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Blood, 15 December 2006, Vol. 108, No. 13, pp. 4003-4008.
Prepublished online as a Blood First Edition Paper on August 31, 2006; DOI 10.1182/blood-2006-04-016725.
Previous Article | Next Article 
Submitted April 21, 2006
Accepted August 1, 2006
Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide and mitoxantrone (R-FCM) in patients with relapsed and refractory follicular and mantle cell lymphomas - results of a prospective randomized study of the German low grade lymphoma study group (GLSG)
Roswitha Forstpointner, Michael Unterhalt, Martin Dreyling, Hans-Peter Bock, Roland Repp, Hannes Wandt, Christiane Pott, John F. Seymour, Bernd Metzner, Annette Hanel, Tanja Lehmann, Frank Hartmann, Hermann Einsele, and Wolfgang Hiddemann*
Department of Internal Medicine III, University of Munich, Grobhadern
Hamatologisch/Onkologische Praxis, Offenbach
Dept. of Internal Medicine III, University of Erlangen, pres. University Hospital Schleswig-Holstein
Department of Internal Medicine V, Klinikum Nord, Nurnberg
Department of Internal Medicine II, University Hospital Schleswig-Holstein, Campus Kiel
Peter MacCallum Cancer Center, Division of Hematology/Oncology, East Melbourne, Australia
Department of Internal Medicine II, Oncology and Hematology, Klinikum Oldenburg
Department of Internal Medicine III, Klinikum Chemnitz
Department of Hematology, Oncology and Tumorimmunology, HELIOS Klinikum Berlin-Buch
Department of Internal Medicine I, University of Homburg/Saar
Department of Internal Medicine, University of Wurzburg
* Corresponding author; email: wolfgang.hiddemann{at}med.uni-muenchen.de.
In follicular lymphoma (FL) and mantle cell lymphoma (MCL) the monoclonal antibody Rituximab (R) improves the prognosis when combined with chemotherapy. The present study investigated R-maintenance after R-chemotherapy. Patients with relapsed or refractory FL and MCL were randomized to 4 courses of fludarabine, cyclophosphamide and mitoxantrone (FCM) alone or combined with R (R-FCM). Responding patients underwent a second randomization for R maintenance comprising two further courses of 4 x weekly doses of R after 3 and 9 months. The first randomization was stopped after 147 patients when R-FCM revealed a significantly better outcome. All subsequent patients received R-FCM. 176 patients are currently evaluable 138 of whom received R-FCM for remission induction. Response duration was significantly prolonged by R-maintenance after R-FCM with the median not being reached versus 16 months (p=0.001). This beneficial effect was also observed when analyzing FL (p=0.035) and MCL (p=0.049) separately. Hence, R-maintenance is effective after salvage with R-chemotherapy and significantly prolongs response duration in patients with relapsed or refractory FL or MCL.

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