SELECT BC -Health Related QOL-
Comprehensive Support Project
•
? –
• (1 ?
Study design
SELECT BC
Taxane
Discretion of the investigator
TS1
(years) 0 1 2 3 4 5 6 7
Taxane 286 240 186 146 55 15 2 S-1 306 258 208 135 55 13 4
100
0
20
40
60
80
Ove
rall
surv
ival
(%)
HR=1.05 (95% CI 0.86, 1.27) p =0.015 (Non-inferiority margin: HR=1.33)
Median OS
No. events
Taxane (n=286) 37.2 M 191 S-1 (n=306) 35.0 M 206
Overall Survival
*TS1 taxane
OK!
*HER2 non-life-threatening
QOL
( )
EORTC QLQ-C30 PNQ (neurotoxicity) EQ-5D
baseline 3 6 12 18 24M (every 6M)
QOL SELECT BC
EORTC QLQ C-30 (version 3.0)
1 2 3 4
1 2 3 4 5 6 7
1-28 29,30
PNQ( )
SELECT BC -Health Related QOL-
Comprehensive Support Project
Survival analysis n=592
Taxane (n=286) S-1 (n=306) DTX (n=146) PTX (n=140)
Patients enrolled N=618) Taxane (n=309) S-1 (n=309)
Eligible n=608 Taxane (n=301) S-1 (n=307)
Ineligible n=10 Taxane (n=8) S-1 (n=2)
No treatment n=16 Taxane (n=15) S-1 (n=1)
From 258 institutions Enrollment period: Oct 2006 - Jul 2010 Median follow up time: 34.6 months Number of death events: 398
QOL analysis n=391
Taxane (n=179) S-1 (n=212) DTX (n=98) PTX (n=81) DTX: Docetaxel, PTX: Paclitaxel
SELECT BC CONSORT diagram SELECT BC QOL
• EORTC QLQ-C30 • EQ-5D • PNQ
)
) )
)
( )
(EORTC QLQ C-30) (On treatment analysis) Global health status/QOL
Physical functioning
Role functioning , Emotional functioning ,
Cognitive functioning , Social functioning ,
Financial difficulties , Pain ,
SELECT BC QOL
• EORTC QLQ-C30 • EQ-5D • PNQ
EQ-5D (5 QOL , )
EQ-5D
(On treatment analysis) SELECT BC
QOL
• EORTC QLQ-C30 • EQ-5D • PNQ
PNQ PNQ
0
10
20
30
40
50
60
70
80
90
*TS1 taxane
QOL
OK!
Global health status Functional scales
S1 taxan
vs
*:HER2 non-life-threatening
