N-SAS BC 06

National Surgical Adjuvant Study of Breast Cancer

NEOS

T1c-T2Ღ
ᲦN0ᲦM0ƷҾႆࣱ‫ࣱڡ‬ʐƕǜ᧍ኺࢸᲦЭ඙ၲƳƠᲦǨǹȈȭǲȳӖܾ˳ࣱᨗᲦHER2ᨏࣱᲦPS 0-1

CSPOR(Comprehensive Support Project forOncology Research)

CSPORӷॖӕࢽᲦɟഏႇ᥵ᘐЭȗȭȈǳȸȫ඙ၲᲴȬȈȭǾȸȫᲢLETᲣ৲ɨ 24ᡵ᳸28ᡵ

New primary Endocrine-therapy Origination StudyȬȈȭǾȸȫƴǑǔᘐЭϋЎඣၲඥƕ‫ڌ‬јƠƨјௐЙ‫ܭ‬•LET᧏‫ࢸڼ‬1ȶஉ
•2ȶஉ
•4ȶஉ
•LETኳʕ଺LETኳʕ଺ƷЙ‫ܭ‬CRᲦPRᲦSD᧍ኺࢸʐƕǜधᎍƴ‫ݣ‬Ƣǔᘐࢸ҄‫ܖ‬ϋЎඣၲඥƱPDƷ‫ئ‬ӳLETɶഥ৖ᘐᲢᘐࡸሁƸਃ࢘ҔƷЙૺƴ‫ۀ‬ƶǔᲣϋЎඣҥ཯ၲඥƷȩȳȀȠ҄ൔ᠋ᚾ᬴Ჴл˄ᛦૢ‫܇׆‬‫܇‬ᘐЭLETƷјௐᲴCR+PR/SD
R+PR/SD
ᴤᴷᴳᴑᴶᴕᴛᴳᴵᴲᴖᴤᴷᴘᴈᲴஊ໯
Ᏻᆾᴰᴵᴢᴷራ᠃ᆆᲴஊ໯
࠰ᱫᲴ60ബச฼/60ബˌɥ଀ᚨᘐЭϋЎඣၲඥ஖᧓ɶƷͤࡍ᧙ᡲQoLᚐௌኽௐʚഏႇ᥵ȩȳȀȠл˄CL፭Ტ҄‫ܖ‬ၲඥĺLETᲣ҄‫ܖ‬ၲඥࢸᲦȬȈȭǾȸȫ৲ɨᲢ4.5-5࠰Უ࠯ ঺ʴᲦ‫ޥ‬ဋ࠼඙Ღᧈ᜿߷ծ௑Ღ‫ק‬ʟ‫ࢠی‬Ღ೮‫ͤ׽‬ʚஙҾฌ૟Ღ‫ޛ‬ӝਏබᲦ‫˰ٻ‬ႾɤᲦɦ‫଻ڸ‬ʚᢹᲦ‫ٻ‬೛᩹ဏPD፭ႇ᥵˓ॖƷ඙ၲL፭ᲢLETҥ཯ᲣȬȈȭǾȸȫ৲ɨᲢ4.5-5࠰Უᚇ‫ݑ‬Ღ౨௹Ღᚸ̖ Ტᄂᆮ஖᧓ኳʕǇưᲣᏑ୎Ჴஜᚾ᬴Ʒॖ፯

CSPORᘐࢸƴ҄‫ܖ‬ၲඥƕ࣏ᙲƳधᎍᲦɧᙲƳधᎍǛȗȭǹȚǯȆǣȖƴӷ‫ܭ‬ࢽǒǕƴƘƍŵƠǑƏƱƍƬƨᚾǈƸᲦෙ‫ٳ‬ƴƓƍƯƸOncotype DX®Ღൔ᠋ႎϐႆȪǹǯƷ˯ƍțȫȢȳӖܾ˳ࣱᨗƷ᧍ኺࢸʐƕǜधᎍƴ

MammaPrint®ƱƍƬƨᢡˡ‫܇‬౨ኧǛဇƍǔ૾ඥƕ౨᚛ƞǕƯƍǔƕᲦƱƬƯƸᲦᘐࢸƷ҄‫ܖ‬ၲඥƸϋЎඣၲඥƴൔǂဃ‫܍‬ƴ݃ɨƢǔșȍƜǕǒƷᢡˡ‫܇‬౨ኧඥƸᝲဇƕ᭗᫇ưƋǔŵȕǣȃȈƕ‫ݲ‬ƳƍŵCSPORțȫȢȳӖܾ˳ࣱᨗƷʐƕǜƴ‫ݣ‬ƠƯƸᘐЭƴࢍщƳ҄‫ܖ‬ၲඥǛᘍƬƯǋ၏ྸ‫ܖ‬ႎ‫ܦ‬μ‫ڌ‬јᲢPathological Complete ResponseᲦpCRᲣƸᏑ୎Ჴஜᚾ᬴Ʒॖ፯ᲢƭƮƖᲣᘐЭϋЎඣၲඥǁƷӒࣱࣖƴǑǓᘐࢸƷᕤཋၲඥǛൿ‫ܭ‬ƢǔƜƱƕӧϋЎඣӒࣱࣖȷɶ᧓ȪǹǯƷ᧍ኺࢸʐƕǜƴ‫ݣ‬ƠƯᘐЭϋЎඣၲඥǛᏡƱƳǕƹᲦଐࠝᚮၲƴƓƚǔஊဇࣱƸΪЎƴ᭗ƍƱᎋƑǒǕǔŵ଀ᘍƠŴӒࣖƠƨधᎍƴ‫ݣ‬ƠƯƸᘐࢸƴᘐЭƱӷơϋЎඣၲඥǛᘍƏƜƱƴǑǓᲦ࣏ƣƠǋ҄‫ܖ‬ၲඥǛᘍƏ࣏ᙲƸƳƍӧᏡࣱƕƋǔŵƜƷǑƏƳधᎍǛᢠКƢǔƜƱƸᐮ࠿ɥƖǘǊƯॖ፯ƷƋǔ඙ၲǹȈȩȆǸȸƱƳǓƏǔŵĺResponse guided therapyƷ‫ࣱ࢘ڲ‬౨ᚰႸႎ
1.

CSPORCSPORႸ ႎᲢƭƮƖᲣȩȳȀȠл˄Ơƨ2፭᧓Ʒ໯၏ဃ‫܍‬஖᧓ᲢDiseaseFree Survival, DFSᲣǛൔ᠋ƢǔƜƱưᲦᘐЭϋЎඣၲ3.

ඥƕ‫ڌ‬јƠƨधᎍƴ‫ݣ‬Ơᘐࢸ҄‫ܖ‬ၲඥƕ࣏ᙲƔԁƔǛᚸ̖ŵ
2.

ƷᡙьјௐƷ᧙̞ƴƭƍƯ੕ኧႎƴ౨᚛ŵ4.

ᘐЭϋЎඣၲඥƷᧈ஖ႎʖࢸǁƷॖ፯Ǜ౨᚛ƢǔƨǊᲦ5.

CSPORHRQOLƷƷᚸ̖ᲴႸႎ

Endpoints໯၏ဃ‫܍‬஖᧓ᲢDisease-Free Survival; DFSᲣ
Secondary endpointsʐƕǜɟᑍᐮ࠿᧙ɨҔࠖƷᐮ࠿ᚾ᬴ӋьǛᡫơƨऴ‫්إ‬ᡫዡƷૢͳƱਘΪǛ‫׋‬ǔŵDFSᲦμဃ‫܍‬஖᧓ᲢOverall Survival, OSᲣǛᚸ̖ŵ

Primary endpoint

Health related qiality of lifeᲢHRQOLᲣŴᝲဇ‫ݣ‬јௐᲢјဇᲣƷᚸ̖ŵᚾ᬴μ˳ǛɟƭƷǹǭȸȠƱƠƯਵƑᲦɟഏႇ᥵धᎍƷᘐЭϋЎඣၲඥƷᐮ࠿ႎјௐ(CR/PR/SD/PD)КƷᘐЭϋЎඣၲඥƷᐮ࠿ƓǑƼ၏ྸ‫ܖ‬ႎјௐƱᲦ҄‫ܖ‬ၲඥ

CSPORஜᚾ᬴Ƹ‫ٻ‬ƖƘɟഏႇ᥵ࢸƷȬȈȭǾȸȫƴǑǔᘐЭϋЎඣၲඥ஖᧓ƱᲦʚഏႇ᥵ƱлǓ˄ƚࢸƷᘐࢸၲඥ஖᧓Ʒʚ஖ƴ‫ٻ‬КƞǕǔŵᐮ࠿ᡶᘍࡇT1c-T2, N0ҾႆࣱʐƕǜƴƓƍƯᲦϋЎඣμဃ‫܍‬஖᧓ᲢOverall Survival; OSᲣᲦၲඥӒࣱࣖƷཎ‫ܭ‬ǛႸႎƱƠƨᲦᘐЭϋЎඣၲඥƕᘐЭLETၲඥ Ʒᐮ࠿ႎ‫ڌ‬јྙᲦHRQOLƴӏǅƢࢨ᪪ƴƭƍƯଢǒƔƴƢǔŵኵጢ‫ܖ‬ႎ඙ၲјௐᲦʐ৐ภ‫܍‬৖ᘐྙᲦᘐЭϋЎඣၲඥƱ৖ᘐኽௐƴǑǓᲦ҄‫ܖ‬ၲඥ፭Ʊ᩼҄ᘐЭLET඙ၲƴǑǔCR/PR/SD/PDधᎍКƷ‫ܖ‬ၲඥ፭ƴ໯˺ໝƴлǓ˄ƚǒǕƨᲬ፭᧓ưƷHRQOLDFS/OSᲦ‫ܤ‬μࣱᲦHRQOLᲦᝲဇ‫ݣ‬јௐᲢјဇᲣƷࠀီǛଢǒƔƴƢǔŵCSPORኽௐᲴTrail profileHRQOL‫ݿ‬‫ࡇݿ‬Ტᛦ௹ᅚᲣƱᘐЭᚸ̖଺஖

CSPORᚸ̖‫ࡇݿ‬
FACT (Functional Assessment of Cancer Therapy)- ES(Endocrine Symptom), B (Breast)Ჴƕǜᐮ࠿ᚾ᬴ưɟᑍႎƴဇƍǒǕǔQOL‫ࡇݿ‬FACT-GƷᡙь‫ࡇݿ‬ƱƠƯESᲢϋЎඣ᧙ᡲၐཞᲣᲦ

Ⓩ㘓᫬:94%BᲢʐၶᲣHADS (Hospital Anxiety and Depression Scale)Ჴɧ‫ܤ‬Ღ৮ƏƭၐཞƷᚸ̖‫ࡇݿ‬Ტ14᪮ႸᲣ1䞄᭶┠:90%

EQ-5D (EuroQol 5 Dimension)Ჴᢠ‫ڤ‬ƴؕƮƘ‫ࡇݿ‬ƱƠƯᲦҔၲኺฎᚸ̖ƴƓƚǔјဇ͌ย‫ܭ‬ƴဇƍǔᲢ5᪮ႸඥƷǈᲣᚸ̖଺஖ႇ᥵଺ᲦᘐЭϋЎඣဇඥ᧏‫ڼ‬1ᲦᲮȶஉႸƷᲭ଺ໜ

4䞄᭶┠:87%
N Taira, et al. Breast Cancer Res Treat 2014CSPORኽௐᲴᏑ୎‫܇׆‬
VariableAge (years), mean (range)
Body mass index, mean (range)Value
63 (46-75)
23·9 (14·3-37·7)

Tumor size (cm)
1·0 - ā

173 (35%)

2·0- ā321 (65%)

Missing

3 (<1%)CSPORኽௐᲴQoLǹǳǢƷኺ଺ਖ਼ᆆ
Variable

Value

Histologic typeDuctal454 (91%)

Lobular18 (4%)Other

22 (4%)

Missing

3 (<1%)

Planed type of surgery

Nodal status
Negative494 (99%)

Positive0Missing

3 (<1%)

Breast conserving surgery

360 (72%)

Mastectomy

134 (27%)

Missing

3 (<1%)

ECOG performance status0493(99%)

11 (<1%)

Missing

3 (<1%)
N Taira, et al. Breast Cancer Res Treat 2014

N Taira, et al. Breast Cancer Res Treat 2014

CSPOR

ኽௐᲴSocial and Family well-beingƷitem analysisᲢ᪮ႸᚐௌᲣCSPORኽௐᲴ᣻ሶƳϋЎඣ᧙ᡲၐཞƷЎࠋƱਖ਼ᆆᐙ᪘䞉䝟䞊䝖䝘䞊䛸䛾㛵ಀ཭ே䛸䛾㛵ಀ཭ே䛛䜙䛾ຓ䛡ᛶ⏕ά

N Taira, et al. Breast Cancer Res Treat 2014

N Taira, et al. Breast Cancer Res Treat 2014

CSPORኽௐᲴᘐЭϋЎඣၲඥ஖᧓ɶƷɧ‫ܤ‬ȷ৮Əƭ

CSPOR

ኽௐᲴQoLᲢB-TOI)ƴࢨ᪪ǛӏǅƢᙲ‫׆‬Ʒᚐௌɟᑍ҄ዴ࢟Ȣȇȫᚐௌ
Variable
Var

95%CI

p value

Age

-0.19

(-0.33, -0.05)

0.01

Body mass index-0.10(-0.32, 0.12)

0.38

reference㻌㻌㻌㻌Time point (4 weeks)Time point (16 weeks)

N Taira, et al. Breast Cancer Res Treat 2014

Estimated value-0.72(-1.81, 0.36)

0.19

Nuclear grade 1reference㻌㻌㻌㻌

Nuclear grade 2-0.19(-2.15, 1.78)

0.85

Nuclear grade 3-1.99(-5.27, 1.29)

0.23

Baseline tumor size

-0.07(-0.18, 0.03)

0.17

Baseline B-TOI score

0.39(0.30, 0.48)<.0001Baseline HADS score-0.64(-0.81, -0.48)<.0001CSPORኽௐƷᙲኖƱኽᛖ ϋЎඣၲඥӒࣱࣖƷཎ‫ܭ‬ǛႸႎƱƠƨᲰƔஉƷ ᘐЭϋЎඣၲඥƸμᑍႎƳ3Q.ƴஊॖƳࢨ᪪ǛӏǅƞƳƍ 5QEKCNCPF(COKN[YGNNDGKPIƸ˯ɦƢǔƕᲦ ɼƨǔᙲ‫׆‬ƸܼଈƱƷ᧙ࣱ̞ ϋЎඣ᧙ᡲၐཞƸஊॖƴफ҄ƠᲦஇǋ᫋ᓸƳࢨ᪪Ƹ JQVHNWUJƴᛐǊǒǕǔ ʐƕǜƷᚮૺƴǑǔᲦ࣎ྸ᩿ǁƷࢨ᪪Ღɧ‫ܤ‬ȷ৮ƏƭƸ ᘐЭϋЎඣၲඥ஖᧓ɶƴોծƠᲦफ҄ƞƤǔƜƱƸƳƍᲨ ˯̛᙭ƳKPKVKCNCRRTQCEJƸᲦधᎍƷǳȸȔȳǰǛ᧹ܹƠƳƍᲨ