%0 Journal Article
%A González-Barca, Eva
%A Domingo-Domenech, Eva
%A Capote, Francisco Javier
%A Gómez-Codina, Jose
%A Salar, Antonio
%A Bailen, Alicia
%A Ribera, Jose-María
%A López, Andres
%A Briones, Javier
%A Muñoz, Andres
%A Encuentra, Maite
%A de Sevilla, Alberto Fernández
%T Prospective phase II trial of extended treatment with rituximab in patients with B-cell post-transplant lymphoproliferative disease.
%D 2007
%@ 0390-6078
%U http://hdl.handle.net/10668/1293
%X BACKGROUND AND OBJECTIVESThe 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.DESIGN AND METHODSThis 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.RESULTSThirty-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.INTERPRETATION AND CONCLUSIONSThese 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.
%K Post-transplant lymphoproliferative disorders
%K Rituximab
%K Prognostic factors
%K Anticuerpos monoclonales
%K Estudios prospectivos
%K Trastornos linfoproliferativos
%K Trasplante de órganos
%K Resultado del tratamiento
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