Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.

BACKGROUND Rituximab plus chemotherapy has been shown to be effective in patients with advanced-stage, previously untreated follicular lymphoma; nevertheless, most patients will have a relapse. Combination immunotherapy with lenalidomide and rituximab is an immunomodulatory regimen that has shown promising activity in patients with indolent B-cell non-Hodgkin's lymphoma.METHODS We conducted this multicenter, international, phase 3 superiority trial to evaluaterituximab plus lenalidomide, as compared with rituximab plus chemotherapy, inpatients with previously untreated follicular lymphoma. Patients were randomlyassigned to receive one of the two regimens, followed by maintenance monotherapywith rituximab. Treatment with rituximab plus lenalidomide consisted of 18 cyclesof the two drugs, followed by rituximab maintenance therapy every 8 weeks for 12cycles (six additional doses). Treatment with rituximab plus chemotherapy consistedof the investigator's choice of one of three rituximab-based regimens, followed bymaintenance monotherapy with rituximab every 8 weeks for 12 cycles. The primaryend points were complete response (confirmed or unconfirmed) at 120 weeks andprogression-free survival.RESULTSA total of 1030 patients were randomly assigned to receive rituximab plus lenalidomide(513 patients) or rituximab plus chemotherapy (517 patients). The rate of confirmedor unconfirmed complete response at 120 weeks was similar in the two groups:48% (95% confidence interval [CI], 44 to 53) in the rituximab–lenalidomide groupand 53% (95% CI, 49 to 57) in the rituximab–chemotherapy group (P=0.13). Theinterim 3-year rate of progression-free survival was 77% (95% CI, 72 to 80) and 78%(95% CI, 74 to 82), respectively. A higher percentage of patients in the rituximab–chemotherapy group had grade 3 or 4 neutropenia (32% vs. 50%) and febrileneutropenia of any grade (2% vs. 7%), and a higher percentage of patients in therituximab–lenalidomide group had grade 3 or 4 cutaneous reactions (7% vs. 1%).CONCLUSIONSAmong patients with previously untreated follicular lymphoma, efficacy results weresimilar with rituximab plus lenalidomide and rituximab plus chemotherapy (withboth regimens followed by rituximab maintenance therapy). The safety profile differedin the two groups. [ABSTRACT FROM AUTHOR]