来曲唑做为绝经后激素受体阳性的乳腺癌辅助内分泌治疗

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1、来曲唑做为绝经后激素受体阳性的乳腺癌辅助内分泌治疗第一次结果报告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试验设计TAMn=2484来曲唑n=2484TAM来曲唑来曲唑n=1530TAMn=1530随机分组ABCD2年3年2-armoption3/98-3/001835pts4-armoption9/99-5/036193ptsBIG1－98时间表19982001200220032004200519992000开始数据库锁定首次核心分析•来曲唑vs.他莫昔芬(headtohead)•包括所有病人•中位跟踪时间：26个月不包括交

4、叉换药C&D后的跟踪TAM来曲唑TAM来曲唑来曲唑TAMABCD2－arm4－armPrimaryendpoint-DFS从随机分组到发生第一次事件的时间–复发•同侧乳房•胸壁•局部复发（乳腺内/腋窝淋巴结）•远处转移（包括同侧锁骨上淋巴结)–对侧乳腺(侵犯)第二原发恶性肿瘤（非乳腺癌）非复发引起的死亡统计学假设目标样本量:79352-armoption:18354-armoption:6100实际入组:8028复发事件数目:647forprimarycoreanalysis80%powertodetecta20%reductionintheriskofaDFSevent实际复发事件:779首

5、次核心分析8028随机133(1.66%)ineligiblecasesincludedinprimarycoreanalysis18个出组（无治疗/随访）8010核心分析4003来曲唑组Vs.4007TAM组病人/肿瘤特征来曲唑他莫昔芬中位年龄6161N+41.5%41.2%N-(包括前哨)52.0%52.3%N状况未知6.5%6.5%肿瘤>2cm36.5%37.7%诊断时未绝经2.3%2.5%病人/肿瘤特征来曲唑他莫昔芬ER+/PgR+63.5%62.7%ER+/PgR-20.2%20.5%ER+/PgRunk14.5%14.3%ER-/PgR+1.5%2.1%乳腺癌的治疗来曲唑他莫昔芬既

6、往化疗25.3%25.3%手术/放疗组保乳手术＋放疗53.3%54.0%保乳手术未放疗2.8%3.3%乳房切除术＋放疗18.3%17.6%乳房切除术未放疗25.4%24.8%他莫昔芬020406080100012345PercentAliveandDisease-Free从随机分组开始的时间（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首次复发部位来曲唑他莫昔芬P失败（复发事件）8.8%10.7%0.004原位复发0.5%0.9%0.047对侧乳腺癌0.4%0.7%0.125局部复发*0.3%0.3%0.845远处转移4.4%5.8%0.006第二原发恶性肿瘤（除乳腺癌）1.7%2.0%0.324未复发死亡1.4%0.9%0.077死亡率4.1%4.8%0.176SDFS**8.1%9.6%0.020*局部复发包括