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首页> 外文期刊>British Journal of Haematology >A prospective phase II randomized study of deferasirox to prevent iatrogenic iron overload in patients undertaking induction/consolidation chemotherapy for acute myeloid leukaemia
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A prospective phase II randomized study of deferasirox to prevent iatrogenic iron overload in patients undertaking induction/consolidation chemotherapy for acute myeloid leukaemia

机译：地拉罗司用于预防急性髓样白血病的诱导/巩固化疗患者中医源性铁超负荷的前瞻性II期随机研究

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This prospective randomized phase II study aimed to determine the safety and efficacy of deferasirox in preventing iatrogenic iron overload in patients receiving induction/consolidation chemotherapy for acute myeloid leukaemia (AML) ize. Serum ferritin, transferrin saturation and CRP were measured pre-, mid- and post- each chemotherapy cycle. Patients were randomized to receive either therapy with deferasirox vs. no deferasirox therapy once serum ferritin increased to >500 μg/l. The trial was stopped prematurely due to excess gastrointestinal (GI) and infectious toxicity demonstrable in the deferasirox arm, after 10 patients had been randomized to deferasirox and 6 patients to the control arm. Overall, deferasirox was poorly tolerated, with median maximum tolerated dose only 13·8 mg/kg/d and no patient able to tolerate doses >20 mg/kg/d. Median duration of deferasirox therapy was only 72 d (range 19-130 d), with 9/10 patients requiring unplanned dose interruptions and 4/10 patients unable to continue the drug predominantly due to GI effects. Although all 3 treatment-related deaths occurred in the deferasirox arm (P = 0·25), median overall survival was similar between treatment arms. Use of deferasirox to prevent iatrogenic iron overload in AML patients undertaking induction/consolidation is poorly tolerated and appears to be associated with excess GI and infectious toxicity.
机译：这项前瞻性随机II期研究旨在确定Deferasirox预防接受诱导/巩固化疗的急性髓细胞性白血病（AML）患者的医源性铁超负荷的安全性和有效性。在每个化疗周期之前，中期和之后测量血清铁蛋白，转铁蛋白饱和度和CRP。一旦血清铁蛋白增至> 500μg/ l，患者就随机接受两种药物的联合治疗：非铁拉司治疗与非铁拉司治疗。由于10例患者被随机分配给Deferasirox，6例患者被随机分配到对照组，由于过量的胃肠道（GI）和可证明其在Deferasirox组具有传染性毒性，该试验被提前终止。总体而言，地拉罗司的耐受性较差，中位最大耐受剂量仅为13·8 mg / kg / d，没有患者能够耐受> 20 mg / kg / d的剂量。 Deferasirox治疗的中位持续时间仅为72 d（范围19-130 d），其中9/10例患者需要计划外的剂量中断，而4/10例患者主要由于GI作用而无法继续用药。尽管所有3例与治疗相关的死亡均发生在地拉罗司组中（P = 0·25），但各治疗组的中位总体生存率相似。在接受诱导/巩固治疗的AML患者中，使用地拉罗司来预防医源性铁超负荷耐受性差，并且似乎与过量的GI和感染毒性有关。

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