Morschhauser F, et al. - In patients with previously untreated follicular lymphoma this multicenter, international, phase 3 superiority trial assessed rituximab plus lenalidomide vs with rituximab plus chemotherapy. Data reported that efficacy results were similar with rituximab plus lenalidomide and rituximab plus chemotherapy among patients with previously untreated follicular lymphoma. They found that the safety profile varied in the two groups.

Methods

• For this investigation, study participants were randomized to receive one of the two regimens, followed by maintenance monotherapy with rituximab.
• Treatment with rituximab in addition to lenalidomide comprised of 18 cycles of the two drugs, followed by rituximab maintenance therapy every 8 weeks for 12 cycles (six additional doses).
• Treatment with rituximab in addition to chemotherapy comprised of the investigator’s choice of one of three rituximab-based regimens, followed by maintenance monotherapy with rituximab every 8 weeks for 12 cycles.
• Complete response (confirmed or unconfirmed) at 120 weeks and progression-free survival were the primary end points.

Results

• An aggregate of 1,030 subjects were randomized to receive rituximab plus lenalidomide (513 patients) or rituximab plus chemotherapy (517 patients).
• It was noted that the rate of confirmed or unconfirmed complete response at 120 weeks was similar in the two groups: 48% (95% confidence interval [CI], 44 to 53) in the rituximab–lenalidomide group and 53% (95% CI, 49 to 57) in the rituximab–chemotherapy group (P=0.13).
• Findings revealed that the interim 3-year rate of progression-free survival was 77% (95% CI, 72 to 80) and 78% (95% CI, 74 to 82), respectively.
• The data presented in this work showed a higher percentage of patients in the rituximab–chemotherapy group had grade 3 or 4 neutropenia (32% vs 50%) and febrile neutropenia of any grade (2% vs 7%).
• A higher percentage of patients in the rituximab-lenalidomide group had grade 3 or 4 cutaneous reactions (7% vs 1%).