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Blood, 15 April 2006, Vol. 107, No. 8, pp. 3053-3057.
Prepublished online as a Blood First Edition Paper on October 27, 2005; DOI 10.1182/blood-2005-01-0377.
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CLINICAL TRIALS AND OBSERVATIONS
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,
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, and
Noel Milpied
From the Haematology Unit, La Pitié Salpêtrière Hospital, Paris, France; Department of Oncology, Hautepierre Hospital, Strasbourg, France; Department of Hematology and Transplantation, Saint Louis Hospital–Institut National de la Santé et de la Recherche Médicale (INSERM) 0220, Paris, France; Haematology Unit, Paoli Calmettes Institute, Marseille, France; University Hospitals, Leuven, Belgium; Departments of Pediatric Immunology and Hematology, Immunology, and Hematology, and Nephrology and Transplantation Unit, Necker Hospital, Paris, France; Department of Hematology, Centre Hospitalier Universitaire (CHU) Lille, France; Department of Hematology, Lyon Sud Hospital EA3737, Claude Bernard Lyon 1 University, Pierre-Benite, France; Department of Hematology, Erasmus Hospital, Brussels, Belgium; Department of Hematology, Robert Debré Hospital, Paris, France; Nephrology and Transplantation Unit, Henri Mondor Hospital, Créteil, France; Nephrology and Transplantation Unit, Bretonneau Hospital, Tours, France; Department of Immunology, Saint-Louis Hospital, Paris, France; Nephrology and Transplantation Unit, Edouard Herriot Hospital, Lyon, France; Department of Hematology, Pontchaillou Hospital, Rennes, France; Department of Hematology, CHU Limoges, France; Louvain Catholic University, Brussels, Belgium; Ziekenhuis University, Gent, Belgium; Department of Pathology, Hotel Dieu Hospital, Nantes, France; Virology Unit, Albert Michallon Hospital, Grenoble, France; Roche Neuilly sur Seine, France; and the Department of Hematology, Hotel Dieu Hospital, Nantes, France.
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). Fortysix 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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