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Blood, 1 December 2005, Vol. 106, No. 12, pp. 3725-3732.
Prepublished online as a Blood First Edition Paper on August 25, 2005; DOI 10.1182/blood-2005-01-0016.


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CLINICAL TRIALS AND OBSERVATIONS

Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group

Wolfgang Hiddemann, Michael Kneba, Martin Dreyling, Norbert Schmitz, Eva Lengfelder, Rudolf Schmits, Marcel Reiser, Bernd Metzner, Harriet Harder, Susanna Hegewisch-Becker, Thomas Fischer, Martin Kropff, Hans-Edgar Reis, Mathias Freund, Bernhard Wörmann, Roland Fuchs, Manfred Planker, Jörg Schimke, Hartmut Eimermacher, Lorenz Trümper, Ali Aldaoud, Reza Parwaresch, and Michael Unterhalt

From the Department of Internal Medicine III, University of Munich, Klinikum Großhadern; Department of Internal Medicine II, University Hospital Schleswig-Holstein, Campus Kiel; Department of Hematology and Oncology, Hospital St Georg, Hamburg; Department of Internal Medicine III, Klinikum Mannheim, University of Heidelberg; Department of Internal Medicine I, University of Homburg/Saar; Department of Internal Medicine I, University of Cologne; Department of Internal Medicine II, Oncology and Hematology, Klinikum Oldenburg; Department of Hematology, Oncology, and Tumor Immunology, Robert-Rössle-Klinik at the Helios Clinic Berlin-Buch, Charité, Campus Berlin-Buch; Department of Oncology, Klinikum Eppendorf, University of Hamburg; Department of Internal Medicine III, University of Mainz; Department of Internal Medicine A, University of Münster; Department of Hematology and Oncology, Kliniken Maria Hilf, Mönchengladbach; Department of Hematology and Oncology, University of Rostock; Department of Internal Medicine, Städtisches Klinikum Braunschweig; Department of Hematology and Oncology, St Antonius Hospital Eschweiler; Department of Hematology and Oncology, Städtische Krankenanstalten Krefeld; Praxis for Hematology and Oncology, Saarbrücken; Department of Hematology and Oncology, Katholisches Krankenhaus Hagen; Department of Hematology and Oncology, University of Göttingen; Praxis for Hematology and Oncology, Leipzig; and Department of Hemato-Pathology, University Hospital Schleswig-Holstein, Campus Kiel, Germany.

Phase 2 studies suggest that the monoclonal antibody rituximab may improve the prognosis of patients with follicular lymphoma (FL) when it is added to chemotherapy. In the current study, 428 patients with untreated, advanced-stage FL were randomly assigned for therapy with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) alone (n = 205) or CHOP combined with rituximab (R-CHOP) (n = 223). R-CHOP reduced the relative risk for treatment failure by 60% and significantly prolonged the time to treatment failure (P < .001). In addition, a significantly higher overall response rate (96% vs 90%; P = .011) and a prolonged duration of remission (P = .001) were achieved. In spite of a relatively short observation time, these beneficial effects even translated to superior overall survival (P = .016), with 6 deaths in the R-CHOP group compared with 17 deaths in the CHOP group within the first 3 years. The predominant treatment-related adverse effect was myelosuppression. Severe granulocytopenia was more frequently observed after R-CHOP (63% vs 53%; P = .01). However, severe infections were rare and of similar frequency after R-CHOP and CHOP (5% and 7%). Hence, adding rituximab to CHOP significantly improves the outcome for patients with previously untreated advanced-stage FL and does not induce major adverse effects.


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