enhanced efficacy with iressa (ahmad hudoyo)
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7/21/2019 Enhanced Efficacy With Iressa (Ahmad Hudoyo)
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Enhanced Efficacy ofGefitinib for NSCLC in
AsiansAhmad Hudoyo
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Treatment Goals and 2 nd LineTreatment for Advanced NSCLC
Longer life Increasing overall survival !S"
#etter life Sym$tom im$rovement %rolonging $rogression free survival %&S" 'educed to(icity Im$roved )uality of life *oL"
Second+line treatment is an im$ortant issue ,ithlimited outcomes of current -st+line thera$y.
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Gefitinib vs Ta(otere as 2nd line treatment for advanced NSCLC
INTE'EST / a global study of -011 $atients/ demonstratednon+inferiority of gefitinib relative to doceta(el in terms ofoverall survival ha ard ratio 3H'4 -.525/ 617 confidenceinterval 3CI4 5.658+-.-859 median survival :.1 vs ;.5 months"/,ith gefitinib having a more favorable tolerability and )ualityof life $rofile.
ISTANA conducted in
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Gefitinib I'ESSA" versus doceta(el in$atients ,ith locally advanced or metastatic
non+small cell lung cancer $re+treated ,ith$latinum+based chemothera$y=a randomi ed/ o$en+label %hase III study
INTE'EST"
:2= -;56/ 255;
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INTE'EST Study ?esign
Aged -; years
Life e($ectancy ; ,ee@s
%rogressive or recurrent
disease follo,ing
chemothera$y CT"
Considered candidates for
further CT ,ith doceta(el
- or 2 CT regimens -
$latinum"
%erformance status 5+2
%rimary Co+$rimary analyses of !verall survival !S"
non+inferiority in all $atientsand su$eriority in $atients,ith high EG&' gene co$ynumber"
Secondary %rogression+free survival
%&S" !b ective res$onse rate *uality of life ?isease+related sym$toms Safety and tolerability
I'ESSA
285 mgBday
?oceta(el
:8 mgBm > every> ,ee@s
%atients End$oints
-=- randomisation
:2= -;56/ 255;
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'ecruitment by geogra$hical region
SA and Canada -87
Asia China/ Hong
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?oceta(el
Gefitinib
%ost+discontinuation treatmentsITT $o$ulation"
Nothing a$art from further EG&' T
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!verall survival
:2>86> ;2.57"
:-58:1 ;-.-7"
NEvents
%rimary Co( analysis ,ithout covariates
H' 617 CI" -.525 5.658/ -.-85 "
Dedian !S months"-+year survival
:.1>27
;.5>07
Gefitinib ?oceta(el
Conclude non+inferiorityin the overall %% $o$ulation
:2> >>1 228 ->- ;> 85 >- -0 5 5:-5 >>6 22; ->6 ;6 01 20 : 5 5
8-;85>
5 0 ; -2 -1 25 20 2; >2 >1 05
5.5
5.2
5.0
5.1
5.;
-.5
Donths
%
r o b a
b i l i t y o
f s u r v
i v a
l
At ris@ =Gefitinib?oceta(el
The study met its $rimary ob ective of demonstrating non+inferiority of gefitinib relative todoceta(el in terms of overall survival
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!b ective tumour res$onse rate via 'ECIST"
Gefitinib ,as similar to doceta(el in terms of !b ective 'es$onse 'ate
!' 687 CI" -.22 5.;2/ -.;0"$ 5.>28:
7 $
a t i e n
t s r e s $ o n
d i n g
n 186 n 18:
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At ris@ =Gefitinib 186 :: >0 -; 6 8 > 5 5 5?oceta(el 18: 02 -1 0 2 - 5 5 5 5
-6025;
% r o
b a
b i l i t y o
f $ r o g r e s s i o n +
f r e e s u r v
i v a
l
5 0 ; -2 -1 25 20 2; >2 >1 05
5.5
5.2
5.0
5.1
5.;
-.5
Donths
%rogression+free survival
F H' - im$lies a lo,er ris@ of $rogression on gefitinib
H' 687 CI" -.50 5.6>/ -.-;"/ $ 5.018;
NEvents
Co( analysis ,ith covariates
Dedian %&S months"0 months1 months
18686> 65.57"
18:800 ;2.;7"
2.2>27-67
2.:>;7-;7
Gefitinib ?oceta(el
Gefitinib ,as similar to doceta(el in terms of %rogression &ree Survival
PROGRESSION FREE
PROGRESSION FREE
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!S by smo@ing historyNever+smo@er
% r o
b a
b i l i t y o
f s u r v
i v a
l Gefitinib
?oceta(el
Ever+smo@er
% r o
b a
b i l i t y o
f s u r v
i v a
l
Gefitinib?oceta(el
At ris@=
-0;-0>
->5--6
----5-
;-::
8-82
>0>8
-6-:
->:
>-
55
55
8:881:
>;;>;0
2282>;
-00-8-
;5;:
0680
>-26
-;-:
--1
55
55
Gefitinib
?oceta(el
N
Events
Dedian mo"
Gefitinib
8:8
060
1.0
?oceta(el
81:
0:;
1.6
H' 687 CI" -.58 5.6>/ -.-6" $ 5.022-
N
Events
Dedian mo"
Gefitinib
-0;
66
-0.-
?oceta(el
-0>
6;
->.6
H' 687 CI" 5.6> 5.:5/ -.2>" $ 5.122:
-.5
5.;
5.1
5.0
5.2
5.55 0 ; -2 -1 25 20 2; >2 >1 05
Donths
-.5
5.;
5.1
5.0
5.2
5.55 0 ; -2 -1 25 20 2; >2 >1 05
Donths
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!S by gender &emale Dale
% r o
b a
b i l i t y o
f s u r v
i v a
l
efitiniboceta(el
At ris@=2102>1
25;-;>
-1>->8
--160
1:8;
01>;
2022
->--
80
55
55
0860:0
>-5>25
-:>250
-56->0
10;-
>:8-
2120
-;->
6>
55
55
Gefitinib?oceta(el
N
Events
Dedian mo"
Gefitinib
086
>65
1.-
?oceta(el
0:0
>6:
:.5
H' 687 CI" -.56 5.68/ -.28" $ 5.2>18
N
Events
Dedian mo"
Gefitinib
210
25>
--.2
?oceta(el
2>1
-:6
-5.5
H' 687 CI" 5.68 5.:;/ -.-:" $ 5.1822
% r o
b a
b i l i t y o
f s u r v
i v a
l
-.5
5.;
5.1
5.0
5.2
5.55 0 ; -2 -1 25 20 2; >2 >1 05
Donths
Gefitinib?oceta(el
-.5
5.;
5.1
5.0
5.2
5.55 0 ; -2 -1 25 20 2; >2 >1 05
Donths
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!S by histology Non+adenocarcinomaAdenocarcinoma
% r o
b a
b i l i t y o
f s u r v
i v a
l
Gefitinib?oceta(el
05;050
>5>268
2->2-0
-85-06
6;60
8;12
>8>2
2>-:
;0
55
55
At ris@=
% r o
b a
b i l i t y o
f s u r v
i v a
l
>-8>51
2-825;
-2>-28
:8:6
>>08
282:
-8-0
;:
1>
55
55
-.5
5.;
5.1
5.0
5.2
5.55 0 ; -2 -1 25 20 2; >2 >105
Donths
Gefitinib?oceta(el
-.5
5.;
5.1
5.0
5.2
5.55 0 ; -2 -1 25 20 2; >2 >1 05
Donths
Gefitinib?oceta(el
N
Events
Dedian mo"
Gefitinib
>-8
2:0
1.0
?oceta(el
>51
286
1.6
H' 687 CI" -.5: 5.65/ -.2:" $ 5.001:
N
Events
Dedian mo"
Gefitinib
05;
>-6
;.8
?oceta(el
050
>-:
;.6
H' 687 CI" 5.66 5.;0/ -.-8" $ 5.;10:
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!S by racial origin Non+Asian originAsian origin
% r o
b a
b i l i t y o
f s u r v
i v a
l
% r o
b a
b i l i t y o
f s u r v
i v a
l
Gefitinib
?oceta(el
-80
-15
-2:
->>
61
--5
12
::
>6
08
21
2:
-;
-1
->
:
8
-
5
5
5
5
At ris@=
816
885
>6-
>:5
205
226
-1>
-8-
62
60
8:
12
>2
>5
-;
-:
6
1
5
5
5
5
Gefitinib?oceta(el
Gefitinib?oceta(el
-.5
5.;
5.1
5.0
5.2
5.55 0 ; -2 -1 25 20 2; >2 >1 05
Donths
-.5
5.;
5.1
5.0
5.2
5.55 0 ; -2 -1 25 20 2; >2 >1 05
Donths
N
Events
Dedian mo"
Gefitinib
816
0;-
1.6
?oceta(el
885
086
1.6
H' 687 CI" -.5- 5.;6/ -.-0" $ 5.6286
N
Events
Dedian mo"
Gefitinib
-80
--2
-5.0
?oceta(el
-15
--:
-2.2
H' 687 CI" -.50 5.;5/ -.>8" $ 5.::--
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High EG&' gene co$y number ,as notassociated ,ith clinical characteristics
A d e n
o c a r c
i n o m a
N o n
+ a d e n
o c a r c
i n o m a
% S 5 + -
% S
2
N e v e
r + s m o
@ e d
E v e r +
s m o @
e d
S e c o
n d + l i n
e
T h i r d
+ l i n e
D a l e
& e m a
l e A s
i a n
N o n + A
s i a n
7 of sam$les,ith highEG&'+gene+co$ynumber
15
85
05
>5
25
-5
5
!verall high EG&'+gene+co$y number rate= 01.87 -:0B>:0"
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!verall survival by EG&'+gene+co$ynumber status ITT $o$ulation"
High EG&'+gene+co$y number
EG&'+gene+co$y number status by treatment interaction test $+value 5.8-1>
% r o
b a b
i l i t y o
f s u r v
i v a
l Gefitinib n ;8"?oceta(el n ;6"
Lo, EG&'+gene+co$y number
% r o
b a b
i l i t y o
f s u r v
i v a
l Gefitinib n 6>"?oceta(el n -5:"
-.5
5.;
5.1
5.0
5.2
5.55 0 ; -2 -1 25 20 2; >2 >1 05
-.5
5.;
5.1
5.0
5.2
5.55 0 ; -2 -1 25 20 2; >2 >1 05
%rimary Co( analysis ,ithout covariates
DonthsDonths
H' 687 CI" 5.6> 5.1;/ -.21" $ 5.10-1
Dedian survival mo"= gefitinib 1.0/ doceta(el :.:
H' 687 CI" -.56 5.:;/ -.8-" $ 5.1-66
Dedian survival mo"= gefitinib ;.0/ doceta(el :.8
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EG&' mutation a$$eared to be associated,ith some clinical characteristics
A d e n
o c a r c
i n o m a
N o n
+ a d e n
o c a r c
i n o m a
% S 5 + -
% S
2
N e v e
r + s m o
@ e d
E v e r +
s m o @
e d
S e c o
n d + l i n
e
T h i r d
+ l i n e
D a l e
& e m a
l e A s
i a n
N o n + A
s i a n
7 of sam$lesEG&'mutation$ositive
15
85
05
>5
25
-5
5
!verall EG&' mutation $ositive rate -0.;7 00B26:"
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!b ective res$onse rate by treatment andbiomar@er status E&' $o$ulation"
->
:.8 6
-8.;
02.-
1.1
5
6.1:.0
-5.- -- 6.;
>.:1.-
2-.-
--.6
5
-5
25
>5
05
85Gefitinib
?oceta(el
$+values from logistic regression ,ith covariates9 NC/ not calculated
EG&'+gene+co$y number
:: ;- ;5 66
EG&' $roteine($ression
-22 ->1 >; 06
EG&' mutation
-6 -6 -51 -2> 25 2: -56N
$ 5.5>1- $ 5.>:25$ 5.2:0-$ 5.1815$ 5.21;;$ 5.5>;: $ NC $ 5.1262
!''7"
$ositive negativeHigh Lo, $ositive ,ild+ty$e
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!verall survival by EG&' mutation statusITT $o$ulation"
EG&' mutation $ositive
EG&' mutation status by treatment interaction test $+value 5.8;;8
% r o
b a b
i l i t y o
f s u r v
i v a
l Gefitinib n 22"?oceta(el n 22"
EG&' mutation ,ild+ty$e
% r o
b a b
i l i t y o
f s u r v
i v a
l Gefitinib n --6"?oceta(el n ->0"
-.5
5.;
5.1
5.0
5.2
5.55 0 ; -2 -1 25 20 2; >2 >1 05
Donths
-.5
5.;
5.1
5.0
5.2
5.55 0 ; -2 -1 25 20 2; >2 >1 05
Donths
Co( analysis ,ithout covariates
H' 687 CI" -.52 5.:;/ -.>>" $ 5.6->-
Dedian survival mo"= gefitinib 1.0/ doceta(el 1.5
H' 687 CI" 5.;> 5.0-/ -.1:" $ 5.150>
Dedian survival mo"= gefitinib -0.2/ doceta(el -1.1
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%rogression+free survival by EG&' mutationstatus E&' $o$ulation"
EG&' mutation $ositive
Co( analysis ,ith covariates
% r o
b a
b i l i t y o
f % & S
Gefitinib n -6"?oceta(el n -6"
EG&' mutation ,ild+ty$e
% r o
b a
b i l i t y o
f % & S
Gefitinib n -51"?oceta(el n -2>"
-.5
5.;
5.1
5.0
5.2
5.55 0 ; -2 -1 25 20 2; >2 >1 05
Donths
-.5
5.;
5.1
5.0
5.2
5.55 0 ; -2 -1 25 20 2; >2 >1 05
Donths
H' 687 CI" -.20 5.60/ -.10" $ 5.->8>
Dedian %&S mo"= gefitinib -.:/ doceta(el 2.1
H' 687 CI" 5.-1 5.58/ 5.06" $ 5.55-2
Dedian %&S mo"= gefitinib :.5/ doceta(el 0.-
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*oL and sym$tom im$rovement rates
P
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Summary of INTE'EST
This ,as the first time an EG&'+T
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A randomi ed o$en+label study of gefitinibversus doceta(el in $atients ,ith
advancedBmetastatic non+small+cell lungcancer NSCLC" ,ho have $reviously
received $latinum+based chemothera$y
ISTANA Iressa as S econd line Thera$y in Advanced NSCLC+
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ISTANA study design
Gefitinib 285mg daily
?oceta(el :8mgBm 2
every > ,ee@s
Aged -; years Life e($ectancy of at least -2 ,ee@s %rogressive or recurrent disease follo,ing $rior chemothera$y Considered candidates for further chemothera$y ,ith doceta(el %revious chemothera$y regimens must have contained $latinum" %S 5 2 2 nd +line Target number of $rogression events= -25 in ITT $o$ulation 'andomi ation stratified for histology adenocarcinoma vs. others"/ se(/ %S 5+- vs. 2"/
$rior thera$y refractory vs. received"/ smo@ing history ever vs. never" and center.
%rimary end$oint=
%&S-=- 'andomisation
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End$oints of ISTANAThe $rimary end$oint
- Progression-free surviva !P"S#
The Secondary end$oints
- Overa surviva !OS#- O$%e&'ive 'u(or res)onse ra'e !O**#- +o- Safe' an 'o era$i i'
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Dethods of ISTANAStatistical methods -"
The sam$le si e ,as calculated assuming a >:7reduction in the ris@ of $rogression ,ith gefitinib trueH' 5.1>".
nder this assum$tion -25 $rogression events ,ould$rovide ;57 $o,er to detect su$eriority of gefitinib todoceta(el at the 87 -+sided significance level.
!ne hundred and fifty $atients ,ere $lanned to berecruited to allo, the -25 events to be detected ,ithin areasonable timeframe
All efficacy analyses ,ere $erformed in the intent+to+
treat $o$ulation ITT/ all randomi ed $atients".*oL ,as analy ed in the evaluable+for+*oL $o$ulationand safety ,as analy ed in the evaluable+for+safety$o$ulation
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Dethods of ISTANA
Statistical methods 2" nad usted Co( $ro$ortional ha ards model ,as used
to com$are %&S and overall survival bet,een treatmentgrou$s.Su$$ortive analyses using a Co( $ro$ortional ha ardsmodel ad usting for gender/ histology/ smo@ing history/$erformance status/ and disease stage ,ere also$erformed.H's and their associated 657 for %&S" or 687 foroverall survival" CIs and $+values ,ere estimated
!''/ *oL im$rovement rates/ and sym$tomim$rovement ,ere com$ared bet,een treatment grou$susing the Chi+s)uared test
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Dethods of ISTANA*oL and Sym$tom im$rovement assessment
+ &ACT+L )uestionnaires/ com$leted ) >,ee@s until visit :/then ) 0 ,ee@s.
+ &ACT+L consists of >0 )uestions ,hich cover all as$ects
of life= $hysical ,ell being % #"/ functional ,ell being& #"/ socialBfamilial ,ell being S #"/ emotional ,ellbeing E #"/ lung cancer subscale LCS".
+ Trial !utcome Inde( T!I" is the sum of the % #/ & #
and LCS domains.
+ Clinically relevant im$rovement ,as defined as 1 $ointim$rovement for &ACT+L and T!I/ 2 $oint im$rovement forLCS/ maintained for at least 2- days
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%atient characteristics ITT $o$ulation"
Dedian age range"/ years&emale/ 7
H! %S/ 7
5-2
Never+smo@er/ 7Adenocarcinoma/ 7
#est res$onse to last CT%?BNEBun@no,n/ a 7Locally advanced disease/ 7
Gefitinibn ;2"
8: 2-+:0">>
265:
>:11
21
->
?oceta(eln :6"
8; 25+:>"0>
0651
01:5
28
-;
a?efinition of refractory used as one of the stratification factorsH!/ orld Health !rgani ation9 %S/ $erformance status9 CT/ chemothera$y9
%?/ $rogressive disease9 NE/ not evaluable
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?emogra$hy in $atients of Asian racial origin
ISTANAGefitinib
n ;2"
ISTANA?oceta(el
n :6"
INTE'EST
AsianGefitinib
n -80"
INTE'EST
Asian?oceta(el
n -16"
INTE'ESToveralln -011"
ISELAsiansn >02"
Adeno 117 :57 :-7 :-7 8:7 107
%S 5/- 6>7 607 ;67 ;87 ;;7 :27
Never smo@ers >:7 017 827 857 257 0-7
2 nd +line -557 -557 :>7 :07 ;07 8:7
&emale >>7 0>7 0:7 027 >87 057
18 yrs :;7 :87 :07 :;7 107 1-7
#est res$onse to$rior chemoC'B%'
>07 >;7 -;7 -67 267 2-7
#est res$onse to$rior chemo
%?BNE
217 287 0>7 >:7 >-7 087
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'esults of ISTANA%atients
At data cut+off for %&S/ -25 $rogression events:0.87 maturity" and 88 deaths >0.27
maturity" had occurred
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%rogression+free survival ITT $o$ulation"
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!' 687 CI" 0.:0 -.;-/ -2.0-"9 $ 5.555: 2+sided"
%atients7"
n ;2" n :6"
!' M - im$lies a greater chance of res$onse on gefitinib
!b ective 'es$onse rate via 'ECIST ITT"
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&irst $ost+discontinuation treatment
/o&e'a e
efi'ini$
o' ing a)ar' fro( fur' er 4 "* 5 71
! o' ing 20 , gefi'ini$:er o'ini$ 3 #
/o&e'a e 26
O' er in&. & e(o' era) 31
o' ing a)ar' fro( fur' er o&e'a e30
! o' ing 30 , o&e'a e 1 #
4 "* 5 7 a' an )oin' 62
O' er ;
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Early loo@ of overall survival ITT $o$ulation"
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Dost common adverse events evaluable for safety$o$ulation" 3-4
Adverse event/ n 7"All adverse events
Gastrointestinal disorders
?iarrheaNauseaConsti$ation
omitingStomatitis a
?ys$e$siaGeneral disorders
Asthenic conditions a
Chest $ain%ain
All grades:6 6:.8"
2- 28.6"-> -1.5"6 --.-"0 0.6"> >.:"
-5 -2.>"
25 20.:": ;.1"; 6.6"
Grade >B0-: 2-.5"
- -.2"5 5.5"5 5.5"5 5.5"5 5.5"5 5.5"
- -.2"5 5.5"2 2.8"
All grades:2 60.:"
-2 -8.;"-0 -;.0"6 --.;"; -5.8"6 --.;"8 1.1"
2; >1.;"-2 -8.;"
8 1.1"
Grade >B02- 2:.1"
5 5.5"5 5.5"5 5.5"5 5.5"- -.>"5 5.5"
> >.6"5 5.5"5 5.5"
Gefitinib 285 mgn ;-"
?oceta(el :8 mgBm 2n :1"
a
Grou$ed term sum of several $referred terms
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Dost common adverse events evaluable for safety$o$ulation" 324
Adverse event/ n 7"
Detabolism and nutritiondisorders
Anore(iaa
Dusculos@eletal andconnective tissue disorders
Dyalgia
Arthralgia
Nervous system disorders
Neuroto(icity a
?i iness
%sychiatric disorders
Insomnia
All grades
26 >8.;"
0 0.6"> >.:"
-: 2-.5"6 --.-"
-> -1.5"
Grade >B0
5 5.5"
5 5.5"5 5.5"
5 5.5"5 5.5"
5 5.5"
All grades
>1 0:.0"
26 >;.2"6 --.;"
2- 2:.1": 6.2"
-; 2>.:"
Grade >B0
2 2.1"
5 5.5"5 5.5"
5 5.5"5 5.5"
5 5.5"
Gefitinib 285 mgn ;-"
?oceta(el :8 mgBm 2n :1"
a
Grou$ed term sum of several $referred terms
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Dost common adverse events evaluable for safety$o$ulation" 3>4
Adverse event/ n 7"'es$iratory/ thoracic andmediastinal disordersCough?ys$nea%roductive coughHemo$tysis
S@in and subcutaneousdisorders
'ashBAcnes a%ruritus a
Alo$ecia?ry s@inNail and nail bed conditions a
All grades
28 >5.6"25 20.:"2- 28.6"6 --.-"
1- :8.>"05 06.0"
0 0.6"-2 -0.;"
2 2.8"
Grade >B0
5 5.5"> >.:"5 5.5"5 5.5"
> >.:"2 2.8"5 5.5"5 5.5"5 5.5"
All grades
28 >2.6"2- 2:.1"-; 2>.:"
0 8.>"
1 :.6"8 1.1"
>> 0>.0"5 5.5"
6 --.;"
Grade >B0
5 5.5"> >.6"5 5.5"5 5.5"
5 5.5"- -.>"5 5.5"5 5.5"5 5.5"
Gefitinib 285 mgn ;-"
?oceta(el :8 mgBm 2n :1"
a
Grou$ed term sum of several $referred terms
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Summaries of ISTANA
The enrolled $atients ,ere more natural Asian $o$ulation,ho $rogressed after - st line treatment com$ared ,ith theAsian $atients in INTE'EST trial.
The !'' ,as higher ,ith gefitinib com$ared ,ith doceta(el/,hich ,as also different from INTE'EST.
%&S ,as longer ,ith gefitinib com$ared ,ith doceta(el. This,as statistically significant at the $re+defined -+sided 87significance level -+sided $ 5.500-".
An early analysis of overall survival suggests that survivalmay be longer ,ith gefitinib com$ared ,ith doceta(el/ but
the number of events ,as small and follo,+u$ is ongoing.
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D'S O-I'ESSA NI 25-5
LI 25-5 da$at ber alan/ bisamela@sana@an tugas sebagai
guru berdiri dide$an @las tan$a@eluhan.
Evaluasi AN A'I 25--'es$on thera$i sangat bai@
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CHEST O 'AJNI 25-5
CT SCAN TTH!'AO NI 25 5
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CT SCAN TTH!'AO NI 25-5
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C O ' AN A'I 25--
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CT SCAN TH!'AO AN A'I 25--
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#'!NCH!SC!%J 25--
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Conclusion
Gefitinib offers an im$ortant alternative todoceta(el and is $referred 2 nd line treatment that is effective and ,ell tolerated for $atientsin Asian $o$ulation ,ith locally advanced ormetastatic NSCLC ,ho have received $rior$latinum+based chemothera$y and areconsidered candidates for furtherchemothera$y.
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Ta@e Home Dessages
Gefitinib demonstrated e)uivalent survivalas a 2 nd line treatment in all ty$es of$atients regardless of racial ethnicity/gender/ smo@ing history and histology.
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Than@ Jou for Jour AttentionP
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