2024.V1版NCCN指南更新：乳腺癌用药选择.docx

2024.V1版NCCN指南更新：乳腺癌用药选择2024年1月25日，乳腺癌NCCN指南更新至2024.V1版，此次药物治疗方面的更新主要涉及化疗药物的选择和剂量的调整，具体更新内容如下。并且本文汇总了最新版乳腺癌NCCN指南推荐的靶向、免疫药及方案选择，仅供参考。01、术前/辅助治疗方案HER2阴性的三阴性乳腺癌（TNBC）其他推荐方案调整：紫杉醇+卡钳（不同给药方式）调整为2A类证据多西他赛+卡钳删除“仅用于新辅助治疗”，调整为2A类证据National Comprehensive Cancer Network-NCCN Guidelines Version 1.2024 Invasive Breast Cancer° PMierts in th» OMnP0tfi dd MreCa ae petM>rv. ttjt. them m no data On se9jenerg or 2 guide *le<aon Of one agent om te other. MQt>m ma EUde Mge IMIITNBC. 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ACfollowedT®IrMtuzumabh(doxorbcincyc*opbopmMIoIIowmIbyPyplutrMtuamb.vhou38us) ACIollowodbyTbtrastuzumabpo<tuzumsbh(doxorubkArVcyclophosphamidofoBowdbypcMulplustrastuzienabpluspertuzumab.vdouSCMaUiM) Nratinlb0(XJUVantXlngonly) P>clitax4trastuzumabPortUZUfnabh AdotrMtuzutnabmtantin(TDM-1)(duvlMttmgOrtfy)OtherRconwnn<MRgmm:ACfoliowodSfdoct>xlbtrastuzumab(doxorubclrVcyclophopamktofoHcwdbydocUxdtrMtuzum«b)ACt/odbydoc*taxlbtrMummbXrtMZUrnt(donJbklnGeoph<*p3nMfoowmlbydocCax4PcWU3Qo"M»MuzumabprtuzumbAddHIonaICoidratlonforThoMReceivingProprattvodjuvMTh«ra”(BlxVL3)HER2阴性乳腺癌其他推荐方案给药剂量调整:多西他赛+卡钳（46个周期），删除“仅限术前”NCCNNeCN GwddDea IndexTab工 o* * Cort<6iQUQiSAfioS11sivNCCNGuidelinesVersion1.2024InvasiveBreastCancerDOSING:PREOPERAa11VE/ADJUVANTTHERAPYREGIMENS PaciiUxoi Carbopkatln Woekly pdrtnl CMtK)pBnu (PreoPolat“o 0thn9 Og)O Paciitaxd 0 Brni days 1.8. end 15O CetioplBiinAUC 5ordsy 1;-Cyded every 21 days * 4 Cydee Weekly pMtUel weekly Carbogtin',” O Pacxd 80 Bm3 days 1.8. and 15OCabopielnAUC 1.5-2*s i.,an 15-CVCted em 28 davs X 6 cvd Docctaxol CMboptaIin (4-4 cyci)1u DDaBUKd 75 fngn3 day 1 Cafboptefen AUC day 1OCycMevwy 21 (te0 x 4-6 cydMHER2"awOtherRtcomwwMtdRtglwnmACfallwdi»ydocetaxelovovy3weeks7»DaIOrUDIan60rgrtvonday1,CydoptKKphflnwlo600mgfm,IVday10Cydevery21daysfor4(yctw0Followed”Docetftvd100fTQffnaIVonday1OCycMevery21for4cydes.ECCtMMOttMrepy AC folowed by week" t>clU*<a Doxoruttan 60 m<fn1 rv 0 1,CyCiOPho6 amide 600 j*n N dey 1 CCydeevery2idaystx 4 cycftn CFoBowedby PaCRW 80 BBay IhlVSUBOOEAlyQ 12weM C»ctAbine<Zftenance therapy严 MO mg3 PO *ice daiy OndSyB 1-28 Oycted CVery 2B day¾ for 11Car.EPrgCrl1mgfrrfvday1.CydOPhaH)horned830mgn*rday10QrBdevery21Osfor8cyclesTACChomothorapyt»Docctvci75mgfrntIVds1Doiorubian50mgffIVday1.Cydopt*hawS9SOOmgfrneIVdBy1OCycirtevery21(toysfor6cydrHERZNO9athUMfUlifICertainCrcumtancoMt Aa v*C4nmeacl«aa»« ar caf4ry 2A mfeM rhrM rtfcatB<Ctmai nute: NCCMMr>tm*mQmQfimwc*rcMnBiPv*cipBUnscAji3wck6CMdBINVI5OF9HER2阳性乳腺癌首选方案调整：新增TDMT方案，剂量每日3.6mgkg,21天一个疗程，共14个疗程NCCNColensiveNCCNGuidelinesVersion1.2024InvasiveBreastCancerPBMfMr(Vw*tof 1Z wa*aW Tfuruna 4 mgf¥QfVwlMf(l 00M Qf P<J<*tfo FoBowtIbv *r4Mm 2 ¼Qrvwo e i y OfWWtnant A an ,Ete ct>un*n. m99 Z v(y2i d* m ba IMd to*>*VQ Z 60Mon & pUx Z 9ca*t 1 yo<lmm*M tMlnrt.75 ErrVdey 1 CMboptekI AUC va*y 1 0 C*cM *y 21d*rfor eyd Vn TraMUaM»4 V*4" M i OFtfKMWdte RkruMt> > V* IV or 17， OReDWid， Dec*Ml 79 Jbo0M(M« Cywy2l etof6ey tn Nturat> 8 >ngM Wg 1.ruvwfrM0 2 rv，i：F<M4tr TV Mhvucwb m0g IV0 CycM vy 21 Ckrn to COa(M IyOfMBfW/(8, Tr MtaeuM mgl IV wl 1 FaDWed Wn*hrunemg*Qlv6 CycM E 214V 10 COMCto IWWWuw11wrbutata>Ltd*Wwf*MWrWerotwr*nMVq02全身治疗方案ER和/或PR阳性复发不可切除（局部或区域）或IV期（Ml）乳腺癌其他推荐治疗方案调整：修改第二条：选择性ER下调剂（氟维司群）+非俗体芳香化酶抑制剂（阿那曲哇、来曲嘎）（1类），删除氟维司群的“1类推荐”iv.NCCNGuidelinesVersion1.2024弑黑kInvasiveBreastCancer复发性不可切除（局部或区域）或IV期（Ml）疾病靶向治疗和相关生物标志物检测调整:新增任何亚型的生物标志物检测：胚系BRCAl或BRCA2突变，胚系测序，FDA批准用药为奥拉帕利、他拉理帕利，NCCN指南的证据类别为1类，NCCN指南推荐为首选方案HR阳性/HER2阴性的生物标志物检测修订为：PIK3CA或AKTl激活突变或PTEN突变；NGS检测的样本类型修改为：血液或如果血液阴性则使用肿瘤组织National Comprehensive Cancer Network*其他检测的样本类型修改NCCNNCCNGuidelinesVersion1.2024InvasiveBreastCancerTARGETEDTHERAPIESANDASSoClATEDBIOMARKERTESTINGFORRECURRENTUNRESECTALE(LOCALORREGIONAL)ORSTAGEIV(M1>DISEASEBINVO 6 OF 14BiomerkersAwocietedwitFDA-ApprovedTr*pBfttCncrS*Jt*ypBonrtcrHOnFDA-ApprovedA9ntNCCNC*goryofEvkSonceNCCNCtgo<yo<PrfroncoNGS.PCR(BlOOdOrIiiwmue(blood»gM)A4>cM.VMslrvM1Ct90ry1PfefenedscgJ-OrwbM<eMrwHER2-neggflvyXplKXAorAKTIIIadvatngmU3cndICrPTaaleratomNGS.似OOdortumort*uetftlo<xlne9»M>CaciVsMflb.MveMrertvCM90ry1PrcfcfrcdSfiCixid-OrWbeegjcnMne5erPT*nelcpabcnts,fSfmacnpCRl(TUmOrbSueorEtoOeSIranKCateQary2ACXhcrrccomededrenenGeffntoW8«CAlorG<mrwSquccirggartbjC-orylPreferredAnyNTRKIjwFISHNGS.PCRhumortsuBMoM"JLfym<ebMErtreClrtbMCM0ry2AEMSH¼1MMRHC.NGS.PCRgumorPemtrolzifnat?6ocCategory伏UMMGCertaSCrcumitanMTMB-H(10mUA4bNGSkIfno,Mueorbk×NCategory2AAnye4uwNGSTif11orissueorbldjSdpercjt!11bCategory2AHER2阴性方案化疗药物调整:新增抗代谢药物：卡培他滨150Omg口服，每日两次，第1-7天和第1521天，每28天循环NCCNNational Comprehensive Cancer NetworkeNCCN Guidelines Version 1.2024 Invasive Breast CancerNCCN Gtxlelnes ItxtexTbte of Contents DtscusoDOSING: SYSTEMIC THERAPY REGIMENS FOR RECURRENT UNRESECTABLE (LOCAL OR REGIONAL) OR STAGE IV (M1) DISEASEHER2N<gJtv Rggimona:, AntincycBnM: DcuoruMn 6O-T5 m9*n4fV day t <cied ev*y2i m,. DomMn 20 BC(Uy 1.UPMOmti 如 OrUeaCan$ 50 rrm1 IV M 1; CydedeveryMddyt Um:.R>dtt*d i75tn9M1(lVday 1; cyaodrr*y 21 8y'4a, Pbcttud 80mm, IV51 WeeMy9 AnlmKaboitM. Capecilflbtfv4 1OOO-X25O mgn, PO twiceLalPKMaD<n noo mgPO wod*ty*y 1-7 M d)f 15-21 CyMevery 2S dyt nd t$. cyclM eory 28d*y Motutji inhMlors:» WiOfefetwa-10。2S mjm, IV day 1 weeat; CrQ 20-35 mg*n* IVdeyt 1 and 8: <ded every 21 doron-3OmQ*v0yl.S.M15. CyoM r<rv28 dya.4 fffm* Mdayft 1 and 8; <yddvery 21 day* PtotlnUm for TNBC nd gtrmtoe ACA Ifl muMon)» CMcpMm12 AUC 6/on day 1O Cyctodcvay 21-28 d*Q<n1375mgMnlfVody 10cMcvy 21 dBys CydoplmphamM14 50 mg POdMyonOeyt 1-21» Cyded tfry 28 day*DocU,su WMOOmmlrV 则 1 Cy<M p 21 Sy.DocetaMl17» 36 m9to1, IV weeitar6waeKst)A0wM ty 2*mM* rMM*Mt AKMimtnound pcltx4,t1t.IOOmotn1Of Q5m9*nvrdVyl.<M H Cy<M *ry day*ABMm*nbound PaCltAMiIB20mg,/ Cyded w«ry 21 day* EPirUbUi60>e0fnIiVdeyl Cy<M OF 2i (toysx4bpik>i40mg*nl IV<toy 1» Cyded every 21 OeyB Sc<uarab govttc*wtfy(ICf TMBC Cr HR*HER2)2x3 IOmgftg N onde)s 1 and 8, Cy<M wery 21 Odyt-FaHHrMtuzumabdefu Mocan <«uki(lor HCR2 HC 1* or >4X ngau ”产» 5>4 mQAglVdoy 1 餐B21 Sys, DoKOrUtKin 60 trm N <My 1 CydQ(IhMPtW*te 00 BH IVdy 1OCycMevary 21 d*ytEC 3UMITSBn"V Uy 1 CydoctmpharmSe 600 mgFw, IVdey 1O CyM every 21 ytCMFn CydopMprMrmto 100 Be PO dy 1-14 Mctnorexa» 40 E即'Z d 1 andS，Muovouraal 600 BNIV dyt 1 MSOCycMMry 2一 DCUs*C4p*Ct>W rw2a DOC«UxH 75fifm rdy 1 CApMMtfMt ¢60 m* PO tM0» dalydys 14 OCycMewory 210T»» PmMaiei 175 mgtnledy 1 GencaMne 1250 IngKi» N dVy» 1 M (Voo>g PeCMaae1 6 5 1) OCycMMfy 21 一GemubineJCAfboPiBttn)O» GemaUfcme 1000 B# on dy> 1 E S*CrbpmnAUC2Vondys1 MS« Cyded Mry 21CefboplMinteItiu(ViM)Ound pcUx' CMtOpUIin AUC 2 IVonOtyt 1 M 8 XfttfYWMXXMK125mgn< IVon<Uy1 W8 Cycled Mry 21 dytOtfboPiMinZlKAl< j3 PKtUitf 17MDO mgn' IVdey 1» CarbopKmAUC 6IV dr 1 Cycled every 21 daysB» PttCiUid l00mgf<n,IVdyl.e,d15 » CMOpUIin AUC 2IVy 1.S.M15 » OycAedewy 28 d*ysS doMQ Ior Urg Wd tmp on B*MniaIhe ecfecr dDMr> and *wwtatan erf f* cncr 9tf* and ta tnaea9eTMrt <tfaM0Mldtocaa a* cor*0n. acwt arfd09 da E tff .E ron dcv <«OnS v 0n nc*ry fiec. . «Bp»CM tana ar*am<Ju -E WuOf PrVftevn< an8"1OrM Te yz<Mbey o，.Q<»«Yxr *genE-re .QJre heW10* <tew .amBMenOed IlMU. 5b cancar a9en. 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Afl rwwwteM - Ctft*y 2A*M OMMleC4l.Cfcff YHBb: NCCN MtoV tbit *- << PMantMAhsreerf cl cal M Parttc*Hr <BnAMltfM<ncourQd.MR UBtHU JQt -1 Q>a C*N*kaFCOTlVUCO <>,taal Mi « *«««««l C e9aMB9t ««* *BMMM>CLCOntinUedBINV-Q8 OF 14现将2O24.V1版乳腺癌NCCN指南推荐的靶向、免疫药物及使用方案汇总如下：Ol术前/辅助治疗方案HER2阴性首选方案：奥拉帕利，如果基因检测为胚系BRCAl/2突变高危的三阴性乳腺癌（TNBC）:术前帕博利珠单抗+卡伯+紫杉醇，随后术前帕博利珠单抗+环磷酰胺+阿霉素或表柔比星，随后辅助帕博利珠单抗脚注：c.以下情况考虑加用奥拉帕利辅助治疗1年,胚系BRCAI/2突变且:三阴性乳腺癌（TNBC）,如果1）pT2或）pNl辅助化疗后，或2）新辅助化疗后残留病灶。*HR阳性，HER2阴性，如果1）辅助化疗后4个阳性淋巴结（2A类），或2）术前治疗后残留病变和临床分期、病理分期、雌激素受体状态和肿瘤分级（CPS+EG）评分3。辅助奥拉帕利可与内分泌治疗同时使用。d.OlympiA研究中的患者未接受卡培他滨治疗，因此没有先后顺序或一种方案优于另一种的证据。e.High-risk高危标准包括1111I期TNBC。辅助帕博利珠单抗（2A类）的使用可能需要个体化。NCCNNational Comprehensive Cancer Network"NCCN Guidelines Version 1.2024 Invasive Breast CancerPreoperativezadjuvanttherapyregimens*7rgfemnslkdIngUblIorHER2rwgtZ<SsmmaeMCMegOry1<xcptwhrindicated)wnUMdIntd)uv<tMtUng.i noce&sty , hyperwmwr rofion> Ifdo 0 Cf 9 5 n>b(rd AMmjfi* Uxanes 0t. docouxM WtxttUtod Ior WGCK" PJKKeXOl orHER2-mtl一ProfgrrOdRagimana:"D”<toAC(SoxofubicinzcycIophoephamkto)followedorprecededbyclUxlvry2wsbDoWn“AC(doxofubicinyclophophml(>)followedorpreceded百WMkIy(>cBUxlbTCfva!andr<rlftg><mlfto Ohparib.SrfnlifWBRCAf2muUtio Hhrtek*TNBC:PreoperativePembrollWmbUrboplatin时CIitaXelfolowdbypreopr*thrPembrOtEUmbcyclophopmiddo>rubAcnofttDkublci.foMowodbv*diuvatKMfnbroliJyQTNBCandresidualdoasoafterProOPerativ©therapywithtaxan.alkyiator*,andanlhr»cyclin»*baMdchomothorapy:C«pocitabinoUmIuIInJrtainClrCUmtSncc Dos«-dnsAC(doxorubicinyclophophmkS) AC(doxorubkincydophosphamid)every3WMkS(category2B) CMF(CyclophosphamidezmethotrexateznuofouraciI) ACfollowed>WMkIypcStaxlb Capocltabino(maintenancetrapyforTNBCafteraduvantCbomothOraPy)OtMrRecommecxSedRgit: ACfollowed5doc<Uxlvy3wksb EC(prubidrVcyclophosphamd) TAC(d8<gUdo*OfUbiCWCvCIOPh80mid) ForTNBC: PactttaxolCarboPUtin(variousschoduls)(category2A) DocoUxoICarbopkatin(category2A)AdditionalContiderMiorwfor11k>mRcMgProprUv3AQuMtTrpy(BVL3>HER2阳性首选方案：紫杉醇+曲妥珠单抗TCH（多西他赛/卡粕/曲妥珠单抗）TCHP（多西他赛/卡铛/曲妥珠单抗/帕妥珠单抗）如果术前治疗后无残留病灶或未接受术前治疗：使用曲妥珠单抗（1类）士帕妥珠单抗完成长达一年的抗HER2靶向治疗如果术前治疗后残留病灶：单独使用恩美曲妥珠单抗（T-DMI）（I类）o如果因毒性停用恩美曲妥珠单抗（T-DMl）,则使用曲妥珠单抗（1类）±帕妥珠单抗完成一年的治疗。如果初始淋巴结阳性，采用曲妥珠单抗+帕妥珠单抗（1类）在某些情况下使用：多西他赛+环磷酰胺+曲妥珠单抗AC序贯T+曲妥珠单抗（阿霉素/环磷酰胺序贯紫杉醇+曲妥珠单抗，多种方案）AC序贯T+曲妥珠单抗+帕妥珠单抗（阿霉素/环磷酰胺序贯紫杉醇十曲妥珠单抗+帕妥珠单抗，多种方案）来那替尼（仅辅助治疗）紫杉醇+曲妥珠单抗+帕妥珠单抗恩美曲妥珠单抗（T-DMD（仅辅助治疗）其他推荐方案：AC序贯多西他赛+曲妥珠单抗（阿霉素+环磷酰胺序贯多西他赛+曲妥珠单抗）AC序贯多西他赛+曲妥珠单抗+帕妥珠单抗（阿霉素/环