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Tumor necrosis factor a release is a major biological event associated with rituximab treatment

Jacques Bienvenu, Roland Chvetzoff, Gilles Salles, Cecile Balter, Herve Tilly, Raoul Herbrecht, Pierre Morel, Pierre Lederlin, Philippe Solal-Celigny, Bruno Audhuy, Bernard Christian, Jean Gabarre, Olivier Casasnovas, Gerald Marit, Catherine Sebban, Bertrand Coiffier


Introduction: In patients with low-grade non-Hodgkin's lymphoma, rituximab (MabTheraI) produces infusion-related toxicity, including fever, rigors, and chills in greater than 50% of those treated. The majority of these reactions are grade 1 or 2. Materials and methods: In the GELA study LNH98-5, a total of 400 elderly patients with previously untreated di􏰀use large B-cell lymphoma were randomized to treatment with CHOP or with rituximab plus CHOP (R-CHOP). In a detailed investigation of biological events which may be associated with adverse reactions speci®c to rituximab infusion, a subgroup of 55 patients (26 in the CHOP group and 29 in the R-CHOP group) were selected for measurement of several biological parameters at baseline and at 1, 4 and 8 h (H1, H4 and H8, respectively) after commencing therapy. For 27 patients, measurements included cytokine and complement levels. Results: Baseline demographic and disease characteristics were similar for patients in both treatment groups. Compared with the CHOP treatment group, patients in the R-CHOP group had signi®cantly higher post-treatment changes in neutrophil, lymphocyte, and monocyte counts, LDH levels, C3a levels, and TNF-a levels. In the R-CHOP group, neutrophil levels increased at H4 (PS0.05), lymphocyte levels decreased at H1 (PS0.05), H4 (PS0.001) and H8 (PS0.05), monocytes levels decreased at H1 (PS0.01), LDH levels increased at H4 (PS0.05) and H8 (PS0.01), and C3a decreased at H1 (PS0.01). The most statistically signi®cant changes were observed for TNF-a levels: Mean values of TNF-a increased more than 250% at H1 and H4 and were still increased by 170% at H8 (PS0.001 at all timepoints). Since only six of the 55 evaluated patients had severe adverse events, it was not possible to correlate severe toxicity with these biological variations. Conclusion: This analysis demonstrates that rituximab infusion was rapidly followed by activation of complement, B-lymphocyte cytolysis, and TNF-a release.

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Submitted: 2013-09-03 10:07:41
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