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

• Published in: Blood 2006-04, Vol.107 (8), p.3053-3057
• Main Authors: Choquet, Sylvain, Leblond, Veronique, Herbrecht, Raoul, Socié, Gérard, Stoppa, Anne-Marie, Vandenberghe, Peter, Fischer, Alain, Morschhauser, Franck, Salles, Gilles, Feremans, Walter, Vilmer, Etienne, Peraldi, Marie-Noelle, Lang, Philippe, Lebranchu, Yvon, Oksenhendler, Eric, Garnier, Jeanne Luce, Lamy, Thierry, Jaccard, Arnaud, Ferrant, Augustin, Offner, Fritz, Hermine, Olivier, Moreau, Anne, Fafi-Kremer, Samira, Morand, Patrice, Chatenoud, Lucienne, Berriot-Varoqueaux, Nathalie, Bergougnoux, Loïc, Milpied, Noel
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Antibodies, Monoclonal; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal, Murine-Derived; Antineoplastic Agents; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; B-Lymphocytes; Biological and medical sciences; Disease-Free Survival; Female; Hematologic and hematopoietic diseases; Humans; Hydro-Lyases; Hydro-Lyases - blood; Immunology; Immunotherapy; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis; Life Sciences; Lymphoproliferative Disorders; Lymphoproliferative Disorders - blood; Lymphoproliferative Disorders - drug therapy; Lymphoproliferative Disorders - etiology; Lymphoproliferative Disorders - mortality; Male; Medical sciences; Middle Aged; Organ Transplantation; Organ Transplantation - mortality; Pharmacology. Drug treatments; Prospective Studies; Remission Induction; Remission Induction - methods; Rituximab
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood-2005-01-0377

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.