Abstract
BackgroundThe addition of Rituximab (R) to standard chemotherapy (C) has been reported to improve the end of treatment outcome in patients affected by CD-20 positive malignant lymphomas (CD20+ ML). Nevertheless, given the profound and prolonged immunosuppression produced by R there are concerns that severe infections may arise. A systematic review and meta-analysis were performed to determine whether or not the addition of R to C may increase the risk of severe infections in adults undergoing induction therapy for CD20+ ML.MethodsOnly randomised controlled trials comparing R-C to C standard alone in adult patients with CD20+ ML were included. Meta-analysis was performed on overall incidence of severe infection, risk of dying as the consequence of infection, risk of febrile neutropenia, risk of severe leucopenia, risk of severe granulocytopenia and overall response assuming a fixed effect model. Heterogeneity was investigated, if present and I2 >20%, according to several predefined baseline characteristics of the study populations.ResultsSeveral relevant results have emerged. First, the addition of R to standard C does not increase the overall risk of severe infections (RR = 1.00; 95% CI 0.87 to 1.14) nor does it increase the risk of dying as a consequence of infection (RR = 1.60; 95% CI 0.68 to 3.75). Second, we confirmed that the addition of R to standard C increases the proportion of overall response (RR = 1.12; 95% CI 1.09 to 1.15), but it also increases the risk of severe leucopenia (RR = 1.24; 95% CI 1.12 to 1.37) and granulocytopenia (RR = 1.07; 95% CI 1.02 to 1.12).ConclusionsR-C is superior to standard C in terms of overall response and it does not increase the overall incidence of severe infection. However, data on special groups of patients (for example, HIV positive subjects and HBV carriers) are lacking. In our opinion more studies are needed to explore the potential effect of R on silent and chronic viral infections.
Highlights
The addition of Rituximab (R) to standard chemotherapy (C) has been reported to improve the end of treatment outcome in patients affected by CD-20 positive malignant lymphomas (CD20+ ML)
Several relevant results emerged: 1). addition of R to standard C does not increase the global risk of infections nor does it increase the risk of lethal infections during therapy in patients with CD20+ ML; 2). there is a paucity of data about reactivation of latent viral pathogens which might be relevant in particular groups of patients; 3). the addition of R to standard C can increase the risk of severe leucopenia and granulocytopenia during therapy in patients with CD20+ ML; and 4). compared to standard chemotherapy alone, R and C (R-C) increases the overall response both in indolent and aggressive lymphomas clinical variants
Of the 10 studies included in the meta-analysis for global risk of infection, none found a significant increase of infections in the R-C arm compared to the standard C arm, and one (Coiffer 2002) found a reduction (RR = 0.60, 95% 95% confidence interval (CI) 0.38 to 0.96)
Summary
The addition of Rituximab (R) to standard chemotherapy (C) has been reported to improve the end of treatment outcome in patients affected by CD-20 positive malignant lymphomas (CD20+ ML). Given the profound and prolonged immunosuppression produced by R there are concerns that severe infections may arise. A systematic review and meta-analysis were performed to determine whether or not the addition of R to C may increase the risk of severe infections in adults undergoing induction therapy for CD20+ ML. Effective multi-drug chemotherapy (C) protocols for CD20+ ML have been available for the last 30 years with variable results in indolent and aggressive ML but protocols have been changing recently with the introduction of rituximab (R) [3]. Given the profound and prolonged immunosuppression produced by R, there are concerns that infections may arise [7]
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