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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 | Table of Contents | Next Article 
CLINICAL TRIALS AND OBSERVATIONS
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 recurring 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 Böck,
Roland Repp,
Hannes Wandt,
Christiane Pott,
John F. Seymour,
Bernd Metzner,
Annette Hänel,
Tanja Lehmann,
Frank Hartmann,
Hermann Einsele, and
Wolfgang Hiddemann
From the Department of Internal Medicine III, University of Munich, Großhadern, Germany; Hämatologisch/Onkologische Praxis, Offenbach, Germany; Department of Internal Medicine III, University of Erlangen, Germany; Department of Internal Medicine V, Klinikum Nord, Nürnberg, Germany; Department of Internal Medicine II, University Hospital Schleswig-Holstein, Campus Kiel, Germany; Peter MacCallum Cancer Center, Division of Hematology/Oncology, East Melbourne, Australia; Department of Internal Medicine II, Oncology and Hematology, Klinikum Oldenburg, Germany; Department of Internal Medicine III, Klinikum Chemnitz, Germany; Department of Hematology, Oncology and Tumorimmunology, HELIOS Klinikum Berlin-Buch, Germany; Department of Internal Medicine I, University of Homburg/Saar, Germany; and the Department of Internal Medicine, University of Würzburg, Germany.
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 recurring 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 2 further courses of 4-times-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. Of the 176 patients who are currently evaluable (as of October 2005), 138 received R-FCM for remission induction. Response duration was significantly prolonged by R-maintenance after R-FCM, with the median not being reached in this evaluation versus an estimated median of 16 months (P = .001). This beneficial effect was also observed when analyzing FL (P = .035) and MCL (P = .049) separately. Hence, R-maintenance is effective after salvage with R-chemotherapy and significantly prolongs response duration in patients with recurring or refractory FL or MCL.
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