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首页> 外文期刊>Prescrire international >Nelarabine: new drug. T-lymphoblastic leukaemia/lymphoma: more evaluation needed.
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Nelarabine: new drug. T-lymphoblastic leukaemia/lymphoma: more evaluation needed.

机译：Nelarabine：新药。 T淋巴细胞白血病/淋巴瘤：需要更多评估。

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1) Acute T-lymphoblastic leukaemia and T-lymphoblastic lymphoma are closely related malignant haemopathies. There is a better prognosis for children with these disorders than for adults. There is no consensus treatment in case of relapses. However, only haematopoietic stem cell transplantation following chemotherapy offers a chance of long-term survival; 2) Nelarabine is a purine analogue closely related to clofarabine, fludarabine and cytarabine. It is marketed for the treatment of children and adults with one or the other of these two malignant haemopathies, after failure of at least two lines of chemotherapy; 3) Clinical evaluation of nelarabine in this setting includes two non-comparative trials in accordance with the conditions of the marketing terms, one in 48 children and the other in 28 adults. A complete haematological response was observed in about 20% to 25% of patients overall. But this type of non-comparative trial cannot demonstrate whether a specific drug increases survival time compared with existing alternatives; 4) In addition to haematological and gastrointestinal disorders, the main adverse effects of nelarabine were neurological (headache, drowsiness, peripheral neuropathies). Some adverse effects were serious, and they did not all resolve after treatment cessation. It is not known to what extent they affect quality of survival; 5) In practice, there are too many outstanding questions to determine whether nelarabine represents a therapeutic advance compared with clofarabine, or even whether it should be used outside the clinical trial setting.
机译：1）急性T淋巴细胞性白血病和T淋巴细胞性淋巴瘤是密切相关的恶性血液病。与成人相比，患有这些疾病的儿童的预后更好。在复发的情况下，没有共识疗法。但是，只有化学疗法后的造血干细胞移植才有可能长期存活。 2）Nelarabine是一种与氯法拉滨，氟达拉滨和阿糖胞苷密切相关的嘌呤类似物。该产品用于治疗至少两种化疗失败后患有这两种恶性血液病中的一种或另一种的儿童和成人。 3）在这种情况下，奈拉拉滨的临床评估包括两项根据销售条款的条件进行的非对比试验，一项是48名儿童，另一项是28名成人。总体上约有20％至25％的患者观察到完全的血液学反应。但是，这种类型的非比较试验无法证明某种特定药物与现有替代药物相比是否能延长生存时间; 4）除血液和胃肠道疾病外，奈拉滨的主要不良反应是神经系统的（头痛，嗜睡，周围神经病）。一些不良反应是严重的，并且在停止治疗后并不能完全消除。目前尚不清楚它们在多大程度上影响生存质量; 5）在实践中，有太多悬而未决的问题来确定奈拉拉滨与氯法拉滨相比是否代表治疗上的进步，或者是否应在临床试验环境之外使用。

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    《Prescrire international》 |2009年第99期|共3页
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  • 正文语种 eng
  • 中图分类 药学;
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