ASH2010慢性髓性白血病.ppt

ENESTnd Update: Continued Superiority of Nilotinib Versus Imatinib In Patients with Newly Diagnosed Chronic Myeloid Leukemia In Chronic Phase (CML-CP) Timothy P. Hughes, MD, MBBS Oral Session: Chronic Myeloid Leukemia - Therapy: Optimizing Treatment Outcome207 目的--评价尼洛替尼治疗初诊Ph+ CML-CP患者的疗效和安全性 (中位随访18个月的ENESTnd研究结果更新) 研究设计 --随机开放的多中心的3期临床研究 --846例初诊CML-CP患者入组 --主要终点：12个月MMR (≤ 0.1% BCR-ABLIS) --次要终点：24个月持续MMR --其他： 24 个月加速/急变率、EFS、PFS和OS Timothy P. Hughes, MD, MBBS Oral Session: Chronic Myeloid Leukemia - Therapy: Optimizing Treatment Outcome207 ? 中位随访18个月的总体有效性 Nilotinib 300 mg bid (n = 282) Nilotinib 400 mg bid (n = 281) Imatinib 400 mg qd (n = 283) ?MMR, % 66 P .0001* 62 P .0001* 40 ?????? Sokal危险度, % ? ? ? 低危(n = 103, n = 103, n = 104) 70 69 51 中危 (n = 101, n = 100, n = 101) 67 63 39 高危 (n = 78, n = 78, n = 78) 59 51 28 BCR-ABLIS 0.0032% , % 21 P .0001* 17 P .0001* 6 ?CCyR, % 85 P .001* 82 P = .017* 74 ?向加速/急变进展 ?????? 不包括克隆演进, n (%) 2 (0.7) P = .006** 1 (0.4) P = .003** 12 (4.2) ??????包括克隆演进, n (%) 2 (0.7) P .001** 3 (1.2) P = .002** 17 (6.9) 估计18个月总生存 % 98.5 P = .28** 99.3 P = .03** 96.9 ENESTnd Update: Continued Superiority of Nilotinib Versus Imatinib In Patients with Newly Diagnosed Chronic Myeloid Leukemia In Chronic Phase (CML-CP) 结果 ENESTnd Update: Continued Superiority of Nilotinib Versus Imatinib In Patients with Newly Diagnosed Chronic Myeloid Leukemia In Chronic Phase (CML-CP) Timothy P. Hughes, MD, MBBS Oral Session: Chronic Myeloid Leukemia - Therapy: Optimizing Treatment Outcome207 结论 与伊马替尼相比，尼洛替尼 --加速/急变率和治疗失败率显著降低 --CML相关死亡更少，OS更高 --MMR，CMR和CCyR更高 对于初诊Ph+ CML-CP患者,尼洛替尼疗效优于伊马替尼 Dasatinib Versus Imatinib In Patients with Newly Diagnosed Chronic Myeloid Leukemia In Chronic Phase (CML-CP) In the DASISION Trial: 18-Month Follow-up Neil Shah, MD, Ph.D. Oral Session: Chronic Myeloid Leukemia - Therapy: Optimizing Treatment Outcome206 目的--评价达沙替尼治疗初诊Ph+CML-CP患者的疗效和安全性 (中位随访18个月