ࡱ> _"zbjbj4bbIIIII]]]]y]_mmmmmH H H ^^^^^^^$Pbe@_-IH H H H H _IImm>_&&&H ImIm^&H ^&&V,[m<*~i!ZY6^T_0_=YRBeP&pBel[[BeI[4H H &H H H H H __&4H H H _H H H H BeH H H H H H H H H ? :">40B>: ! 2 4> B5=45@=>W 4>:C<5=B0FVW >40TBLAO #G0A=8:>< =0 DV@<>2><C 1;0=:C, (C @07V =0O2=>ABV) 70 ?V4?8A>< B0 ?5G0B:>N (C @07V =0O2=>ABV) $ &/   % "%'    " #:  021:2015: 85140000-2 >A;C38 C AD5@V >E>@>=8 74>@>2 O @V7=V (>A;C38 7 ?@>2545==O V<C=>3VAB>EV<VG=>3> 4>A;V465==O 70  021:2015: 85145000-7: >A;C38 <548G=8E ;01>@0B>@V9: V03=>AB8G=0 % 1 :0B53>@VW A:;04=>ABV; V03=>AB8G=0 % 2 :0B53>@VW A:;04=>ABV; V03=>AB8G=0 % 3 :0B53>@VW A:;04=>ABV; ALK (54) GCB;82VABL ?CE;8= 4> ALK V=3V1VB>@V2 (%); PD-L1 (22!3), GCB;82VABL 4> V<C=>B5@0?VW; A-kit (CD117); EGFR (exons 18, 19, 20, 21,  ); KRAS (codons 12, 13, 59, 61, 117, 146,  ); NRAS (codons 12, 13, 59, 61, 117, 146,  ); Her-2/neu; 87=0G5==O 1V;:V2 @5?0@0FVW ?><8;>: :><?;V<5=B0@=>ABV  <V:@>A0B5;VB=0 AB01V;L=VABL/=5AB01V;L=VABL ?CE;8=8); <?;VDV:0FVO HER-2/neu (FISH); 548:>-35=5B8G=0 :>=AC;LB0FVO) !09<5=C20==O ?>A;C384. 28<V@CV;L:VABL"5@<V= 28:>=0==O1V03=>AB8G=0 % 1 :0B53>@VW A:;04=>ABV (4V03=>AB8:0 "30;>" =52CAV2, >FV=:0 3;818=8 V=207VW 70 @5A;>C ?@8 A:;04=8E <5;0=><0E, CB2>@5=L 3@C4=>W 70;>78 (>:@V< DV;>W4=8E, <575=EV<0;L=8E ?CE;8= B0 ;V<D><), >;5:C;O@=89 B8? @0:C 3@C4=>W 70;>78 (ER, PR, HER2, Ki-67)?>A;C308007 4=V22V03=>AB8G=0 % 2 :0B53>@VW A:;04=>ABV (CB2>@5==O/?CE;8=8 A5G>2>3> <VEC@0, A5G>2>4V2, ?5@54<VEC@>2>W 70;>78, I8B>?>4V1=>W 70;>78, 3>;>2=>3> B0 A?8==>3> <>7:C (>:@V< <575=EV<0;L=8E ?CE;8= B0 ;V<D><); 045=><8 3V?>DV70, 3>;>28 B0 H8W, 3>@B0=V, B@0E5W, AB@02>E>4C, H;C=:0, :8H:8, H:V@8, OTG=8:C, 5=4><5B@VN, H89:8 <0B:8, 2C;L28 B0 ?VE28, OTG:0)?>A;C3021012 4=V23V03=>AB8G=0 % 3 :0B53>@VW A:;04=>ABV (287=0G5==O >@30==>3> ?>E>465==O <5B0AB07V2 :0@F8=>< =5287=0G5=>3> ?>E>465==O (2 1C4L-O:89 >@30=), ?CE;8=8 ;535=L, =8@>:, =04=8@=8:V2, ?5GV=:8, ?V4H;C=:>2>W 70;>78, CB2>@5==O >G5@528=8 B0 A5@54>ABV==O, 287=0G5==O 3VAB>;>3VG=>3> B8?C =548D5@5=FV9>20=8E 7;>O:VA=8E ?CE;8=, ;V<D> - B0 <VT;>?@>;VD5@0B82=>W ?0B>;>3VW (;V<D045=>?0BVW, ;V<D><8 %>46:V=0 B0 =5E>46:V=AL:V, ;V<D><8 H:V@8, ?;07<>:;VB8==V ?CE;8=8, <0AB>F8B>78, 3VABV>FVB>78, <VT;>?@>;VD5@0B82=V 70E2>@N20==O), ?CE;8=8 :VAB>:, < O:8E B:0=8= (A0@:><8, 30AB>@>V=B5ABV=0;L=V AB@><0;L=V ?CE;8=8), DV;>W4=0 ?CE;8=0 3@C4=>W 70;>78)?>A;C3022012 4=V24ALK (54) GCB;82VABL ?CE;8= 4> ALK V=3V1VB>@V2 (%)?>A;C30307 4=V25PD-L1 (22!3), GCB;82VABL 4> V<C=>B5@0?VW?>A;C30207 4=V26A-kit (CD117)?>A;C30107 4=V27EGFR (exons 18, 19, 20, 21,  )?>A;C30207 4=V28KRAS (codons 12, 13, 59, 61, 117, 146,  )?>A;C30207 4=V29NRAS (codons 12, 13, 59, 61, 117, 146,  )?>A;C30207 4=V210Her-2/neu?>A;C30207 4=V21187=0G5==O 1V;:V2 @5?0@0FVW ?><8;>: :><?;V<5=B0@=>ABV  (<V:@>A0B5;VB=0 AB01V;L=VABL/=5AB01V;L=VABL ?CE;8=8)?>A;C30607 4=V212<?;VDV:0FVO HER-2/neu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