Lenalidomide plus rituximab is active as first-line therapy in patients with mantle-cell lymphoma.
Major finding: Lenalidomide plus rituximab is active as first-line therapy in patients with mantle-cell lymphoma.
Clinical relevance: Combination of biologic agents was effective as induction and maintenance therapy.
Impact: Further studies of this combination and other novel approaches are warranted in patients with mantle-cell lymphoma.
Treatment for mantle-cell lymphoma usually includes chemoimmunotherapy, often consisting of high-dose chemotherapy and hematopoietic-cell transplantation which may not be tolerated by all patients. However, the disease is generally incurable with a median survival of about 4–5 years. Lenalidomide, a second generation immunomodulatory drug, has shown clinical efficacy both alone and in combination with the anti-CD20 monoclonal antibody rituximab in patients with recurrent mantle-cell lymphoma, and has been shown to overcome rituximab resistance. To assess the efficacy and safety of lenalidomide plus rituximab as first-line therapy, Ruan and colleagues performed an uncontrolled, multicenter phase II study in 38 patients with previously untreated mantle-cell lymphoma. The combination of lenalidomide and rituximab was administered during induction and maintenance phases; overall response rate was evaluated as the primary end point, and secondary end points included progression-free and overall survival and safety. Among 36 evaluable patients, the overall response rate was 92% with a complete response rate of 64% and a partial response rate of 28%, including 28 (78%) patients who remained in remission without disease progression. There was an increase in complete responses following continuous treatment. The two-year progression-free survival rate was 85%, and the two-year overall survival rate was 97%. The most common grade 3 or 4 adverse events included neutropenia, thrombocytopenia, anemia, rash, and inflammatory syndrome, consistent with previously reported adverse events associated with these drugs. Overall, the results of this study indicate that combination therapy with lenalidomide and rituximab is active as first-line therapy for mantle-cell lymphoma. Additionally, these findings suggest that this novel up-front approach is efficacious as both induction and maintenance therapy and support further studies of the combination of lenalidomide plus rituximab in larger clinical studies and potentially in combination with other agents.
- ©2015 American Association for Cancer Research.