Combination biologic therapy with lenalidomide and rituximab was active as initial therapy for patients with mantle-cell lymphoma, a new study published in The New England Journal of Medicine has shown.1
Lenalidomide, an immunomodulatory agent, and rituximab, an anti-CD20 antibody, have demonstrated activity in patients with recurrent mantle-cell lymphoma. Because initial therapy for mantle-cell lymphoma is not standardized and usually includes cytotoxic chemotherapy, researchers sought to evaluate the combination as first-line therapy.
For the single-group, multicenter, phase 2 study, researchers enrolled 38 treatment-naïve patients with mantle-cell lymphoma.
During the induction phase, participants received lenalidomide 20 mg daily on days 1 to 21 of every 28-day cycle for 28 cycles plus rituximab once weekly for the first 4 weeks and then once every other cycle until disease progression.
Lenalidomide could be dose-escalated to 25 mg daily after the first cycle if no dose-limiting toxicities occurred during the first cycle. Lenalidomide was then reduced to 15 mg daily during the maintenance phase
Results showed that at median follow-up of 30 months, the overall response rate among evaluable patients was 92% (95% CI, 78 – 98). The complete response rate was 64% (95% CI, 46 – 79).
Researchers found that the 2-year progression-free and overall survival was 85% (95% CI, 67 – 94) and 97% (95% CI, 79 – 99), respectively.
In regard to safety, the most common grade 3 or 4 adverse events were neutropenia, rash, thrombocytopenia, tumor flare, anemia, serum sickness, and fatigue.
The study also demonstrated an improvement in quality of life associated with response to treatment.
- Ruan J, Martin P, Shah B, et al. Lenalidomide plus rituximab as initial treatment for mantle-cell lymphoma. N Engl J Med. 2015; 373(19):1835-1844.