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【Blood】新药氯法拉滨在老年AML中作为一线治疗的
We previously reported the feasibility of clofarabine and cytarabine combinations in AML. Questions remain as to (1) the therapeutic advantage of this combination and (2) the role of lower doses of clofarabine and cytarabine in older patients. We have conducted an adaptively randomized study of lower-dose clofarabine with or without low-dose cytarabine in previously untreated patients with AML aged 60 years and older. Patients received 30 mg/m2 clofarabine intravenously daily for 5 days with or without 20 mg/m2 cytarabine subcutaneously daily for 14 days as induction. Consolidation consisted of 3 days of clofarabine with or without 7 days of cytarabine. Seventy patients were enrolled. The median age was 71 years (range, 60-83 years). Sixteen patients received clofarabine and 54 the combination. Overall, 56% achieved complete remission (CR). CR rate was significantly higher with the combination (63% vs 31%; P = .025). Induction mortality was 19% with the combination versus 31% with clofarabine alone (P = .276). The combination showed better event-free survival (7.1 months vs 1.7 months; P = .04), but not overall survival (11.4 months vs 5.8 months; P = .1). Clofarabine plus low-dose cytarabine has a higher response rate than clofarabine alone with comparable toxicity. This trial is registered at www.clinicaltrials.gov as no. NCT00088218 [ClinicalTrials.gov] . 本
A randomized study of clofarabine versus clofarabine plus low-dose cytarabine as front-line therapy for patients aged 60 years and older with acute myeloid leukemia and high-risk myelodysplastic syndrome
对应用氯法拉滨或氯法拉滨联合小剂量阿糖胞苷治疗的 60岁及以上的急性髓性白血病和骨髓增生异常综合征的高危病人进行一项随机研究。
We previously reported the feasibility of clofarabine and cytarabine combinations in AML.我们曾对应用氯法拉滨联合阿糖胞苷治疗AML的可行性进行报道
Questions remain as to (1) the therapeutic advantage of this combination and (2) the role of lower doses of clofarabine and cytarabine in older patients.
目前仍需明确的问题包括：(1)联合治疗的优点；(2)在老年病人中应用小剂量氯法拉滨联合阿糖胞苷的作用
We have conducted an adaptively randomized study of lower-dose 氯法拉滨 with or without low-dose cytarabine in previously untreated patients with AML aged 60 years and older. Patients received 30 mg/m2 clofarabine intravenously daily for 5 days with or without 20 mg/m2 cytarabine subcutaneously daily for 14 days as induction. Consolidation consisted of 3 days of clofarabine with or without 7 days of cytarabine. Seventy patients were enrolled. The median age was 71 years (range, 60-83 years). Sixteen patients received clofarabine and 54 the combination. Overall, 56% achieved complete remission (CR). CR rate was significantly higher with the combination (63% vs 31%; P = .025). Induction mortality was 19% with the combination versus 31% with clofarabine alone (P = .276). The combination showed better event-free survival (7.1 months vs 1.7 months; P = .04), but not overall survival (11.4 months vs 5.8 months; P = .1). clofarabine plus low-dose cytarabine has a higher response rate than clofarabine alone with comparable toxicity. This trial is registered at www.clinicaltrials.gov as no. NCT00088218 [ClinicalTrials.gov] .
因此我们对单独应用小剂量氯法拉滨或小剂量氯法拉滨联合小剂量阿糖胞苷的治疗进行了一项可控性随机研究，研究对象为60岁以上未接受过治疗的AML患者。所有患者静脉注射氯法拉滨，剂量为30 mg/m2每天，连续应用5天，联合或是不联合应用阿糖胞苷皮下注射诱导治疗14天，剂量为20 mg/m2每天。维持治疗方案为应用氯法拉滨 3天联合或不联合阿糖胞苷7天。70例患者接受了研究。中位年龄为71岁（60岁至83岁）。16名患者接受了氯法拉滨，54名患者接受了联合治疗。总体上，56%的患者获得了完全缓解，完全缓解率远高于联合治疗组(完全缓解率分别为：63% 和 31%; P = .025)。联合用药组诱导死亡率为19%，而单独应用氯法拉滨的诱导死亡率为31%。联合用药组的无病生存率更高(7.1 月 相对于 1.7 月； P = .04)。但总体生存率并无显著提高(11.4 月 相对于 5.8 月; P = .1)。氯法拉滨联合小剂量阿糖胞苷与单独应用氯法拉滨相比可以获得更高的缓解率，而毒性相当。本研究已发表在www.clinicaltrials.gov，编号为no. NCT00088218
对应用氯法拉滨或氯法拉滨联合小剂量阿糖胞苷治疗的 60岁及以上的急性髓性白血病和骨髓增生异常综合征的高危病人进行一项随机研究。
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作者:admin@医学,生命科学 2011-02-07 05:14
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