Lenalidomide-rituximab or lenalidomide-rituximabbendamustine for relapsed/refractory follicular lymphoma: primary and final analysis of the randomized phase II HOVON110/ReBeL study.
Marie José Kersten, Martin Dreyling, Kim M Linton et al.
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In 30 seconds
The multinational, prospective, randomized, non-comparative phase II HOVON110/ReBeL trial compared lenalidomide-rituximab (R2) with the same regimen plus bendamustine (R2B) in relapsed/refractory follicular lymphoma. Ninety-two patients were randomized, but the trial stopped early because of slow accrual. End-of-induction complete remission rates were 11.4% (95% CI: 3.8-24.6%) with R2 and 15.2% (95% CI: 6.3-28.9%) with R2B. At 60 months, event-free survival was 39.5% and 56.4%, respectively; R2B had numerically better survival outcomes but higher toxicity.
Key findings
- End-of-induction complete remission rates were 11.4% (95% CI: 3.8-24.6%) with R2 and 15.2% (95% CI: 6.3-28.9%) with R2B.
- At 60 months, event-free survival was 39.5% (95% CI: 25.1-53.6%) with R2 and 56.4% (95% CI: 40.1-69.3%) with R2B.
- Predefined severe toxicities occurred in 6.8% with R2 and 13.0% with R2B; grade 3-4 adverse events affected 43% and 66%, respectively.
- Overall survival at 60 months was 72.1% with R2 and 86.3% with R2B.
Why it matters
The study provides prospective randomized data on adding bendamustine to lenalidomide-rituximab in relapsed/refractory follicular lymphoma. The numerically higher event-free and overall survival with R2B should be considered alongside its greater toxicity, while the low complete remission rates and early trial closure limit certainty about comparative benefit.
What to keep in mind
The trial stopped prematurely because of slow accrual, and its randomized design was non-comparative. The sample was limited to 92 patients, and the abstract reports numerical rather than definitive comparative advantages.