Inclusion of Rituximab in Treatment Protocols for Non-Hodgkin's Lymphomas and Risk for Progressive Multifocal Leukoencephalopathy

被引:38
|
作者
Tuccori, Marco [1 ]
Focosi, Daniele [2 ]
Blandizzi, Corrado [1 ,5 ]
Pelosini, Matteo [2 ]
Montagnani, Sabrina [1 ,5 ]
Maggi, Fabrizio [3 ,4 ]
Pistello, Mauro [3 ,4 ]
Antonioli, Luca [1 ]
Fornai, Matteo [1 ]
Pepe, Pasquale [6 ]
Rossi, Giuseppe [6 ]
Petrini, Mario [2 ]
机构
[1] Univ Pisa, Dept Internal Med, Div Pharmacol & Chemotherapy, Pisa, Italy
[2] Univ Pisa, Div Haematol, Dept Oncol Transplantat & New Technol Med, Pisa, Italy
[3] Univ Pisa, Virol Sect, Pisa, Italy
[4] Univ Pisa, Retrovirus Ctr, Dept Expt Pathol, Pisa, Italy
[5] Tuscan Reg Ctr Pharmacovigilance, Pisa, Italy
[6] CNR, Unit Epidemiol & Biostat, Inst Clin Physiol, Pisa, Italy
关键词
Rituximab; Progressive multifocal leukoencephalopathy; JCV; Monoclonal antibody; Non-Hodgkin's lymphoma; ADVERSE DRUG EVENTS; NATALIZUMAB; EFALIZUMAB; THERAPY; PROJECT; DISEASE; PML;
D O I
10.1634/theoncologist.2010-0098
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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. The Oncologist 2010;15:1214-1219
引用
收藏
页码:1214 / 1219
页数:6
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