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Prospective phase II trial of extended treatment with rituximab in patients with B-cell post-transplant lymphoproliferative disease

Hematology Department, Hospital Duran I Reynals, Institut Catalá d’ Oncología, L’Hospitalet de Llobregat, Barcelona, Spain (EDD); Hematology Department Hospital Universitario puerta del Mar, Cadiz Spain (FJC); Oncology Department Hospital La Fe, Avda de Campanar, Valencia, Spain (JG-C); Hematology Department, Hospital del Mar, Barcelona, Spain (AS); Hematology Department, Hospital Universitario Carlos Haya, Málaga Spain (AB); Hematology Department, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain (JMR); Hematology Department, Hospital Valle Hebron, Barcelona, Spain (AL); Hematology Department, Hospital de la S.ta Creu i Sant Pau, Barcelona, Spain (JB); Oncology Department, Hospital Doce de Octubre, Madrid, Spain (AM); Hematology Department, Hospital Duran I Reynals, Institut Catalá d’ Oncología, L’Hospitalet de Llobregat, Barcelona, Spain (ME); Hematology Department Hospital Duran I Reynals, Institut Catalá d’ Oncología, L’Hospitalet de Llobregat, Barcelona, Spain (AFdS)

Correspondence: Eva González-Barca, PhD, 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-mail: e.gonzalez{at}iconcologia.net

Background and Objectives: 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.

Design and 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.

Interpretation and 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.

Key words: post-transplant lymphoproliferative disorders, rituximab, prognostic factors.

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