Severe and fatal adverse events risk associated with rituximab addition to B-cell non-Hodgkin's lymphoma (B-NHL) chemotherapy: a meta-analysis.

PURPOSE: Rituximab is a monoclonal antibody targetting the CD20 antigen with the ability to increase overall remission (OR) in B-cell non-Hodgkin's lymphoma (B-NHL). A systematic review and meta-analysis were conducted to determine the risk of the most clinically relevant severe and fatal adverse events (AEs) associated with the use of rituximab in the treatment of B-NHL.

PATIENTS AND METHODS: We included phase III clinical trials that used chemotherapy in combination with rituximab or chemotherapy alone as for B-NHL. Statistical analyses were conducted to calculate summary risk ratio (RR) of the relevant severe and fatal AEs related with rituximab.

RESULTS: Eight randomised controlled clinical trials were included in this meta-analysis. Summary RR obtained showed no statistically significant rituximab-associated increased risk in 13 severe adverse events (SAEs) (infection, fever, anaemia, thrombocytopaenia, granulocytopenia, liver toxicity, cardiac toxicity, neurologic toxicity, lung toxicity, mucositis, nausea/vomiting, diarrhoea, alopecia) except leukocytopenia (36.4% versus 31%; RR = 1.13; 95%CI, 1.01-1.27; P = 0.03). The incidences of fatal AEs showed noteworthy difference between rituximab group and control group (RR = 1.45; 95% CI, 1.04-2.02; P = 0.03).

CONCLUSION: This meta-analysis indicates that there was no proof of statistically higher incidence of most SAEs in rituximab containing group compared with chemotherapy alone. However, fatal infections were more frequently observed in patients who received rituximab. Considering the low-incidence infection-induced death during the treatment period, the effects of rituximab on infections need further investigation.