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Blood, 15 November 2004, Vol. 104, No. 10, pp. 3064-3071.
Prepublished online as a Blood First Edition Paper on July 29, 2004; DOI 10.1182/blood-2004-04-1323.
 Previous Article | Next Article 
Submitted April 7, 2004
Accepted June 30, 2004
The addition of rituximab to a combination of fludarabine, cyclophosphamide, mitoxantrone (FCM) significantly increases the response rate and prolongs survival as compared to FCM alone 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, Martin Dreyling, Roland Repp, Sandra Hermann, Annette Haenel, Bernd Metzner, Christiane Pott, Frank Hartmann, Frank Rothmann, Robert Rohrberg, Hans-Peter Boeck, Hannes Wandt, Michael Unterhalt, and Wolfgang Hiddemann*
Department of Internal Medicine III, University of Munich, Klinikum Grosshadern, Munich, Germany
Department of Internal Medicine III, University of Erlangen, Erlangen, Germany
Department of Hematology, Oncology and Tumorimmunology, Robert-Roessle Klinik, Berlin, Germany
Department of Internal Medicine III, Klinikum Chemnitz, Chemnitz, Germany
Department of Internal Medicine II, Oncology and Hematology, Klinikum Oldenburg, Oldenburg, Germany
Department of Internal Medicine II, University Hospital Schleswing-Holstein, Campus Kiel, Kiel, Germany
Department of Internal Medicine I, University of Homburg/Saar, Homburg/Saar, Germany
Department of Hematology and Oncology, Klinikum Ernst-von-Bergmann, Potsdam, Germany
Haematologisch/Onkologische Praxis, Halle (Saale), Germany
Haematologisch/Onkologische Praxis, Offenbach, Germany
Department of Internal Medicine V, Klinikum Nord, Nuernberg, Germany
* Corresponding author; email: wolfgang.hiddemann{at}med.uni-muenchen.de.
In follicular lymphoma (FL) and mantle cell lymphoma (MCL) the monoclonal antibody Rituximab may improve the prognosis when combined with chemotherapy. This was investigated in a prospective randomized study in patients with relapsed disease. 147 patients were randomized to receive 4 courses of chemotherapy with fludarabine 25 mg/m2 d 1-3, cyclophosphamide 200 mg/m2 d 1-3 and mitoxantrone 8 mg/m2 d1 (FCM) alone or combined with Rituximab (375 mg/m2) (R-FCM). Of 128 evaluable patients 62 were randomized for FCM and 66 for R-FCM. R-FCM revealed an overall response rate of 79% (33% CR, 45% PR) as compared to 58% for FCM alone (13% CR, 45% PR; p=0.01), with similar results in a subgroup analysis of FL (94% vs. 70%) and MCL (58% vs. 46%). In the total group, the R-FCM arm was significantly superior concerning progression-free (PFS) (p=0.0381) and overall survival (OS) (p=0.0030). In FL PFS was significantly longer in the R-FCM arm (p=0.0139) while in MCL a significantly longer OS was observed (p=0.0042). There were no differences in clinically relevant side effects in both study arms. Hence, the addition of Rituximab to FCM chemotherapy significantly improves the outcome of relapsed or refractory FL and MCL.
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