A Phase III open-label randomized study to compare the efficacy of lenalidomide-rituximab with bendamustine- rituximab in treatment-naïve follicular lymphoma.

INTRODUCTION: Bendamustine-rituximab (BR) is the preferred regimen for the treatment of naïve follicular lymphoma (FL). Recently, lenalidomide-rituximab (LR), a chemotherapy-free protocol, has shown a good response rate in advanced FL. These regimens have never been compared in a randomized controlled trial for treatment-naïve FL in Indian patients.

MATERIALS AND METHODS: This Phase III open-label randomized controlled trial was conducted to compare the efficacy and safety of BR and LR. Treatment-naïve patients older than 18 years of age, ECOG PS (Eastern Cooperative Oncology Group Performance Status) ≤2, who were diagnosed with FL (Stages II-IV) were included in this study. Patients were randomized in a 1:1 ratio to receive six cycles of BR (bendamustine 90 mg/m 2 Days 1-2 and rituximab 375 mg/m 2 Day 1) every 4 weeks or LR (lenalidomide 20 mg Days 1-21 and rituximab 375 mg/m 2 ) every 4 weeks. The primary end point was complete response (CR) and secondary end points were overall response rate (ORR) and toxicity.

RESULT: We enrolled 40 patients, 20 in each group with a median age of 53 years. The CR rate was 60% and 20% in BR and LR arms, respectively ( P = 0.01); however, the ORR was 88.8% and 87.3% in BR and LR arms, respectively ( P = 1.0). Anemia (35% versus 10%), skin rash (35% versus 30%), diarrhea (30% versus 10%), vomiting (20% versus 10%), nephrotoxicity (15% versus 0%), and transaminitis (10% versus 0%) were more in LR than in BR, and thrombocytopenia was higher in the BR than in the LR group but statistically not different. All grade toxicities were seen in 90% and 45% in LR and BR, respectively ( P = 0.05), but there was no significant difference in Grade 3 or 4 toxicity between the BR and the LR regimens (20% versus 25%).

CONCLUSION: The ORR was similar in both the arms; however, the CR rate was significantly higher in the BR arm. BR was better tolerated than LR.(CTRI/2016/05/006904).