㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 2015JUNE䠜CSP-HOR㧗㱋໬䛻క䛔་⒪㈝䛿ᛴ㏿䛻ቑຍ䛧䛶䛔䜛䚹᪂⸆䞉᪂་⒪ᶵჾ䛾㈝⏝䛿ቑຍ䛧䛶䛔䜛䠄䛸䛟䛻䛜䜣ศ㔝䠅䚹ᅜẸⓙಖ㝤ไᗘ䜢⥔ᣢ䛩䜛䛸䛩䜜䜀䚸ఱ䜙䛛䛾ຠ⋡໬䜢䛚䛣䛺䜟䛺䛡䜜䜀䛺䜙䛺䛔䚹CSP-HOR◊◊✲䛥䜙䛻HTA䜢䜑䛦䛧䛶䠄බ┈ἲே䠅䝟䝤䝸䝑䜽䝦䝹䝇䝸䝃䞊䝏䞉⮫ᗋ◊✲ᨭ᥼஦ᴗ(CSP)ᢸᙜ
NPO᪥ᮏ⮫ᗋ◊✲ᨭ᥼䝴䝙䝑䝖⌮஦㛗䝇䝍䝑䝖䝁䝮䠄ᰴ䠅ྲྀ⥾ᙺ఍㛗NPO᪥ᮏ䝯䝕䜱䜹䝹䝷䜲䝍༠఍⌮஦㛗䠄୍⯡♫ᅋ䠅᪥ᮏ⮫ᗋヨ㦂Ꮫ఍௦⾲⌮஦䠄୍⯡♫ᅋ䠅᪥ᮏಖ೺᝟ሗ䝁䞁䝋䝅䜴䝮⌮஦㛗୰ኸ኱Ꮫ⌮ᕤᏛ㒊㻌 ே㛫⥲ྜ⌮ᕤᏛ⛉㻌 ⏕≀⤫ィᏛᮾி኱Ꮫྡ㄃ᩍᤵ኱ᶫ㟹㞝12㐺ṇ䛺་⒪㈨※㓄ศ䛸䛿䠛䜎䛪ゝⴥ䛛䜙 ᐇ䛿㈝⏝䠄♫఍䛻୚䛘䜛䝁䝇䝖䠅䛾ᐇែᢕᥱ䛿ᅔ㞴䛯䛸䛘䜀⢾ᒀ⑓㻌 ┤᥋་⒪㈝䛿1.2඙䛰䛜䞉䞉䞉 QOL ≉ᐃ䛾⑌ᝈ䛻ᑐ䛩䜛἞⒪ἲ䠄⸆๣䠅㑅ᢥ䝆䜵䝛䝸䝑䜽䚸OTCබ㈝䛛⚾㈝䛛䠄ΰྜ་⒪䠅 ἞⒪ᡓ␎䛾㑅ᢥ ἞⒪䛛䜙ண㜵䜈㻌⢾ᒀ⑓䜢30%ண㜵䛷䛝䜜䜀䛜䜣἞⒪䛿↓ᩱ໬ྍ⬟䠄ᮾ໭኱Ꮫ䞉㩾἟ᩍᤵ䛾ヨ⟬䠅䛭䜒䛭䜒䛂㐺ṇ䛃䜢䛹䛖ุ᩿䛩䜛䛛䠛㻌 㻌 㻌 㻌 Quality of Life QALY
Quality-Adjusted-Life-Year(s) PRO
Patient Reported Outcome
 HTA
Health Technology Assessment㻌㻌
34

2012ASCO㻌㻌 Educational Session ‘Endpoints’ (D.Bruner)೺ᗣ䜰䜴䝖䜹䝮䠄ᡂᯝ䚸⤖ᯝ䚸䜶䞁䝗䝫䜲䞁䝖䠅 Benefit䜒䛳䛸ᝈ⪅䛻Ⓨゝᶒ䜢䟿⸆䛾ሙྜ䛿⸆⌮ⓗ᭷ຠᛶ䛛䜙᭷⏝ᛶefffectiveness἞⒵䚸⏕Ꮡ⋡䚸⏕άᶵ⬟䞉⮬❧ᗘ೺ᗣ㛵㐃QOL䚸ᝈ⪅‶㊊ᗘ Harm᭷ᐖ཯ᛂ䠄๪స⏝䠅㻌 㻌 ▷ᮇ䞉㛗ᮇ䠄Ⓨ䛜䜣ྵ䜐䠅೺ᗣ㛵㐃QOL䚸ᝈ⪅‶㊊ᗘ㝈䜙䜜䛯㈨※䛾୰䛷㻌 㻌 䞉䞉䞉㻌 ㈝⏝ᑐ䠄䜰䜴䝖䜹䝮ୖ䛾䠅ຠᯝ䛾་⒪⤒῭ホ౯䛜ồ䜑䜙䜜䛶䛔䜛
52012ASCO㻌㻌 Educational Session ‘Endpoints’ (D.Bruner)⡿ᅜRTOG䛾䜰䜴䝖䜹䝮䝰䝕䝹

6QALY䛻
䛻䜘䜛་⒪⤒῭ホ౯
Quality-Adjusted-Life-Year(s) ⱥᅜNICE䠄National Institute for Health and ClinicalExcellence䠅䜢䜢䛿䛨䜑䛸䛧䛶䚸䜹䝘䝎䚸䜸䞊䝇䝖䝷䝸䜰䚸䝶䞊䝻䝑䝟ㅖᅜ䚸㡑ᅜ䚸䞉䞉䞉

78஬༑ᔒ୰㻌 䛂ㅖእᅜ䛾䜰䜴䝖䜹䝮◊✲䛚䜘䜃HTA䛾ືྥ䛃䚸2013ᖺ7᭶13᪥㻌 㻌 㻌 ➨䠓ᅇ㻌 CSP-HORᖺ఍㻌 䠜ᮾ኱ఀ⸨ㅰᜠ䝩䞊䝹㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 ➨䠍㒊䠖᪥ᮏ䛸ㅖእᅜ䛾䜰䜴䝖䜹䝮◊✲䛾ືྥ㻌 㻌 㻌 ➨2㒊䠖䜰䜴䝖䜹䝮䛻㛵䛩䜛ಶே䛸♫఍䛾㑅ᢥ
910

ཌ⏕ປാ┬ಖ㝤ᒁ䛷䜒ಖ㝤ൾ㑏䛻QALY䝕䞊䝍䜢฼⏝䛩䜛䛣䛸䜢᳨ウ䠄ᖹᡂ28ᖺ䛛䜙ヨ⾜䠅ヨ⾜䛿᪤཰㍕ရ䛛䜙䚸䛹䛣䛜䛂෌ศᯒ䛃䜢⾜䛺䛖䛛䠛11

2013June27

2015June20

12HTAᶵᶵ㛵䛾ᙧែHTA:ලලయⓗ䛺ホ౯ᡭἲ䛾ά⏝㻔㻝㻕㻌ពᚿỴᐃ䝥䝻䝉䝇䛻┤᥋㛵୚䛧䛶䛔䜛ᶵ㛵㻌㻔㼍㻕㻌⊂❧䛧䛯බⓗ㻔ᅜ❧➼㻕◊✲ᶵ㛵㻌㻺㻵㻯㻱㻔䜲䜼䝸䝇㻕䚸㻯㻭㻰㼀㻴㻔䜹䝘䝎㻕䚸㻺㻯㻼㻱㻔䜰䜲䝹䝷䞁䝗㻕䚸㻴㻭㻿㻔䝣䝷䞁䝇㻕䚸㻵㻽㼃㼕㻳㻔䝗䜲䝒㻦䛯䛰䛧་⒪⤒῭ホ౯䛿䜎䛰ά⏝஦౛䛺䛧㻕䛺䛹㻌㻔㼎㻕㻌ᨻᗓ䛾㒊ᒁ䛒䜛䛔䛿እᒁ䚸⊂❧⾜ᨻἲே䛺䛹㻌㼀㻸㼂㻌㻔䝇䜴䜵䞊䝕䞁㻕䚸㻼㻼㻮㻌㻔䝣䜱䞁䝷䞁䝗㻕䚸㻼㻮㻭㻯㻔䜸䞊䝇䝖䝷䝸䜰㻕䚸㻼㻴㻭㻾㻹㻭㻯㻔㻺㼆㻕䛺䛹㻌㻔㼏㻕㻌ಖ㝤⪅䞉ᑂᰝᶵ㛵㻌㻯㼂㼆㻔䜸䝷䞁䝎㻕䚸㻵㻺㻭㻹㻵㻔䝧䝹䜼䞊㻕䚸㻴㼂㻮㻔䜸䞊䝇䝖䝸䜰㻕䚸㻴㻵㻾㻭㻔㡑ᅜ㻕䛺䛹㻌㻔㼐㻕㻌་⸆ရ䛾ᑂᰝᶵ㛵㻌㻺㻻㻹㻭㻔䝜䝹䜴䜵䞊㻕䚸㻿㼁㻷㻸㻌㻔䝏䜵䝁㻕䚸㻵㻺㻲㻭㻾㻹㻱㻰㻔䝫䝹䝖䜺䝹㻕䚸㻯㻰㻱㻌㻔ྎ‴㻕㻌㻔㻞㻕㻌ពᚿỴᐃ䛻䛿┤᥋㛵୚䛧䛺䛔䛜䚸་⒪ᢏ⾡ホ౯䜢⾜䛖ᶵ㛵㻌㻿㻮㼁㻔䝇䜴䜵䞊䝕䞁㻕䚸㻺㻻㻷㻯㻔䝜䝹䜴䜵䞊㻕䚸㻷㻯㻱㻔䝧䝹䜼䞊㻕䚸㻭㼁㼚㻱㼀㻿㻔䝇䝨䜲䞁㻕䚸㻺㻱㻯㻭㻔㡑ᅜ㻕䛺䛹㻌

➨15ᅇ㻌 ୰་༠䞉㈝⏝ᑐຠᯝホ౯ᑓ㛛㒊఍㈨ᩱ
14

13➨9ᅇ㻌 ୰་༠䞉㈝⏝ᑐຠᯝホ౯ᑓ㛛㒊఍㈨ᩱ

QOL䠛
䠛HTA䜺䜺䝷䝟䝂䝇䜜䜛䛿䛪䛜䛺䛔䛾䛻 䜜䜛䛸୍㒊䛾ே䛜ಙ䛨䚸⌧ᐇⓗ䛺◊✲⪅䜢㎢᫆䛥䛫䜛䜒䛾䛷䚸ᐩᒣ┴䛺䛹䛷ฟ⌧䛩䜛䛸⻐Ẽᴥ䛸䜒࿧䜀䜜䜛䠄㔛ぢ䞉ྜྷᮧ䠖ㄡ䜒ᩍ䛘䛶䛟䜜䛺䛛䛳䛯⒴⮫ᗋヨ㦂䛾ṇ䛧䛔ゎ㔘䚸୰እ་Ꮫ♫䚸2011䠅 ᝈ⪅䛾❧ሙ䛻䛯䛳䛯ホ౯䛸䛔䛖Ⅼ䛷䛿୍⮴㻌ᅜ❧䛾HTAᶵ㛵䜢タ❧䛧䛶䛔䛺䛔OECDຍ┕ᅜ䛿䜟䛪䛛䛧䛛䛺䛟䚸䛭䛾୰䛻䛿⡿ᅜ䛸᪥ᮏ䛜ྵ䜎䜜䛶䛔䜛䚹➨15ᅇ㻌 ୰་༠䞉㈝⏝ᑐຠᯝホ౯ᑓ㛛㒊఍㈨ᩱ
15

 ㄆ㆑䛾㐪䛔㻌ᐈほⓗ䛺ホ౯䞉⑕≧PS䚸๪స⏝䚸య㔜ኚ໬䚸ឤᰁ䚸ධ㝔᪥ᩘ䚸䠄③䜏䛸䠅㙠③๣ᝈ⪅⮬㌟䛻䜘䜛ィ㔞ᚰ⌮ⓗ≉ᛶ䛾୺ほⓗホ౯䠄Patient Reported Outcome)ᵓᡂᴫᛕconstruct䛸䛧䛶䛾QOL
ᝈ⪅⮬㌟䛾䝣䜱䝹䝍䞊䜢㏻䛧䛯ㄆ㆑ከḟඖᑻᗘ䠄ㄪᰝ⚊䠅㛤Ⓨ16

䛂QOLホ౯䛃䛜᎘䛔䛺⌮⏤ᵓᡂᴫᛕconstruct䛸䛧䛶䛾QOL⚟⏣἞ᙪ㻌 2012DEC21㻌 JCOG⥲ྜ⌜఍㆟䠄⭘⒆ෆ⛉ 2013;12:440-9.䠅
 䝧䞊䝇䝷䜲䞁䜒ឤᗘ䜒␗䛺䜛ᝈ⪅ホ౯䛜䛂἞⒪ἲ䛃ホ౯䛸⥲ྜホ౯䛧䛶㐺ษ䛛 ๪స⏝䛻ᑐ䛩䜛ホ౯䛜་ᖌ䞉ᝈ⪅䛷␗䛺䜛䠄๓⪅䛜୍⯡䛻㕌䛔䠅䛺䜙䚸་ᖌホ౯䛾ᶆ‽໬䜢⾜䛖䜉䛝䛷䛿䛺䛔䛛 QOLホ౯⮬㌟䛜ᝈ⪅䛾QOL䜢ᦆ䛽䜛䛣䛸䛜䛒䜛 ホ౯䛻䛿ᅜ㝿ⓗ䛻䞂䜯䝸䝕䞊䝅䝵䞁䛥䜜䛶䛔䜛ㄪᰝ⚊䜢౑䛖ᚲせ䛜䛒䜛䛜䚸䛧䜀䛧䜀䛭䛾᪥ᮏㄒ䛿୙⮬↛䛷䛒䜛 QOLホ౯ᑓ㛛ᐙ䛾䛯䜑䛻ㄪᰝ䛻䛺䛳䛶䛔䛺䛔䛛 䛭䜒䛭䜒᪥ᮏᩥ໬䛻䛿ゝⴥ䛻䜘䜛䛒䛛䜙䛥䜎䛺⾲ฟ䜢᎘䛖ഴྥ䛜䛒䜛䠄QOLホ౯䛿୍⚄ᩍ䛾ୡ⏺䛾⏘≀䠛䠅౯್ほ䞉▱㆑䞉ุ᩿ຊ
QOL domain㌟
యάື㌟య≧ែ⢭⚄≧ែ♫఍ᛶ⑕≧ᐃྍ⬟䠛䛺㡯┠

QOLホホ౯䛾Ỉ‽㻝㻤㻌17ᢠ䛜䜣๣ホ౯䛻䛚䛡䜛QOLㄪᰝᵓᡂᴫᛕconstruct䛸䛧䛶䛾QOL ᪥ᮏ䛾་ᖌ◊✲⪅䛾ែᗘ᪂䛧䛔㡿ᇦ䛸䛧䛶䛾ᮇᚅ䛖䛥䜣䛟䛥䛥䇺୺ほⓗ䛷᭕᫕䛺QOLᵓᡂᴫᛕ≉ᛶdomain㡯┠item▱⬟

ィ⟬⬟ຊ
ᬯグ⬟ຊ
……

ຍἲ
ῶἲ
……

ලయⓗ䛺ၥ㢟䠄᫬㛫ᣦᐃྵ䜐䠅㌟య≧ែ㌟యάື
……

⑂ປឤ
╧╀
……

䛂⑂䜜Ẽ࿡䛷䛩䛛䛃䛸䛔䛖㉁䛻
4ẁ㝵䛷⟅䛘䜛

QOL

ᑻᗘscaleᐃ䛻䛹䜣䛺ព⩏䛜䛒䜛䛾䛛?’ ᪤Ꮡㄪᰝ⚊䛾⩻ヂ䞉ᑟධ

EORTC, FACT ᪥ᮏ⊂⮬䛾ㄪᰝ⚊䛾㛤ⓎQOL-ACD (Kurihara et al.(1999䚸ᐇ㉁ⓗ䛻䛿1990㡭䠅䠅 ➨III┦ヨ㦂䛷䛾฼⏝(1995-⫵⒴䚸ங⒴) CSP-HOR䛾άື PRO (Patient Reported Outcome䠅䛾ᴫᛕ㻝㻥㻌 QALYᐃ䛸⤒῭ホ౯䠄䠛䠅㻌 䠄GEST◊✲䚸CSPOR-SELECT䠅
20

http://www.csp.or.jp/hor/

ங⒴Ꮫ఍䛷Ⓨ⾲䚸ஒ䛤ᮇᚅ㻌 㻌 㻌 07/02㻌 10-11᫬㻌 10533
21

CSP-HOR⬺⬺ẟ㛵㐃◊✲䛾Ⓨ⾲䠄2015ங⒴Ꮫ఍䠅䠍䠅䛂ங⒴⿵ຓ໬Ꮫ⒪ἲ䛻䛚䛡䜛⬺ẟ䛾ᐇែ䛻㛵䛩䜛ከ᪋タ䜰䞁䜿䞊䝖ㄪᰝ䛃㻌 Ⓨ⾲⪅䠖Ώ㎶㝯⣖䠄௝ྎ་⒪䝉䞁䝍䞊䠅㻌 ₇㢟␒ྕ䠖OS-1-02-02
㻌 䝉䝑䝅䝵䞁ྡ䠖ཝ㑅ཱྀ₇2䛂QOL䛃㻌㻌 ᪥᫬䠖2015/07/02䠄ᮌ䠅㻌 10:00 - 11:00㻌 ఍ሙ䠖➨4఍ሙ䠄5F 䝩䞊䝹B5䠅䠎䠅䛂ங⒴໬Ꮫ⒪ἲ䝺䝆䝯䞁ู䛻䜏䛯㢌㧥䛾㛗ᮇⓗᅇ᚟䠉඲ᅜ䜰䞁䜿䞊䝖ㄪᰝ䛛䜙䛃㻌 Ⓨ⾲⪅䠖▮ᙧ㻌 ᐶ䠄ᇸ⋢་⛉኱Ꮫ ⥲ྜ་⒪䝉䞁䝍䞊 䝤䝺䝇䝖䜿䜰⛉ 䠅
㻌 ₇㢟␒ྕ䠖PD1-1
㻌 䝉䝑䝅䝵䞁ྡ䠖䝫䝇䝍䞊ウ㆟71䛂⸆≀⒪ἲ㻌 ๪స⏝䛃㻌㻌 ᪥᫬䠖2015/07/03䠄㔠䠅18䠖10 - 18䠖50㻌 ఍ሙ䠖䝫䝇䝍䞊఍ሙ䠄B2F㻌 ᒎ♧䝩䞊䝹䠅䠏䠅䛂໬Ꮫ⒪ἲ䜢ཷ䛡䜛ங⒴ᝈ⪅䛾∎䛾ኚ໬䛾ᐇែ䠉ከ᪋タ䜰䞁䜿䞊䝖ㄪᰝ䛛䜙䛃㻌 Ⓨ⾲⪅䠖⋢஭ዉ⥴䠄ᮾி኱Ꮫ䠅㻌 ₇㢟␒ྕ䠖OS-1-03-05
㻌 䝉䝑䝅䝵䞁ྡ䠖ཝ㑅ཱྀ₇3䛂␿Ꮫ䛃㻌 ᪥᫬䠖2015/07/02䠄ᮌ䠅 11:00 - 12:00㻌 ఍ሙ䠖➨4఍ሙ䠄5F 䝩䞊䝹B5䠅䠐䠅䛂ங⒴䛾໬Ꮫ⒪ἲ䛻㉳ᅉ䛧䛯⬺ẟ䛻ᑐ䛩䜛ண㜵ⓗ௓ධ䠖䝅䝇䝔䝬䝔䜱䝑䜽䝺䝡䝳䞊䛃㻌 Ⓨ⾲⪅䠖ᒸ⏣ᏹᏊ䠄ᮾி኱Ꮫ䠅㻌 ₇㢟␒ྕ䠖GP-2-12-35
㻌 䝉䝑䝅䝵䞁ྡ䠖䝫䝇䝍䞊ᥖ♧䛂⸆≀⒪ἲ䐠䛃㻌 ᪥᫬䠖2015/07/03䠄㔠䠅 8:00 - 8:50㻌 ఍ሙ䠖䝫䝇䝍䞊఍ሙ䠄B2F㻌 ᒎ♧䝩䞊䝹䠅
23㻌㻌㻌22Health related QOL䠛䠛
“Does subjective and vague measurementof QOL have any significance?”“It is much more reliable and clinically significant than measuring natural killer”
D. Cella (Tutorial of Japan Stat. Assoc., 1996)“It is relatively uncommon that studies of new drugs in oncology provide
unambiguous evidence of a survival benefit. So in trying to assess clinicalbenefit for patients who are enrolled in oncology drug studies, QOL isbecoming an increasingly important component of those types of applications
and as a means of assessing clinical benefit for patients who are receiving one
kind of therapy or another”
R. Shilsky (ODAC subcommittee, 2000 Feb 10)24⤒㻌 ⦋2005, 7䝶䞊䝻䝑䝟་⸆ရᶵᵓホ౯ᶵᵓ䠄EMEA)
་⸆ရホ౯䛻䛚䛡䜛೺ᗣ㛵㐃QOL౑⏝䛻㛵䛩䜛䜺䜲䝎䞁䝇䠄䝗䝷䝣䝖∧䠅䜢බ⾲→ෆᐜ䛿ᰂ㌾䠈ᴫせ䛻䛴䛔䛶ゝཬ
http://www.ema.europa.eu/
2006, Fed Register 71FDA་⸆ရ䞉ᶵჾ䛾㛤Ⓨ䛻䛚䛡䜛ᝈ⪅୺ほⓗ䜰䜴䝖䜹䝮䛾౑⏝䜺䜲䝎䞁䝇䠄䝗䝷䝣䝖∧䠅䜢බ㛤→䜘䜚ヲ⣽䛺ゝཬ䠈᥎ዡᙧᘧ䇾should”

FDA㻌㻌 PRO䜺䜲䝎䞁䝇 㐺ษ䛻ᐃ⩏䛥䜜䠄well-defined䠅䚸ಙ㢗ᛶ䛾㧗䛔ᑻᗘ䛷ᐃ䛥䜜䛯⤖ᯝ䛿䚸་⸆ရ䛾ຠ⬟⾲♧䛾⿬௜䛡᰿ᣐ䛸䛧䛶౑⏝ྍ⬟䛷䛒䜛 ᝈ⪅⮬㌟䛜᭱䜒Ⰻ䛟ㄆ㆑䛧䛶䛔䜛䛛䚸ᝈ⪅䛾どⅬ䛛䜙䛾ᐃ䛜᭱䜒㐺ษ䛺ᴫᛕ䛻䛴䛔䛶䛿䚸PRO䛾౑⏝䜢᥎ዡ䛩䜛2009, FDA་⸆ရ䞉ᶵჾ䛾㛤Ⓨ䛻䛚䛡䜛ᝈ⪅୺ほⓗ䜰䜴䝖䜹䝮䛾౑⏝䜺䜲䝎䞁䝇䜢බ㛤
26

25

Basch et al. JNCI 2011; 24: 1808-10.

IASLC2013

1, S.
D. Galetta
G lS Pisconti
ii2, SS. CiCinieri
i i3, V. GGebbia
bbi 4, A. Morabito
bi 5, N. Borsellino
lli 6 , E. Maielloi ll 7, A.
Febbraro8, A. Catino1, P. Rizzo3, M. Montrone2, A. Misino1, D. Rizzi9, G. Colucci9
1Medical Oncology U.O., National Cancer Research Center “Giovanni Paolo II” , Bari, Italy
2Division of Medical Oncology, “S.G. Moscati” Hospital, Taranto, Italyಶ䚻䛾୺ほⓗ⤒㦂䜢ሗ࿌䛩䜛䛾䛻᭱㐺䛷䛒䜛䛾䛿ᝈ⪅䚸䛣䜜䜢⑌ᝈ䛾ほⅬ䛛䜙ㄝ᫂䛩䜛䛾䛻᭱㐺䛺䛾䛿་ᖌ䚹୧⪅䛿┦⿵ⓗ䞉䞉䞉䚸᫬ᮇ䛾CTCAEv5䛿⑕≧䛾ṇ☜ᛶ䜢ྥୖ䛥䛫䜛䛯䜑PRO䜢⤌䜏㎸䜐ணᐃ

Cisplatin 75 mg/m2 d1
Pemetrexed 500 mg/m2 d1
N=60
every 3 wks up to 6 cycles
Non-squamousAge 18-70

Stratification•ECOG PS 0-1•Stage IIIB/IV(TNM 7th Ed)•CenterR
ANDO
M

N=58
* drug supplied by Eli Lilly

SD,PR,CR

5 Thoraco-pulmonary Department, National Cancer Institute “G. Pascale” Hospital, Napoli, Italy
taalyal
6 Medical Oncology Unit, “Buccheri-La Ferla” Hospital, Palermo, Italy
7 Division of Medical Oncology, “Casa Sollievo della Sofferenza” , San Giovanni Rotondo (FG) Italy
8 Division of Medical Oncology, “Fatebenefratelli” Hospital, Benevento, Italy
9Gruppo Oncologico Italia Meridionale (GOIM), Italy

IASLC2013

QoL
L

QoL
L

QoL

QoL
Q

baseline

after 3rdd cycle

after 6th cycle

after 12 wks

after 18 wks

Minimum Important Difference(~ ECOG-PS change 1)

ARM A

Bevacizumab 15mg/kg
Beva

SD,PR,CR eevery
ver 3 wks until PD

2928

CO-PRIMARY ENDPOINTS IASLC2013

PemPemetrexed
500 mg/m2eevery
ver 3 wks until PD*

QoLoLL

Carboplatin AUC 6 d1
Paclitaxel 200 mg/m2 d1
Bevacizumab 15 mg/kg d1
Beevery 3 wks up to 6 cycles

Presenter: Domenico Galetta, MD
National Cancer Research Centre "Giovanni Paolo II "Medical Oncology Division
Bari (Italy)

QOL䜢䜢䝥䝷䜲䝬䝸䜶䞁䝗䝫䜲䞁䝖䛻タᐃ䛧䛯ヨ㦂
CSP-BC,㻌 HOR䛷䜒ྠᵝ䛾ヨ㦂䜢ィ⏬୰

27

STUDY DESIGN

3 Medical Oncology & Breast Unit, “Sen. Perrino” Hospital, Brindisi, Italy
4 Division of Medical Oncology, “La Maddalena” Hospital, Palermo, Italy

betterARM B

Student’s t-test: 2.12 (2P=0.04)
Δ between means: 0.15
95% Cl 0.01 to 0.29
Mann-Whitney U: 375.50 (2P=0.04)

ARM A

betterARM B

Student’ s t-test: 0.35 (2P=0.73)
Δ between means: 1.82
95% Cl -8.60 to 12.24
Mann-Whitney U: 375.50 (2P=0.04)

EQ5D-I = 0.15 (95%CI 0.01 to 0.29); P[Mann-Whitney]=0.04
EQ5D-VAS = 1.82 (95%CI -8.60 to 12.24); P[Mann-Whitney]=0.73

30

Secondary Endpoints: PFS and OS

IASLC2013

PFS

OS

Arm A (CP-P)
N=60
Arm B (CbTBe-Be) N=58

N=60
Arm A (CP-P)
Arm B (CbTBe-Be) N=58

CSP-HOR䛷䛷䛿䝁䞁䝋䝅䜴䝮ᙧᘧ䛷䛜䜣ᝈ⪅QOL䠄PRO)䜢
ㄪᰝ䛩䜛◊✲䜢ィ⏬୰䛤ᮇᚅ䛟䛰䛥䛔䚸䛭䛧䛶䛬䜂ཧຍ䛟䛰䛥䛔

Median:Median:

Arm A 8.2 months (95%CI 6.3 – 10.1)
Arm B 8.0 months (95%CI 6.2 – 9.7)

Arm A 15.3 months (95%CI 10.7 – 19.9)
Arm B 14.7 months (95%CI 9.9 – 19.4)

Hazard Ratio (Cox model) 0.62

Hazard Ratio (Cox model) 0.93

(95% CL 0.41 – 0.95)(95% CL 0.49 – 1.37)

3132