Pilot study of idarubicin-based intensive-timing induction therapy for children with previously untreated acute myeloid leukemia: Children's Cancer Group Study 2941
Pilot study of idarubicin-based intensive-timing induction therapy for children with previously untreated acute myeloid leukemia: Children's Cancer Group Study 2941
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DOI：
10.1200/jco.2004.04.016
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发表时间：
2004-01-01
影响因子：
45.3
通讯作者：
Alonzo, TA
中科院分区：
文献类型：
--
作者：
Lange, BJ;Dinndorf, P;Alonzo, TA
研究目的：随机比较伊达比星（IDA）和柔红霉素（DNR）治疗成人急性髓系白血病（AML）的疗效，IDA的缓解率高，缓解持续时间长。在儿童癌症组初步研究CCG-2941中，我们评估了CCG-2891中使用的以柔红霉素为基础的强化定时诱导治疗（DNR/DNR）中用1 mg IDA替代4 mg DNR的毒性和可行性。患者和方法在第1 - 3天和第10 - 14天，患者接受两个疗程的地塞米松、阿糖胞苷、6-硫鸟嘌呤、依托泊苷和IDA（IDA/IDA）。65例患者入组后，毒性促使其余28例患者在第10天至第14天用DNR（IDA/DNR）替代IDA。结果IDA/IDA、IDA/DNR和DNR/DNR方案诱导2个疗程后的死亡率差异无统计学意义（P> 0.05），IDA/IDA、IDA/DNR和DNR/DNR方案诱导2个疗程后的死亡率分别为14%、7%和9%。在CCG-2941 IDA/IDA的I期中，11%的患者退出，而CCG-2891为1.5%（P <0.05）。
PurposeRandomized comparisons of idarubicin (IDA) with daunorubicin (DNR) show that in adults with acute myeloid leukemia (AML), IDA achieves higher remission rates and longer remission durations. In Children's Cancer Group Pilot Study CCG-2941, we assessed toxicity and feasibility of substituting 4 mg of DNR with 1 mg of IDA in intensive-timing daunorubicin-based induction therapy (DNR/DNR) used in CCG-2891.Patients and MethodsOn days 1 through 3 and 10 through 14, patients received two courses of dexamethasone, cytarabine, 6-thioguanine, etoposide, and IDA (IDA/IDA). After enrollment of 65 patients, toxicity prompted replacement of IDA with DNR (IDA/DNR) on days 10 through 14 for the remaining 28 patients. Outcomes were compared with those of intensive timing in CCG-2891.ResultsTreatment-related mortality after two courses of induction was not significantly different among the three regimens: 14% with IDA/IDA, 7% with IDA/DNR, and 9% with DNR/DNR. In course I of CCG-2941 IDA/IDA, 11% of patients withdrew compared with 1.5% in CCG-2891 (P