Imatinib mesylate is effective in children with chronic myelogenous leukemia in late chronic and advanced phase and in relapse after stem cell transplantation
Imatinib mesylate is effective in children with chronic myelogenous leukemia in late chronic and advanced phase and in relapse after stem cell transplantation
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DOI：
10.1038/sj.leu.2404051
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发表时间：
2006-02-01
期刊：
影响因子：
11.4
通讯作者：
Suttorp, M
中科院分区：
文献类型：
--
作者：
Millot, F;Guilhot, J;Suttorp, M
进行了一项多中心2期研究，以确定甲磺酸伊马替尼在慢性粒细胞白血病（CML）儿童中的疗效和耐受性，这些儿童患有疾病的晚期、干细胞移植后复发或基于干扰素a的方案失败。共有来自8个欧洲国家的30名儿童参加了研究。在18名可评估血液学应答的儿童中，甲磺酸伊马替尼在慢性期10名患者中的8名（80%）和在晚期疾病中的8名患者中的6名（75%）中诱导了完全血液学应答，毒性可接受。在27例可评估细胞遗传学缓解的患者中，甲磺酸伊马替尼诱导慢性期20例儿童中的12例（60%）和晚期7例儿童中的2例（29%）费城染色体阳性骨髓细胞消失。11名（50%）慢性期儿童的bcr-abl/abl比值降至10（-4）以下。慢性期入组患者的12个月总生存率估计为95%（95% CI，87-100%），晚期入组患者的12个月总生存率估计为75%（95% CI，45-100%）。甲磺酸伊马替尼耐受性良好，CML儿童可实现分子缓解。
A multicentric phase 2 study was conducted to determine the efficiency and the tolerance of imatinib mesylate in children with chronic myelogenous leukemia (CML) in advanced phase of the disease, in relapse after stem cell transplantation, or in case of failure to an interferon a-based regimen. In all, 30 children from eight European countries were enrolled. In 18 children assessable for hematologic response, imatinib mesylate induced complete hematologic response in eight (80%) of the 10 patients included in chronic phase and in six (75%) of eight enrolled in advanced phase of the disease with acceptable toxicity. In 27 patients assessable for cytogenetic response, imatinib mesylate induced disappearance of Philadelphia chromosome-positive bone marrow cells in 12 (60%) of 20 children included in chronic phase and in two (29%) of seven included in advanced phase. A reduction of the bcr-abl/abl ratio to less than 10(-4) was achieved in 11 (50%) of the children included in chronic phase. Estimated 12-month overall survival rate was 95% ( 95% CI, 87-100%) for the patients included in chronic phase and 75% ( 95% CI, 45-100%) for those enrolled in advanced phase. Imatinib mesylate is well tolerated and molecular remission can be achieved in children with CML.