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Efficacy and safety of rituximab in B-cell post-transplantation lymphoproliferative disorders: results of a prospective multicenter phase 2 study.

Sylvain Choquet Veronique Leblond Raoul Herbrecht Gérard Socié 1 Anne-Marie Stoppa Peter Vandenberghe Alain Fischer 2, 3 Franck Morschhauser 4 Gilles A. Salles 5, 6 Walter Feremans Etienne Vilmer 7 Marie-Noelle Peraldi Philippe Lang 8 Yvon Lebranchu 9 Eric Oksenhendler 10 Jeanne Luce Garnier Thierry Lamy Arnaud Jaccard 11, 12 Augustin Ferrant Fritz Offner Olivier Hermine 13 Anne Moreau 14 Samira Fafi-Kremer 15 Patrice Morand 16 Lucienne Chatenoud 17 Nathalie Berriot-Varoqueaux Loïc Bergougnoux Noel Milpied 18 
Abstract : B-cell posttransplantation lymphoproliferative disorder (B-PTLD) is a rare but severe complication of transplantation, with no consensus on best treatment practice. This prospective trial, the first to test a treatment for PTLD, was designed to evaluate the efficacy and safety of rituximab in patients with B-PTLD after solid organ transplantation (SOT). Forty-six patients were included and 43 patients were analyzed. Patients were eligible if they had untreated B-PTLD that was not responding to tapering of immunosuppression. Treatment consisted of 4 weekly injections of rituximab at 375 mg/m2. At day (d) 80, 37 (86%) patients were alive, and the response rate was 44.2%, including 12 complete response/unconfirmed complete response (CR/CRu). The only factor predictive of a response at d80 was a normal lactate dehydrogenase level (P = .007, odds ratio [OR] = 6.9). At d360, responses were maintained in 68% of patients, and 56% of patients were alive. The overall survival rate at 1 year was 67%. We conclude that rituximab is effective and safe in PTLD, with stable responses at 1 year. The response rate and overall survival might be improved by combining rituximab with other treatments.
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https://hal.archives-ouvertes.fr/hal-00452946
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Submitted on : Wednesday, February 3, 2010 - 3:03:27 PM
Last modification on : Thursday, October 20, 2022 - 3:10:07 PM

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Sylvain Choquet, Veronique Leblond, Raoul Herbrecht, Gérard Socié, Anne-Marie Stoppa, et al.. Efficacy and safety of rituximab in B-cell post-transplantation lymphoproliferative disorders: results of a prospective multicenter phase 2 study.. Blood, 2006, 107 (8), pp.3053-7. ⟨10.1182/blood-2005-01-0377⟩. ⟨hal-00452946⟩

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