㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 CSP-HORᖺ఍2014June21

QALY䛻䜘䜛་⒪⤒῭ホ౯QOL/PRO◊✲䛾᭱๓⥺u ⱥᅜNICE䠄National Institute for Health and ClinicalExcellence䠅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Ꮫ

኱ᶫ㟹㞝
1

2

㻌

஬༑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
34

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೺ᗣ䜰䜴䝖䜹䝮
u Benefit⸆䛾ሙྜ䛿⸆⌮ⓗ᭷ຠᛶ䛛䜙᭷⏝ᛶefffectiveness἞⒵䚸⏕Ꮡ⋡䚸⏕άᶵ⬟䞉⮬❧ᗘ೺ᗣ㛵㐃QOL䚸ᝈ⪅‶㊊ᗘ
u 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 ㈝⏝ᑐຠᯝ䛾་⒪⤒῭ホ౯562013June27ᖹᡂ22ᖺᗘ㻌 ᅜẸ་⒪㈝䛾ᴫἣ䠄ཌ⏕ປാ┬䠅㐺ṇ䛺་⒪㈨※㓄ศ䛸䛿䠛u ᐇ䛿ᐇែᢕᥱ䛿ᅔ㞴䛯䛸䛘䜀⢾ᒀ⑓㻌 ┤᥋་⒪㈝䛿1.2඙䛰䛜u ≉ᐃ䛾⑌ᝈ䛻ᑐ䛩䜛἞⒪ἲ䠄⸆๣䠅㑅ᢥ䝆䜵䝛䝸䝑䜽䚸OTC
බ㈝䛛⚾㈝䛛䠄ΰྜ་⒪䠅
u ἞⒪ᡓ␎䛾㑅ᢥu ἞⒪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
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8

QOL䠛
䛂QOLホ౯䛃䛜᎘䛔䛺⌮⏤⚟⏣἞ᙪ㻌 2012DEC21㻌 JCOG⥲ྜ⌜఍㆟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

u 䝧䞊䝇䝷䜲䞁䜒ឤᗘ䜒␗䛺䜛ᝈ⪅ホ౯䛜䛂἞⒪ἲ䛃ホ౯䛸u ᝈ⪅䛾❧ሙ䛻䛯䛳䛯ホ౯䛸䛔䛖Ⅼ䛷䛿୍⮴㻌䛧䛶㐺ษ䛛u ๪స⏝䛻ᑐ䛩䜛ホ౯䛜་ᖌ䞉ᝈ⪅䛷␗䛺䜛䠄๓⪅䛜୍⯡u ㄆ㆑䛾㐪䛔㻌

䛻㕌䛔䠅䛺䜙䚸་ᖌホ౯䛾ᶆ‽໬䜢⾜䛖䜉䛝䛷䛿䛺䛔䛛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๣

u QOLホ౯⮬㌟䛜ᝈ⪅䛾QOL䜢ᦆ䛽䜛䛣䛸䛜䛒䜛u ホ౯䛻䛿ᅜ㝿ⓗ䛻䞂䜯䝸䝕䞊䝅䝵䞁䛥䜜䛶䛔䜛ㄪᰝ⚊䜢౑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Ⓨ䛖ᚲせ䛜䛒䜛䛜䚸䛧䜀䛧䜀䛭䛾᪥ᮏㄒ䛿୙⮬↛䛷䛒䜛u QOLホ౯ᑓ㛛ᐙ䛾䛯䜑䛻ㄪᰝ䛻䛺䛳䛶䛔䛺䛔䛛u 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
910ᵓᡂᴫᛕconstruct䛸䛧䛶䛾QOL
ᵓᡂᴫᛕconstruct䛸䛧䛶䛾QOL
⥲ྜホ౯

ᵓᡂᴫᛕ

≉ᛶdomain㡯┠itemᑻᗘscale

▱⬟

ィ⟬⬟ຊ
ᬯグ⬟ຊ
……

ຍἲ
ῶἲ
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ලయⓗ䛺ၥ㢟䠄᫬㛫ᣦᐃྵ䜐䠅

QOL

㌟య≧ែ
㌟యάື
……

⑂ປឤ
╧╀
……

䛂⑂䜜Ẽ࿡䛷䛩䛛䛃䛸䛔䛖㉁䛻
4ẁ㝵䛷⟅䛘䜛౯್ほ䞉▱㆑䞉ุ᩿ຊ
QOL domain
㌟
య
ά
ື

㌟
య
≧
ែ

⢭
⚄
≧
ែ

♫
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ᐃྍ⬟䠛䛺㡯┠QOLホ౯䛾Ỉ‽㻝㻝㻌㻝㻞㻌

Health related QOL䠛ᢠ䛜䜣๣ホ౯䛻䛚䛡䜛QOLㄪᰝ“Does subjective and vague measurementof QOL have any significance?”u ᪥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QOL

ᐃ䛻䛹䜣䛺ព⩏䛜䛒䜛䛾䛛?’u ᪤Ꮡㄪᰝ⚊䛾⩻ヂ䞉ᑟධ

EORTC, FACTu ᪥ᮏ⊂⮬䛾ㄪᰝ⚊䛾㛤Ⓨ

QOL-ACD (Kurihara et al.(1999䚸ᐇ㉁ⓗ䛻䛿1990㡭))u ➨III┦ヨ㦂䛷䛾฼⏝(1995-⫵⒴䚸ங⒴)“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)

u PRO (Patient Reported Outcome䠅䛾ᴫᛕu QALYᐃ䛸⤒῭ホ౯䠄䠛䠅㻌 䠄GEST◊✲䚸CSPOR-SELECT䠅
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⤒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 71
FDA་⸆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 PRO䜺䜲䝎䞁䝇u 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u 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
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Basch et al. JNCI 2011; 24: 1808-10.

ෆᐜ
u

u

ಶ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ணᐃASCO2013䛷䛿educational session䛜⾜䜟䜜䛯

u
u

17

ᙜึ䛾ᠱᛕ䛸⌧ᅾ䛾ぢゎᐇ౛䠖ఱ䜢Ꮫ䜣䛰䛛*Validation study of QOL-ACD
Matsumoto et al. 2002, QOL Research 11; 483-93.
*Sensitivity of instrument (comparison of oral vs infusion)
Shimozuma et al. 2000, ASCO Proc.; 2544A.
Individual weight for global QOL
Morita et al. 2003, J. Clin. Epid. 56; 744-51.
*AE and QOL
Kobayashi et al. 2003, ASCO Proc.; 2982.
㻌 㻌 (Morita et al. 2003, Jpn. J. Clin. Oncol. 33; 470-6.)㻌 *㈈ᅋἲே䝟䝤䝸䝑䜽䝦䝹䝇䝸䝃䞊䝏䝉䞁䝍䞊CSP-HOR◊✲఍䠄2012䠅
QALY ᐃ䛾౛䠄⮅⮚䛜䜣◊✲GEST)
QOL䛛䜙PRO䜈䚸Comparative Effectiveness Study䛻䛚䛡䜛PROPRO ᐃ䛾䝥䝷䝑䝖䝣䜷䞊䝮䛸ePROᐃ䚸
18⌧᫬Ⅼ䛷䛾ぢゎᙜึ䛾ᠱᛕuᮏே䛻Ώ䜜䜀
ᅇ⟅⋡㧗䛔䛯䛰䛧PD/PSຎ໬䛾ሙྜᅔ㞴u ື䛟䛾䛛䚸๪స⏝ㄪᰝ䛷༑ศ䛷䛿䛺䛔䛾䛛ឤᗘ㧗䛔๪స⏝䛾ᙳ㡪䛿⸆๣䛻䜘䜛㐪䛔䛒䜚u ㄪᰝ⚊෌⌧ᛶ䛿䚸ጇᙜᛶ䛿୍㒊䛾㡯┠䛻ၥ㢟䛒䜚u Ḟᦆ䛿἞⒪ᚋ䛿ከ䛔䚸⪃៖䛧䛯ゎᯒᚲせu ゎᯒ/ά⏝䛷䛝䜛䛾䛛๪స⏝䛸QOLணᚋண ᛶಶேẖ䛾㔜䜏
ᝈ⪅⮬㌟䛾ホ౯䠄PRO)䛸་ᖌホ౯u ᅇ཰䛷䛝䜛䛾䛛uu 䠄䛸䛟䛻㐍⾜䛜䜣ᝈ⪅䛻䠅⟅䛘䛶䛔䛯䛰䛡䜛䛾䛛u ື䛟䛾䛛䚸๪స⏝ㄪᰝ䛷༑ศ䛷䛿䛺䛔䛾䛛u ㄪᰝ⚊෌⌧ᛶ䛿䚸ጇᙜᛶ䛿u Ḟᦆ䛿u ゎᯒ䛷䛝䜛䛾䛛ᅇ཰䛷䛝䜛䛾䛛
⟅䛘䛶䛔䛯䛰䛡䜛䛾䛛

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QOL-ACD (1)άືᛶ1) ᪥ᖖ䛾⏕ά䠄άື䠅䛜䛷䛝䜎䛧䛯䛛䚹

Validation study of QOL-ACD2) 䜂䛸䜚䛷እฟ䛩䜛䛣䛸䛜䛷䛝䜎䛧䛯䛛䚹3) 30ศ䛟䜙䛔䛾ᩓṌ䛿䛷䛝䜎䛧䛯䛛䚹4) ᑡ䛧Ṍ䛔䛶䜒䛴䜙䛔䛸ᛮ䛔䜎䛧䛯䛛䚹5) 㝵ẁ䛾᪼䜚㝆䜚䛜䛷䛝䜎䛧䛯䛛䚹6) 䜂䛸䜚䛷䛚㢼࿅䛻ධ䜛䛣䛸䛜䛷䛝䜎䛧䛯䛛䚹

21

QOL-ACD (2)22

QOL-ACD (3)⢭⚄ᛶ㌟యᛶ7) య䛾ㄪᏊ䛿䛔䛛䛜䛷䛧䛯䛛䚹12) 䜘䛟╀䜜䜎䛧䛯䛛䚹8) 㣗ḧ䛿䛒䜚䜎䛧䛯䛛䚹13) ఱ䛛䛻ἐ㢌䠄⇕୰䠅䛩䜛䛣䛸䛜䛷䛝䜎䛧䛯䛛䚹9) 㣗஦䛜䛚䛔䛧䛔䛸ᛮ䛔䜎䛧䛯䛛䚹14) ᪥䚻䛾䝇䝖䝺䝇䛿䛖䜎䛟ゎᾘ䛷䛝䜎䛧䛯䛛䚹10) ྤ䛟䛣䛸䛜䛒䜚䜎䛧䛯䛛䚹15) 㞟୰ຊ䛜ⴠ䛱䛯䛸ឤ䛨䜎䛧䛯䛛䚹11) 䜔䛫䜎䛧䛯䛛䚹16) ఱ䛛ᚰ䛾ᨭ䛘䛻䛺䜛䜒䛾䛻䜘䛳䛶ຬẼ䛵䛡䜙䜜䛶䛔䜎䛩䛛䚹䠄ᐙ᪘䡠▱ே䡠᐀ᩍ䡠㊃࿡䛺䛹䠅

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By Morita

QOL-ACD (4)CPT11 trial (1995-1998) 㻌♫఍ᛶ䠋䜾䝻䞊䝞䝹QOL

u Untreated patients with Stage IIIB / IV NSCLC and ECOG PS(Collected questionnaires䠖N=390, total=5338䠅

0-217) 䛒䛺䛯䛾⑓≧䛻୙Ᏻ䜢ឤ䛨䜎䛧䛯䛛䚹18) ᐙ᪘௨እ䛾ே䛸᥋䛩䜛䛾䛜ⱞ③䛷䛧䛯䛛䚹19) 䛒䛺䛯䛜἞⒪䜢ཷ䛡䛶䛔䜛䛣䛸䛷ᐙ᪘䛻㏞ᝨ䜢䛛䛡䛶䛔䜛䛸ᛮ䛔䜎䛩䛛䚹20) 䛒䛺䛯䛾ᑗ᮶䛾♫఍⏕ά䛻䛴䛔䛶୙Ᏻ䜢ឤ䛨䜎䛩䛛䚹21) ⑓Ẽ䛻䜘䜛⤒῭ⓗ䛺㈇ᢸ䛜Ẽ䛻䛺䜚䜎䛩䛛䚹22)㻯㻰㻰㻼䠇㻯㻼㼀㻝㻝㻌㻌㻤㻜㻌 㻦㻌㼐㻝㻌㻌㻌㻌㻌㻢㻜㻌 㻦㻌㼐㻝㻘㻤㻘㻝㻡㻌㻯㻰㻰㻼䠇㼂㻰㻿㻌㻌㻤㻜㻌 㻦㻌㼐㻝㻌㻌㻌㻌㻌㻌㻟㻌 㻦㻌㼐㻝㻘㻤㻘㻝㻡㻌㻯㻼㼀㻝㻝㻌㼍㼘㼛㼚㼑㻌
㼙㼓㻛㼙㻞

㼙㼓㻛㼙㻞

㼙㼓㻛㼙㻞

㼙㼓㻛㼙㻞

㻾㼍㼚㼐㼛㼙㼕㼦㼑㻌㻾㼍㼚㼐㼛㼙㼕㼦㼑㻌㻳㼞㼛㼡㼜㻌㼃㼑㼟㼠㻌㻔㼚㻩㻟㻥㻤㻕 㻌㻌㻌㻳㼞㼛㼡㼜㻌㻱㼍㼟㼠㻌㻔㼚㻩㻞㻝㻜㻕㻯㻰㻰㻼䠇㻯㻼㼀㻝㻝㻌㻌㻤㻜㻌 㻦㻌㼐㻝㻌㻌㻌㻌㻌㻢㻜㻌 㻦㻌㼐㻝㻘㻤㻘㻝㻡㻌㻌㻯㻰㻰㻼䠇㼂㻰㻿㻌
㼙㼓㻛㼙㻞

㼙㼓㻛㼙㻞

㻤㻜㻌㼙㼓㻛㼙㻞㻦㻌㼐㻝㻌㻌㻌㻌㻌㻌㻟㻌㼙㼓㻛㼙㻞㻦㻌㼐㻝㻘㻤㻘㻝㻡㻌㻝㻜㻜㻌㼙㼓㻛㼙㻞㻦㻌㼐㻝㻘㻤㻘㻝㻡㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌u Primary endpoint: Survivalu Secondary endpoints: Tumor response, Time to PD, Duration of

response, Toxicities, QOL, Cost-effectiveness25

26

By Morita

By Morita

Patients Characteristics.
Data Collection

Chemotherapy

Baseline
Course 1Lastadministration

Course 2

Course3

Course4…

After treatment

1 Month

2 Month

3 Month

4 Month…

27

By Morita

Patient response of each item

Characteristic
GenderMale
Female
PS
0
1
2
Stage
IIIB
IV

No. (%)
295 (75.6)
95 (24.4)
101 (25.9)
273 (70.0)
16 (4.1)
154 (39.5)
236 (60.5)

N = 390 of 583 eligible patients in the phase III trials.
5338 forms were collected

Response rate of each institute᪋㻌㻌㻌㻌タ㻌㻌㻌㻌ྡ㡯┠᏶⟅๭ྜ㻌㻔㻑㻕

㡯┠᏶⟅๭ྜ㻌㻔㻑㻕

㻝㻚㻌᪥ᖖ䛾⏕ά㻥㻥㻚㻣㻝㻞㻚㻌╧╀

㻥㻥㻚㻡㻞㻚㻌䜂䛸䜚䛷እฟ㻥㻤㻚㻜㻝㻟㻚㻌ἐ㢌

㻥㻥㻚㻡㻟㻚㻌㻟㻜ศ䛾ᩓṌ㻥㻤㻚㻡㻝㻠㻚㻌䝇䝖䝺䝇

㻝㻜㻜㻚㻜㻠㻚㻌ᑡ䛧䛾Ṍ䛝㻥㻥㻚㻡㻝㻡㻚㻌㞟୰ຊ

㻥㻥㻚㻣㻡㻚㻌㝵ẁ䛾᪼㝆㻥㻤㻚㻡㻝㻢㻚㻌ᚰ䛾ᨭ䛘㻥㻥㻚㻞㻢㻚㻌䜂䛸䜚䛷㢼࿅㻥㻢㻚㻡㻝㻣㻚㻌⑓≧䛻୙Ᏻ㻥㻤㻚㻡㻣㻚㻌య䛾ㄪᏊ

㻝㻜㻜㻚㻜㻝㻤㻚㻌ᐙ᪘௨እ䛾ே

㻥㻥㻚㻣

㻤㻚㻌㣗ḧ

㻥㻥㻚㻡

㻝㻥㻚㻌ᐙ᪘䛻㏞ᝨ

㻥㻥㻚㻞

㻥㻚㻌㣗஦

㻥㻥㻚㻣

㻞㻜㻚㻌♫఍⏕ά㻝㻜㻜㻚㻜㻝㻜㻚㻌ྤ䛟䛣䛸

㻥㻥㻚㻡㻞㻝㻚㻌⤒῭ⓗ㈇ᢸ

㻥㻥㻚㻣㻝㻝㻚㻌䜔䛫䜛䛣䛸㻥㻥㻚㻞㻞㻞㻚㻌䝣䜵䞊䝇

29
㻥㻥㻚㻣

Characteristic No. (%)
Weight loss
Ӎ5%
79 (20.3)<5%269 (68.9)
unknown 42 (10.8)
AlbuminMedian
3.8
Range
2.6-5.0
LDH
Median327
Range
83-3246䞉䞉䞉䞉䛜䜣䝉䞁䝍䞊䞉䞉䞉䞉䞉⑓㝔ᅜ❧䛜䜣䝉䞁䝍䞊ᮾ⑓㝔ᅜ❧䛜䜣䝉䞁䝍䞊୰ኸ⑓㝔䞉䞉䞉䞉䛜䜣䝉䞁䝍䞊䞉䞉䞉䞉䞉䞉⑓㝔䞉䞉䞉䞉䞉䞉䝉䞁䝍䞊䞉䞉䞉䞉䞉䞉⑓㝔䞉䞉䞉䞉䞉䛜䜣䝉䞁䝍䞊䞉䞉䞉኱Ꮫ䞉䞉䞉䞉䞉䝉䞁䝍䞊䞉䞉䞉䞉䞉䛜䜣䝉䞁䝍䞊䞉䞉䞉䞉䞉䞉䞉䝉䞁䝍䠉䞉䞉䞉䞉䞉䞉䞉䞉䞉䞉䞉䞉䞉䞉䞉䞉䞉䞉䞉䞉

By Morita㐺᱁౛ 㻽㻻㻸ᅇ཰౛

ᅇ཰⋡

㻝㻣
㻝㻝
㻠㻠
㻞㻢
㻞㻢
㻡㻝
㻟㻟
㻞㻜
㻞㻝
㻞㻥
㻝㻥
㻝㻢
㻡㻠
䞉䞉䞉䞉䞉

㻝㻜㻜㻚㻜㻑
㻝㻜㻜㻚㻜㻑
㻥㻡㻚㻡㻑
㻤㻤㻚㻡㻑
㻤㻤㻚㻡㻑
㻣㻢㻚㻡㻑
㻣㻡㻚㻤㻑
㻣㻡㻚㻜㻑
㻣㻝㻚㻠㻑
㻢㻥㻚㻜㻑
㻢㻤㻚㻠㻑
㻟㻣㻚㻡㻑
㻟㻝㻚㻡㻑
䞉䞉䞉䞉䞉

㻝㻣
㻝㻝
㻠㻞
㻞㻟
㻞㻟
㻟㻥
㻞㻡
㻝㻡
㻝㻡
㻞㻜
㻝㻟
㻢
㻝㻣
䞉䞉䞉䞉䞉

28

30

㻝㻜౛௨ୖ䛾㐺᱁౛Ⓩ㘓᪋タ

Score of physical domain

By Morita඲䛶䛾㡯┠䜢౑䛖䜉䛝䛛䠛2㡯┠䛿ゎᯒ㝖እu ෌⌧ᛶ䛾ၥ㢟䜂䛸䜚䛷㢼࿅䠄䠒䠅u ᅉᏊጇᙜᛶ䛾ၥ㢟ఱ䛛ᨭ䛘䠄䠍䠒䠅
spiritual䚸᐀ᩍ䛾⤡䜏ᝈ⪅䛻䛸䛳䛶䛿᭱㔜せ31

32

By Shimozuma

IMPACT OF SURGICAL ADJUVANTCHEMOTHERAPY ON QUALITY OF
LIFE (QOL) OF PATIENTS WITH
BREAST CANCER (BC) FOR THE
FIRST YEAR OF TREATMENT

Sensitivity of instrument- A PHASE III RANDOMIZED TRIAL
COMPARING UFT (URACIL/TEGAFUR)
WITH CMF IN HIGH-RISK NODE NEGATIVEPATIENTS K. Shimozuma, N. Katsumata, Y. Ohashi, H. Makino,
S. Takashima, H. Sonoo, T. Watanabe
for the National Surgical Adjuvant Study Group of Breast
Cancer(N䞉SAS-BC), Tokyo, Japan
36th American Society of Clinical Oncology Annual Meeting,May 20-23, 2000 2544A

33

N䞉SAS-BC-01

34

By Shimozuma

Breast cancer (I - IIIA)

By Shimozuma

Impact of UFT and CMF on QOL- EORTC QLQ -Surgery• Design: Noninferiority

100

Social100

90

Mean฀ SE.

90

Node negative
High nuclear grade

Clinical eligibility (age,organ function, etc.)• Primary endpoint:– Disease-free survival

70

UFT
CMF

70

Baseline

4 mos.

ANOVA

12 mos.

UFT
CMF

60

60

EligibleMean฀ SE.

80

80

50

Global QoL

Score

Score

50

Time

Treatment
P=0.017
Treatment x Time P=0.0001

Baseline
ANOVA

Time

4 mos.
12 mos.
฀
Treatment
P=0.0043

Treatment x Time P=0.0007

Higher score indicates higher QOL• Secondary endpoints:

I.C.

]

Score

– Overall survival– Adverse events– QOL– Direct costs

Fatigue

50

Randomization
Randomization
Randomization
Randomization

Mean฀ SE.

40sTAM p.o. 5 yrs.

UFT
CMF

10

CMF 6
cycle

Nausea / vomiting Mean฀ SE.

30

20

UFT p.o. 2 yrs.

50
40

30

0

Score

20

UFT
CMF

10
Baseline
ANOVA

4 mos.

12 mos.

Treatment
Treatment x TimeTime
P=0.044
P=0.0001

0

Baseline

4 mos.

ANOVA

Time

12 mos.

Treatment
Treatmet x Time

P=0.024
P=0.0001

Lower score indicates higher QOL
35

36

ASCO2003, 2982
By Kobayashi

Quality of Life Evaluation During Chemotherapyof Patients with Advanced Non-Small-Cell Lung
Cancer: Comparison between CPT-11 plus

AE and QOL

CDDP and VDS plus CDDP in Randomized Trial.

K. Kobayashi, S. Morita, K. Eguchi,
T. Matsumoto, M. Shibuya, Y. Yamaji, Y. Ohashi.
Saitama Cancer Center, Kyoto University, Tokai University,
Musashigaoka Hospital, Nippon Medical School,
Mitoyo General Hospital, University of Tokyo, all in Japan. 㻟㻤㻌

37

ASCO2003, 2982
By Kobayashi

Subjects

䢳䢲䢲CDDP䠇CPT1180 mg/m2: d1

60 mg/m2: d1,8,15

CDDP䠇VDS
80

mg/m2

: d1

3

mg/m2

㻯㼛㼙㼜㼍㼞㼕㼟㼛㼚㻌㼎㼑㼠㼣㼑㼑㼚㻌㼍㼞㼙㼟㻻㼢㼑㼞㼍㼘㼘㻌㼙㼑㼍㼚㻌㼜㻩㻜㻚㻜㻜㻟㻿㼘㼛㼜㼑㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㼜㻩㻜㻚㻜㻜㻤䢻䢲Mean QOL Score

Randomize

Randomized phase III trial in untreatedpatients with Stage IIIB / IV NSCLC and
ECOG PS 0-2

Physical Domain

ASCO2003, 2982
By Kobayashi䢺䢲䢹䢲䣏䣧䣣䣰䤒䢻䢷䢧䣅䢰䣋䢰䣅䣆䣆䣒䢭䣅䣒䣖
䣅䣆䣆䣒䢭䣘䣆䣕䢸䢲䢷䢲: d1,8,15
䢶䢲Primary endpoint: Survival
Secondary endpoints: Tumor response, Timeto PD, Toxicities, QOL

䢵䢲㻔㼚㻕㻌㻌㻣㻣㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻣㻠㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻢㻥㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻣㻝㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻢㻤㻌㻌㻌㻔㻯㻰㻰㻼㻗㻯㻼㼀㻕㻌㻌㻌㻌㻌㻌㻤㻠㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻣㻥㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻣㻥㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻣㻤㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻌㻣㻠㻌㻌㻌㻔㻯㻰㻰㻼㻗㼂㻰㻿㻕䢴䢲䣄䣣䣵䣧䣮䣫䣰䣧
㻟㻥㻌䣙䣧䣧䣭䢢䢳

䣙䣧䣧䣭䢢䢴

䣙䣧䣧䣭䢢䢵

䣙䣧䣧䣭䢢䢶

㻔㼀㼕㼙㼑㻕
㻠㻜㻌

2982
Nonhematological ASCO2003,
By Kobayashi
Toxicity

CDDP+CPT(n=77)
䍹G1
G3/4
42.9
0/66.2
6.5/36.4
6.5/3.9

AdverseeventsFever
N&V
Diarrhea

Physical Domain& Toxicity
CDDP+CPT-11

CDDP+VDS(n=84)
䍹G1
G3/4
35.7
0/33.3
1.2/9.5
0/0

Adverse events

ASCO2003, 2982
By Kobayashi

CDDP+VDS

Coefficient*P

Coefficient*

P

Fever

-0.9

0.734

-6.8

0.002

Nausea/vomiting-12.4<0.001-13.5<0.001

Diarrhea

-3.5

0.038

-5.1

0.276

* Estimate of coefficient with adjustment for age, sex, stage, baseline PS, andtime (weeks 1 to 4).
㻠㻝㻌

㻠㻞㻌

㈈ᅋἲேPHRF⮫ᗋ◊✲ᨭ᥼஦ᴗCSP㻌 㻌 䛜䜣㻌 CSPOR㻌 㻌 㦵⢒䛧䜗䛖⑕㻌 CSP-ATOP㻌 㻌 ⏕ά⩦័⑓㻌 CSP-LD䝦䝹䝇䜰䜴䝖䜹䝮㻌 CSP-HOR

43

44

CSP-HOR 2012ᖺ఍㻌 ୗጔ㻺㻙㻿㻭㻿㻌㻜㻞㻌἞⒪䝇䜻䞊䝬㻌
ACP

⾡ᚋங䛜䜣
Stage I-IIIA
ᏳᆾȪȳȑ
ራ᠃ᆆࣱᨗ
70ৗˌɦ
PS 0-1䡭䢀䢚䢔䡭䢋䡮䡸䢙 䠇䡸䡴䢗䢊䡹䢈䡣䢌䢀䢚㻌 㻌 䢆䢛䡴䢔䡼䡳䡺䢕

䝷
䞁
䝎
䝮
๭
௜

ACD
䢀䢚䡺䡼䡳䡺䢕

ᨺ
ᑕ
⥺
↷
ᑕ

吖
吹
各
后
听
叾
呉

PTX
䢆䢛䡴䢔䡼䡳䡺䢕
DTX
45䢀䢚䡺䡼䡳䡺䢕

CSP-HOR 2012ᖺ఍㻌 ୗጔ

47

46

CSP-HOR 2012ᖺ఍㻌 ୗጔ

48

Improving Drug Safety: From Toxicity Assessment toPost-marketing Surveillance
Education Session 㻌 Chair(s): David Cella, PhD

CSP-HOR 2012ᖺ఍㻌 ▮ᙧ㻌་ᖌ䞉ᝈ⪅䛾ホ౯䛾㐪䛔䝽䞊䜻䞁䜾䜾䝹䞊䝥άື㻌 㻌 ᪋タ䛾䝃䝫䞊䝖ᐇែㄪᰝ㻌 㻌 ᝈ⪅ㄪᰝ䠄‽ഛ୰䠅㻌 㻌 ᩍ⫱ᩍᮦసᡂ㻌 㻌 䝅䝇䝔䝬䝏䝑䜽䝺䝡䝳䞊㻌 㻌 ከ᪋タ◊✲

49

CSP-HOR 2012ᖺ఍㻌 ▮ᙧ㻌

50

CSP-HOR 2012ᖺ఍㻌 ▮ᙧ㻌

51

52

CSP-HOR 2012ᖺ఍㻌 ⚟⏣CSP-HOR 2012ᖺ఍㻌 ⚟⏣㈝⏝ㄪᰝ䝁䝇䝖䛾ศ㢮ẟ฼ගᏊ, ᘅ℩ዉὠᏊ, ⚟⏣ᩗ, ኱ఫ┬୕, ྥ஭༤ᩥ, ᳃⏣ᬛど, ௒஭༤ஂ, Ώ㎶஽,ୗጔ᫭஧㑻, ኱ᶫ㟹㞝.
◊✲⪅୺ᑟ䛜䜣⮫ᗋヨ㦂䛻䛚䛡䜛䝁䝇䝖䝕䞊䝍཰㞟᪉ἲ䛾᳨ウ᪥ᮏ⸆๣␿Ꮫ఍㻌 ➨11ᅇᏛ⾡⥲఍, 2005ᖺ7᭶11᭶┤᥋་⒪㈝䞉䞉 䞉 ་⒪ᶵ㛵䛻㻌 ᨭᡶ䜟䜜䜛㈝⏝┤᥋㈝⏝Fukuda T, Mouri M, Hirose N, Ohsumi S, Mukai H, Morita S, Imai H, Watanabe T,
Shimozuma K, Ohashi Y.
Methods of cost data collection for pharmacoeconomic study along with aclinical trial.
ISPOR 2nd Asia-Pacific Conference, March 2006┤᥋㠀་⒪㈝䞉䞉㏻㝔㈝⏝⑌⑓䛻㛵㐃䛩䜛

ୗጔ᫭஧㑻, ⚟⏣ᩗ, ẟ฼ගᏊ, ᘅ℩ዉὠᏊ, ኱ఫ┬୕, ྥ஭༤ᩥ, ᳃⏣ᬛど,௒஭༤ஂ, Ώ㎶஽, ኱ᶫ㟹㞝.
་⒪⤒῭ホ౯䜢ྵ䜐䛜䜣⮫ᗋヨ㦂䛻䛚䛡䜛䝁䝇䝖䝕䞊䝍཰㞟᪉ἲ䛾ᶆ‽໬᪥ᮏங⒴Ꮫ఍㻌 ➨14఍Ꮫ⾡⥲఍, 2006ᖺ7᭶⿵⿦ල䛾㉎ධ㈝㛫᥋㈝⏝䞉䞉䞉䞉ປാ᫬㛫ᦆኻ䜢ᶵ఍㈝⏝䛸䛧䛶⟬ฟ
53

54

CSP-HOR 2012ᖺ఍㻌 ⚟⏣CSP-HOR 2012ᖺ఍㻌 ⚟⏣䝕䞊䝍཰㞟䛾ὶ䜜㻌 㻌䝕䞊䝍䝋䞊䝇䛾ㄪᰝ䝫䜲䞁䝖
┤᥋་⒪㈝
㻝᭶

㻞᭶

㻟᭶

㻠᭶

㻡᭶

㻢᭶

㻣᭶

㻤᭶

㻥᭶

㻝㻜 ᭶ 㻝㻝᭶ 㻝㻞᭶ 㻝ᖺ

䝺䝉䝥䝖
⸆๣ᢞ୚

䢖䡺䢈䢛䢀ᅇ཰

┤᥋㠀་⒪㈝䞉㛫᥋㈝⏝䡭䢙䡵䡬䢀ㄪᰝ

㈝⏝䛸⏕ά䛻䛴䛔䛶䛾䜰䞁䜿䞊䝖䝕䞊䝍䝉䞁䝍䞊

㻽㻻㻸ㄪᰝ

㻤ᅇ

㻝㻞ᅇ

㻟ᅇ

㻢ᅇ

55

56

CSP-HOR 2012ᖺ఍㻌 ⚟⏣CSP-HOR 2012ᖺ఍㻌 ⚟⏣┤᥋㠀་⒪㈝㻌 ㉁ၥ⚊㛫᥋㈝⏝㻌 ㉁ၥ⚊3ųᡫᨈƷƨǊƷኺែƸƲƷǑƏƴƳƬƯƍǇƢƔᲹᐯܼဇ៻ưᡫᨈƠƯƍǔ‫ئ‬ӳƸŴ
3=3ưžƸƍſƱƝ‫ׅ‬ሉƷ૾ƷǈŴƓሉƑƘƩƞƍ?
ųƜƷȶஉ᧓ưŴʻ‫ׅ‬Ʒ၏ൢƷƨǊƴˁʙǍܼʙǛ˞ǜƩƷƸ˴ଐ᧓ưƢƔᲹ༾ᢊƷុᩉǛƓሉƑƘƩƞƍŵᝲဇƸƓǑƦƷ᣿᫇ưኽನưƢŵųᡫᨈଐƸᨊƍƯƓሉƑƘƩƞƍŵƨƩƠ᣿᫇ƕǘƔǒƳƍ‫ئ‬ӳƸᆰഇƷǇǇưኽನưƢŵų˞ǜƩଐƸƳƔƬƨģᚡλ̊Ĥų˞ǜƩଐƕƋƬƨኺែųᲢ༾ᢊᲣ

ʩᡫ৖െ

ኖ Ტ

Უ ଐ᧓

ᝲဇ
3ųƜƷȶஉ᧓ưŴʻ‫ׅ‬Ʒ၏ൢƷƨǊƴˁʙǍܼʙǛถǒƠƨƷƸ˴ଐ᧓ưƢƔᲹᲢ ᐯ‫ܡ‬ࢻഩųόųถǒƠƨଐƸƳƔƬƨ

3ǁƓᡶǈƘƩƞƍŵ

Უ

Ȑǹ

ųό

ųถǒƠƨଐƕƋƬƨųኖᲢųųųųᲣଐ᧓3ǁƓᡶǈƘƩƞƍŵ

ųό3ų=3ưžถǒƠƨଐƕƋƬƨſƱƝ‫ׅ‬ሉƞǕƨ૾ƷǈƓሉƑƘƩƞƍ?

ųόᲣ ᳸ Ტ ŨŨͣသ৑ ᲣᲢ ŨŨͣသ৑ Უ ᳸ Ტ ššᬜᲢ ššᬜᲣ ᳸ Ტ ţţᬜ

Უ

,4

Ტ ţţᬜ

Უ ᳸ Ტ gg၏ᨈᲣࢻഩˁʙǛถǒƠƨኽௐŴƦǕǒƷଐƷˁʙƸ࠯‫ר‬ƠƯŴ୍െƷˁʙƷƲƷᆉࡇưƠƨƔᲹᆉࡇųųųųҞЎᆉࡇųųųųųᆉࡇ

3ʐƕǜƷƨǊƴˁʙǛᠴǊƨǓŴ᠃ᎰƠƨǓƠƨƜƱƕƋǓǇƢƔᲹųӷơ˟ᅈϋưᢿፙƕ‫٭‬ǘƬƨ‫ئ‬ӳǋԃǊǇƢŵ
ųƋǔ

ųƳƍ

3ų৖ᘐǛӖƚƨˌᨀƴŴˌɦƷǑƏƳǋƷƴƍƘǒᝲဇƕƔƔǓǇƠƨƔᲹ
3ųƋƳƨƷྵ‫נ‬ƷƝᎰಅƸ˴ưƢƔᲹஇǋ࢘ƯƸǇǔǋƷᲫƭƴŨǛƭƚƯƘƩƞƍŵ

ųƋƯƸǇǔǋƷμƯƴƝᚡλƘƩƞƍŵ
3ųǉƘǈǛ᠉ƘƢǔƨǊƷǵȝȸǿȸȷ֥φƷទλǍȬȳǿȫ Ტų‫ݦ‬ಅɼۡųȑȸȈƷѮѦᎰųᐯփಅ

ųƦƷ˂ᲢųųųųųųųųųųųųᲣᲣόųࠝѮᎰ

3ųȑȃȉǍᙀദဇƷȖȩǸȣȸሁƷទλᲢᲣό3ųƔƭǒƷទλǍȬȳǿȫ

ᲢᲣό3ųܼʙੲяƷƨǊƷȘȫȑȸǍܼ૎ۡᲢᲣό3ųࠀƠૅƑƳƚǕƹŴˁʙƔǒࢽǒǕǔዅɨǛ૙ƑƯƍƨƩƚǇƢƔᲹࠝѮᎰƷ‫ئ‬ӳᲴȶஉƷዅɨᲢᲣόȑȸȈᎰƷ‫ئ‬ӳᲴଐƋƨǓ࠯‫ר‬

Ტ

Უό

57

58

CSP-HOR 2012ᖺ఍㻌 ⚟⏣CSP-HOR 2012ᖺ఍㻌 ⚟⏣EQ-5D䜢⏝䛔䛯ຠ⏝್ㄪᰝ䠍ᖺ㛫䛾㈝⏝

Shimozuma K, Shiroiwa T, Fukuda T, Mouri M, Ohashi Y, Watanabe T.
Comparison of EQ-5D score between treatment with 4 cycles ofanthracycline followed by 4 cycles of taxane and 8 cycles of taxane fornode positive breast cancer patients after surgery: N-SAS BC 02 trial.
ISPOR 13th Annual European Congress, November 2010

Shiroiwa T, Fukuda T, Shimozuma K, Kuranami M, Suemasu K, Ohashi Y,
Watanabe T.
Comparison of EQ-5D scores among anthracycline-containing regimens
followed by taxane and taxane-only regimens for node-positive breast
cancer patients after surgery: the N-SAS BC 02 trial.
Value in Health 2011; 14(5): 746-751.

59

CSP-HOR 2012ᖺ఍㻌 ⚟⏣60

CSP-HOR 2012ᖺ఍㻌 ⚟⏣EQ5D䠄EuroQol 5 Dimension䠅㻌 ㉁ၥ⚊◊✲ᑐ㇟䛚䜘䜃ᑻᗘ• N-SAS BC 02䛻Ⓩ㘓䛧䛯1,060౛䛾䛖䛱䚸ึᮇ䛾㐃⥆300౛䠄2001ᖺ11᭶䠉2003ᖺ5᭶Ⓩ㘓䠅䜢CIPN䛸
HRQOL䛾◊✲ᑐ㇟䛸䛧䛯䚹• ⏝䛔䛯ᑻᗘ:p FACT-G (27㡯┠, 108Ⅼ): physical well-being [PWB],
social/family well-being [SFWB], emotional well-being[EWB] and functional well-being [FWB]
p FACT-B (FACT-G + 9㡯┠, 144Ⅼ)
p FACT-Taxane (FACT-G + 16㡯┠, 172Ⅼ)
p EQ-5D (5㡯┠, ᭱኱್:1)
61

62

CSP-HOR 2012ᖺ఍㻌 ⚟⏣CSP-HOR 2012ᖺ఍㻌 ⚟⏣EuroQol᪥ᮏㄒ∧᪥ᮏ∧᥮⟬䜴䜵䜲䝖䠄䠪䠏䝰䝕䝹䠅㸳ḟඖࠊ㸱ẁ㝵࡟ࡼࡿ42/ホ౯㸦(4'㸧ᐃᩘ         ③ࡳ㸭୙ᛌឤ   㸰 
⛣ືࡢ⛬ᗘ   㸰           㸱  ḟඖ         ࣞ࣋ࣝ        㸱  ୙Ᏻ㸭ࡩࡉࡂ㎸ࡳ 㸰  ⛣ືࡢ⛬ᗘ      㸯 ၥ㢟ࡀ࡞࠸㌟ࡢᅇࡾࡢୡヰ 㸰           㸱 
 ㌟ࡢᅇࡾࡢ⟶⌮    㸰 ࠸ࡃࡽ࠿ၥ㢟ࡀ࠶ࡿ        㸱  ࣞ࣋ࣝ㸱        ࡩࡔࢇࡢ⏕ά     㸱 ၥ㢟ࡀ࠶ࡿࡩࡔࢇࡢάື  㸰   ③ࡳ㸭୙ᛌឤ        㸱   ୙Ᏻ㸭ࡩࡉࡂ㎸ࡳ
63

Tsuchiya A, Ikeda S, Ikegami N, Nishimura S, Sakai I, Fukuda T, Hamashima C, Hisashige A,
Tamura M. Estimating an EQ-5D population value set: the case of Japan. Health Economics
2002; 11: 341-353

64

CSP-HOR 2012ᖺ఍㻌 ⚟⏣EQ5D䛻䜘䜛ຠ⏝್䛾᥎⛣

CSP-HOR 2012ᖺ఍㻌 ⚟⏣EQ5D䛻䜘䜛ຠ⏝್䛾䝧䞊䝇䝷䜲䞁䛛䜙䛾ኚ໬

65

66

CSP-HOR 2012ᖺ఍㻌 ⚟⏣CSP-HOR 2012ᖺ఍㻌 ⚟⏣Results of the linear mixed model analysis

Comparison with previous study

F-valueP-value

BASELINE

Effect45.75<.0001 *

GROUP

6.67

0.0002 *

TIME

8.40

<.0001 *TIME*GROUP

2.33

0.0061 *DifferenceSE

P-value

95% CIACP vs DTX

Comparison

0.052

0.01850.0048 *[0.016 - 0.089]

ACD vs DTX

0.077

0.0185<.0001 *[0.040 - 0.113]

PTX vs DTX

0.021

0.01860.269[-0.016 - 0.057]

AC followed by taxane vs taxane alone

0.054

0.0132<.0001 *[0.028 - 0.080]

Paclitaxel vs Docetaxel-0.0020.01310.889[-0.028 - 0.024]*: P<0.05
Abbreviations: SE, standard error; CI, confidence interval.
Pickard AS, Wilke CT, Lin HW, Lloyd A. Health utilities using the EQ-5D in studies of cancer.
Pharmacoeconomics 2007;25:365-84

67

68

CSP-HOR 2012ᖺ఍㻌 ኱ఫᾋ⭘䛾ホ౯ἲ㻌య㔜ᐃ㻌䠄ᐈほⓗホ౯䠅㻌 㻌㻌 㻌 Ⓩ㘓᫬䚸ྛ䝃䜲䜽䝹㼐㼍㼥㻝䚸䠓䞃᭶᫬䚸䛭䛾ᚋ䠒䞃᭶䛤䛸㻌㻲㻭㻯㼀㻙㻮㻘㻌㻙㼀㼍㼤㼍㼚㼑㻌䠄୺ほⓗホ౯䠅㻌㻌 㻌 Ⓩ㘓᫬䚸䝃䜲䜽䝹㻟㻘㻌㻡㻘㻌㻣䛾㼐㼍㼥㻝䚸䠓䠈䠍䠎䞃᭶ᚋ㻌

70

69

CSP-HOR 2012ᖺ఍㻌 ኱ఫᾋ⭘䛻䛴䛔䛶䛾㻌
㻲㻭㻯㼀㻙㻮㻘㻌㻙㼀㼍㼤㼍㼚㼑䛾㉁ၥ㡯┠㻌䠞䠔㻌 య㔜䛾ኚ໬䛻ᝎ䜣䛷䛔䜛䚹㻌㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 䠄య㔜䛾ኚ໬䠅㻌㼀㻭㼄㻝㻌 ඲㌟䛜䜐䛟䜣䛷䛔䜛Ẽ䛜䛩䜛䚹㻌㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 䠄඲㌟䛾ᾋ⭘䠅㻌㼀㻭㼄㻞㻌 ୧ᡭ䛜䛿䜜䛶䛔䜛䚹㻌㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌㻌㻌䠄ᡭ䛾ᾋ⭘䠅㻌㼀㻭㼄㻟㻌 ୧㊊䛜䛿䜜䛶䛔䜛䚹㻌㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌 㻌㻌㻌䠄㊊䛾ᾋ⭘䠅㻌
㻌

CSP-HOR 2012ᖺ఍㻌 ኱ఫ୺἞་ุᐃ䛾ᾋ⭘䛾㢖ᗘ㻌㻼㼍㼠㼕㼑㼚㼠㼟㻘㻌㻺㻌㻳㼞㼍㼐㼑㻌㻜㻌

㻳㼞㼍㼐㼑㻌㻝㻌

㻳㼞㼍㼐㼑㻌㻞㻌

㻳㼞㼍㼐㼑㻌㻟㻌

㻳㼞㼍㼐㼑㻌㻠㻌

㻭㻯㻼㻌㻔㼚㻌㻩㻌㻣㻠㻕㻌

㻢㻞㻌

㻝㻞㻌

㻜㻌

㻜㻌

㻜㻌

㻭㻯㻰㻌㻔㼚㻌㻩㻌㻣㻡㻕㻌

㻠㻝㻌

㻞㻞㻌

㻝㻝㻌

㻝㻌

㻜㻌

㻼㻭㻯㻌㻔㼚㻌㻩㻌㻣㻢㻕㻌

㻢㻜㻌

㻝㻡㻌

㻝㻌

㻜㻌

㻜㻌

㻰㻻㻯㻌㻔㼚㻌㻩㻌㻣㻡㻕㻌

㻝㻞㻌

㻞㻞㻌

㻟㻠㻌

㻣㻌

㻜㻌

Ⓩ㘓᫬䛛䜙䠒䞄᭶䜎䛷䛾᭱ᝏ䛾㼓㼞㼍㼐㼑㻌㻔㻺㻯㻵㻙㻯㼀㻯㻌㼢㼑㼞㼟㼕㼛㼚㻌㻞㻚㻜㻕㻌
71

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CSP-HOR 2012ᖺ఍㻌 ኱ఫయ㔜䛾ኚ໬㻌

CSP-HOR 2012ᖺ఍㻌 ኱ఫ㻲㻭㻲㻭㻯㼀㻙㻮㻌㻮㻤㻌䠄య㔜䛾ኚ໬䛾ᝎ䜏䠅㻌

㻡㻥㻌

㻡㻤㻌

㻡㻣㻌

㻡㻢㻌

㻡㻡㻌
㻭㻯㻼㻌
㻡㻠㻌

㻼㻌㻩㻌㻜㻚㻜㻠㻡㻜㻌㻔㻰㻻㻯㻌㼢㼟㻚㻌㻻㼠㼔㼑㼞㼟㻌㼏㼛㼙㼎㼕㼚㼑㼐㻕㻌㻭㻯㻰㻌㻼㻌㻩㻌㻜㻚㻜㻝㻤㻠㻌㻔㻰㻻㻯㻌㼢㼟㻚㻌㻻㼠㼔㼑㼞㼟㻌㼏㼛㼙㼎㼕㼚㼑㼐㻕㻌

㻼㻭㻯㻌
㻡㻟㻌

㻼㻌㻨㻌㻜㻚㻜㻜㻜㻝㻌㻰㻻㻯㻌㻗㻌㻭㻯㻰㻌㼢㼟㻚㻌㻭㻯㻼㻌㻗㻌㻼㻭㻯㻌㻼㻌㻩㻌㻜㻚㻜㻠㻠㻠㻌㻔㻰㻻㻯㻌㻗㻌㻭㻯㻰㻌㼢㼟㻚㻌㻭㻯㻼㻌㻗㻌㻼㻭㻯㻕㻌

㻰㻻㻯㻌

㻡㻞㻌
㼎㼍㼟㼑㼘㼕㼚㼑㻌

㻞㼚㼐㻌

㻟㼞㼐㻌

㻠㼠㼔㻌

㻡㼠㼔㻌

㻢㼠㼔㻌

㻣㼠㼔㻌

㻤㼠㼔㻌

㻤㼙㼛㼚㼠㼔㻌
㻣㻌㼙㼛㼚㼠㼔㼟㻌㻝㼥㼑㼍㼞㻌
㻣㻌㼙㼛㼚㼠㼔㼟㻌

73

74

CSP-HOR 2012ᖺ఍㻌 ኱ఫ

CSP-HOR 2012ᖺ఍㻌 ኱ఫ㻲㻭㻯㼀㻙㼀㼍㼤㼍㼚㼑㻌㼀㼍㼤㻝㻌䠄඲㌟ᾋ⭘䠅㻌㻲㻭㻲㻭㻯㼀㻙㼀㼍㼤㼍㼚㼑㻌㼀㼍㼤㻞㻌䠄ᡭ䛾ᾋ⭘䠅㻌㻲㻭㻼㻌㻩㻌㻜㻚㻜㻜㻝㻢㻌㻔㻰㻻㻯㻌㼢㼟㻚㻌㻻㼠㼔㼑㼞㼟㻌㼏㼛㼙㼎㼕㼚㼑㼐㻕㻌㻼㻌㻨㻌㻜㻚㻜㻜㻜㻝㻌㻔㻰㻻㻯㻌㼢㼟㻚㻌㻻㼠㼔㼑㼞㼟㻌㼏㼛㼙㼎㼕㼚㼑㼐㻕㻌㻼㻌㻨㻌㻜㻚㻜㻜㻜㻝㻌㻔㻰㻻㻯㻌㻗㻌㻭㻯㻰㻌㼢㼟㻚㻌㻭㻯㻼㻌㻗㻌㻼㻭㻯㻕㻌㻼㻌㻨㻌㻜㻚㻜㻜㻜㻝㻌㻔㻰㻻㻯㻌㻗㻌㻭㻯㻰㻌㼢㼟㻚㻌㻭㻯㻼㻌㻗㻌㻼㻭㻯㻕㻌㻣㻌㼙㼛㼚㼠㼔㼟㻌㻣㻌㼙㼛㼚㼠㼔㼟㻌

75

76

CSP-HOR 2012ᖺ఍㻌 ኱ఫ

CSP-HOR 2012ᖺ఍㻌 ኱ఫ⤖㻌 ㄒ㻌㻲㻭㻯㼀㻙㼀㼍㼤㼍㼚㼑㻌㼀㼍㼤㻟㻌䠄㊊䛾ᾋ⭘䠅㻌㻲㻭䝷䞁䝎䝮໬ẚ㍑ヨ㦂䛷䚸䝗䝉䝍䜻䝉䝹䠔䝃䜲䜽䝹䛾⩌䛜௚䛾⩌䛻ẚ䛧䛶䚸ᐈほⓗ䛻䜒୺ほⓗ䛻䜒ᾋ⭘䛜ᙉ䛟㉳䛣䛳䛶䛔䜛䛣䛸䛜♧䛥䜜䛯㻌㻌 䠄䝗䝉䝍䜻䝉䝹䠐䝃䜲䜽䝹䛷䛿ᾋ⭘䛿䛒䜎䜚ၥ㢟䛸䛿䛺䜙䛺䛔䠅㻌
య㔜䛾ኚ໬䛷䜏䜛䛸䚸䝗䝉䝍䜻䝉䝹䛻䜘䜛ᾋ⭘䛿᭱⤊ᢞ୚䛛䜙䠍䡚䠎䜹᭶䛷ᅇ᚟䛩䜛䛸ᛮ䜟䜜䜛㻌୺ほⓗ䛺ᾋ⭘䛾ᝎ䜏䛾ゎᾘ䛿䚸ᐇ㝿䛾య㔜䛾ᅇ᚟䜘䜚ᑡ䛧㐜䜜䛶䛔䜛㻌㻼㻌㻨㻌㻜㻚㻜㻜㻜㻝㻌㻔㻰㻻㻯㻌㼢㼟㻚㻌㻻㼠㼔㼑㼞㼟㻌㼏㼛㼙㼎㼕㼚㼑㼐㻕㻌㻼㻌㻨㻌㻜㻚㻜㻜㻜㻝㻌㻔㻰㻻㻯㻌㻗㻌㻭㻯㻰㻌㼢㼟㻚㻌㻭㻯㻼㻌㻗㻌㻼㻭㻯㻕㻌㻣㻌㼙㼛㼚㼠㼔㼟㻌77

CSP-HOR 2012ᖺ఍㻌 ኱ఫ

78

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Quality of life (QOL) evaluation within a randomized
phase III study of gemcitabine plus S-1 (GS) versus
S-1 versus gemcitabine (Gem) in unresectableadvanced pancreatic cancer (PC) in Japan andTaiwan䠖 GEST study

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GEST study designGem1000 mg/m2 d1, 8, 15
repeated every 4 wks

Y. Ohashi, M. Tanaka, N. Boku, H. Ueno, T. Okusaka on behalf of the GEST study group

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䞉Metastatic vs. Locally advanced
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S-1
80, 100, 120mg*/body d1-28
repeated every 6 wks
Gem + S-1
GEM: 1000mg/m2 d1, 8
S-1: 60, 80, 100mg*/body d1-14
repeated every 3 wks*According to body surface area,
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BSA < 1.25 m2, 1.25=<BSA <1.5, BSA >=1.5

Primary objectives of the QOL
analysis4007

To assess differences between the treatment groups
Ø EQ-5D utility index
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䠄Randomized trial vs. observational studies)

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Improving Drug Safety: From Toxicity Assessment to Post-marketing Surveillance
Education Session 㻌 Chair(s): David Cella, PhD㻌 㻌 㻌 㻌 FACT 䛾㛤Ⓨ⪅

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Improving Drug Safety: From Toxicity Assessment to Post-marketing Surveillance
Education Session 㻌 Chair(s): David Cella, PhD

Improving Drug Safety: From Toxicity Assessment to Post-marketing Surveillance
Education Session 㻌 Chair(s): David Cella, PhD

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Improving Drug Safety: From Toxicity Assessment to Post-marketing Surveillance
Education Session 㻌 Chair(s): David Cella, PhD

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Improving Drug Safety: From Toxicity Assessment to Post-marketing Surveillance
Education Session 㻌 Chair(s): David Cella, PhD

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2012ASCO㻌 Educational Session ‘Endpoints’ (D.Bruner)

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2012ASCO㻌 Educational Session ‘Endpoints’ (D.Bruner)

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2012ASCO㻌 Educational Session ‘Endpoints’ (D.Bruner)

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2012ASCO㻌 Educational Session ‘Endpoints’ (D.Bruner)

Gan To Kagaku Ryoho. 2004 Aug;31(8):1187-92.

[Reliability at the National Cancer Institute-Common Toxicity Criteria version㻌 2.0].
[Article in Japanese]
Kaba H, Fukuda H, Yamamoto S, Ohashi Y.
Statistics and Cancer Control Division, Research Center for Cancer Prevention andScreening, National Cancer Center Research Institute.

We evaluated the reliability of CTC v 2.0 based on source documents and alsostudied the degree of inconsistency in toxicity grading. Five clinical researchcoordinators from the National Cancer Center Hospital independently reviewed䡡䡡䡡䞉
environment, variability exists in the toxicity assessment and grading. Good
training and education on toxicity assessment using common criteria anddevelopment of translated manual, including the interpretation of criteria
assessment, may help reduce variability.
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2012ASCO㻌 Educational Session ‘Endpoints’ (D.Bruner)

2012ASCO㻌 Educational Session ‘Endpoints’ (D.Bruner)

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Hufford MR et al. Applied Clinical Trials, 2002 August 38-43.
Result from Stone et al. BMJ 2002; 324: 1193-4:

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Hufford MR et al. Applied Clinical Trials, 2002 August 38-43.
Result from Stone et al. BMJ 2002; 324: 1193-4:

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