title: 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.affiliation: Hematology Unit, CHU La Pitié Salpêtrière Hospital, 47 bd de l'Hopital, 75651 Paris Cedex 14, France. sylvain.choquet@psl.ap-hop-paris.fr
authors.forename: Sylvain
authors.initials: S
authors.lastname: Choquet
authors.forename: Veronique
authors.initials: V
authors.lastname: Leblond
authors.forename: Raoul
authors.initials: R
authors.lastname: Herbrecht
authors.forename: Gérard
authors.initials: G
authors.lastname: Socié
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Stoppa
authors.forename: Peter
authors.initials: P
authors.lastname: Vandenberghe
authors.forename: Alain
authors.initials: A
authors.lastname: Fischer
authors.forename: Franck
authors.initials: F
authors.lastname: Morschhauser
authors.forename: Gilles
authors.initials: G
authors.lastname: Salles
authors.forename: Walter
authors.initials: W
authors.lastname: Feremans
authors.forename: Etienne
authors.initials: E
authors.lastname: Vilmer
authors.forename: Marie-Noelle
authors.initials: MN
authors.lastname: Peraldi
authors.forename: Philippe
authors.initials: P
authors.lastname: Lang
authors.forename: Yvon
authors.initials: Y
authors.lastname: Lebranchu
authors.forename: Eric
authors.initials: E
authors.lastname: Oksenhendler
authors.forename: Jeanne Luce
authors.initials: JL
authors.lastname: Garnier
authors.forename: Thierry
authors.initials: T
authors.lastname: Lamy
authors.forename: Arnaud
authors.initials: A
authors.lastname: Jaccard
authors.forename: Augustin
authors.initials: A
authors.lastname: Ferrant
authors.forename: Fritz
authors.initials: F
authors.lastname: Offner
authors.forename: Olivier
authors.initials: O
authors.lastname: Hermine
authors.forename: Anne
authors.initials: A
authors.lastname: Moreau
authors.forename: Samira
authors.initials: S
authors.lastname: Fafi-Kremer
authors.forename: Patrice
authors.initials: P
authors.lastname: Morand
authors.forename: Lucienne
authors.initials: L
authors.lastname: Chatenoud
authors.forename: Nathalie
authors.initials: N
authors.lastname: Berriot-Varoqueaux
authors.forename: Loïc
authors.initials: L
authors.lastname: Bergougnoux
authors.forename: Noel
authors.initials: N
authors.lastname: Milpied
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001402:B-Lymphocytes; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D006836:Hydro-Lyases / Q000097:blood; D008232:Lymphoproliferative Disorders / Q000097:blood / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D008297:Male; D008875:Middle Aged; D016377:Organ Transplantation / Q000401:mortality; D011446:Prospective Studies; D012074:Remission Induction / Q000379:methods; D000069283:Rituximab
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D000069283:Rituximab; D006836:Hydro-Lyases; C045581:lactate dehydratase