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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 | Table of Contents | Next Article 
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
The addition of rituximab to a combination of fludarabine, cyclophosphamide, mitoxantrone (FCM) significantly increases the response rate and prolongs survival as compared with 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
Roswitha Forstpointner,
Martin Dreyling,
Roland Repp,
Sandra Hermann,
Annette Hänel,
Bernd Metzner,
Christiane Pott,
Frank Hartmann,
Frank Rothmann,
Robert Rohrberg,
Hans-Peter Böck,
Hannes Wandt,
Michael Unterhalt, and
Wolfgang Hiddemann
From the Department of Internal Medicine III, University of Munich, Klinikum Großhadern; the Department of Internal Medicine III, University of Erlangen; the Department of Hematology, Oncology and Tumorimmunology, Robert-Rössle-Klinik, Berlin; the Department of Internal Medicine III, Klinikum Chemnitz; the Department of Internal Medicine II, Oncology and Hematology, Klinikum Oldenburg; the Department of Internal Medicine II, University Hospital Schleswig-Holstein, Campus Kiel; the Department of Internal Medicine I, University of Homburg/Saar, the Department of Hematology and Oncology, Klinikum "Ernst-von-Bergmann," Potsdam; the Hämatologisch/Onkologische Praxis, Halle (Saale); the Hämatologisch/Onkologische Praxis, Offenbach; and the Department of Internal Medicine V, Klinikum Nord, Nürnberg, Germany.
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. A total of 147 patients were randomized to receive 4 courses of chemotherapy with 25 mg/m2 fludarabine on days 1 to 3, 200 mg/m2 cyclophosphamide on days 1 to 3, and 8 mg/m2 mitoxantrone on day 1 (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% complete remission [CR], 45% partial remission [PR]) as compared with 58% for FCM alone (13% CR, 45% PR; P = .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 survival (PFS; P = .0381) and overall survival (OS; P = .0030). In FL PFS was significantly longer in the R-FCM arm (P = .0139) whereas in MCL a significantly longer OS was observed (P = .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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