1、g:.lIffitP (csco) 6i/m*1fllffimzmfi2022 . t:plEllffitP (csco) 6/tm*llffimzmfjij 2022 GUIDELINES OF CHINESE SOCIETY OF CLINICAL ONCOLOGY (CSCO) IMMUNE CHECKPOINT INHIBITOR CLINICAL PRACTICE ;f. t:l. _ J,!. .t ffi 1 Jt&:xpjf, 1:X9! lIItE)lJHIiQ 13 (CIP) fm 9=OOIIiliJ5tRrrifl/$fi (eseo) :tR.)9:;f&1!,gj
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10、m1U*lim:aJ&tm m, m-1Jllfl*fiB1iAtB, fRthZ*p;jt5Imm(, fCSCO tllflBJf4ti, IEtnDB1x,i(i0 9 csco iffmiiiiEtIiSO / 1 csco ifftljiiinUm / 2 CSCO milfliHClJ1M1fOllflimzfflmiii 2022 .JT, / 3 -, f$t1gB / 11 =, / 19 =-, /NIIIDD1Ii / 31 !I, r-)Jm/JffilDD1Ii / 65 li, DJliii8Jffli / 71 , LD* / 79 t, BiWn / 95 ),
11、 q:.B!UDfffilD / 105 11, BiJmm:Mi / 123 +, BiJm / 129 +-, I*.t / 143 +=, -g / 161 +=, f$t1T-gJlii / 167 + !I, t1mm / 173 11 19m +E:, t9 / 179 +1, :&/ *;3tittES / 195 +t, bi: (t9) / 205 +), MSI-H/dMMR , TMB-H f* 211 Pf1m / 219I Pf13R 1 A;3fff*1jffi51MiJi / 220 Pft3R 2 NMPA tlt/i$BgH&i!;iJP%U1fUiQ;m:i
12、iE / 224 -12 FaMafi. *.mR -3&i (3t1J7i!. 80% ) Fa Meta :fJT. *.:fJlxtR *-3&i (3t1J7i!. 60%-80% ) fillifi -I9HI:iJ Meta fi. Jj .mxt, R. i9:it I:HfiJ * 1WltiR. m19 -xtR -3&i (3t1J7i!. 80% ) fifi -J9l:.iJ Meta :fJT. Jj.:fJlxt, R. i9:it HiJ * WYH1liJfR. mi9 -xt,liJfR *-3&i (3tHJ7i!. 60%-80% ) ifi iJ jff
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14、ijOJ&tt, 1f*mJlU 2A iiEtiS, 1F m#o : ij pl;j:9llJlitJl:xt9,tJf, t1nIJiiEt, OJ&ttffi; *RBffiUmm., *$.OJ figR, mOJ1F m# 2B iiHJi!ifD 3 iiEms .*.m, ffimm., M.iiEiiEmffi ,1f*ffi.ruOJ., IIIm# cs 6tE!*H$I1 m1ll -tlil1lifIH 1fifIJ:f)f(JfLfJL + uW :j4f -tlil1lifJj! m i*f2i1f5f jt-gm; -=.f:lffm F/MHlJliPm; 1
15、C1;fJ. :j4f iIT*ifJj! ifI:l1B ( lA) 7 i;J1filll+ -t1EI 1NSCLC -f:l;lT Ff NSCLC -F )JbHHT 2A m-5fif1rm5E. *i5Ui$ :t*fjlIJiH. ttjiftii:. *,1!fDJ $H$1i3.w:g:m ;f,Ifi/W -FlW;fIj:r;?KJj!tiLtflWllf;fljJj!tJL + rf1tjJA +JilnB, JU/9Qm;lff I 2Hl#; f;fIj:r;?KJj!tiL + rfjflf1tP.1 +)1fB, JU/9m2Hl#o lW:r;?KJj!m*
16、/9.m;=fi IT*#o JJTj:1I iJK;fIjJj!tj , JIJ/9=,*llffmtt#o ttlfm =iff#JTJ: 1ll;fIj:f;j;Jj!tiL /9 I tt#o F/MIII$m 7Ci9J?I1!ff.JF NSCLC PJ;fIj:r;?KJj!tiL ( PD-Ll TC 50%.!J(: rc 10%) ( lA), 1HUIj:r;?KJj!tjClIX:if!%ifflJ 5f1JfB ( lA) Jj/9NAA7GZijj;5, F NSCLC lff I tt#; i% PJ1J;fIj:fJKJj!tJLlm ifj:%i fflJ+
17、-FfB ( lA ), if:fiHIjJj!1iLtmifj:%ifflJfjfB ( l A) JIj/9NAAXZij;!j!;j;5, F NSCLCff I *#; tlW1r;fIjJj!mtmifj:%ifflJ5f1JfB ( lA)JIJ/9NAAXZ)Jj;5, F NSCLC lfi IT *#o :lt wllfjfiJ.J)j(!jittL ( lA:2R) fH,&:7;IlftMF NSCLC =il1T I lHl#o PJtI7g)m:ff!1-tfiJtmiHjfIJJfLttL ( lA :2R) 1j:7;fi.nj)IlftWjF NSCLC JfL
18、IIDilfi ill ilktt#o :lt IIA mA M*frHmfl:lJ1-tfiFoplJ#jflj.J)j(!jitMfHifil1i (PD-Ll TC 1%) JIj:7;F NSCLC $fflllMilfi II !&m#o fI3itjfiJft!jittLItk-f131-tfi ( IA :2R) JIj:7;FNSCLC JitIi$fflfl:lJil;fimilkm#o * NSCLC (f) :lt iiJjijfiJ.J)j(!jittL ( PD-Ll TC 50% IC 10%) (IA :2R), fil!jfiJ!jittLItittnl.!l1
19、illi1J f13:2R ( lA :2R), ifiliijflj.J)j(1j!t)tItitlWi1JfB:2R ( lA:2R) fH&:7;IlftMif(: NSCLC -il:fT I ilktt lfr !:i #; :lt ijflj-ij3.ttLItit!w;.filf13:2R ( lA:2R) JIj:7;IlftWlif(: NSCLC 1ilfi I !&tt#; :lt i* ,l!Il j(il1fjfiJJfLttLItJClrM;.filf13:2R ( lA:2R), tiflffilil1fjfiJJfIttLllrfTEljHir;fUfB:2R
20、( lA:2R) JIj:7;IlftWl1M rJIlia; l if(: NSCLC -fiII !;&tt#o t-z :lt WJjfIJ.J)j(1j!ttL ( lA :2R) fr!,&:7;IlftMif(: NSCLC =j,tilff I !&ttBo* ill tiii Wi IJtI7:!llUfllH!1.tffFo1tmijfiJ1j!t)t ( lA :2R) JIj:7; .rmffllIltMif(: NSCLC JfLlIDtilff ill !& tt#o :f: *JT IIA-mAM*Fo$ffll:l.iJ1-tffFoiiJwjfIJ.J)j(!j
21、i:fMlijiftiliT ( PD-Ll TC 1% ) JIj :7;if(:NSCLC , $ffll:l.iJ tiliT II !;& m#0 itjfIJ:1t!jittLIftit*f131.tiT ( 1A:2R) 3i1j j;if(: NSCLC JitIi$ffll:l.iJif:1ff milktiI# o J)WlIMIH JlElMiJ N1:U iJ:1t!jiJ .%iJ H(8 J1i ffli -)g.fi: I ilktt#/GWIR II ilktiI# (I;fJD i m!&tiI#:!Jn j =)g.fi : i*J itjfiJ ftlfJ
22、t)t milktiI#tJD 11:!Jn =:.&l,C I !&tiI# 11j m!&tiI#j LmiHil!i JitIi / JitIi11ff;f 8 : m irfi ill bt t1f.# 0 ) 35UpNSCLC ifltJ01!HntrTffit!. t;fQ :LC -i1fi I f1f. ff I t1f.#; iit lA ?R) 35UW:I j)Wl/JIHJlE!HiP $J )jt1:fIjJt!)!tJi: + 11XttYElif / -FlS:(;JillIilS ifoJj?zM/JmJlPlnrIH-*fi I ttf#o ffijJ H(
23、8) W. !fM -)fi: I t1f.#-;NIX7tPLEz,f1tt.&: MPM o II tit#j&1JO )jt1:fIjJttJi:Jt,H:0)jg)lUIB.t; + JIJlS ill bttit#j&JJO JifIjJt!)!tJi:Jt*il-* BE 1 + JIl9lfS 0 =)fi: Vgm:fIjJt!)!tJi: EI3 ill tit#ij(7:J I bttif#o ill fit#j&1JO RrefUJ#;,tJi: c j&)0 =:&lV.LYi1fi : I m#j&)D Vgm:fUJt!)!tJi: 0 ill tit#j&)D B
24、iWfUJ#;!)!tJi: 0 Lm JfJi / tJTj&ff b, c, d, e, f, g, k, L 0, p, q, r 0 Wlm; -ri;tff ( HER2 jHi ) : ifJTfi PD-Ll CPS 5, XELOX l:ifiJ:iI.!iUJl:rJt (lA) :h I iilHIi#o ifJT PD-Ll CPS5 B;Zt&lY1IJ/fPJJJe FOLFOXIXELOX) l)(ifm:iUftifi:rJr: ( lB ), PD-Ll CPS5 !H1PJ:& , XELOXll:iffii:il.!;fUifi:rJt ( lB #2) I
25、I W.tl:1J:o ifJT WJm:;fUftJl:rJtl:if1fil21*JlHJ: (2B, dMMRIMSI-H) , BiW;fiJ.l*1f!:r1LJlM*ifJIlP!4B I j:1Jj(1I&;1l;E (2B , dMMRfMSI-H) , i*J.fiUiJftiji:rJtl:if FOLFOXIXELOX (2B , dMMRlMSI-H) (fJ () :h ill 1H1ER8 0 !e ifJT t1ilfi (HER2 DIE) pgoN ! =ri;tff: ifJT;fIJ:r1L (2A , dMMRlMSI-H) :h I lHlRo ,jq
26、J ri,Gri;tff: JlIl1JW; Btw;fIJ:)jcJfltJt II Rt1Eo 1M 1IJ IIfn AAHIIlJm;* III til AA HCCiliff-rimWi :t1J ifT:iI.!,TIJiJ!1JLlxtfIJUXJ*$:rJi:R1!:Jr!1J ( IA) flW.:h I iHi #; iJ *Ii J! flJd*J!.:JJt ( lA) Jljjg 1 Rtff.#o ,AAHCCiliff=rim ft.tt I w.m#, u.ffinJ!.m:hIw.m# JJL1xiUftJf-:J1Lltxifflf WlHJlPjm; Jl
27、Il1JW; xiB RAS f dMMRlMSI-r dMMRlMSI-H IJM.W IJ nRt1f#1t!.9:h AAm; aHmJm; f B1x + f B1x+ f u-f.lifij;fIJ:)jcifi FaJlJm; f i*Jm:;fUftiji Jj(J:&:m; I BiW;fU:)jc1f!. BiW;fIJ:)jc1f!fi I w.m#o it ( IB ), PD-Ll dtfL!jlJI-%JllYlf8 I , dMMRlMSI-H ) IlJfJl t;!ifllmWi JlIJlJ x it RAS %11 BRAF i!i!i1El3tk0 itf
28、 dMMRlMSI-H iJ1 WHi!i1Jl3J J!ii =&i5 Uirff (-& * 1t Jtj leIs , xt-jUrr1J), dMMR/MSI-H EfJM1Jl3JJ!ii&M,Jrr (-& . =&*1tffl leIs, xit-&, =&irr1J) EfJ IT !lHi7#:i5J:.X1J le Is (PD-IIPD-L1 1f!.I1!:)o ( 2A )0 MWi MIIlJWi l-i?:1:Jt+ IPBji;ljtrj!jlm rj1J-&irr (1f&JXrlHi) EfJ I Hi7#o l-i?:f:lG + Bji;ljtrj!jl
29、ffL 5irj1J-&irr (r:p. JXl:&l) EfJ I !&ti7#o l-!jlm+*=&fim!&m7#o JltlIlJmo l-WtrjjtJ!.ffLJl-jC%ji;Ij :9rjIT !&ti7#o Jlj(.t$:m . BJ:Wtrj!jlffL (2A ) 7t!&M17REzjilIi-&iff I !&m7#o l-Bji;ljtIJ!jlffL ( lA ), t:fiI;jll1ftrj!jltfL ( lA ) :9rj7-JM17RMrEzJ!ii=&!lX:&Foi ff I !&ti7#o i : rjigffi:5fUjCijitj ( l
30、A ) JIJ4fjH!Jjli1fi I *o ;9jmi PD-Ll Brt;D.1!fjliMstW5fIJ:;jcijitj + JIS / ;t;lW lil f:lGj(-tjj,MSiW5fUJ*-tj + f is / ,fj.lW JJ:! 1:lGJ*ijitjJ1 ( 1 ); =1i1?T*m89B3!j&Jiffftjigffi:if!-tjmT PD-Ll B-ril! (2A )o 6tX:tiT;I*Jmi o (fJ =1i1?Yiim Dostarlimab-gxly mT dMMRlMSl-H !-(28 )oo o 1 lfr !l 6tttmi j(j
31、l !ifff Yi1=,ff bo w J m 11$ ;,z* .,Ell t Si: * FrT 4fflJl;lJ, t1Jaxt IT B IT C AA IPSiW5fUtt;Jf!tJi: 1 (2A ) 89i1f#o i Iii. .d *M m* 6t / tl)ti 1Ja a)7 NKI fFj.Jrniio Si:mi (F ltAA:fH!Il SiW5fUJ*iji ffiIf MSI-H/dr. ffiIf Ilft* 2 NI Eili:AOO1* !OO #J$lliM fEIIT#.&tt#EfiJ:rg:IJo t:fftij5fUij!m (PD-Ll
32、 StE)o ltJL + -tiEl I tM !tt:i! (2A )o !6: / *;li1;ll;Hii#E!Ji J:lJu s!J NKiT 1HJli* BfflI (NKTCL), * 1JjlUUij!tJl: ( 3 ), EI5fIjE(!m (3 ) fF:fiJ JU#.&tt#o Hlfl1c (FJi) Elj;l(m; 1f R5fUJJKE(!tJL (2A ) J:3t:fiJ I 2Ht#o ilVrJ:rg MSI-HldMMR 5fO TMB-H 3i.;i*fflI r*Jo ;JTj:rg 1lff3Jt 2 NMPA JttliiJ:E!3t1
33、&ftTJ#JIjJfIj:il1J.ili:i.iE 0 E,:ittA 00 *12ii* 3JtRJ!3t1&jtt,S:trP#JIjJfIJ, J:II/:lJo # tffiiJ o E ill Wt1lI*gz E( 9 ;P,; 6roi: - nONA:;:DJ - 1l p (vr ) SW/J( + ?t!,ifIJ!fI!-* + Jf,f n,L!j(HiIf fU p (VI ) Stl( p (Vr ) Sl( + ?t!,lit-!fI!-* + ?t!,lit-!fI!-* + Jff:t:fO:f; + Jf,f n:f;W!f*-I y,1j! JijIi
34、f ZE: = 1l (VI) ( I : SdJ ) Jff:*nts p. (VI ) L.r-+ S-/ SWiJ( WM + Jff: :t1 O:f; *I. s 11 1f!:tJL + WWft!.m + ) d II = jl;jf (IA)b Mt m;fIJJt1f!:t)t f;M rilfi tJii;illf;flj1f!:t)t (2A) e# i*llf;flj1f!tt ( 2A ) e i2Jii;i;flj*1f!tt (2A ) e WJit;fIJ:tt1f!:tJL (2B ) e Stf;flj1*1f!:tJL (2B ) e ji a TKEYN
35、OTE-048 :PJfJi: I 1, OOit1gJ.jiffJj!fiD (Food and Drug Administration, FDA) T 2019 1f 6 fl:tltl1iJstf;fljlJI;1f!:jJtJtx1f1-tfi (4SfQ 5-FU) ff.f.J-:/Jiilfittf3;tt:k Jjtfj)JM, IPJ BHlti1IJstf;flj1*J!vt1f!gJ.jiilfi.pjfijmMHR:iisl1i1r:ftHET-.-:5t1*J!lc1* -1 (programmed cell death ligand-I, PD-Ll) tf;irB
36、tti-ijZ?t (combined positive score, CPS) :;?: 1 B9:;tt 0 Jltll, IE! Jlt frJ.Y!Uf:MIlJ!l:VLxtRRiJ ( randomized controlled trial, RCT ) i=f, B1t:tiJl?K-fltJLlJ;ir1tff89i=f c f KEYNOTE 1iLA1fBtrB (overall survival, OS) j. 13.01-Jj , lm.1:ftftV.fHJf;iB91ffi1jttJLlIJcir1tff sf.iJJ 1ilff tV. tt:. 89 10.7
37、1-Jj (HR 0.77; 95% CI 0.630.93; P=0.006 n, # llfrj(Jlfliif-$ (objective response =1ilff*y!;ril rate, ORR), x:i1!JI.iit:l.1f (progression-free survival, PFS) :fI;f :!J1LI ( adverse event, AE) XtR KEYNOTE JJW9:fjiIQ.:HHjiJo ffxt CPS:;?: 1 B9It, B1t:tiJl?K1jtIJLB9i=f1iL OS J; 12.31-Jj, iIQ. J5t.sf.i?il
38、ffr5!jo/j (I 1Jt f1ffitr1jtIJHJHHHJB 10.3 1-Jj (HR 0.78; 95% CI 0.640.96; P=0.008 6), # i Lfr P=0.016 1 ), # J J:(tEJJW_,E.1Jtfm 0 2020 if 12 Jj, *r5 &dl1ffj!fm (National Medical Products lffgS PD-Ll :it Administration, NMPA) :fitJy!1iJf1iJ!j*, kJ,RillUfH :l!lB9iJ&jJiHlUiB1t:tiJ l?K1jttJL i(l.89 ;ti
39、lMB1t:tiJ DiziiE (CPS:;?: 20), 19:f FDA tlUiB.IDiziiE , *tliilJ1lJr.HBro:tiJl?K1jttJL-fl0fFJ; 1Ytltiiilifiil71-,w CPS:;?: 1 ,J!fo81 I t1f#o m1ffB9:, B1t:tiJ:I3fc1jtIJLJfL01lB1 ORR :fI PFS lm.1ij;T!j:ir d f CAPTAIN1tffll, IE!JltT:iJ#/GtTrpj:ili:fft ilj E*Ejj(;*mJ3i:i1!JI.iit B9 ,w,$1 0 J3K-fl-1)t:flt
40、if:fiiff jt b f CheckMate 141 1iJf 2 1, FDA T 2016 if 11 Jj tlUifEt:tiJjt-flmtFJ;=Ejj(;J5t.sf.iJJ1il fr CAPTAIN-1st fftV.ttffEjj(;M.tt*$.ofrmMvuti=f, fEt1jt 1-Jj (HR 0.54; t tJtFI9 rr1iL OS 7-1 7.5 1-Jj, lOl.1JtT1mEi9J5t.sf.iflff0!jo/j (q:J9tPt, 1ffitl!.1i1:g:JnJ1ItrltJL) ff IPJ *E.itfT i=f 1l !I 5.
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44、 ;filII Jl tltiit:fiUiJ 1fl.fJt;fllMfi1fl.fJtI&Cff(Jmm;fllmfFiJ-jJff9X;f$tt.o 7-J =*.t1Jil tE CAPTAIN-1st 1iJfH:P. -FifiJ1fl.tJOJ:1tffP1iI PFS iJ 9.71-Jl. 1:!tf1tffil 6.9 AP, rJjifiJjt. 1-Jl (HR 0.54; 95% CI 0.390.76; P=O.OOO 2)0 :(:f JUPITER-021iJfH:P, *fiifiJ.tJi:l:1t rg11M!fJm1f1fl.tA) fflnf#!tTP
45、1iI PFS ( 11.7 vs. S.O 1-Jl; HR 0.52; 95% CIO.360.74; P=O.OOO 3), *.Ei 2 ryt mJllJ:jJTIolttJtT 1iJfH:6:ffi tb Bj: OS Bjfo tE RATIONALE 3091iJfP, w1t;fiJJ?Ic.tJi:l:1t1flnffi 6:j1jfA.;fIJ :.1t1fl.tA TffSM.*.Ei1iJfH:*mTXff,:flTm:%ff.Amo PD-Ll 7&:iEBttB e TPOLARIS-021iJf, NMPA T 2021 if 2 Jl ttU1HfiifiJ
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48、II ;fIlIPBiWt1jJ)/-(#LtJL 12 J , rp1lRtJj1bt NOTE-040): a raJR911JH*, 19Fo1f KEYNOTE-I221iJf 13 J 9=t3iNff15JtJj1jtT1m:J:(R,*tJY 0 6 J YANG Y, QU S, platin as first-Iini 3tilV: multicentre, rand, 7 MAl HQ, CHEl 1 BURTNESS B, HARRINGTON KJ, GRElL R, et al. Pembrolizumab alone or with chemotherapy ver
49、! treatment in ad,sus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and :it Med, 202 J , 27 (9 *Ii neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet, 2019; 394 (10212): 1915 l8 J WANG FH, WE11 1928. in previously tl 2 FERRIS RL, BLUMENSCHEIN G JR, FAYETTE J, et al. Nivolumab for recurrent squamous-cell carI trial (POLARlS-1jjlJj cinoma of the head and neck. N Engl J Med, 2016, 375 (19): 1856-1867. 9 FANG W, YANG 3 FERRIS RL, BLUMENSCHEIN G JR, FAYETTE J, et al. Nivolumab vs investigators choice in recurrent or metastatic squamou
