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
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Yamaguchi Univ, Grad Sch Med, Dept Neurol & Clin Neurosci, Yamaguchi, JapanYamaguchi Univ, Grad Sch Med, Dept Neurol & Clin Neurosci, Yamaguchi, Japan
Sano, Yasuteru
Nakano, Yuta
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Yamaguchi Univ, Grad Sch Med, Dept Neurol & Clin Neurosci, Yamaguchi, JapanYamaguchi Univ, Grad Sch Med, Dept Neurol & Clin Neurosci, Yamaguchi, Japan
Nakano, Yuta
Omoto, Masatoshi
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Yamaguchi Univ, Grad Sch Med, Dept Neurol & Clin Neurosci, Yamaguchi, JapanYamaguchi Univ, Grad Sch Med, Dept Neurol & Clin Neurosci, Yamaguchi, Japan
Omoto, Masatoshi
Takao, Masaki
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Tokyo Metropolitan Geriatr Hosp, Dept Neuropathol, Brain Bank Aging Res, Tokyo, JapanYamaguchi Univ, Grad Sch Med, Dept Neurol & Clin Neurosci, Yamaguchi, Japan
Takao, Masaki
Ikeda, Eiji
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Yamaguchi Univ, Grad Sch Med, Dept Pathol, Yamaguchi, JapanYamaguchi Univ, Grad Sch Med, Dept Neurol & Clin Neurosci, Yamaguchi, Japan
Ikeda, Eiji
Oga, Atsunori
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Yamaguchi Univ, Grad Sch Med, Dept Pathol, Yamaguchi, JapanYamaguchi Univ, Grad Sch Med, Dept Neurol & Clin Neurosci, Yamaguchi, Japan
Oga, Atsunori
Nakamichi, Kazuo
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Natl Inst Infect Dis, Dept Virol 1, Tokyo, JapanYamaguchi Univ, Grad Sch Med, Dept Neurol & Clin Neurosci, Yamaguchi, Japan
Nakamichi, Kazuo
Saijo, Masayuki
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Natl Inst Infect Dis, Dept Virol 1, Tokyo, JapanYamaguchi Univ, Grad Sch Med, Dept Neurol & Clin Neurosci, Yamaguchi, Japan
Saijo, Masayuki
Maoka, Takashi
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Res Inst Prod Dev, Tsukuba, Ibaraki, JapanYamaguchi Univ, Grad Sch Med, Dept Neurol & Clin Neurosci, Yamaguchi, Japan
Maoka, Takashi
Sano, Hironori
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Yamaguchi Univ, Grad Sch Med, Dept Neurol & Clin Neurosci, Yamaguchi, JapanYamaguchi Univ, Grad Sch Med, Dept Neurol & Clin Neurosci, Yamaguchi, Japan
Sano, Hironori
Kawai, Motoharu
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Yamaguchi Univ, Grad Sch Med, Dept Neurol & Clin Neurosci, Yamaguchi, JapanYamaguchi Univ, Grad Sch Med, Dept Neurol & Clin Neurosci, Yamaguchi, Japan
Kawai, Motoharu
Kanda, Takashi
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Yamaguchi Univ, Grad Sch Med, Dept Neurol & Clin Neurosci, Yamaguchi, JapanYamaguchi Univ, Grad Sch Med, Dept Neurol & Clin Neurosci, Yamaguchi, Japan