乳腺癌 安东尼奥.ppt

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 monotherapy comparison 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(.70-1.06) ITT(12/2008)[76 months] .88(.78-.99) .87(.75-1.02) (p=0.08) 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) (p0.05) 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 E T BCFS 425 508 HR(95%CI) 0.81(0.71-0.92） P value 0.001 deaths 352 405 Os HR(95%CI) P value 0.86(0.75-0.99) 0.04 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 treatment completion. 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(A