title: Prospective phase II trial of extended treatment with rituximab in patients with B-cell post-transplant lymphoproliferative disease.
abstract: 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.
authors.affiliation: 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
authors.forename: Eva
authors.initials: E
authors.lastname: González-Barca
authors.forename: Eva
authors.initials: E
authors.lastname: Domingo-Domenech
authors.forename: Francisco Javier
authors.initials: FJ
authors.lastname: Capote
authors.forename: Jose
authors.initials: J
authors.lastname: Gómez-Codina
authors.forename: Antonio
authors.initials: A
authors.lastname: Salar
authors.forename: Alicia
authors.initials: A
authors.lastname: Bailen
authors.forename: Jose-María
authors.initials: JM
authors.lastname: Ribera
authors.forename: Andres
authors.initials: A
authors.lastname: López
authors.forename: Javier
authors.initials: J
authors.lastname: Briones
authors.forename: Andres
authors.initials: A
authors.lastname: Muñoz
authors.forename: Maite
authors.initials: M
authors.lastname: Encuentra
authors.forename: Alberto Fernández
authors.initials: AF
authors.lastname: de Sevilla
mesh_terms: 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
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab