Effect of the addition of rituximab to front line therapy with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) on the remission rate and time to treatment failure (TTF) compared to CHOP alone in mantle cell lymphoma (MCL): Results of a prospective randomized trial of the German Low Grade Lymphoma Study Group (GLSG)

Abstract

6501 Background: MCL is a disease of higher age and carries a bad prognosis with a median survival of only 3 to 4 years. New treatment modalities are therefore warranted. Based on the highly encouraging results of combining Rituximab with the Fludarabine, Cyclophosphamide, Mitoxantrone (FCM) regimen for salvage therapy of relapsed MCL, the GLSG embarked on a prospective randomised trial comparing CHOP versus Rituximab plus CHOP (R-CHOP) for first line therapy. Methods: 122 consecutive patients with newly diagnosed MCL of stages III and IV were randomised between CHOP versus R-CHOP. Results: Of the 122 patients 60 were randomised to CHOP and 62 to R-CHOP. A significantly higher rate of CR of 34% vs. 7% (p=0.00024) and of CR + PR of 94% versus 75% (p=0.005) was achieved for R-CHOP vs. CHOP treated patients. In addition, TTF was significantly longer (p=0.0131) while the time to progression was not statistically different. No differences were observed either within the two postremission strategies between R-CHOP or CHOP treated cases. Treatment associated side effects comprised predominantly myelosuppression and granulocytopenia in particular. Grade III and IV granulocytopenia was more frequent after R-CHOP (63% versus 53%, p=0.01). This was clinically not of major relevance, however, since severe infections were observed after 5% and 7% of courses, only. Conclusions: R-CHOP induces remissions in almost all patients with previously untreated MCL and prolongs the time to treatment failure significantly over CHOP alone. R-CHOP is a highly effective, well tolerated regimen for front line therapy of MCL. No significant financial relationships to disclose.