1. Induction therapy and maintenance therapy for mantle-cell lymphoma with lenalidomide plus rituximab was found to be effective and safe.
2. A response to treatment with these biologic agents was associated with improvement in quality of life.
Evidence Rating Level: 2 (Good)
Study Rundown: Mantle-cell lymphoma is generally incurable and is associated with a median survival of approximately 4 to 5 years. Initial treatment for mantle-cell lymphoma usually includes chemoimmunotherapy, which is frequently augmented with high-dose chemotherapy and hematopoietic stem cell transplant. Lenalidomide is an immunomodulatory drug that exerts a host of anti-tumor effects. Rituximab is an anti-CD20 antibody. Combination of these two chemoimmunotheraputic agents has been shown to be promisingly cytotoxic to mantle-cell lymphoma in vitro and in vivo. Lenalidomide has also been shown to overcome resistance to rituximab in lymphoma.
With this background, the authors conducted a prospective, multicenter, cohort study to evaluate the efficacy and safety of lenalidomide and rituximab in combination as induction and maintenance therapy in patients with previously untreated mantle-cell lymphoma. At the median follow-up of 30 months, among patients who could be evaluated, overall response rate was 92%, complete response rate was 64%, partial response rate was 28%, 3% had stable disease, and 6% had progressive disease. Quality-of-life measures during follow-up were compared to those obtained at baseline, and a significant increase could be appreciated by 12 months. This study showed lenalidomide plus rituximab as an effective and safe combination biologic induction and maintenance therapy for previously untreated mantle-cell lymphoma. However, this study is limited by being uncontrolled and its modest sample size.
In-Depth [prospective cohort]: A total of 38 patients were enrolled in the study. In patients with creatinine clearance > 60 mL/min, the induction phase was comprised of 20 mg lenalidomide daily on days 1 to 21 of every 28 day cycle (escalated to 25 mg daily if no adverse effects after the first cycle). In patients with creatinine clearance 30-60 mL/min, the induction phase was comprised of 10mg lenalidomide daily during the induction phase and the dose was escalated to 15 mg daily if no dose-limiting side effects occurred. Both groups received 375 mg/m2 body-surface area rituximab for a total of nine doses over 45 weeks or until disease progression, development of unacceptable adverse effects, or withdrawal from the study. The maintenance phase consisted of 15 mg (creatinine clearance > 60 mL/min) or 5 mg (creatinine clearance 30-60 mL/min) lenalidomide daily on days 1-28 of every 28-day cycle plus rituximab once every 8 weeks. The primary end point was the overall response rate to the combination therapy. Secondary end points of progression-free and overall survival were assessed.
A complete response was confirmed by means of PET-CT and, when indicated, bone marrow biopsy. Among patients who could be evaluated, partial response rate was 28%, complete response rate was 64% and overall response rate was 92%. The 2-year progression-free survival rate was 85% (95% [CI], 67% to 94%). The 2-year overall survival rate was 97% (95% [CI], 79% to 99%). Quality-of-life scores (FACT-Lym questionnaire) were 139.1±19.1 at month 12 vs. 133.6±22.8 at baseline (p=0.04).
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