Prospective phase II trial of extended treatment with rituximab in patients with B-cell post-transplant lymphoproliferative disease.
OBJECTIVE
The elective treatment of patients with post-transplant lymphoproliferative disorders is controversial. The purpose of this trial was to evaluate the efficacy of treatment with extended doses of rituximab adapted to the response in patients with post-transplant lymphoproliferative disorders after solid organ transplantation.


METHODS
This was a prospective, multicenter, phase II trial. Patients were treated with reduction of immunosuppression and four weekly infusions of rituximab. Those patients who did not achieve complete remission (CR) received a second course of four rituximab infusions. The primary end-point of the study was the CR rate.


RESULTS
Thirty-eight patients were assesable. One episode of grade 4 neutropenia was the only severe adverse event observed. After the first course of rituximab, 13 (34.2%) patients achieved CR, 8 patients did not respond, and 17 patients achieved partial remission. Among those 17 patients, 12 could be treated with a second course of rituximab, and 10 (83.3%) achieved CR, yielding an intention-to-treat CR rate of 60.5%. Eight patients excluded from the trial because of absence of CR were treated with rituximab combined with chemotherapy, and six (75%) achieved CR. Event-free survival was 42% and overall survival was 47% at 27.5 months. Fourteen patients died, ten of progression of their post-transplant lymphoproliferative disorder.


CONCLUSIONS
These results confirm that extended treatment with rituximab can obtain a high rate of CR in patients with post-transplant lymphoproliferative disorders after solid organ transplantation without increasing toxicity, and should be recommended as initial therapy for these patients.
González-Barca
Eva
E
Clinical Hematology Department, Hospital Duran I Reynals, Institut Catalá d' Oncología, Av Gran Vía s/n Km 2,7, 08907 L'Hospitalet de Llobregat, Barcelona, Spain. e.gonzalez@iconcologia.net
Domingo-Domenech
Eva
E
Capote
Francisco Javier
FJ
Gómez-Codina
Jose
J
Salar
Antonio
A
Bailen
Alicia
A
Ribera
Jose-María
JM
López
Andres
A
Briones
Javier
J
Muñoz
Andres
A
Encuentra
Maite
M
de Sevilla
Alberto Fernández
AF
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000633:toxicity; D058846:Antibodies, Monoclonal, Murine-Derived; D001402:B-Lymphocytes / Q000473:pathology*; D005260:Female; D006801:Humans; D008232:Lymphoproliferative Disorders / Q000150:complications / Q000188:drug therapy* / Q000209:etiology* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D016377:Organ Transplantation / Q000009:adverse effects*; D011446:Prospective Studies; D000069283:Rituximab; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab