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为确定增加诱导和巩固治疗的强度能否增加急性髓细胞白血病(AML)的缓解率并延长生存时间,同时探讨巩固治疗时加用非交叉耐药药物是否比使用诱导时的相同药物更有效,美国东南肿瘤研究组进行了一项Ⅲ期临床试验。试验始于1981年,至少经过8年随访。 病例选择 新近诊断的初治AML患者,年龄15～50岁。诱导治疗方案:柔红霉素(DNR)45mg/m~2·d×3d,静脉推注,阿糖胞苷(Ara-C)200mg/m~2·d×10d持续输注。后因5/29例死于严重的胃肠道毒性而将Ara-C减为100mg/m~2·d×10d。巩固治疗方案:完全缓解(CR)患者接受巩固治疗。36岁以下且有HLA相配供者的患者纳入D组行异基因骨髓移植(Allo-
To determine whether increasing the intensity of induction and consolidation therapy can increase the remission rate and prolong survival of acute myeloid leukemia (AML), it is also explored whether consolidating treatment with noncross-resistance drugs is more effective than using the same drug at the time of induction. The Southeastern Cancer Research Group of the United States conducted a phase III clinical trial. The trial began in 1981 and has been followed for at least 8 years. Case selection Newly diagnosed patients with newly diagnosed AML aged 15 to 50 years. Induction therapy program: Daunorubicin (DNR) 45mg/m~2d3d, intravenous injection, Ara-C 200mg/m~2d 10d continuous infusion. After 5/29 died of severe gastrointestinal toxicity, the Ara-C was reduced to 100 mg/m~2d for 10 days. Consolidation treatment: Complete remission (CR) patients receive consolidation therapy. Patients under the age of 36 and with HLA-matched donors were included in group D for allogeneic bone marrow transplantation (Allo-