Department of Experimental Pathology, University of Pisa, Pisa, Italy.
Oncologist. 2010;15(11):1214-9. doi: 10.1634/theoncologist.2010-0098. Epub 2010 Nov 1.
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.
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。
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。
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）。
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。
