Multicenter prospective trial evaluating the tolerability of imatinib for Japanese patients with chronic myelogenous leukemia in the chronic phase: Does body weight matter?
Multicenter prospective trial evaluating the tolerability of imatinib for Japanese patients with chronic myelogenous leukemia in the chronic phase: Does body weight matter?
复制标题
DOI：
10.1002/ajh.21274
复制
发表时间：
2008-11-01
影响因子：
12.8
通讯作者：
Ikeda, Yasuo
中科院分区：
文献类型：
--
作者：
Kanda, Yoshinobu;Okamoto, Shinichiro;Ikeda, Yasuo
伊马替尼每日剂量为400 mg是慢性期慢性髓细胞性白血病的标准治疗。然而，该剂量用于日本小型成人的可行性尚未阐明。我们前瞻性研究了该剂量在日本成人患者中的毒性和疗效。在89例中位体重为62.8 kg的可评价患者中，40例受试者（45%）因3-4级毒性（30例患者（75%））和2级毒性（主治医生酌情决定）（10例患者（25%））暂停伊马替尼治疗。然而，重新开始治疗，并逐渐增加剂量，直至89例患者中有62例耐受400 mg的维持剂量。年龄较大和体重较低是停用伊马替尼的重要独立风险因素。在中位随访31个月后，84名患者存活，无进展。在开始伊马替尼治疗后6个月和1年，完全细胞遗传学缓解率分别为60%和90%。年龄较大的患者和体重较轻的患者不太可能达到完全的细胞遗传学缓解。这些结果表明，体重对伊马替尼在小体型患者中的毒性和疗效有显著影响，尽管与体重成比例的剂量减少可能导致对伊马替尼的反应不足。Am. J. Hematol. 83：835-839，2008. (C)2008 Wiley-Liss，Inc.
Imatinib at a daily dose of 400 mg is the standard treatment for chronic myelogenous leukemia in the chronic phase. However, the feasibility of this dose for small Japanese adults has not been clarified. We prospectively investigated the toxicity and efficacy of this dose in adult Japanese patients. Among the 89 evaluable patients with a median body weight of 62.8 kg, imatinib therapy was held in 40 subjects (45%), due to Grade 3-4 toxicities in 30 patients (75%) and Grade 2 toxicities at the discretion of the attending physician in 10 patients (25%). However, treatment was resumed and the dose was gradually increased until 62 of the 89 patients tolerated a maintenance dose of 400 mg. Older age and lower body weight were significant independent risk factors for discontinuation of imatinib. After a median follow-up period of 31 months, 84 patients were alive without progression. The complete cytogenetic response rate was 60 and 90% at 6 months and 1 year after starting imatinib, respectively. Older patients and those with a lower body weight were less likely to achieve a complete cytogenetic response. These findings suggest that the body weight has a significant influence on the toxicity and efficacy of imatinib in patients with a small body size, although dose reduction in proportion to weight may result in an inadequate response to imatinib. Am. J. Hematol. 83:835-839, 2008. (C) 2008 Wiley-Liss, Inc.