ComprehensiveSupportProject*QTVQDCI[Kࡢ㌿⛣ᛶங⒴἞⒪࢔ࣝࢦࣜࢬ࣒
ணᚋ୙Ⰻࡲࡓࡣ࣍ࣝࣔࣥ㠀ឤཷᛶணᚋⰋዲ࡛࣍ࣝࣔࣥឤཷᛶ

SELECT BCḟ࣍ࣝࣔࣥ⒪ἲ

ḟ໬Ꮫ⒪ἲ #QT6 ḟ࣍ࣝࣔࣥ⒪ἲ

ḟ໬Ꮫ⒪ἲ -Health Related QOL-ḟ໬Ꮫ⒪ἲ ḟ࣍ࣝࣔࣥ⒪ἲ
*'4㝧ᛶ౛࡛ࡣࣁ࣮ࢭࣉࢳࣥ➼ࡶຍࢃࡿ

SELECT BC䝸䝃䞊䝏䜽䜶䝇䝏䝵䞁Taxane• 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ឤཷᛶ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

Discretion ofthe investigator㌿⛣䡡෌Ⓨங⒴୍ḟ἞⒪TS1Overall SurvivalMedianOSNo.
eventsTaxane (n=286)

37.2 M

191

S-1 (n=306)

35.0 M

206

Overall survival (%)

100
80

HR=1.05 (95% CI 0.86, 1.27)
p =0.015 (Non-inferiority margin:HR=1.33)

60
40

䛹䛱䜙䛛䜙ጞ䜑䛶䜒OK!

䞉ᶆ‽἞⒪䜢ඃඛ䛩䜛㑅ᢥ
䞉QOL䚸๪స⏝䜢ඃඛ䛩䜛㑅ᢥ

20
0TaxaneS-1᠃ᆆ᳽ϐႆʐၶ*ƴ‫ݣ‬Ƣǔɟഏ҄‫ܖ‬ၲඥƱƠƯŴ
TS1Ǜ̅ဇƠƨ፭ƕŴtaxaneኒ৴ƕǜдǛ̅ဇƠƨ፭ƴൔƠƯμဃ‫܍‬஖᧓ưэǒƳƍ

0

1

2

3

4

5

6

286
306

240
258

186
208

146
135

55
55

15
1324SELECT BC

7(years)*HER2㝜ᛶ䚸non-life-threatening

ͤࡍ᧙ᡲQOLホ౯ᑻᗘ(㉁ၥ⚊)䖃EORTC QLQ-C30䖃PNQ (neurotoxicity)
䖃EQ-5Dbaseline㻌 3㻌6㻌 㻌 㻌 12㻌 㻌 㻌 18㻌 㻌 㻌 24M䞉䞉

䖃㻌 㻌 䖃㻌 䖃㻌 㻌 㻌 䖃㻌 㻌㻌 䖃㻌䖃㻌 䖃㻌 㻌 㻌 䖃㻌 㻌 㻌 䖃㻌 㻌 㻌 䖃䞉䞉䞉(every 6M)

EORTC QLQ C-30
(version 3.0)㻌㻱㻻㻾㼀㻯㻌㻽㻸㻽㻙㻯㻟㻜㻌㻝㻌㔜䛔㈙䛔≀⿄䜔䝇䞊䝒䜿䞊䝇䜢㐠䜆䛺䛹䛾ຊ௙஦䛻ᨭ㞀䛜䛒䜚䜎䛩䛛㻌㻝㻢㻌౽⛎䛜䛒䜚䜎䛧䛯䛛㻌㻞㻌㛗䛔㊥㞳䜢Ṍ䛟䛣䛸䛻ᨭ㞀䛜䛒䜚䜎䛩䛛㻌㻝㻣㻌ୗ⑩䛜䛒䜚䜎䛧䛯䛛㻌㻟㻌ᒇእ䛾▷䛔㊥㞳䜢䛒䜛䛟䛣䛸䛻ᨭ㞀䛜䛒䜚䜎䛩䛛㻌㻝㻤㻌⑂䜜䛶䛔䜎䛧䛯䛛㻌㻠㻌୍᪥୰䝧䝑䝗䜔䜲䝇䛷㐣䛤䛥䛺䛡䜜䜀䛺䜚䜎䛫䜣䛛㻌㻝㻥㻌③䜏䛜䛒䛺䛯䛾᪥䚻䛾άື䛾䛥䜎䛯䛢䛻䛺䜚䜎䛧䛯䛛㻌㣗䜉䜛䛣䛸䚸⾰㢮䜢╔䜛䛣䛸䚸㢦䜔య䜢Ὑ䛖䛣䛸䚸౽ᡤ䛻䛔䛟䛣䛸䛻ே䛾ᡭ䜢䜒䛾䛤䛸䛻㞟୰䛧䛻䛟䛔䛣䛸䛜䛒䜚䜎䛧䛯䛛䚹㻌䛯䛸䛘䜀᪂⪺䜢ㄞ䜐䛸䛝䜔䚸䝔䝺䝡䜢ぢ䜛䜘䛖㻡㻌㻞㻜㻌೉䜚䜛ᚲせ䛜䛒䜚䜎䛩䛛㻌䛺䛸䛝䛺䛹䚹㻌㻢㻌௙஦䜢䛩䜛䛣䛸䜔᪥ᖖ⏕άάື䛻ᨭ㞀䛜䛒䜚䜎䛧䛯䛛㻌㻞㻝㻌⥭ᙇ䛧䛯Ẽศ䛷䛧䛯䛛㻌㻣㻌㊃࿡䜔䝺䝆䝱䞊䜢䛩䜛䛾䛻ᨭ㞀䛜䛒䜚䜎䛧䛯䛛㻌㻞㻞㻌ᚰ㓄䛜䛒䜚䜎䛧䛯䛛㻌㻤㻌ᜥษ䜜䛜䛒䜚䜎䛧䛯䛛㻌㻞㻟㻌ᛣ䜚䛳䜍䛔Ẽศ䛷䛧䛯䛛㻌㻥㻌③䜏䛜䛒䜚䜎䛧䛯䛛㻌㻞㻠㻌ⴠ䛱㎸䜣䛰Ẽศ䛷䛧䛯䛛㻌㻝㻜㻌ఇᜥ䜢䛸䜛ᚲせ䛜䛒䜚䜎䛧䛯䛛㻌㻝㻞㻌యຊ䛜ᙅ䛟䛺䛳䛯䛸ឤ䛨䜎䛧䛯䛛㻌㻞㻡㻌䜒䛾ぬ䛘䛜ᝏ䛟䛺䛳䛯䛸ᛮ䛔䜎䛧䛯䛛㻌㌟య䛾ㄪᏊ䜔἞⒪䛾ᐇ᪋䛜䚸ᐙ᪘䛾୍ဨ䛸䛧䛶䛾䛒䛺䛯䛾⏕ά䛾䛥䜎䛯䛢䛻䛺䜚䜎䛧䛯㻞㻢㻌䛛㻌㻞㻣㻌㌟య䛾ㄪᏊ䜔἞⒪䛾ᐇ᪋䛜䚸䛒䛺䛯䛾♫఍ⓗ䛺άື䛾䛥䜎䛯䛢䛻䛺䜚䜎䛧䛯䛛㻌㻝㻟㻌㣗ḧ䛜䛺䛔䛸ឤ䛨䜎䛧䛯䛛㻌

㻞㻤㻌㌟య䛾ㄪᏊ䜔἞⒪䛾ᐇ᪋䛜䚸䛒䛺䛯䛾⤒῭ୖ䛾ၥ㢟䛻䛺䜚䜎䛧䛯䛛䚹㻌㻝㻠㻌ྤ䛝Ẽ䛜䛒䜚䜎䛧䛯䛛㻌㻞㻥㻌䛣䛾୍㐌㛫䛾䛒䛺䛯䛾೺ᗣ≧ែ䛿඲య䛸䛧䛶䛹䛾⛬ᗘ䛰䛳䛯䛷䛧䜗䛖䛛㻌㻝㻡㻌ྤ䛝䜎䛧䛯䛛㻌㻟㻜㻌䛣䛾୍㐌㛫䚸䛒䛺䛯䛾඲యⓗ䛺⏕άෆᐜ䛿㉁ⓗ䛻䛹䛾⛬ᗘ䛰䛳䛯䛷䛧䜗䛖䛛㻌㻝㻝㻌╧╀䛻ᨭ㞀䛜䛒䜚䜎䛧䛯䛛㻌ᶵ⬟ᑻᗘ㻌 ㌟యᶵ⬟

1-28

29,30
1

䜎䛳䛯䛟䛺䛔 㻌 ᑡ䛧䛒䜛㻌 㻌 ከ䛔㻌 㻌 䛸䛶䜒ከ䛔
12
342

඲⯡ⓗ೺ᗣ
㻌 ඲⯡ⓗ೺ᗣ

34567

㻌 ᙺ๭ᶵ⬟㻌 ᚰ⌮ᶵ⬟㻌 ㄆ▱ᶵ⬟㻌 ♫఍ᶵ⬟⑕≧ᑻᗘ㻌 ೏ᛰឤ㻌 ᝏᚰ䞉჎ྤ㻌 ⑊③㻌 ࿧྾ᅔ㞴ឤ㻌 ୙╀㻌 㣗ḧ୙᣺
㻌 ౽⛎
㻌 ୗ⑩㻌
㻌 ⤒῭ⓗᅔ❓

'3&PNQ(⚄⤒ẘᛶᑻᗘ)་⒪⤒῭ホ౯䛻䜒⏝䛔䜙䜜䜛ୗጔ䜙䛜ṇᘧ䛺᪥ᮏㄒ∧䜢㛤Ⓨ䚸∧ᶒ䛿ཎ∧䛾㛤Ⓨ⪅䛷䛒䜛'U+DXVKHHU䛜ᡤ᭷'3&
࠙㉁ၥࠚ ⛣ືࡢ⛬ᗘ࡟ࡘ࠸࡚࠾ࡁࡁࡋࡲࡍ ⚾ࡣṌࡁᅇࡿࡢ࡟ࠊၥ㢟ࡣ࡞࠸ ⚾ࡣṌࡁᅇࡿࡢ࡟ࠊ࠸ࡃࡽ࠿ၥ㢟ࡀ࠶ࡿ ⚾ࡣ࣋ࢵࢺ㸦ᗋ㸧࡟ᐷࡓࡁࡾ࡛࠶ࡿ
࠙㉁ၥࠚ ㌟ࡢᅇࡾࡢ⟶⌮࡟ࡘ࠸࡚࠾ࡁࡁࡋࡲࡍ ⚾ࡣ㌟ࡢᅇࡾࡢ⟶⌮࡟ࠊၥ㢟ࡣ࡞࠸ ⚾ࡣὙ㠃ࡸ╔᭰࠼ࢆ⮬ศ࡛ࡍࡿࡢ࡟ࠊ࠸ࡃࡽ࠿ၥ㢟ࡀ࠶ࡿ ⚾ࡣὙ㠃ࡸ╔᭰࠼ࢆࠊ⮬ศ࡛࡛ࡁ࡞࠸
࠙㉁ၥࠚ ࡩࡔࢇࡢ⏕ά㸦౛㸸௙஦ࠊຮᙉࠊᐙ᪘ࠊవᬤάື㸧࡟ࡘ࠸࡚࠾ࡁࡁࡋࡲࡍ ⚾ࡣࡩࡔࢇࡢάືࢆ⾜࠺ࡢ࡟ࠊၥ㢟ࡣ࡞࠸ ⚾ࡣࡩࡔࢇࡢάືࢆ⾜࠺ࡢ࡟ࠊ࠸ࡃࡽ࠿ၥ㢟ࡀ࠶ࡿ ⚾ࡣࡩࡔࢇࡢάືࢆ⾜࠺ࡇ࡜ࡀ࡛ࡁ࡞࠸
࠙㉁ၥࠚ ③ࡳ୙ᛌឤ࡟ࡘ࠸࡚࠾ࡁࡁࡋࡲࡍ ⚾ࡣ③ࡳࡸ୙ᛌឤࡣ࡞࠸ ⚾ࡣ୰⛬ᗘࡢ③ࡳࡸ୙ᛌឤࡀ࠶ࡿ ⚾ࡣࡦ࡝࠸③ࡳࡸ୙ᛌឤࡀ࠶ࡿ
࠙㉁ၥࠚ ୙Ᏻࡩࡉࡂ㎸ࡳ࡟ࡘ࠸࡚࠾ࡁࡁࡋࡲࡍ ⚾ࡣ୙Ᏻ࡛ࡶࠊࡩࡉࡂ㎸ࢇ࡛ࡶ࠸࡞࠸ ⚾ࡣ୰⛬ᗘ࡟୙Ᏻࠊ࠶ࡿ࠸ࡣࡩࡉࡂ㎸ࢇ࡛࠸ࡿ ⚾ࡣࡦ࡝ࡃ୙Ᏻࠊ࠶ࡿ࠸ࡣࡩࡉࡂ㎸ࢇ࡛࠸ࡿ

SELECT BC CONSORT diagramPatients enrolled䠄N=618)
Taxane (n=309)
S-1 (n=309)

Eligible䠄n=608䠅
Taxane (n=301)
S-1 (n=307)
Survival analysis䠄n=592䠅
Taxane (n=286)
S-1 (n=306)
DTX (n=146)
PTX (n=140)
QOL analysis䠄n=391䠅
Taxane (n=179)
S-1 (n=212)
DTX (n=98)
PTX (n=81)

From 258 institutions
Enrollment period: Oct 2006 - Jul 2010
Median follow up time: 34.6 months
Number of death events: 398
Ineligible䠄n=10䠅
Taxane (n=8)
S-1 (n=2)Comprehensive
SupportProject

SELECT BC-Health Related QOL⤖ᯝSELECT BC
QOL ᐃ㡯┠• EORTC QLQ-C30• EQ-5D• PNQ

No treatment䠄n=16䠅
Taxane (n=15)
S-1 (n=1)

DTX: Docetaxel, PTX: Paclitaxel
7:DWDQDEHHWDO6$%&63

⤖ᯝ(EORTC QLQ C-30)

(On treatment analysis)

㻌㻌㻌㻌

㻌㻌

㻌㻌 㻌㻌㻿㼡㼎㻌㼟㼏㼍㼘㼑㻌㻌㻌Global health status/QOL䠄඲⯡ⓗ೺ᗣ䠅ΰྜຠᯝ䝰䝕䝹䠄஺஫స⏝㡯䛺䛧䠅㻌㻌㻌⩌㻌㻌㻌㻜㻚㻜㻠㻌㼀㻿㻙㻝㻪㼀㼍㼤㼍㼚㻌㻼㼔㼥㼟㼕㼏㼍㼘㻌㼒㼡㼚㼏㼠㼕㼛㼚㼕㼚㼓㻌㻔㌟యᶵ⬟)㻨㻚㻜㻝㻌㼀㻿㻙㻝㻪㼀㼍㼤㼍㼚㻌㻾㼛㼘㼑㻌㼒㼡㼚㼏㼠㼕㼛㼚㼕㼚㼓㻌㻔ᙺ๭ᶵ⬟)㻨㻚㻜㻝㻌㼀㻿㻙㻝㻪㼀㼍㼤㼍㼚㻌㻱㼙㼛㼠㼕㼛㼚㼍㼘㻌㼒㼡㼚㼏㼠㼕㼛㼚㼕㼚㼓㻌㻔ᚰ⌮ᶵ⬟㻕㻨㻚㻜㻝㻌㼀㻿㻙㻝㻪㼀㼍㼤㼍㼚㻌㻯㼛㼓㼚㼕㼠㼕㼢㼑㻌㼒㼡㼚㼏㼠㼕㼛㼚㼕㼚㼓㻌㻔ㄆ▱ᶵ⬟㻕㻜㻚㻜㻞㻌㼀㻿㻙㻝㻪㼀㼍㼤㼍㼚㻌㻿㼛㼏㼕㼍㼘㻌㼒㼡㼚㼏㼠㼕㼛㼚㼕㼚㼓㻌㻔♫఍ᶵ⬟㻕㻨㻚㻜㻝㻌㼀㻿㻙㻝㻪㼀㼍㼤㼍㼚㻌

䛆㉁ၥ㡯┠䛇㻳㼘㼛㼎㼍㼘㻌㼔㼑㼍㼘㼠㼔㻌㼟㼠㼍㼠㼡㼟㻌㻛㻽㼛㻸㻌㻔඲⯡ⓗ೺ᗣ)䛆⤖ᯝ䛇㻲㼡㼚㼏㼠㼕㼛㼚㼍㼘㻌㼟㼏㼍㼘㼑㼟㻌㻿㼥㼙㼜㼠㼛㼙㻌㼟㼏㼍㼘㼑㼟㻌㻛㻌㼕㼠㼑㼙㼟㻌㻲㼍㼠㼕㼓㼡㼑㻌㻔೏ᛰឤ)㻌㻌㻌㻌㻜㻚㻝㻞㻌㻺㼍㼡㼟㼑㼍㻌㼍㼚㼐㻌㼢㼛㼙㼕㼠㼕㼚㼓㻌㻔ᝏᚰ䞉჎ྤ㻕㻜㻚㻡㻞㻌㻼㼍㼕㼚㻌㻔⑊③㻕㻜㻚㻜㻠㻌㻰㼥㼟㼜㼚㼑㼍㻌㻔࿧྾ᅔ㞴ឤ㻕㻜㻚㻥㻝㻌㻵㼚㼟㼛㼙㼚㼕㼍㻌㻔୙╀㻕㻜㻚㻥㻣㻌㻭㼜㼜㼑㼠㼕㼠㼑㻌㼘㼛㼟㼟㻌㻔㣗ḧ୙᣺㻕㻜㻚㻝㻠㻌㻯㼛㼚㼟㼠㼕㼜㼍㼠㼕㼛㼚㻌㻌 (౽⛎㻕㻜㻚㻤㻥㻌㻰㼕㼍㼞㼞㼔㼑㼍㻌㻔ୗ⑩)㻌
㻲㼕㼚㼍㼚㼏㼕㼍㼘㻌㼐㼕㼒㼒㼕㼏㼡㼘㼠㼕㼑㼟㻌㻔⤒῭ⓗᅔ❓㻕㻜㻚㻡㻢㻌㻨㻚㻜㻝㻌㼀㻿㻙㻝㻪㼀㼍㼤㼍㼚㻌㼀㻿㻙㻝㻪㼀㼍㼤㼍㼚㻌 㻌(257&4/4&඲⯡ⓗ೺ᗣ䝇䜿䞊䝹䛻䛚䛔䛶6⩌䛜Ⰻዲ䛷䛒䛳䛯䚹

Role functioning䠄ᙺ๭ᶵ⬟䠅,Emotional functioning䠄ᚰ⌮ᶵ⬟䠅,

Physical functioning䠄㌟యᶵ⬟䠅䛆㉁ၥ㡯┠䛇䛆⤖ᯝ䛇

䛆㉁ၥ㡯┠䛇
䛆㉁ၥ㡯┠䛇䛆⤖ᯝ䛇䛆⤖ᯝ䛇(257&4/4&㌟యᶵ⬟䝇䜿䞊䝹䛻䛚䛔䛶6⩌䛜Ⰻዲ䛺⤖ᯝ䛷䛒䛳䛯䚹
(257&4/4&㻌 ᙺ๭ᶵ⬟䚸ᚰ⌮ᶵ⬟䝇䜿䞊䝹䛻䛚䛔䛶䚸6⩌䛜Ⰻዲ䛺⤖ᯝ䛷䛒䛳䛯䚹㻌 㻌 Cognitive functioning䠄ㄆ▱ᶵ⬟䠅,Social functioning䠄♫఍ᶵ⬟䠅,
䛆㉁ၥ㡯┠䛇

䛆㉁ၥ㡯┠䛇
䛆㉁䛆⤖ᯝ䛇䛆⤖ᯝ䛇䛆⤖ᯝ䛇

(257&4/4&㻌 ㄆ▱ᶵ⬟䚸♫఍ᶵ⬟䝇䜿䞊䝹䛻䛚䛔䛶䚸6⩌䛜Ⰻዲ䛺⤖ᯝ䛷䛒䛳䛯䚹㻌 㻌 

SELECT BCQOL ᐃ㡯┠• EORTC QLQ-C30• EQ-5D• PNQ

Financial difficulties䠄⤒῭ⓗᅔ❓䠅,Pain䠄⑊③䠅,
䛆㉁ၥ㡯┠䛇

䛆㉁ၥ㡯┠䛇

䛆⤖ᯝ䛇

䛇
䛆⤖ᯝ䛇

(257&4/4&㻌 ⤒῭ⓗᅔ❓䚸⑊③䝇䜿䞊䝹䛻䛚䛔䛶䚸6⩌䛜Ⰻዲ䛺⤖ᯝ䛷䛒䛳䛯䚹㻌 㻌 EQ-5D (5㡯┠䛾QOLᑻᗘ,ຠ⏝್䜈䛾᥮⟬䛜ᐜ᫆)

EQ-5D (On treatment analysis)

SELECT BCQOL ᐃ㡯┠• EORTC QLQ-C30• EQ-5D• PNQ(4'䛿6⩌䛷Ⰻዲ䛰䛳䛯
7:DWDQDEHHWDO6$%&63

PNQ䛻䜘䜛⚄⤒㞀ᐖホ౯⤖ᯝ

314ホ౯䛻䜘䜛⚄⤒ẘᛶ䛾᭱኱䜾䝺䞊䝗䛿䚸'7;37;䛸ẚ䜉䛶6⩌䛷㍍ᗘ䛺⤖ᯝ䛷䛒䛳䛯䚹᭷ᐖ஦㇟㻌㻦㻌⮫ᗋᡤぢ㻌PNQ䛻䜘䜛⚄⤒㞀ᐖホ౯⤖ᯝ

314ホ౯䛻䜘䜛⚄⤒ẘᛶ*UDGH௨ୖ䛾⣼✚๭ྜ䛷䛿䚸
6⩌䛸ẚ㍑䛧䛶䝍䜻䝃䞁⩌䛷䛿᫬㛫⤒㐣䛸䛸䜒䛻*UDGH䛾ᮎᲈ⚄⤒㞀ᐖ䛾Ⓨ⏕㢖ᗘ䛜㧗䛟䛺䛳䛶䛔䛯䚹

᠃ᆆ᳽ϐႆʐၶ*ƴ‫ݣ‬Ƣǔɟഏ҄‫ܖ‬ၲඥƱƠƯŴ
TS1Ǜ̅ဇƠƨ፭ƕŴtaxaneኒ৴ƕǜдǛ̅ဇƠƨ፭ƴൔƠƯμဃ‫܍‬஖᧓ưэǒƳƍ

9080

㼀㼍㼤㼍㼚㼑㻌70᭷ᐖ஦㇟䛿㻭㼘㼘㻌㻳㼞㼍㼐㼑㻌㻌
60
50
4030
20
100㻿㻙㻝㻌

*:HER2㝜ᛶ 䜎䛯䛿non-life-threatening䛹䛱䜙䛛䜙ጞ䜑䛶䜒OK!

䞉ᶆ‽἞⒪䜢ඃඛ䛩䜛㑅ᢥ䞉QOL䚸๪స⏝䜢ඃඛ䛩䜛㑅ᢥ䠘ᝈ⪅䛻᝟ሗᥦ౪䠚䞉Global health status䜔Functional scales䚸▱ぬ㞀ᐖ䛥䜙䛻⬺ẟ䚸ᾋ⭘䛺䛹䛻䛚䛔䛶S1䛜Ⰻዲ䞉ᾘ໬ჾ⑕≧䛻䛚䛔䛶䛿taxan䛜䜔䜔Ⰻዲ䠛䞉Ⅼ⁲vsෆ᭹䚸⤒῭㠃