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Annals of Oncology 2004 15(11):1691-1698; doi:10.1093/annonc/mdh425
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© 2004 European Society for Medical Oncology

Original Article

Rituximab consolidation after high-dose chemotherapy and autologous blood stem cell transplantation in follicular and mantle cell lymphoma: a prospective, multicenter phase II study

W. Brugger1,*,{dagger}, J. Hirsch1, F. Grünebach1, R. Repp3, P. Brossart1, W. Vogel1, H.-G. Kopp1, M. G. Manz1, M. Bitzer2, G. Schlimok4, M. Kaufmann5, A. Ganser6, K. Fehnle7, M. Gramatzki3 and L. Kanz1

Departments of 1 Hematology, Oncology, Immunology and Rheumatology, and 2 Radiology, University of Tübingen, Tübingen; 3 University of Erlangen, Erlangen; 4 Zentralklinikum Augsburg, Augsburg; 5 Robert-Bosch Krankenhaus, Stuttgart; 6 Hannover Medical School, Hannover; 7 Algora, Clinical Research Organization, Munich, Germany

* Correspondence to: Dr W. Brugger, Department of Hematology, Oncology, Immunology and Rheumatology, University of Tübingen, Otfried-Müller Strasse 10, 72076 Tübingen, Germany. Tel: +49-7721-93-4001; Fax: +49-7721-93-4099; Email: imo.wolfram.brugger{at}klinikumvs.de

Background: Patients with follicular (FL) or mantle cell lymphoma (MCL) are incurable with conventional therapy. We investigated the safety and efficacy of rituximab consolidation after autologous stem cell transplantation (ASCT) in order to prevent relapse by clearance of minimal residual disease (MRD).

Methods: Rituximab was given ~8 weeks after CD34+ cell enriched ASCT at 375 mg/m2, weekly for 4 weeks. Monitoring of MRD was performed by repetitive PCR analyses.

Results: Thirty-one patients were included; one died early after ASCT before rituximab administration. Thirty patients (20 FL, 10 MCL) were evaluable after rituximab consolidation, and 27 of these were assessable for MRD detection. Rituximab consolidation post-ASCT was safe, the most common toxicity being infection. At a median follow-up of 42 months (range 13–96) after ASCT, 25 patients were censored with an actuarial event-free survival (EFS) of 81% at 4 and 5 years. Four patients (two FL, two MCL) relapsed, and one additional MCL patient died unexpectedly in complete remission. PCR-negativity was observed in 22% of the patients before ASCT, 53% post-ASCT (P=0.0547), 72% after rituximab (P=0.0018) and 100% at 6 months post-transplant (P < 0.001).

Conclusions: One single course of rituximab consolidation given after ASCT is safe, may help to eliminate MRD and may translate into improved EFS in both FL and MCL patients.

Key words: autologous transplantation, follicular lymphoma, mantle cell lymphoma, rituximab consolidation


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