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首页> 外文期刊>Experimental Hematology Oncology >French “real life” experience of clofarabine in children with refractory or relapsed acute lymphoblastic leukaemia
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French “real life” experience of clofarabine in children with refractory or relapsed acute lymphoblastic leukaemia

机译：法国对难治性或复发性急性淋巴细胞白血病患儿使用氯法拉滨的“现实生活”经历

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Background Clofarabine alone or in combination with cyclophosphamide and etoposide has shown a good efficacy and a tolerable toxicity profile in previous studies of children with relapsed or refractory leukaemia. This report describes a retrospective study of 38 French patients who received clofarabine as a monotherapy or in combination for relapsed or refractory acute lymphoblastic leukaemia (ALL) outside of clinical trials after marketing authorization. Methods We retrospectively analysed data for 38 patients, up to 21 years old, attending 17 French centres. Thirty patients received clofarabine alone or in combination for a bone marrow relapse of acute lymphoblastic leukaemia (ALL) or refractory disease and eight patients for a high level of minimal residual disease (MRD). Survival and response durations were estimated by the Kaplan-Meier method. Results For the 30 patients who received clofarabine for a bone marrow relapse of ALL (number of relapse, 1-3; median, 1), the overall remission rate (ORR) was 37%: eight complete remission (CR) and three complete remission without platelet recovery (CRp). Ten of the 11 responding patients subsequently underwent haematopoietic stem cell transplantation (HSCT). Only four of the eight patients who received clofarabine while in remission for a high level of MRD, showed a moderate improvement of MRD. Seven of these eight patients received HSCT and six of them were alive at the end of the study. One other patient was alive without receiving HSCT. However, clofarabine treatment was associated with a high risk of infection and hepatotoxicity. Febrile neutropenia grade ≥ 3 was reported in 79% of patients and documented infections grade ≥ 3 occurred in nine patients (24%). Hepatotoxicity grade 3 was reported in nine patients (24%). We observed four deaths related to treatment. Conclusion In our experience, the efficacy of clofarabine is poorer than previously reported. Its toxicity is high and can be life threatening. Prospective studies on clofarabine used during earlier phases of the disease may help to define how best this new drug can be exploited for childhood and adolescent ALL.
机译：背景单独的氯法拉滨或与环磷酰胺和依托泊苷联用的氯法拉滨在先前对复发或难治性白血病儿童的研究中显示出良好的疗效和可耐受的毒性。该报告描述了一项38例法国患者的回顾性研究，这些患者在上市许可后接受氯法拉滨单药或联合治疗复发或难治性急性淋巴细胞白血病（ALL）的临床或复发治疗。方法我们回顾性分析了法国17个中心的38名21岁以下患者的数据。 30例患者因急性淋巴细胞性白血病（ALL）或难治性疾病的骨髓复发而单独或联合使用氯法拉滨，而8例因高水平的微小残留疾病（MRD）而接受氯法拉滨治疗。生存和反应持续时间通过Kaplan-Meier方法估算。结果对于接受氯法拉滨治疗的ALL骨髓复发患者（复发次数1-3;中位数1），其30例患者的总缓解率（ORR）为37％：8个完全缓解（CR）和3个完全缓解没有血小板恢复（CRp）。 11名反应患者中的10名随后接受了造血干细胞移植（HSCT）。在缓解期间因高水平的MRD而接受氯法拉滨的八位患者中，只有四位显示出中度改善。在研究结束时，这八名患者中有七名接受了HSCT，其中六名还活着。另一例患者未接受HSCT存活。但是，氯法拉滨治疗与感染和肝毒性的高风险有关。据报道79％的患者出现发热性中性粒细胞减少症≥3级，并且有9例患者（24％）的感染度≥3级。据报道有9位患者（24％）达到3级肝毒性。我们观察到四例与治疗有关的死亡。结论根据我们的经验，氯法拉滨的疗效比以前报道的要差。其毒性很高，可能会危及生命。在疾病早期阶段使用的氯法拉滨的前瞻性研究可能有助于确定如何最好地将这种新药用于儿童和青少年ALL。

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