來曲唑做為絕經(jīng)后激素受體陽性的乳腺癌輔助內(nèi)分泌治療

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1、來曲唑做為絕經(jīng)后激素受體陽性的乳腺癌輔助內(nèi)分泌治療第一次結(jié)果報(bào)告IBCSG18-98/BIG1-98BeatThürlimannfortheBIG1-98CollaborativeCoordinatedbytheInternationalBreastCancerStudyTrialCoordinatedbyIBCSG?IBCSG:Studydesign?IBCSG:Databaseanddatamanagement?IBCSG:DSMCandEthicsCommitteeIBCSG:Medicalreview?IBCSG:Statisticalanalysis?IBCSG:Coordinati

2、onandcommunication?Novartis:Drugdistribution?Novartis:FinancialsupportArgentina123NewZealand157Australia667Peru51Belgium634Poland277Brazil17Portugal64Canada20Russia240Chile22Slovenia15CzechRep.109SouthAfrica187Denmark1396Spain70France1016Sweden64Germany113Switzerland611Hungary334Turkey54Iceland6Unit

3、edKingdom401Italy1285Uruguay1Netherlands94TOTAL8028BIG1-98WorldwideCollaborativeBIG1－98試驗(yàn)設(shè)計(jì)TAMn=2484來曲唑n=2484TAM來曲唑來曲唑n=1530TAMn=1530隨機(jī)分組ABCD2年3年2-armoption3/98-3/001835pts4-armoption9/99-5/036193ptsBIG1－98時(shí)間表19982001200220032004200519992000開始數(shù)據(jù)庫鎖定首次核心分析?來曲唑vs.他莫昔芬(headtohead)?包括所有病人?中位跟蹤時(shí)間：26個(gè)月不包括交

4、叉換藥C&D后的跟蹤TAM來曲唑TAM來曲唑來曲唑TAMABCD2－arm4－armPrimaryendpoint-DFS從隨機(jī)分組到發(fā)生第一次事件的時(shí)間–復(fù)發(fā)?同側(cè)乳房?胸壁?局部復(fù)發(fā)（乳腺內(nèi)/腋窩淋巴結(jié)）?遠(yuǎn)處轉(zhuǎn)移（包括同側(cè)鎖骨上淋巴結(jié))–對(duì)側(cè)乳腺(侵犯)第二原發(fā)惡性腫瘤（非乳腺癌）非復(fù)發(fā)引起的死亡統(tǒng)計(jì)學(xué)假設(shè)目標(biāo)樣本量:79352-armoption:18354-armoption:6100實(shí)際入組:8028復(fù)發(fā)事件數(shù)目:647forprimarycoreanalysis80%powertodetecta20%reductionintheriskofaDFSevent實(shí)際復(fù)發(fā)事件:779首

5、次核心分析8028隨機(jī)133(1.66%)ineligiblecasesincludedinprimarycoreanalysis18個(gè)出組（無治療/隨訪）8010核心分析4003來曲唑組Vs.4007TAM組病人/腫瘤特征來曲唑他莫昔芬中位年齡6161N+41.5%41.2%N-(包括前哨)52.0%52.3%N狀況未知6.5%6.5%腫瘤>2cm36.5%37.7%診斷時(shí)未絕經(jīng)2.3%2.5%病人/腫瘤特征來曲唑他莫昔芬ER+/PgR+63.5%62.7%ER+/PgR-20.2%20.5%ER+/PgRunk14.5%14.3%ER-/PgR+1.5%2.1%乳腺癌的治療來曲唑他莫昔芬既

6、往化療25.3%25.3%手術(shù)/放療組保乳手術(shù)＋放療53.3%54.0%保乳手術(shù)未放療2.8%3.3%乳房切除術(shù)＋放療18.3%17.6%乳房切除術(shù)未放療25.4%24.8%他莫昔芬020406080100012345PercentAliveandDisease-Free從隨機(jī)分組開始的時(shí)間（年）Disease-FreeSurvival弗隆97.797.6YearlyDFS%95.193.490.589.086.884.684.081.4NHR(95%CI)p80100.81(.70-.93)0.003No.atRisk3892389629642926126112388928664003400

7、7567544首次復(fù)發(fā)部位來曲唑他莫昔芬P失?。◤?fù)發(fā)事件）8.8%10.7%0.004原位復(fù)發(fā)0.5%0.9%0.047對(duì)側(cè)乳腺癌0.4%0.7%0.125局部復(fù)發(fā)*0.3%0.3%0.845遠(yuǎn)處轉(zhuǎn)移4.4%5.8%0.006第二原發(fā)惡性腫瘤（除乳腺癌）1.7%2.0%0.324未復(fù)發(fā)死亡1.4%0.9%0.077死亡率4.1%4.8%0.176SDFS**8.1%9.6%0.020*局部復(fù)發(fā)包括