Efficacy and safety of rituximab in B-cell post-transplantation lymphoproliferative disorders: results of a prospective multicenter phase 2 study.
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.
Choquet
Sylvain
S
Hematology Unit, CHU La Pitié Salpêtrière Hospital, 47 bd de l'Hopital, 75651 Paris Cedex 14, France. sylvain.choquet@psl.ap-hop-paris.fr
Leblond
Veronique
V
Herbrecht
Raoul
R
Socié
Gérard
G
Stoppa
Anne-Marie
AM
Vandenberghe
Peter
P
Fischer
Alain
A
Morschhauser
Franck
F
Salles
Gilles
G
Feremans
Walter
W
Vilmer
Etienne
E
Peraldi
Marie-Noelle
MN
Lang
Philippe
P
Lebranchu
Yvon
Y
Oksenhendler
Eric
E
Garnier
Jeanne Luce
JL
Lamy
Thierry
T
Jaccard
Arnaud
A
Ferrant
Augustin
A
Offner
Fritz
F
Hermine
Olivier
O
Moreau
Anne
A
Fafi-Kremer
Samira
S
Morand
Patrice
P
Chatenoud
Lucienne
L
Berriot-Varoqueaux
Nathalie
N
Bergougnoux
Loïc
L
Milpied
Noel
N
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
D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D000069283:Rituximab; D006836:Hydro-Lyases; C045581:lactate dehydratase