本中國ⅠA 78% 95%93.7%ⅠB 58% 86% 80.2%Ⅱ 34% 71% 65.7%ⅢA 20% 59% 44.8%ⅢB 8% 35% 23.1%Ⅳ 7% 17%10.8%總計(jì) 28% 61.4％

40%>檢測大于15個(gè)淋巴結(jié)Cancer2000,88:921-32

中國胃癌患者預(yù)后——5年生存率進(jìn)展期胃癌需全身治療5精品課件中國胃癌發(fā)病的特點(diǎn)JSurgConceptsPract2021,Vol.13,No.1：24上海市胃癌發(fā)病流行現(xiàn)況早診率低治療水平差異大國內(nèi)高水平的臨床研究少，循證醫(yī)學(xué)依據(jù)較少更要求標(biāo)準(zhǔn)治療行為，統(tǒng)一診療標(biāo)準(zhǔn)，特別是綜合治療6精品課件東方國家胃癌預(yù)后好于西方的可能原因早期診斷日韓國家在≥40歲的人群中每2年一次開展全國性胃癌篩查〔如上消化道造影/胃鏡〕治愈切除患者>50%為I期患者治療差異手術(shù):D2切除術(shù)是東方國家的標(biāo)準(zhǔn)治療方式腫瘤侵襲生物活性弱胃食管交接癌發(fā)病率低7精品課件術(shù)后隨訪，1-3年：每3-6月一次，3-5年：6月一次，以后每年一次8精品課件2021年中國版與2021年相比，主要更新內(nèi)容GAST-2●初始治療：身體狀況差的Tis或T1a期患者的初始治療，新增內(nèi)鏡粘膜下剝離術(shù)〔ESD〕作為可選方案之一。GAST-3●術(shù)后治療新增S-1單藥輔助治療，并增加腳注說明僅適用于D2根治術(shù)后患者，對于根治術(shù)后II期或IIIA期患者可以考慮推薦；對于IIIB期，僅適用于年老體弱或體力狀況較差的患者。GAST-5●新增一項(xiàng)隨訪工程：“胃癌根治術(shù)后患者或ESD、EMR術(shù)后患者進(jìn)行HP檢測，如陽性，那么給予去除；全胃切除或復(fù)發(fā)轉(zhuǎn)移性胃癌患者可不常規(guī)檢測及去除HP。〞●姑息治療：更新版本指出，腫瘤復(fù)發(fā)局限于殘胃的患者可以考慮進(jìn)行手術(shù)。胃癌或胃食管結(jié)合部腺癌的全身治療原那么(GAST-C2-1)●術(shù)后化療：刪除術(shù)前未行ECF方案化療的患者的術(shù)后化療方案。●新增術(shù)后S-1輔助化療，并增加腳注說明僅適用于D2根治術(shù)后患者，對于根治術(shù)后II期或IIIA期患者可以考慮推薦；對于IIIB期，僅適用于年老體弱或體力狀況較差的患者。●轉(zhuǎn)移性或局部晚期腫瘤〔不推薦進(jìn)行化放療時(shí)〕：順鉑加氟尿嘧啶類方案中，氟尿嘧啶的選擇新增替吉奧膠囊，為2A類推薦。胃癌最正確支持治療原那么〔GAST-E2-1〕●出血：對于胃癌慢性出血的患者，新增化療作為一項(xiàng)治療手段?！窆Ｗ瑁盒略瞿懙拦Ｗ璧闹委煷胧褐萌肽懝軆?nèi)支架或PTCD外引流?！駩盒愿顾盒略鲇胁“Y及無病癥腹水的治療方案。治療指南更細(xì)化，關(guān)注各期患者，特別是細(xì)化最正確支持治療手術(shù)前后的治療仍存爭議9精品課件去除幽門螺旋桿菌感染與早期胃癌術(shù)后預(yù)防復(fù)發(fā)的關(guān)系10精品課件RANDOMIZEEradicationgroup(272)9patientslansoprazole30mgBidamoxicillin750mgBidclarithromycin20mgBid1weeksControlgroup(272)24patientsstandardcarenotreatmentforHP544patientswithearlygastriccancer,eithernewlydiagnosedorinpostresectionfollow-upafterendoscopictreatment,allwithHPinfection.UMIN1169臨床研究

—Amulti-centre,open-label,randomisedcontrolledtrialmetachronousgastriccancer3-yearfollow-upKazutoshiFukaseetal;Lancet2021;372:392–97對于早期胃癌合并HP感染者EMR術(shù)后三聯(lián)藥物去除治療可以降低再次胃癌風(fēng)險(xiǎn)！(HR:0.353,95%CI0.161-0.775;p=0.009)11精品課件2009.v.22019.v.2清除幽門螺旋桿菌只要陽性即應(yīng)治療如果患者有癥狀，即應(yīng)治療對于根治性胃大部切除術(shù)后患者:

檢測HP,如陽性給予治療

但對于全胃切除術(shù)后患者，是否根除?對于不可切除的復(fù)發(fā)轉(zhuǎn)移性胃癌患者，無需清除HP,僅對癥支持治療2021.v.2NCCN胃癌指南更新——中國版12精品課件2009.v.22019.v.2轉(zhuǎn)移性或局部進(jìn)展期胃癌-1DCF1ECFECF改良方案

1伊立替康+順鉑

2B奧沙利鉑+氟尿嘧啶

(5-FU或卡培他濱)2B伊立替康+氟尿嘧啶(5-FU或

卡培他濱)2BDCF改良方案

2B紫杉醇為基礎(chǔ)方案2BDCF1ECF1ECF改良方案

1伊立替康+順鉑

2B奧沙利鉑+氟尿嘧啶

(5-FU或卡培他濱)2B伊立替康+氟尿嘧啶(5-FU或卡培他濱)2BDCF改良方案

2B紫杉醇為基礎(chǔ)方案2B曲妥珠單抗

12021.v.2NCCN胃癌指南更新——美國版13精品課件ToGA試驗(yàn)設(shè)計(jì)HER2-positive

advancedGC

(n=584)5-FUorcapecitabinea

+cisplatin(n=290)R

aChosenatinvestigator’sdiscretion

GEJ,gastroesophagealjunction5-FUorcapecitabinea

+cisplatin+trastuzumab(n=294)StratificationfactorsadvancedvsmetastaticGCvsGEJmeasurablevsnon-measurableECOGPS0-1vs2capecitabinevs5-FUPhaseIII,randomized,open-label,international,multicenterstudy

1Bangetal;Abstract4556,ASCO20213807patientsscreened1810HER2-positive(22.1%)來自24個(gè)國家3807份腫瘤樣本中心實(shí)驗(yàn)室檢測，3667份腫瘤樣本被檢810例HER2陽性,總的陽性率22.1%584例HER2陽性患者被隨機(jī)分為兩組進(jìn)行觀察14精品課件HER2-positivityrate

Europe(23.6%)

Asia(23.5%)

Taiwan5.9%

(n=34)

Australia32.8%

(n=61)

China22.6%±

〔n=590〕HER2陽性率在歐亞地區(qū)是相似的，而在各國家之間有差異15精品課件HER2陽性率與腫瘤部位和類型有關(guān)胃食管結(jié)合部腺癌HER2陽性率高腸型胃癌陽性率高，混合型次之，彌漫型最低16精品課件Primaryendpoint:OSTime(months)2942902772662462232091851731431471171139090647147563243243016211413712665401000No.

atrisk11.113.80.00.10.20.30.40.50.60.70.80.91.0024681012141618202224262830323436EventFC+TFCEvents167

182HR0.7495%CI0.60,0.91pvalue0.0046Median

OS13.8

11.1T,trastuzumab17精品課件Secondaryendpoint:PFS0246810121416182022242628303234Event2942902582382011821419995626033411728721513393826261614020005.56.7No.

atrisk0.00.10.20.30.40.50.60.70.80.91.0Time(months)FC+TFCEvents226

235HR0.7195%CI0.59,0.85pvalue0.0002Median

PFS6.7

5.518精品課件113OSinIHC2+/FISH+orIHC3+(exploratoryanalysis)1.00.80.60.40.20.0363432302826242220181614121086420Time(months)11.816.0FC+TFCEvents120

136HR0.6595%CI0.51,0.83Median

OS16.0

11.8Event0.10.30.50.70.921819840531242011228218196170170141142112122

96100758453653951281000No.

atrisk3920281319精品課件Secondaryendpoint:

tumorresponserate2.4%5.4%32.1%41.8%34.5%47.3%IntenttotreatORR=CR+PR

CR,completeresponse;PR,partialresponsep=0.0599p=0.0145F+C+trastuzumabF+Cp=0.0017Patients(%)CRPRORR20精品課件Safety:與對照組比較無明顯增加hematologicalAEs%F+C

n=290F+C+trastuzumab

n=294AllGrade3/4AllGrade3/4NeutropeniaFebrileneutropeniaAnemiaThrombocytopenia57321113031035352816275125AE,adverseeventnon-hematologicalAEs%NauseaVomitingFatigueDiarrheaConstipationAstheniaStomatitisWeightdecreaseAbdominalpain6346282832181514147824232216750353726192423167649<14<12121精品課件Safety:cardiacAEsaMeasuredatbaselineandevery12weeks;MI,myocardialinfarctionCardiacevent,n(%)F+C

(n=290)F+C+trastuzumab

(n=294)AllGrade3/4AllGrade3/4CardiacAEs,total18(6)

9(3)17(6)4(1)Cardiacfailure2(<1)2(<1)1(<1)1(<1)AsymptomaticLVEFdropsa<50%

<50%andby

10%2(1.1)

2(1.1)14(5.9)

11(4.6)CardiacAEsleadingtodeath2(<1)

Cardiacarrest;

cardio-respiratoryarrest2(<1)

AcuteMI;anginaunstableandcardiacfailureCardiacAEsrelatedtotreatment2(<1)2(<1)22精品課件結(jié)論和前景ToGA試驗(yàn)顯示trastuzumab聯(lián)合化療減少了HER2陽性胃癌患者26%的死亡風(fēng)險(xiǎn)(HR0.74)延長HER2陽性胃癌患者中位生存期近3月(11.1to13.8months;p=0.0046)PFS,TTP,ORR,CBR,DoR得到顯著性改善化療加用赫賽汀后，患者耐受性良好，所有平安性指標(biāo)包括心臟不良反響與對照組比較沒有顯著差異將成為Her-2陽性晚期胃癌的新的治療選擇23精品課件2009.v.22019.v.2轉(zhuǎn)移性或局部進(jìn)展期胃癌DDP+氟尿嘧啶DDP+

卡培他濱

2A

DDP+5FU2B口服氟尿嘧啶類

2B(老年或體力狀況較差者)DDP+氟尿嘧啶

DDP+5FU2B

DDP+

卡培他濱

2A

DDP+

替吉奧膠囊

2A？口服

氟尿嘧啶類

(老年或體力狀況較差者)

卡培他濱

2B？

替吉奧膠囊

2B？2021.v.2NCCN指南更新——中國版24精品課件RS-1+CDDP

S-1:40-60mg,bidfor21daysq5wksCDDP60mg/m2ivonday8S-1

40-60mg,bid(28daysq6wks)主要研究終點(diǎn):OS次要研究終點(diǎn):PFS,TTF,有效率,平安性納入病例數(shù):298例Evidence:SPIRITSWKoizumi:TheLancetOncology9,215-21,2021入組患者：不可切除/復(fù)發(fā)性胃癌25精品課件OS不良反響(3/4級)S-1/CDDP(%)S-1(%)中性粒細(xì)胞減少4011腹瀉43粘膜炎10惡心111厭食306結(jié)論S-1及S-1+CDDP兩組有效率均較高，31%及54%S-1及S-1+CDDP兩組中位生存期分別為11.0月及13.0月S-1+CDDP可作為進(jìn)展期胃癌的標(biāo)準(zhǔn)一線治療方案26精品課件phaseIIIRamdomized3-armedstudyofS-1monotherapyversusS-1/CDDP(SP)versus5-FU/CDDP(FP)inpatientswithadvancedgastriccancer(AGC)

(SC-101study)Chinesepatients;Ramdomized;MulticenterComparisonstudyPekingUniversitySchoolofOncology27精品課件分層因素:

KPS,轉(zhuǎn)移器官數(shù)目是否胃切除術(shù)RS-1S-1:40mg/m2,bid(4weekson/2weeksoff)S-1+CDDP

CDDP:60mg/m2iv(d8)S-1:40mg/m2,bid(3weekson/2weeksoff)5-FU+CDDP

CDDP:20mg/m2iv(d1-5)5FU:600mg/m2civ(d1-5)q4ws.主要研究終點(diǎn):RR次要研究終點(diǎn):OS,TTF,不良事件

最終分析患者數(shù):224例Evidence:SC-101Jinetal.ASCO2021#4533入組患者：不可切除/復(fù)發(fā)性胃癌Iffailed,canswitchtoS-128精品課件S-1SPFPRR24.7%37.8%19.2%SPvsFPp=0.0021有效率FP組41例患者進(jìn)展后轉(zhuǎn)入S-1組，又到達(dá)14.6%有效率(S-1作為二線化療)不良反響(3/4)S-1(%)SP(%)FP(%)中性粒細(xì)胞減少3.817.116.2白細(xì)胞減少1.313.29.5貧血2.55.35.4血小板減少06.612.2腹瀉3.86.60嘔吐1.36.60惡心02.65.4OS結(jié)論S-1及SP均平安有效S-1+DDP可作為中國進(jìn)展期胃癌一線治療選擇29精品課件RANDOMIZECS

S-125mg/m2POBIDfor21days,every4wks

Cisplatin75mg/m2IVinfusiononday1,every4wksformax6cycles

CF

5-FU1000mg/m2/24hrsCIfor5days,every4wks

Cisplatin100mg/m2IVinfusiononday1,every4wksformax6cycles

Stratificationfactors:Typeofdisease(locally

advanced;1metastaticsite;

≥2metastaticsites)Prioradjuvanttherapy(y/n)Measurablevs

non-measurablediseaseCenterPrimaryEndpoint: ?OverallSurvivalSecondaryEndpoints:

?Progression-FreeSurvival ?Safety ?TimetoTreatmentFailure ?OverallResponseRateClinicalTID:

NCT00400179FLAGSStudyDesign24countries/146centers/1053patients/nonasiantrial30精品課件Log-rankTest:p=0.1983HazardRatio:0.92(95%CI:0.80,1.05)MedianOverallSurvival:

CS:8.6months

CF:7.9monthsOverallSurvival(FAS)31精品課件RANDOMIZECS

S-125mg/m2POBIDfor21days,every4wks

Cisplatin75mg/m2IVinfusiononday1,every4wksformax6cycles

CF

5-FU1000mg/m2/24hrsCIfor5days,every4wks

Cisplatin100mg/m2IVinfusiononday1,every4wksformax6cycles

Stratificationfactors:Typeofdisease(locally

advanced;1metastaticsite;

≥2metastaticsites)Prioradjuvanttherapy(y/n)Measurablevs

non-measurablediseaseCenterDose? DDP:75mgvs100mgS-1:25mgvs40mgTTF?

?3.8moinbotharms ?SecondlineTherapy:29.6%vs33.3%(CSvsCF) ?OverallResponseRate:29.1%vs31.9%?SafetyFLAGS?StudyDesign!?Subgroupanalysis?32精品課件AdvancedGastricCancerS-1MonotherapyforpatientswithpoorconditionPatientsBackgroundTrialDesignAuthorJournalNRegimenRRTTPOSWithperitonealdisseminationCaseReportOsugietal.OncolRep.201918S-180mg/m2/day,d1-28,q6wNANA8.4moWithpoorperformancestatusPhaseIIJeungetal.BrJCancer.201952S-170mg/m2/day,d1-14,q3w12%2.5mo7.6moWithlowrenalfunctionetc.PostMarketingSurveyNagashimaetal.GastricCancer.20193,801S-180mg/m2/day,d1-28,q6wNANA8.3mo33精品課件AdvancedGastricCancerS-1MonotherapyforelderlypatientsTrialDesignAuthorJournalNRegimenRRTTPOSPKtrialFujitaetal.DrugMetabDispos.200910S-180mg/m2/day,d1-28,q6wNANANAPhaseIIKoizumietal.CancerChemotherPharmacol.200931S-180mg/m2/day,d1-28,q6w(AdjustedbyCreatinineClearance)21.2%3.9mo15.7moRandomizedPhaseIILeeetal.BrJCancer.201991·Cape2500mg/m2/day,d1-14,q3w·S-180mg/m2/day,d1-28,q6w27.2%28.9%4.7mo4.2mo9.5mo8.2moRetrospectiveStudySeoletalJpnJClinOncol.200972·Cape2500mg/m2/day,d1-14

CDDP70mg/m2d1,q3w·S-1100-120mg/day,d1-14

CDDP70mg/m2d1,q3w55.0%40.6%5.9mo5.4mo10.2mo9.6mo34精品課件Evidence：phaseIIIML17032:XPvsFP

KangYKAnnOncol.2021Jan20.666-673SuperiorORRwithXPvs.FPConfirmedresponse

%(95%CI)XP

(n=160)FP

(n=156)p-valueOverallresponse41(33–49)29(22–37)0.030SuperiorPFSwithXPvsFPEstimatedprobabilityHR=0.81(95%CI:0.63–1.04)ComparedtoHRupperlimit1.25,p=0.00081.00.80.60.40.20.0XP(n=139)FP(n=137)MedianPFS

months(95%CI)5.6(4.9–7.3)5.0(4.2–6.3)35精品課件2021.6-2021.8納入141例患者(中位年齡Age:53.7ys)化療方案:Cape1000mg/m2Bidd1-14DDP20mg/m2ivd1-5q3WWHO評價(jià)療效CTCv2.0評價(jià)不良反響有效率CR3(2.1%)PR48(34.0%)SD51(36.2%)PD39(27.6%)mOS:12.0m,ORR:36.2%平安性：3/4AE<5%Evidence：中國胃癌XP臨床II期研究

金懋林等.中華腫瘤雜志2021Dec;30(12):940-3結(jié)論卡培他濱聯(lián)合小劑量分次給予順鉑一線治療進(jìn)展期胃癌平安有效。36精品課件Meta-analysisofREAL2andML17032trials

inadvancedoesophago-gastriccancerEvidence:Meta-analysisofREAL2andML17032TrailscomparingCapectabinewith5-Fluorouracil(5-FU)inAdvancedOesophage-gastriccancerAFCOkines,etal.AnnOncol.2021Sep;20(9):1529-34.Epub2021May27.卡培他濱

組5FU組HRPmOS(95%CI)(d)322(300-343)285(265-305)0.87(0.77-0.98)0.027mPFS(95%CI)(d)199(180-217)182(167-197)0.91(0.81-1.02)0.0925ORR(95%CI)(%)45.638.4OR:1.38(1.10-1.73)0.006結(jié)論卡培他濱為根底聯(lián)合化療方案較5-FU為根底方案治療進(jìn)展期胃癌總生存期及有效率。37精品課件38精品課件Evidence：卡培他濱比照S-1ArandomisedmulticentrephaseIItrialof卡培他濱vsS-1asfirst-linetreatmentinelderlypatientswithmetastaticorrecurrentunresectablegastriccancer.

Y.Kang,BrJCancer.2021Aug19;99(4):584-90.PhaseIIXeloda(n=44)S-1(n=45)Regimen1250mg/㎡bidd1-14/3W40-60mg/㎡bidd1-28/6WCR(%)01(2.2%)PR(%)13(29.5)12(26.7)mOS(mo)10.07.9mTTP(mo)4.84.2mTTF(mo)4.4339精品課件Xeloda(n=44)S-1(n=45)?級

(%)1250mg/㎡bidd1-14/3W40-60mg/㎡bidd1-28/6W中性粒細(xì)胞減少6.84.8乏力07.2厭食6.89.5腹瀉2.30手足綜合征6.80Evidence：卡培他濱vsS-1:不良反響

Y.Kang,BrJCancer.2021Aug19;99(4):584-90.40精品課件Capecitabine+cisplatin(n=40)S-1+cisplatin(n=32)Regimen1250mg/㎡bidd1-14DDP:70mg/㎡,q3W50-60mgbidd1-14DDP:70mg/㎡,q3WpRR(%)55%40.6%0.246mOS(mo)10.29.60.343mTTP(mo)5.95.40.6403/4HFS37%6%＜0.05diarrhea32%25%＜0.05兩組中其他血液學(xué)及非血液學(xué)毒性發(fā)生率相似比照XP和SP的回憶性研究YoungMiSeoletal.JpnJclinOncol2021:39(1)43-48doi:10.1093/jjco/hynl1941精品課件2009.v.22019.v.2轉(zhuǎn)移性或局部進(jìn)展期胃癌DDP+氟尿嘧啶DDP+

卡培他濱

2A

DDP+5FU2B口服氟尿嘧啶類

2B(老年或體力狀況較差者)DDP+氟尿嘧啶

DDP+5FU2B

DDP+

卡培他濱

2A

DDP+

替吉奧膠囊

2A口服

氟尿嘧啶類

(老年或體力狀況較差者)

卡培他濱

2B

替吉奧膠囊

2B2021.v.2NCCN指南更新——中國版42精品課件2021.v.2NCCN指南——中國版手術(shù)前、手術(shù)后的化療43精品課件可切除胃癌圍手術(shù)期化療

---MAGICtrial胃癌〔占85%〕或低位食管癌〔15%〕ECF*3cs-手術(shù)-ECF3cs單一手術(shù)N=2505Y38%N=2535Y23%ECF:E50mg/m2C60mg/m2FU200mg/m2/dcivCunninghametal,NEJM2021PatientsatriskLogrankp-value=0.009HazardRatio=0.75

(95%CI0.60-0.93)CSCS250168111795238272531558050311890.00.10.20.30.40.50.60.70.80.91.0Monthsfromrandomization0122436486072149250170253EventsTotalCSCSSurvivalrate44精品課件Patients：3809ptsMethods:12RCTfromJan.2021toDec.20214fromJapan,4fromItaly,2fromFrance,1fromSpainorPolandT1wasexcluded,onlyD1ormorewasincludedSurgeryalonegroup(1913pts)vsCT+surgerygroup(1896pts)BritishJournalofSurgery,Jan,2021;96:26-3345精品課件Results:ThepooledHRforOSwas0·78(95CI0·71to0·85)infavourofchemotherapy.

Subgroupanalysisshowedthattheadvantageofchemotherapywasnotinfluencedby

depthoftumourinfiltrationstatusoflymphnodemetastasistypeoflymphadenectomygeographicaldistributionofpatientsrouteofdrugadministrationMeta-analysisshowssurvivalbenefitofadjuvantchemotherapygroup.Favourschemotherapy+surgeryFavourssurgeryalone46精品課件根治性胃癌切除術(shù)(D2)R單純手術(shù)組S-1S-1:40-60mgBIDfor28daysq6wksfor1year分層因素

:

不同中心

II/IIIA/IIIB期*主要研究終點(diǎn)總生存期次要研究終點(diǎn)無復(fù)發(fā)生存平安性*JapaneseClassificationofGastricCarcinoma,13thed,2021Evidence:ACTS-GC研究設(shè)計(jì)SSakuramoto:NEnglJMed357,1810-20,202147精品課件總生存期不良反響S-1(n=517)單純手術(shù)(n=526)Grade3Grade4Grade3Grade4粒細(xì)胞減少6(1.2%)02(0.4%)0貧血6(1.2%)03(0.6%)1(0.2%)AST升高9(1.7%)017(3.2%)1(0.2%)T-bil升高7(1.4%)1(0.2%)5(1.0%)1(0.2%)肌酐升高001(0.2%)1(0.2%)厭食30(5.8%)1(0.2%)8(1.5%)3(0.6%)惡心19(3.7%)-6(1.1%)-腹瀉16(3.1%)01(0.2%)0皮疹5(1.0%)02(0.4%)0疲乏3(0.6%)03(0.6%)0*NCI-CTC(Ver.2.0)Evidence:ACTS-GCstudyresultSSakuramoto:NEnglJMed357,1810-20,202148精品課件StageII012345050100232233230226186178100882527(years)No.atriskTS-1Surgery3年OS-TS-1

90.7%--Surgeryalone

82.1%HR=0.59[0.36-0.99]p=0.042(log-ranktest)01234505010023123321520716114385681919(years)3yRFS-TS-1

83.7%-surgeryalone

72.1%HR=0.55[0.36-0.83]p=0.004(log-ranktest)OverallsurvivalRelapse-freesurvival(%)49精品課件StageIIIA01234505010019420319119613613267591814(years)No.atriskTS-1surgery3yearOS-TS-1

77.4%--surgery

62.0%HR=0.66[0.45-0.97]p=0.032(log-ranktest)0123450501001942031761701111025247117(years)3yearRFS-TS-1

69.1%--surgery

56.5%HR=0.64[0.45-0.90]p=0.009(log-ranktest)OverallsurvivalRelapse-freesurvival(%)50精品課件StageIIIB01234505010089838576595434251010(years)No.atriskTS-1Surgery3yOS-TS-1

63.4%--surgery

56.6%HR=0.73[0.45-1.18]p=0.192(log-ranktest)012345050100898376604335261756(years)3yRFSTS-1

49.9%--surgery

38.3%HR=0.69[0.46-1.04]p=0.075(log-ranktest)OverallsurvivalRelapse-freesurvival(%)無統(tǒng)計(jì)學(xué)差異！51精品課件II、IIIA期根治術(shù)后患者,S-1單藥輔助化療顯著改善總生存期和無復(fù)發(fā)生存IIIB期根治術(shù)后無統(tǒng)計(jì)學(xué)差異原因分析：患者樣本量缺乏?(每組缺乏90例)聯(lián)合鉑類?(SP或SOX)52Evidence:ACTS-GC亞組分析SSakuramoto:NEnglJMed357,1810-20,202152精品課件局部進(jìn)展期胃癌術(shù)后輔助化療S-1作為2類推薦方案。并增加腳注說明：僅適用于D2根治術(shù)后患者適于根治術(shù)后II期或IIIA期患者；對于IIIB期，僅適用于年老體弱或體力狀況較差的患者。53精品課件如術(shù)前未應(yīng)用(m)ECF，根治術(shù)后應(yīng)該采用何種輔助治療方式及治療方案?替吉奧單藥ECF及ECF改進(jìn)方案卡培他濱+奧沙利鉑---CLASSIC研究(進(jìn)行中)?納入D2根治術(shù)后II/III期患者平安性良好,生存期數(shù)據(jù)正在隨訪放療聯(lián)合化療(XP)----ARTIST研究(進(jìn)行中)?納入D2根治術(shù)后Ib(T2bN0)-IV(除外M1)期患者比較XP比照XP+放療(RT)耐受良好,生存期數(shù)據(jù)正在隨訪其它臨床研究？54精品課件2021.v.2NCCN胃癌指南更新——更新55精品課件術(shù)前放化療依據(jù)

PhaseIIIComparisonofPreoperativeChemotherapyComparedWithChemoradiotherapyinPatientsWithLocallyAdvancedAdenocarcinomaoftheEsophagogastricJunction

MichaelS,JournalofClinicalOncology,Vol27,No6(February20),2021:pp.851-856納入病例

食管下段或賁門腺癌局部進(jìn)展期:uT3-4NxM0方法化療:

PLF術(shù)前化療

(Q6wks,2.5周期)------手術(shù)放化療:

PLF術(shù)前化療(Q6wks,2周期)------CRT(VP16/DDP+30Gy)-------手術(shù)56精品課件EGJadenocarcinomauT3/4NxM0

因入組太慢，提前終止試驗(yàn)。Nov2000-Dec2019CTCRT57精品課件OS(ITT人群)ArmA,n=59(CT-Surgery)

mOS21.1月,

3-年生存率

27.7%.ArmB,n=60(CT-CRT-手術(shù)):

mOS33.1月,

3-年生存率47.7%.結(jié)果及結(jié)論病理緩解率pCR:CRT優(yōu)于CT(15.6%v2.0%)術(shù)后淋巴結(jié)陰性比率:CRT優(yōu)于CT(64.4%

v37.7%)3-年生存率:CRT優(yōu)于CT(27.7%v47.4%,P=0.07)術(shù)后死亡率:兩組無差異結(jié)論：對于胃食管結(jié)合部腺癌，術(shù)前放化療優(yōu)于單純術(shù)前化療尚存爭議58精品課件R59精品課件CROSStrial結(jié)果32%PCR60精品課件CROSStrial結(jié)果鱗癌患者占23%，腺癌為74%61精品課件最正確支持治療—腫瘤部位慢性出血姑息化療或放化療?62精品課件63精品課件mOS：6.7mvs2.4mp=0.08該研究為回憶性研究，觀察梗阻、疼痛、出血等多種病癥的緩解放療雖可緩解病癥，CRT優(yōu)于RT的趨勢考慮的選擇:聯(lián)合放化療？姑息性放療？姑息性化療？(關(guān)于是否增加姑息性化療的征詢:收到9位專家的書面反響意見,6人同意,3人不同意)64精品課件最正確支持治療–梗阻腳注1:梗阻可分為消化道梗阻及膽道梗阻。腳注2:惡性腸梗阻患者的治療請參照NCCN姑息治療中PAL16-17相關(guān)章節(jié)

置入膽道內(nèi)支架或

PTCD(經(jīng)皮肝穿刺膽管引流)2A65精品課件最正確支持治療–腹水惡性腹水無病癥，參照胃癌的系統(tǒng)化療GAST-C有病癥? 腹水引流? 腹腔化療聯(lián)合全身化療---5FU,順鉑,紫杉醇,MMC2A? 腹腔持續(xù)熱灌注化療，IPCH？66精品課件納入患者33例晚期胃癌合并惡性腹腔積液患者方法及結(jié)果同時(shí)靜脈(50mg/m(2)及腹腔給以紫杉醇

(20mg/m(2)，

d1、8,S-1口服80mg/m(2)/d，14天23(70%)例患者

腹水量減少>50%，8例腹水完全消失

每周靜脈及腹腔給予紫杉醇聯(lián)合S-1治療晚期胃癌合并惡性腹水.

KitayamaJ,IshigamiHetal.Oncology.2021;78(1):40-46.Epub2021Mar3.67精品課件納入病例胃癌伴有腹腔內(nèi)播散病灶或腹水細(xì)胞學(xué)陽性患者方法及結(jié)果方法:同前

1年生存率78%.18例有可測病灶患者中，評價(jià)療效示有效率為56%21例惡性腹水患者中13例

(62%)腹水消失。

每周靜脈及腹腔給予紫杉醇聯(lián)合S-1治療晚期胃癌合并惡性腹水的II期臨床研究.

IshigamiH,KitayamaJetal.AnnOncol.2021Jan;21(1):67-70.Epub2021Jul15.68精品課件目的及患者觀察療效及毒副反響81例胃腸道惡性腫瘤合并腹水患者(