在非霍奇金淋巴瘤的治疗方案中加入利妥昔单抗与进行性多灶性白质脑病的风险。
Inclusion of rituximab in treatment protocols for non-Hodgkin's lymphomas and risk for progressive multifocal leukoencephalopathy.
机构信息
Department of Experimental Pathology, University of Pisa, Pisa, Italy.
出版信息
Oncologist. 2010;15(11):1214-9. doi: 10.1634/theoncologist.2010-0098. Epub 2010 Nov 1.
Abstract
Objectives. Rituximab is an anti-CD20 monoclonal antibody that promotes better treatment outcomes in patients with non-Hodgkin's lymphoma (NHL). Case series of progressive multifocal leukoencephalopathy (PML) in patients receiving rituximab within polychemotherapy regimens have led to the introduction of a black box warning, but no risk estimation has ever been provided. Methods. We performed a retrospective, monocentric cohort study on 976 NHL patients diagnosed in 1994-2008, including 517 patients who received at least one dose of rituximab. Results. Inclusion of rituximab into standard chemotherapy regimens for NHL caused a significantly higher incidence of PML cases (rate difference, 2.2 every 1,000 patient-years; 95% confidence interval, 0.1-4.3). Interpretation. Based on this finding, clinical surveillance of PML-related symptoms is recommended in NHL patients exposed to rituximab.
摘要
目的
利妥昔单抗是一种抗 CD20 单克隆抗体，可改善非霍奇金淋巴瘤（NHL）患者的治疗效果。在接受包含利妥昔单抗的联合化疗方案治疗的患者中，陆续出现进行性多灶性白质脑病（PML）的病例系列报告，这导致了黑框警告的发布，但从未提供过风险估计。
方法
我们对 1994-2008 年间诊断的 976 例 NHL 患者进行了回顾性、单中心队列研究，其中包括 517 例至少接受过一次利妥昔单抗治疗的患者。
结果
在 NHL 的标准化疗方案中加入利妥昔单抗会显著增加 PML 病例的发生率（率差为每 1000 患者年 2.2 例；95%置信区间，0.1-4.3）。
结论
基于这一发现，建议对接受利妥昔单抗治疗的 NHL 患者进行与 PML 相关症状相关的临床监测。
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