CML诊疗解读.ppt

* ENESTnd: Comparison of Nilotinib and Imatinib in Newly Diagnosed CP CML Primary endpoint: MMR at 12 mos Secondary endpoint: durable MMR at 24 mos Other endpoints: time to MMR, CCyR by 12 mos, time to CCyR, EFS, PFS, OS, time to AP/BC on study treatment Patients diagnosed with Ph+ CP CML within 6 mos (N = 846) Nilotinib 300 mg BID (n = 282) Imatinib 400 mg QD (n = 283) Nilotinib 400 mg BID (n = 281) 5-yr follow-up Stratified by Sokal risk Saglio G, et al. N Engl J Med. 2010;362:2251-2259. * ENESTnd 3-Yr Update: Cumulative Molecular Responses 分子生物学反应 Larson RA, et al. Leukemia. 2012;[Epub ahead of print]. *P .0001 vs imatinib. ?P = .0004 vs imatinib. ?P = .0003 vs imatinib. Outcome, % Nilotinib 300 mg BID (n = 282) Nilotinib 400 mg BID (n = 281) Imatinib 400 mg QD (n = 283) Cumulative MMR 1 yr 55* 51* 27 3 yrs 73* 70* 53 Cumulative MR4 (4.0 log reduction in BCR-ABL) 1 yr 20* 15? 6 3 yr 50* 44* 26 Cumulative MR4.5 (4.5 log reduction in BCR-ABL) 1 yr 11* 7* 1 3 yrs 32* 28? 15 * ENESTnd 3-Yr Update: Progression to AP/BC 疾病进展的可能性 No new progressions since 2-yr analysis on core treatment 20 15 10 5 0 Patients (n) Nilotinib 300 mg BID Nilotinib 400 mg BID Imatinib 400 mg QD Including Clonal Evolution P = .0059 P = .0185 P = .0003 P = .0085 2 3 12 2 5 17 0.7% 1.1% 4.2% 0.7% 1.8% 6.0% Larson RA, et al. Leukemia. 2012;[Epub ahead of print]. Excluding Clonal Evolution * ENESTnd 3-Year Update: Hematologic AEs and Biochemical Abnormalities 副作用用 Larson RA, et al. Leukemia. 2012;[Epub ahead of print]. Grade 3/4 AEs, % Nilotinib 300 mg BID (n = 279) Nilotinib 400 mg BID (n = 277) Imatinib 400 mg QD (n = 280) Neutropenia 11.8 10.8 21.4 Thrombocytopenia 10.4 12.3 8.9 Anemia 3.9 4.7 5.7 Lipase increase 7.5 7.9 3.9 ALT increase 4.3 9.4 2.5 Total bilirubin increase 3.9 7.9 0.4 Hyperglycemia 6.1 5.4 0 * Patients newly diagnosed with CP CML (N = 519) Dasatinib 100 mg QD (n = 259) Imatinib 400 mg QD (n = 260) DASISION: Comparison of Dasatinib and Imatinib in Newly Diagnosed CP CML