A randomized trial comparing standard versus high-dose daunorubicin induction in patients with acute myeloid leukemia
A randomized trial comparing standard versus high-dose daunorubicin induction in patients with acute myeloid leukemia
复制标题
DOI：
10.1182/blood-2011-06-361410
复制
发表时间：
2011-10-06
期刊：
影响因子：
20.3
通讯作者：
Lee, Kyoo-Hyung
中科院分区：
文献类型：
--
作者：
Lee, Je-Hwan;Joo, Young-Don;Lee, Kyoo-Hyung
我们进行了一项3期随机试验，比较了2种不同剂量的柔红霉素在年轻成人（60岁或以下）急性髓性白血病（AML）诱导化疗中的作用。在383例患者中，189例接受标准剂量柔红霉素（SD-DN，45 mg/m2/d × 3天），194例接受高剂量柔红霉素（HD-DN，90 mg/m2/d × 3天），此外还接受阿糖胞苷（200 mg/m2/d × 7天）诱导完全缓解（CR）。SD-DN组和HD-DN组的CR率分别为72.0%和82.5%（P = 0.014）。在中位随访52.6个月时，HD-DN组的总（OS）和无事件（EFS）生存率高于SD-DN组（OS，46.8% vs 34.6%，P = 0.030; EFS，40.8% vs 28.4%，P = 0.030）。调整其他变量后，CR率以及OS和EFS的差异仍然显着（CR，风险比[HR]，1.802，P = .024; OS，HR，0.739，P = .032; EFS，HR，0.774，P = .048）。HD-DN治疗的生存获益主要在具有中等风险细胞遗传学特征的患者中明显。两组的毒性特征相似。总之，与SD-DN相比，HD-DN改善了年轻成人AML的CR率和生存期。本研究在www.clinicaltrials.gov注册为#NCT 00474006。（血。2011;118（14）：3832-3841）
We conducted a phase 3 randomized trial comparing 2 different doses of daunorubicin as induction chemotherapy in young adults (60 years of age or younger) with acute myeloid leukemia (AML). Of 383 patients who were analyzed, 189 received standard-dose daunorubicin (SD-DN, 45 mg/m(2) per day times 3 days) and 194 received high-dose daunorubicin (HD-DN, 90 mg/m(2) per day times 3 days) in addition to cytarabine (200 mg/m(2) per day times 7 days) to induce complete remission (CR). The CR rates were 72.0% in the SD-DN arm and 82.5% in the HD-DN arm (P = .014). At a median follow-up of 52.6 months, overall (OS) and event-free (EFS) survival were higher in the HD-DN arm than in the SD-DN arm (OS, 46.8% vs 34.6%, P = .030; EFS, 40.8% vs 28.4%, P = .030). Differences in CR rate and both OS and EFS remained significant after adjusting for other variables (CR, hazard ratio [HR], 1.802, P = .024; OS, HR, 0.739, P = .032; EFS, HR, 0.774, P = .048). The survival benefits of HD-DN therapy were evident principally in patients with intermediate-risk cytogenetic features. The toxicity profiles were similar in the 2 arms. In conclusion, HD-DN improved both the CR rate and survival duration compared with SD-DN in young adults with AML. This study is registered at www.clinicaltrials.gov as #NCT00474006. (Blood. 2011;118(14):3832-3841)