Alemtuzumab in clinical practice: A British Columbia experience

Alemtuzumab in clinical practice: A British Columbia experience
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阿仑单抗在临床实践中的应用:不列颠哥伦比亚省的经验

DOI:
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发表时间:
2007
影响因子:
2.6
通讯作者:
L. Sehn
L. Sehn
中科院分区:
医学4区
文献类型:
--
作者:
David Y. Hui;W. Lam;C. Toze;M. Delorme;M. Noble;P. Klimo;J. Sutherland;Karamjit K. Gill;J. Connors;L. Sehn

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关于阿仑单抗在非临床试验中的可用信息有限。我们对2002年10月至2006年8月在不列颠哥伦比亚省连续42例接受阿仑单抗单药治疗的未选择患者进行了疗效和安全性评估。回顾性收集与阿仑单抗相关的患者人口统计学、基线临床特征、剂量和方案、临床反应、生存和毒性等信息。42例患者中有39例患有慢性淋巴细胞白血病,2例患有蕈样真菌病,1例患有t细胞移植后淋巴细胞增生性疾病。与之前的报道相反,42%的患者由社区医生治疗,83%的患者接受阿仑单抗皮下注射。从诊断到阿仑单抗的中位时间为58个月。42例患者中有1例(2%)达到完全缓解,20例(48%)达到部分缓解,13例(31%)病情稳定。阿仑单抗治疗后的中位总生存期为15.1个月。与无应答者相比,阿仑单抗应答与无进展生存期增加相关(11个月vs 3.6个月,p = 0.001)。显著不良事件包括3/4级中性粒细胞减少(76%)、血小板减少(45%)、感染(60%)和死亡(12%)。通过仔细监测,阿仑单抗可以在包括社区实践在内的各种临床环境中安全使用,并且在可用的替代治疗方案很少的情况下具有高水平的活性。
Limited information is available on alemtuzumab in the nonclinical trial setting. We evaluated its efficacy and safety in 42 consecutive unselected patients who received alemtuzumab monotherapy in British Columbia between October 2002 and August 2006. Information on patient demographics, baseline clinical characteristics, dose and schedule, clinical response, survival, and toxicities associated with alemtuzumab was collected retrospectively. Thirty-nine of 42 patients had chronic lymphocytic leukemia, two had mycosis fungoides, and one had T-cell post-transplant lymphoproliferative disorder. In contrast to previous reports, 42% were treated by community practitioners and 83% received alemtuzumab subcutaneously. The median time from diagnosis to alemtuzumab was 58 months. One of 42 patients (2%) achieved a complete response, 20 (48%) achieved a partial response, and 13 (31%) had stable disease. The post-alemtuzumab median overall survival was 15.1 months. Response to alemtuzumab correlated with an increased progression-free survival (11 vs. 3.6 months, p = 0.001) compared to that seen in non-responders. Significant adverse events included grade 3/4 neutropenia (76%), thrombocytopenia (45%), infections (60%) and death (12%). With careful monitoring, alemtuzumab can be safely administered in a wide variety of clinical settings, including community practice, and is associated with a high level of activity in situations with few available alternative treatment options.
DOI: 10.1016/s1053-4296(03)00031-6
发表时间: 2003-07-01
影响因子: 3.5
作者:
Trotti, A;Colevas, AD;Rubin, P
通讯作者: Rubin, P