急性髓系白血病(非APL)中国诊疗指南分析.ppt

* * * * * * * * Background A complete remission is essential for prolonging survival in patients with acute myeloid leukemia (AML). Daunorubicin is a cornerstone of the induction regimen, but the opt imal dose is unknown. In older pat ients, it is usual to give daunorubicin at a dose of 45 to 50 mg per square meter of body-surface area. Methods Patients in whom AML or high-risk refractory anemia had been newly diagnosed and who were 60 to 83 years of age (median, 67) were randomly assigned to receive cytara- bine, at a dose of 200 mg per square meter by continuous infusion for 7 days, plus daunorubicin for 3 days, either at the conventional dose of 45 mg per square meter (411 patients) or at an escalated dose of 90 mg per square meter (402 patients); this treatment was followed by a second cycle of cytarabine at a dose of 1000 mg per square meter every 12 hours for 6 days. The primary end point was event-free survival. Results The complete remission rates were 64% in the group that received the escalated dose of daunorubicin and 54% in the group that received the conventional dose (P = 0.002); the rates of remission after the first cycle of induction treatment were 52% and 35%, respectively (P0.001). There was no significant difference between the two groups in the incidence of hematologic toxic ef fects, 30-day mortal it y (11% and 12% in the two groups, respectively), or the incidence of moderate, severe, or life-threatening adverse events (P = 0.08). Survival end points in the two groups did not differ significantly overall, but patients in the escalated-treatment group who were 60 to 65 years of age, as compared with the patients in the same age group who received the conventional dose, had higher rates of complete remission (73% vs. 51%), event-free survival (29% vs. 14%), and overall survival (38% vs. 23%). Conclusions In patients with AML who are older than 60 years of age, escalation of the dose of daunorubicin