of 4/4
SELECT BC -Health Related QOL- Comprehensive Support Project *QTVQDCI[K㌿⛣ᛶங⒴⒪ணᚋⰋዲឤᛶணᚋⰋࡣࡓ㠀ឤᛶḟ⒪ἲḟᏛ⒪ἲ#QT6 ḟ⒪ἲḟ⒪ἲḟᏛ⒪ἲḟᏛ⒪ἲ*'4㝧ᛶ➼ຍ䝸䝃䞊䝏䜽䜶䝇䝏䝵䞁 ㌿⛣䡡Ⓨங⒴䛻ᑐ䛧䛶䚸స⏝䜢⪃៖䛻ධ䜜䛪 䛂ዌຠ⋡䛾㧗䛔⸆䛛䜙㡰䛻⏝䛩䜛䛃䛸䛔䛖䛣䜜 䜎䛷䛾ᡓ␎䛿ᮏᙜ䛻ṇ䛧䛔䛾䛛? 䝩䝹䝰䞁ឤᛶ䛾䛒䜛ங⒴䛻ᑐ䛧䛶䛿䝩䝹䝰䞁䜢ඛ 䛻⏝䛧䛶䛔䜛䛻䜒䛛䛛䜟䜙䛪 (䛣䜜䜎䛷䛾㟼ὀ⸆䛾ᑐᴟ䛻⨨䛩䜛䠅⤒ᢠ䛜 䜣䜢1ḟ⒪䛸䛧䛶⏝䛧䛶䜒Ⰻ䛔䛾䛷䛿? Study design ㌿⛣䡡Ⓨங⒴ ḟ⒪ 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 Overall survival (%) 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 ᠃ᆆϐʐၶ*ƴݣƢǔɟഏܖඥƱƠƯŴ TS1ǛဇƠƨ፭ƕŴtaxaneኒ৴ƕǜдǛဇƠ ƨ፭ƴൔƠƯμဃ܍᧓ưэǒƳƍ 䛹䛱䜙䛛䜙ጞ䜑䛶䜒OK! *HER2㝜ᛶ䚸non-life-threatening 䞉ᶆ‽⒪䜢ඃඛ䛩䜛㑅ᢥ QOL䚸స⏝䜢ඃඛ䛩䜛㑅ᢥ ౯ᑻᗘ(㉁ၥ⚊) EORTC QLQ-C30 PNQ (neurotoxicity) EQ-5D baseline3 6㻌㻌㻌 12㻌㻌㻌 18㻌㻌㻌 24M䞉䞉 㻌㻌㻌 㻌㻌㻌 㻌㻌㻌 㻌㻌㻌 䖃䞉䞉䞉(every 6M) ᧙ᡲQOL SELECT BC EORTC QLQ C-30 (version 3.0)

Comprehensive Project £ Y, r S c SELECT BC Í Ý Ô å …SELECT BC -Health Related QOL- Comprehensive Support Project *QTVQDCI[K b3?&ã ö $´ $ª Ý Ü ¬ Ò £ , ò [ Í Ý Ô

  • View
    0

  • Download
    0

Embed Size (px)

Text of Comprehensive Project £ Y, r S c SELECT BC Í Ý Ô å …SELECT BC -Health Related QOL-...

  • 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