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

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.

• Authors: Sylvain Choquet, Veronique Leblond, Raoul Herbrecht, Gérard Socié, Anne-Marie Stoppa, Peter Vandenberghe, Alain Fischer, Franck Morschhauser, Gilles Salles, Walter Feremans, Etienne Vilmer, Marie-Noelle Peraldi, Philippe Lang, Yvon Lebranchu, Eric Oksenhendler, Jeanne Luce Garnier, Thierry Lamy, Arnaud Jaccard, Augustin Ferrant, Fritz Offner, Olivier Hermine, Anne Moreau, Samira Fafi-Kremer, Patrice Morand, Lucienne Chatenoud, Nathalie Berriot-Varoqueaux, Loïc Bergougnoux, Noel Milpied
• Journal: Blood (Blood) Vol. 107 Issue 8 Pg. 3053-7 (Apr 15 2006) ISSN: 0006-4971 [Print] United States
• PMID: 16254143 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Murine-Derived
• Antineoplastic Agents
• Rituximab
• Hydro-Lyases
• lactate dehydratase

Topics

• Adolescent
• Adult
• Aged
• Antibodies, Monoclonal (administration & dosage, adverse effects)
• Antibodies, Monoclonal, Murine-Derived
• Antineoplastic Agents (administration & dosage, adverse effects)
• B-Lymphocytes
• Disease-Free Survival
• Female
• Humans
• Hydro-Lyases (blood)
• Lymphoproliferative Disorders (blood, drug therapy, etiology, mortality)
• Male
• Middle Aged
• Organ Transplantation (mortality)
• Prospective Studies
• Remission Induction (methods)
• Rituximab