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