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Clinical Trial
. 2005 Dec 1;106(12):3725-32.
doi: 10.1182/blood-2005-01-0016. Epub 2005 Aug 25.

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  1 , 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, Michael Unterhalt
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Free article
Clinical Trial

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 et al. Blood. .
Free article

Abstract

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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