Comparison of imatinib 400 mg and 800 mg daily in the front-line treatment of high-risk, Philadelphia-positive chronic myeloid leukemia: a European LeukemiaNet Study
Comparison of imatinib 400 mg and 800 mg daily in the front-line treatment of high-risk, Philadelphia-positive chronic myeloid leukemia: a European LeukemiaNet Study
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DOI：
10.1182/blood-2008-12-191254
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发表时间：
2009-05-07
期刊：
影响因子：
20.3
通讯作者：
Simonsson, Bengt
中科院分区：
文献类型：
--
作者：
Baccarani, Michele;Rosti, Gianantonio;Simonsson, Bengt
甲磺酸伊马替尼（Imatinib mesylate， IM），每日400mg，是费城阳性（Ph+）慢性髓性白血病（CML）的标准治疗。临床前数据和单臂研究的结果表明，更高的剂量可以获得更好的结果。为了研究系统使用更高剂量的IM是否能带来更好的结果，根据Sokal指数，216例Ph+ CML高危（HR）患者被随机分配接受每日800 mg或400 mg IM作为一线治疗，至少1年。高剂量组和标准剂量组1年CCgR率分别为64%和58% （P = .435）。3个月和6个月时的CgR、任何时间的分子反应率以及其他事件的发生率均无差异。在25名能够耐受全部800毫克剂量的患者中，24名（94%）达到了CCgR，而在17名耐受少于350毫克的患者中，只有4名（23%）达到了CCgR。本研究不支持在所有CML HR患者中广泛使用高剂量IM（每日800 mg）。该试验在www.clinicaltrials.gov注册为#NCT00514488。(血。2009;113:4497 - 4504)
Imatinib mesylate (IM), 400 mg daily, is the standard treatment of Philadelphia-positive (Ph+) chronic myeloid leukemia (CML). Preclinical data and results of single-arm studies raised the suggestion that better results could be achieved with a higher dose. To investigate whether the systematic use of a higher dose of IM could lead to better results, 216 patients with Ph+ CML at high risk (HR) according to the Sokal index were randomly assigned to receive IM 800 mg or 400 mg daily, as front-line therapy, for at least 1 year. The CCgR rate at 1 year was 64% and 58% for the high-dose arm and for the standard-dose arm, respectively (P = .435). No differences were detectable in the CgR at 3 and 6 months, in the molecular response rate at any time, as well as in the rate of other events. Twenty-four (94%) of 25 patients who could tolerate the full 800-mg dose achieved a CCgR, and only 4 (23%) of 17 patients who could tolerate less than 350 mg achieved a CCgR. This study does not support the extensive use of high-dose IM (800 mg daily) front-line in all CML HR patients. This trial was registered at www.clinicaltrials.gov as #NCT00514488. (Blood. 2009;113:4497-4504)