? Endocrine Therapy BIG1-98 trial IES? targeted therapy Anti-HER2 therapy--N9831 HER-2(-): RIBBON-2 AVADO 舒尼替尼( SU )联合卡培他滨(C) Endocrine Terapy Big 1-98--background ? BIG 1-98 initial results(presented Jan 05) demonstrated superiority of Let over Tam in significantly DFS, and reducing risk of relapse in distant sites. ? Following these results,25% of pts (619/2495) randomized to Tam * 5 selectively crossed over to Let . ? At SABCS 2008 the protocol-specified 8yr update of the parison was presented, as randomized(ITT) and with follow-up of the pts who selectively crossed over artificially censored at the time of the crosser ,as with the earlier result, Let significantly improved DFS,a trend for improved OS ,and was significant in the artificially censored analysis, treatment effect estimates of both analyses are affected by the selective crossover. BIG 1-98 — result(2005---) HR(Let * 5:Tam * 5)(95%CI) Analysis(mo/yr presented) DFS OS ITT(03/2005)[26 months] .81(.70-.93) .86(.70-) ITT(12/2008)[76 months] . 88(.78-.99) .87(.75-) (p=) Artificially censor Tam pts at selective crossover (12/2008)[76 months] .85(.75-.96) .82(.70-.96) IPCW(news analysis)[76 months] .84(.75-.95) .83(.71-.97) (p<) 意义: Let 与 Tam 5 年的 OS 比较, 76 个月结果经 IPCW 分析显著改善了 OS, 该实验是目前第一项在已知的随访时间内得到 OS 获益优势的实验。返回 IES N=4724 绝经后 HR (+)早期乳腺癌他莫昔芬 2-3 年他莫昔芬依西美坦治疗时间 5年 IES 91months follow-up results ET BCFS 425 508 HR HR (95%CI) (- ) P value deaths 352 405 Os HR(95%CI) P value (-) BCFS: breast cancer free survival Conclusions: The protective effect of switching to E ,compared with continuing on T, on relapse rate is maintained for at least 5 years post pletion. Associated with this is a continuing benefit on OS 返回 N9831---1 Arm C: AC-T+H-H Arm A: AC-T events:386 5-y DFS : ArmA:ArmB=72%:80% HR (Arm B/Arm A)=; 95% CI , 57- 86, logrank P= adjusting for age, tumor size, number of posi
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