Adaptive randomized study of idarubicin and cytarabine alone or with interleukin-11 as induction therapy in patients aged 50 or above with acute myeloid leukemia or high-risk myelodysplastic syndromes
Adaptive randomized study of idarubicin and cytarabine alone or with interleukin-11 as induction therapy in patients aged 50 or above with acute myeloid leukemia or high-risk myelodysplastic syndromes
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DOI：
10.1016/j.leukres.2004.11.013
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发表时间：
2005-06-01
影响因子：
2.7
通讯作者：
Estey, E
中科院分区：
文献类型：
--
作者：
Giles, FJ;Kantarjian, HM;Estey, E
在先前的诱导治疗随机研究中，接受吉妥珠单抗（GO）联合白细胞介素-11（IL-11）而不是单独接受GO的急性髓性白血病（AML）患者观察到更高的完全缓解（CR）率。在100例年龄≥ 50岁的AML或高危骨髓增生异常综合征（MDS）患者中进行了一项在依达罗肽和阿糖胞苷（IA）诱导治疗基础上添加IL-11的适应性随机III期研究。中位患者年龄为67岁（范围50-82岁）。随机分配至IA + IL-11组的45例患者中有24例（53%）达到CR。8例（33%）随后复发，4例（17%）在CR中死亡;中位至治疗失败时间（TTF）为37周。55例未接受IL-11治疗的患者中有29例（53%）达到CR。8例（28%）随后复发，2例（7%）在CR时死亡：中位TTF为46周。IA + IL-11和IA队列的中位总生存期分别为21周和59周（p = 0.271，对数秩检验：0.435）。Gehan-Breslow试验）。在接受IA加IL-11的患者中观察到10次以下3级或4级心肺毒性发作。单独接受IA治疗的患者中发生12起此类事件：房颤、胸腔积液、心肌梗死、心动过缓或低血压。每组各有2例患者发生3级外周水肿。治疗组之间任何3级或4级不良事件（包括血小板减少症）的发生率无显著差异。对CR率、TTF、生存期无显著影响。或在>= 50岁的AML患者中，在IA诱导中加入IL-11方案的毒性。(c)2004年由Elsevier Ltd.出版。
A higher complete remission (CR) rate was observed in patients with acute myeloid leukemia (AML) who, on a prior randomized study of induction therapy, received gemtuzumab ozogamicin (GO) plus interleukin-11 (IL-11) rather than GO alone. An adaptive randomized phase III study of the addition of IL-11 to idarubicin and cytarabine (IA) induction in 100 patients >= 50 years of age with AML or high-risk myelodysplastic syndrome (MDS) was conducted. Median patient age was 67 years (range 50-82). Twenty-four of the 45 (53%) patients randomized to IA plus IL-11 achieved CR. Eight (33%) subsequently relapsed, 4 (17%) died in CR; median time to treatment failure (TTF) was 37 weeks. Twenty-nine of the 55 (53%) patients treated without IL-11 achieved CR. Eight (28%) subsequently relapsed, 2 (7%) died in CR: median TTF was 46 weeks. Median overall survivals were 21 and 59 weeks for the IA plus IL-11 and IA cohorts, respectively (p = 0.271, log rank test: 0.435. Gehan-Breslow test). Ten episodes of the following grade 3 or 4 cardiopulmonary toxicities were observed in patients receiving IA plus IL-11. 12 such episodes in those receiving IA alone: atrial fibrillation, pleural effusions, myocardial infarction, bradycardia or hypotension. Two patients in each arm experienced grade 3 peripheral edema. There was no significant difference in incidence of any grade 3 or 4 adverse event, including thrornbocytopenia, between treatment arms. There was no significant impact on CR rates, TTF, survival. or toxicity of adding an IL-11 regimen to IA induction in patients >= 50 years of age with AML. (c) 2004 Published by Elsevier Ltd.