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Click to edit Master title style,Click to edit Master text styles,Second level,Third level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,*,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,*,BIG1-98,研究带来的临床思考,湖南省肿瘤医院乳腺内科 欧阳取长,BIG1-98,：创新和完整的,AI,临床试验设计,TAM:N=911,0,2,5,年,随,机,分,组,随,机,分,组,LET:N=917,TAM:N=1548,LET:,N=1546,TAM,LET:N=1548,LET,TAM:N=1540,A,B,C,D,A,B,单药分析：,肯定了,5,年,弗隆,优于,TAM,，,数据仅来自单药治疗组。,研究人群为,4922,人。已,发表,中位随访,51,和,76,月数据,BIG1-98,目前的分析结果,序贯分析：,希望探索序贯治疗是否优于,LET,单药。研究人群为,B,和,C 3094,人，,B,和,D 3086,人,已发表,中位随访,71,月数据,核心分析：,肯定了,5,年,弗隆,优于,TAM,，,研究人群为,8010,人，已发表,的是,中位随访,26,和,61,月数据,B,C,D,VS,OR,BIG1-98,回答的问题,作为初始辅助治疗，,5,年弗隆是否优于,5,年,TAM?,序贯治疗是否优于,AI,单药治疗？,BIG1-98,回答的问题,作为初始辅助治疗，,5,年弗隆是否优于,5,年,TAM?(26,，,51,，,61,，,76,个月分析,),BIG1-98,核心分析：中位随访,26,和,61,月,TAM:N=911,0,2,5,随,机,分,组,随,机,分,组,LET:N=917,TAM:N=1548,LET:,N=1546,TAM,LET:N=1548,LET,TAM:N=1540,A,B,C,D,A,B,Big 1-98,核心分析,回答的问题,肯定了,5,年弗隆优于,TAM,研究人群为,8010,人，已发表,的是,中位随访,26,和,61,个月数据,中位随访,26,月：,St.,Gallen,2005,ASCO 2005,发表于,NEJM 2005,中位随访,61,月,2009,BIG1-98,核心分析：中位随访,26,月结果,N=8010.,来曲唑 更好,他莫昔芬更好,事件数,(LET:TAM),风险比,(LET:TAM),(CI),P,值,DFS,351,428,0.81 (0.70-0.93),0.003,总生存率,166,192,0.86 (0.70-1.06),0.16,全身,DFS*,323,383,0.83 (0.72-0.97),0.02,DFS(,不包括第二原发肿瘤,),296,369,0.79 (0.68-0.92),0.002,至远处转移时间,184,249,0.73 (0.60-0.88),0.001,至复发时间,228,310,0.72 (0.61-0.86),2 cm,(35%,vs,.26%),交叉后使用弗隆的中位时间是,18,个月,于是，弗隆和,TAM,组进行了以下比较,意向治疗分析,(ITT),截尾分析（,Censor,）,随机,Tamoxifen,Letrozole,0,2,5,ITT,Censored for crossover,Tamoxifen,Letrozole,0,2,5,25%,随机,BIG1-98,核心分析：中位随访,61,月结果,1.,N Engl J Med,353:2747-2757,2005,*,选择接受,LET,的,619,例患者的随访时间截取在交叉时间点,LET,更好,TAM,更好,LET,N,=4003,TAM*,N,=4007,HR(95%CI),P,事件例数,无病生存率,ITT,585,664,0.86(0.770.96),截尾分析,643,0.83(0.740.93),总生存率,ITT,330,374,0.87(0.751.01),截尾分析,330,369,0.81(0.700.94),至远处转移时间,ITT,287,0.79(0.680.92),截尾分析,287,351,0.78(0.670.92),357,585,DFS,不包括第二原发肿瘤,ITT,503,577,0.85(0.750.96),截尾分析,503,564,0.81(0.720.92),至复发时间,(TTR),ITT,368,0.82(0.710.94),截尾分析,368,0.79(0.680.90),441,430,终点,风险比,*,ITT,分析包括,TAM,组在,3-5,年交叉到,LET,组的,25.2%,患者,患者的截断时间是从,TAM,换用,LET,的时间点,中位,26,月,中位,61,月,ITT,*,删失分析,DFS,HR,95%CI,P-,值,0.81,0.70-0.93,0.003,0.86,0.77-0.96,0.008,0.83,0.74-0.93,NR,TDR,HR,95%CI,P-,值,0.73,0.60-0.88,0.001,0.79,0.68-0.92,0.003,0.78,0.67-0.92,NR,OS,HR,95%CI,P,-,值,0.86,0.70-1.06,0.16,0.87,0.75-1.01,0.07,0.81,0.70-0.94,NR,BIG1-98,核心分析：,中位随访,26,和,61,月结果一致,PCA,首次核心分析,;MAA,单药治疗组分析,;DFS,无病生存率,;TDR,至远处复发时间,;,OS,总生存,BIG1-98,核心分析结果总结,中位,26,月：证实,5,年弗隆优于,5,年,TAM,显著提高无病生存率,19%(,P,=0.003),显著降低复发风险,28%(,P,2 cm,(35%,vs,.26%),随机,Tamoxifen,Letrozole,0,2,年,5,年,ITT,分析,删失分析,Tamoxifen,Letrozole,0,2,年,5,年,25%,随机,Mouridsen H et al.,N Engl J Med,2009;361:766-76.,BIG 1-98:IPCW,分析结果（,76,个月随访）,
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