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Cli i l Q ti Clinical Question: EBM 5A EBM 5A PECO (PICO) PECO

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Cli i l Q ti Clinical Question: EBM 5A EBM 5A PECO (PICO) PECO
(!")*#$%&+'+
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2 : ; <
,-./01#2345
2012/07/07!CSP"HOR67 89
=>?@AB
CDEFGHIJKL
MNOPQRSTU =>PQV7WXT
YZZ[\]^_C`Eab cdefHghf+i)jklA)mn&oL
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Cli i l Q ti
Clinical!Question:!=>¸šã:
=>¸šã:
ÄŌƒ“)Ç0È#É45ÊÄ4 %
ÄŌƒ“)Ç0È#É45ÊÄ4Ë%£Ì
ÍÎO¾ÏÐÑҚÓÔՌUÖV×؝Ù*j)#
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ÚÃ'ۚÑ.Ü/Õ'£
ÚÃ'ۚÑ.Ü/Õ'
cÑÒÕºÝÞßà«¬­3á¼­šÕ'Ñ£
Evidence!Based!MedicineHEBMLše؝ï¼oð'Û£
ƒ“)ÚÌ4«¼šÕ'+âÌ
½O¾££££Ì
EBMñòšó*ôõö 5A
*ôõö0O ÍΚ÷ø
Assess!your!patient
*ôõöùO ú:šûüÖHýþÿ L
Ask!clinical/research!question
*ô ö! ú:"¼5š#$%&
*ôõö!O
A i d b t id
Acquired!best!evidence
*ôõö'O ()*­#$š+,/-.
Appraise the evidence
Appraise!the!evidence
*ôõö”O #$šÍÎ/šßà
Apply!evidence!to!patient!care
ú:šûüÖOPECO (PICO)
ú:šûüÖOPECO!(PICO)
P:!Patient!!12Œ«+£
*ôõöóO *ôõöù0”š÷ø
E:!Exposure/Intervention!34Œ«+£
C:!Comparison! 56Œ«+£
O:!Outcome rsŒ«+£
ÑҚ=>WXÕ÷øY*ÛZ[\<·]3Œ
! 19966UASCOš^À¿À)_`!
*ôõöùUú:šûüÖOPECO!(PICO)
Patient:!54EUFG£PS0£
cdfK'6™ ž ¡!7 °±«4
cdfK'6™Už ¡!7U°±«4
ER",!PgR",!HER28G£
a)+
Exposure:!ƒ“)Ç0ȝÙ*j)#ÚÃ
"
ÍΏ\<·]
! &hEU&hGH
! KLMNQOLHPatient!Reported!Outcome:!PRO)
KLMNQOLHPatient Reported Outcome: PRO)
C
Comparison:!ƒ“)Ç0ȚÊéê
i
ƒ“)Ç0ȚÊéê
=>/ìí
Outcome: Ù*j)ÚÚA*Á39k:;õ<
Outcome:!Ù*j)ÚÚA*Á39k:;õ<
=×#>?'Û¸Õ@A«#$
ofã:
2BCU=DEâUF&hGHUIJÃUKLMNQOL
! IJÃUbG Hcd/e.UPRO)
"
JOG
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PQ\<·]
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PQPQE TUV&hGH «$Hcd/e.L
! ÙÀB»–·–UPQ»–·–«$Hcd/e.L
JOG PQšPQÖRsSTUVGHŒâ
JOGUPQšPQÖRsSTUVGHŒâ
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w‰xxvpuqv‰p^ww‹x‰qw‹Šuy€^r‰Š^x‹quˆquqvw^xŠ‹uˆq^wupw‹Š
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! 1973"1982,!MD!Anderson,!1,581Pts.!MBC
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" CR!rate,!16.6%
" 56HCR#€4­°2ŒUFš3.1%
" 206HCR#€4­°2ŒUFš1.6%
12
! "#$%&'()*+,-../012 345
"#$%&
Goal of therapy
678+"#$%&9:;<=>
,-
?@ABCDE
1991 92
438F
1
1994 95
450F
0 97
0.97
0 65
0.65
1997 98
564F
0.84
0.011
1999 01
667F
0.72
<0.001
HR
P
UVW*XY*Z[
AIs,!GHIJ+K;LMNJ
OPQRST
?@AB'\]
^V' J<
^V'9J<_;`
`
Quality of Life'abc12
Quality!of!Life'abc12
Disease of the Breast, 4th edition,
Chia!SK!et!al.!!Cancer,!110,!2007
de'fgQhXSij
Patient:!54k+lmnPS0n
$op)q,r s"#tu ^Vv
$op)q,r+s"#tu+^Vv
ER ,!PgR ,!HER2wmn
13
14
}ƒ„Mth de0…43'†‡ˆ‰ Acquired!best!evidence
ECOG 2100Š‹hNEJM, 2007
AVADOŠ‹h JCO, 2010
Exposure:!GHIJxyz0{|}NJ~OP
Comparison: GHIJxyz'€
Comparison:!GHIJxyz'€
RIBBON!1Š‹h JCO, 2011
Outcome: ‚?@AB'\]ij
E2100: )*+,-./
ECOG 2100Š‹: Ž, !‘, ’“”Q•–Š‹
PFS0123"#$%
㦹㽊䣑ቑ
慱䲊␜䤉ℂሯቶ
n=722
⻳⒴⥯⷟:
• 䎰䡔䞮ⷧ㦮栢
• 慱䲊⊚㟿
• 嫢㈛ቑ▥ⷵ䣑㽤
(ሥቭ vs ቍሺ)
• ኸወ኿ዐ♦⹈⇢ቑ䤉䚍
ኜኊኚዙወ
ኜኊኚዙወ +
ቿክኖኞዐ
10 mg/kg 2拀㹝
⬦㌹ቡቊ倨倩
! 4656-123"#$%-78+,
! !"#$%DEFG5HA
• —˜™š›r:!PFSœ’ž?@ABŸ
—˜™š›r: PFSœ’ž?@ABŸ
– '¡'™š›r:!ORRœ¢i£Ÿ,!OS !"#$%&,
quality
lit off life,
lif safety
f t '!(&
Miller et al. NEJM 2007
17
Objective Response Rate 9:-;<+,=>?@ABC&
IJKLMNOP
021.2%
18
QRSTUVWP 036.9%
p< 0.001
Miller KD et al. NEJM 2007
AVADOXY: )*+, (PFS) -./
AVADOXY: Z[\]^U_`LM2abcXY
rstu
rstu:
• ef|}
• IJ~U-)*/
€‚ƒ*„5?$%
• ˆ‰Š‹Ž
• MU‘’“-i”
IJKd M
IJKdLM
100mg/m2
+ Z[\] 3lm
IJKdLM+
QRSTU7.5mg/kg
3lm
23…p
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no)*pF
!vD
QRSTUw
xyz{
IJKdLM+
QRSTU15mg/kg
3lm
15mg/kgVWPp4n56123"#$%=78ŸA
•–—˜™š: PFS (123"#$%&
›oœ—˜™š: +ž, +$%, !"#$%, quality of life
Pivot et al. JCO 2010
AVADOXY: ¡-¢!"#$% &'(
Z[\]P= 8.2 6
QRSTUVW(7.5mg/kg)
Q
TUVW(
g/ g) = 9.0 6
QRSTUVW(15mg/kg) = 10.1 6
RIBBON 1CDEFG@H5678I@JKLM2NOPCD
]"#!
^_`ab
cVd
e fghij
ersfghij
tuvwm
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no
[pq@
no
<@>6qG†‡@
x‚
‚ƒ„…l
l gmf
ef hij=kefghij=kqo)* (n=705)
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⬦㌹ቡቊ倨倩
⬦㌹㈛ቑቿክኖኞዐ
∎䞷ቒ崜ቤቍሧ
QR#S k
<=>?@
hz{
QR#S k
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hz{
|}
~
€
2 !"#$
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+,
• QR#S!Ž
)*+,-./01234
56789= 31.9:;
<=>?@AB(7 5mg/kg) = 30
<=>?@AB(7.5mg/kg)
30.8
8 :;
<=>?@AB(15mg/kg) = 30.2 :;
‘’“”• PFS (x|}*+,-–
‘’“”•:
—˜™’“”•: š$›, )*+,-œž*+›œŸ) Pivot et al. JCO 2010
Robert NJ et al. JCO 2011
RIBBON 1CD:!"#$% (PFS)!!'(
QR#S¡¢£[pq@/<@>6qG†‡@¤B9
PFS:!x|}*+,-
OS:!)*+,-
¥x|}*+,-V¦2;§¨¢4
¥)*+,- ž*+›./01234
¥)*+,-©ž*+›./01234
Robert NJ et al. JCO 2011
Valachis A et al.
]^&_`abcde
<=>?@AB.Œ!"#$%&'(
)*+,&-.$%/01
2345678&9':;<=/>?@)*+,
A>?@)*+,BCD&EF5G4H/IJKL&+,M
Patient: 54f5ghUPS0U
ijkl6m= nopqr st04
ijkl6m=5nopqr5st04
ER", PgR", HER2uhU
Exposure: vwxyz{|}~€y‚ƒe
>?@)*+,&NO0-.$%PQRST1!U
Comparison: vwxyz{|&„…†
E2100: (6VW5AVADO:(2VW5RIBBON"1:(1VW
XY Z $%P[H0!
XY&Z\$%P[H0!
Outcome: cde
E2100: 21
21.2%
2% vs 36.9%,
36 9% AVADO: 46
46.4%
4% vs 64.1%
64 1%
E210078: cde&‡ˆ
AVADO78: cde&‡ˆ
Bevacizumab‰
L?Š‹!Œh
Žs
‘Ž
’“”•
[–—
˜–™š–
›œ
žŸ
[–—5žŸP ¡?Š
]^&_`abÁÂÃÄQOL
cde&'(
vwxy¢£&cde
" ž–¤¥¦5§¨5©«¬0­
Patient: 54f5ghUPS0U
ijkl6m= nopqr st04
ijkl6m=5nopqr5st04
ER", PgR", HER2uhU
" vw®´¯L/’“h°±²³”•bG3"4,
vw® ¯L/’“h°±²³”• G3 4 (20%
" vw®µ´¯L/¶XbG3"4, (3%
Exposure: vwxyz{|}~€y‚ƒe
~€y‚ƒe42·¸
" [–—bG3"4,
[–—bG3 4 (5"15%
(5 15%
Comparison: vwxyz{|&„…†
" žŸbG3"4, (3%
" ›œbG3"4, (2%
Outcome: ÁÂÃÄQOL
¹G (Grade) 3, 4&cdeb"#&º»¼½¾P¿'0cdeÀ
]^&_`abÁÂÃÄQOL
E2100: HRQOL
Q
Patient: 54f5ghUPS0U
ijkl6m= nopqr st04
ijkl6m=5nopqr5st04
ER", PgR", HER2uhU
Exposure: vwxyz{|}~€y‚ƒe
FACT!General
Å04
Trial Outcome Index (TOI)
Å04
Comparison: vwxyz{|&„…†
Outcome: ÁÂÃÄQOL
ÆÇÈÉÊÈËÌÈÍÎ
ÆÇÈÉÊÈiPÏÐÑÒÓ 32
ÛÜ!"#$%&
E2100: HRQOLªÕÖ5×ØÙ
'
()*+,-./01/2345
67/89:;<=>?@ABCDEFG?B 6H$IJK
67/89:;<=>?@ABCDEFG?BL6H$IJK
2%MNLOPQR:;K25 30STE?U
(VWXY<Z[3\]^E_L:;/`a9KRb8cE?U
de )*+,
de()*+,
67/89deBfgGEhi?jIJK20 50%E?BL
klKmnQRopELOP6 8STEqrKstuv3G?U
Z[3\]^LdeBfgGEhi?jIJB40 65%/wG9
Pacli.+Bevacizum
Pacli.
Bevacizum
17Ú
19%
33Ú
37.1%
Pacli.
30.7%
45.1%
'
'
!"#$%&-}F5
()*+,-~L€[L‚/ƒ„Q…†5
zB"{$m‡QR€[A34Lˆ‰LŠ‹ŒŽL
‘R’“”R_$B•9G?U
‘R “ R_
•9 ?U
–—˜™šEKL0›/œ<ž?3tŸB 20%/0¡G?U
–—˜¢ šEK w£R¤l¥B 2%/0¡G?
–—˜¢™šEKLw£R¤l¥B 2%/0¡G?U
(VWXY<Z[3\]^L67$¦§¨©ªB«¬R
w‹­B 5 15%,!®Š¯B 3%,!°±B 2%/0¡G?U
qrBuv?jGE$CxB1 6ST=tG?U
qrBuv3\]^K y$zB"{<|?@A/R9G?
qrBuv3\]^KLy$zB"{<|?@A/R9G?U
33
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É1ÊË¿š•\9Ì
ª{Í
¾¿À–—Áš
¾¿À–—Áš(ÒÓÕ:!Ö×Ø)
ÄVÅÆÇÈ
45kg
1.5m2
135mg
450mg
[Ã
100mg
30mg
100mg
30mg
Ά
¥30,505
¥10,264
¥15,474
¥5,587
ÏÐ
1
2
1
2
iÑ
¥30,505
¥20,528
¥15,474
¥11,174
100mg
400mg
¥45,563
¥173,511
1
1
¥45,563
¥173,511
(ٞÚÛ7ÜÝ$Þ[<1.5ßà/ÊË¿šA?j)
(ٞÚÛ7ÜÝ$Þ[<
.5ßà/ÊË¿šA?j)
É4á•\9â7ÞÌ
¾¿À–—Ášæ (days!1,!8,!and!15)
¾¿À–—Ášæ (ÒÓÕ)
â7Þãä
¥198,099
¥124,944
3嶷ä
¥59,430!
¥37,483!
¾¿À–—Áš + ÄVÅÆÇÈæ (days
(d
1 and
d 15)
¥636 247
¥636,247
¥190 874
¥190,874
μ೏ᠰ᛭塄၄ (70䀚‫آ‬㻫)ν
'
()*+,-‚„Q…†5
Z[3\]^E_L²‡QR0›$³/`a9KRb8cE?U
¿À–—Áš
¾¿À–—Áš
¾¿À–—Áš (ÒÓÕ)
¾¿À–—Áš +!ÄVÅÆÇÈ
çèéê
m‡
¥59,430
¥37,483
¥151,362
¥59,430
¥37,483
¥83,792
ëéê Ϟԡ᠔ᕫ (໮᭄ಲ) m‡ (kÐì) Ԣ᠔ᕫ (໮᭄ಲ)
¥35,400
,
¥59,430!
,
¥59,430!
,
¥24,600!
,
¥35,400
¥37,483!
¥37,483!
¥24,600!
¥35,400
¥83,400
¥44,400!
¥24,600!
É70íMN:m‡Ì
¾¿À–—Áš
¾¿À–—Áš (ÒÓÕ)
¾¿À–—Áš +!ÄVÅÆÇÈ
1îT
2îT
3îT
4îT
5îT
6îT
¥59,430
¥37,483
¥83,792
¥59,430
¥37,483
¥83,792
¥59,430
¥37,483
¥83,792
¥59,430
¥37,483
¥44,400
¥59,430
¥37,483
¥44,400
¥59,430
¥37,483
¥44,400
Discussion point
Discussion!point
ïð3\ñò/LS\89KRbSó
ïð3\ñò<L'
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ö÷øù$\ú/ûü34bjñòKRbSó
â7Þý£Aâ7´µ$þÿ
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