SELECT BCヨヨ㦂䛾ᴫせSELECT BCヨヨ㦂ᴫせ䛸་⒪⤒῭ホ౯ⓑᒾ ೺㻌 (ᅜ❧ಖ೺་⒪⛉Ꮫ㝔)2017ᖺ7᭶1᪥
@CSP-HORᖺ఍• 䝍䜻䝃䞁⣔ᢠ⒴๣(docetaxel, weekly paclitaxel, triweeklypaclitaxel)䛸S-1䜢ẚ㍑䛧䛯➨3┦↓సⅭ໬ẚ㍑ヨ㦂• ᑐ㇟ᝈ⪅䠖HER2㝜ᛶ䛾㌿⛣ᛶங⒴䛾୍ḟ἞⒪• ୺せホ౯㡯┠: ඲⏕Ꮡᮇ㛫(overall survival: OS)• ๪ḟホ౯㡯┠:• ἞⒪ᡂຌᮇ㛫 (time to treatment failure: TTF)
• ↓ቑᝏ⏕Ꮡᮇ㛫 (progression free survival: PFS)• Ᏻ඲ᛶ (safety)• ೺ᗣ㛵㐃QOL (health-related quality of life: HRQoL)• ㈝⏝ᑐຠᯝ (cost-effectiveness)• 2006ᖺ10᭶䛛䜙2010ᖺ7᭶䜎䛷䛻154᪋タ䛷618ே䜢⤌䜏ධ䜜䛯

QOL/䝺䝺䝉䝥䝖䝕䞊䝍䛾཰㞟᫬Ⅼ᭷ຠᛶホ౯䛾⤖ᯝ(a) OS(b) TTF• EORTC QLQ C-30
䝧䞊䝇䝷䜲䞁3䞄᭶ᚋ

6䞄᭶ᚋ

12䞄᭶ᚋ

• EQ-5D
䝧䞊䝇䝷䜲䞁• 䝺䝉䝥䝖
Lancet Oncol. 2016;17(1):90-8.

Ѝ OS䜢䜶䞁䝗䝫䜲䞁䝖䛸䛧䛶䝍䜻䝃䞁䛻ᑐ䛩䜛S-1䛾㠀ຎᛶ䛜ド᫂䛥䜜䛯

3䞄᭶ᚋ

6䞄᭶ᚋ

12䞄᭶ᚋ

18䞄᭶ᚋ

…

௨ᚋ䚸6䞄
᭶䛤䛸䛻䚸Ṛஸ䜎䛷ྍ⬟䛺㝈䜚ẖ᭶Ⓨ⏕䛩䜛䝺䝉䝥䝖䜢཰㞟…

௨ᚋ䚸Ṛஸ䜎䛷ྍ⬟䛺㝈䜚S-1䛾
䛾་⒪⤒῭ᛶ䛾ศᯒᯟ⤌䜏

QOL/䝺䝺䝉䝥䝖䝕䞊䝍䛾཰㞟䛾ᑐ㇟⪅• ẚ㍑ᑐ↷: 䝍䜻䝃䞁ITT㞟ᅋ• 䝕䞊䝍䝋䞊䝇: SELECT BCヨ㦂QOLㄪᰝ㞟ᅋ (⣙300ே)• ศᯒ䛾❧ሙ: බⓗ་⒪䛾❧ሙ• 䜰䜴䝖䜹䝮ᣦᶆ: QALY (quality-adjusted life year)• ๭ᘬ⋡: 2%䝺䝉䝥䝖ㄪᰝ㞟ᅋ(⣙150ே)• ศᯒᮇ㛫: 4ᖺ
• ㈝⏝䛾⟬ฟ: ༢౯䛿デ⒪ሗ㓘Ⅼᩘ⾲䜔⸆౯ᇶ‽䛻ᇶ䛵䛟䚹䝺䝉䝥䝖䝕䞊䝍䛛䜙ᚓ䜙䜜䜛㈨※ᾘ㈝㔞/Ⅼᩘ䜢⏝䛔䛶⟬ฟ䛩䜛䚹(䛯䛰䛧䚸䝧䞊䝇䜿䞊䝇䛷䛿㈨※ᾘ㈝᫬Ⅼ䛾༢౯䜢⏝䛔䛶䛔䜛)䡡 ᪋タ䛻䜘䜚䛹䛾ㄪᰝ䜎䛷ᐇ᪋䛩䜛䛛䛜Ỵ䜎䛳䛶䛔䜛䚹䡡 ᪋タ䛿᭱ᑠ໬ἲ䛻䛚䛡䜛๭௜ᅉᏊ䚹ᅇ཰⋡䝺䝉䝥䝖䛻䛚䛡䜛᫬Ⅼ㛫ㄪᩚ㻌• ධຊ䛥䜜䛯䝺䝉䝥䝖䝕䞊䝍䛿Ⅼᩘ䛸་⸆ရ䛾䜏Ѝデ⒪⾜Ⅽ䜔≉ᮦ䛿⿵ṇ䛷䛝䛺䛔䚹• ་⸆ရ䝁䞊䝗䛾ኚ໬䛜↓ᩘ䛻㉳䛣䜛㻌

QOL population

Cost population

TaxaneS-1

Taxane

S-1

N=175

N=208

N=70

N=76

Baseline/Month 1

175/175 (100)208/208 (100)5466Month 3

151/171 (88.3)

168/201 (83.6)

70

70

Month 6

138/168 (82.1)

146/190 (76.8)

6666(౛) 䡚2010ᖺ ၟရྡ: 䝔䜱䞊䜶䝇䝽䞁䜹䝥䝉䝹䠎䠌Month 12

107/149 (71.8)

132/170 (77.6)

49

56

㻌 㻌 㻌 䝺䝉㟁䝁䞊䝗: 610421353

Month 18

75/126 (59.5)

107/158 (67.7)

41

45

Month 24

68/117 (58.1)

93/137 (67.9)

38

45

Month 30

51/101 (50.5)

68/110 (61.8)

33

35Month 3645/90 (50.0)

47/84 (56.0)

32

27Month 42

27/61 (44.3)

31/61 (50.8)

29

14Month 48

18/39 (46.2)

21/37 (56.8)

18

152010ᖺ~ၟရྡ:䝔䜱䞊䜶䝇䝽䞁㓄ྜ䜹䝥䝉䝹䠰䠎䠌㻌 㻌 㻌 䝺䝉㟁䝁䞊䝗: 620915501• ᗫ┙䛻䛺䛳䛯䜒䛾䛾ྲྀ䜚ᢅ䛔䛿?

(ͤ) 䝺䝉䝥䝖䛻䛴䛔䛶䛿䛂㈝⏝䛜Ⓨ⏕䛧䛶䛔䛺䛔䜒䛾䛃(᭶་⒪㈝䛜0෇)䛸䛂ᅇ཰୙⬟䛃䛾༊ู䛜䛴䛛䛺䛔䛜䚸䝕䞊䝍䝉䞁䝍䞊䛾グ㘓䛻䜘䜜䜀ᅇ཰⋡䛿䜋䜌100䠂䛸䛾䛣䛸䚹㈝⏝ᑐຠᯝ䛾⤖ᯝ

EQ-5D䝇
䝇䝁䜰(index value)䛾⤒᫬ኚ໬

48䞄᭶䛾ᖹᆒ䝇䝁䜰S-1: 0.764(95% CI, 0.741–0.782)
䝍䜻䝃䞁: 0.742(95% CI, 0.720–0.764)

GroupE(QALY)IE(QALY)C(JPY 1,000)

IC(JPY 1,000)

S-1

2.11

0.070

5,307-424

Taxane

2.04

5,731

E: Effectiveness, IE: Incremental effectiveness, C: Cost, IC: Incremental cost䛆Pharmacoeconomicsㄅ䛾reviewer䝁䝯䞁䝖䛇
That is, neither survival nor quality of life (EQ-5D) differed in the two treatmentgroups. … In the absence of a difference in these outcomes, it would be more
appropriate to limit the analysis to a trial based cost-minimisation analysis.

ATCศศ㢮ู䛾㈝⏝౯᱁䜢⌧ᅾ᫬Ⅼ䛻ㄪᩚᚋ䛾㈝⏝1,000෇
7,000

ATC
code

6,000

ATC name

TaxaneS-1

L01

Antineoplastic agents

66%

59%

5,000

M05

Drugs for treatment of bone diseases

10%

16%

4,000

N02

Analgesics

9%

3%

L02

Endocrine therapy

3%

9%

A04

Antiemetics and antinauseants

3%

2%

3,000
2,000

V08

Contrast media

2%

2%

1,000

V09

Diagnostic raidopharmaceutical

1%

1%

A02

Drugs for acid and related disorders

1%

1%

Others5%

7%4242792230΍ͳ͹ΉΉ

2016೧఼࣎
S-1Taxaneࠫ෾‫ޛ‬൅඾☜⋡ឤᗘศᯒ◊✲䛾㝈⏺

92%• 㝔እฎ᪉䛾ෆᐜ䛿䝺䝉䝥䝖䛻䛿⌧䜜䛺䛔䛯䜑䚸ฎ᪉䛫䜣䜢ู㏵཰㞟䛧䛯䚹㻌 Ѝ ⸆ᒁ䛾ฎ᪉ᩱ➼䛿ィ⟬䛷䛝䛺䛔䚹• 䝺䝉䝥䝖䛛䜙㠀㛵㐃་⒪㈝䜢㝖እ䛷䛝䛺䛔䚹㻌 Ѝ ⒴἞⒪䛾䝺䝉䝥䝖䛻䛚䛡䜛䛭䛾௚䛾⑌ᝈ䛾἞⒪㈝⏝䛜༨䜑䜛๭ྜ䛿ᑠ䛥䛔䛸䛿ᛮ䜟䜜䜛䛜…
• ㌿㝔➼䛧䛯ሙྜ䛿䝺䝉䝥䝖䛿㏣㊧䛷䛝䛺䛔䚹5,000

䡡 dominant䛻䛺䜛☜⋡䛿⣙63䠂

• while nicely done we think this article will have limited
appeal in other countries with different costs and limited or
non use of the agent. we appreciate the submission.
㻌 (breast cancer research and Treatmentㄅ reviewer䛾䝁䝯䞁䝖)