RELEVANCE: rituximab plus lenalidomide in advanced untreated follicular lymphoma
A chemotherapy-free combination of rituximab and lenalidomide worked as well as rituximab with chemotherapy for untreated follicular lymphoma, though not better, with different side effects.
Overview
Open-label phase 3 superiority trial: 1,030 patients with previously untreated follicular lymphoma were randomised to rituximab plus lenalidomide (513) or rituximab plus chemotherapy (517), each followed by rituximab maintenance.
Confirmed or unconfirmed complete response at 120 weeks was 48 percent against 53 percent (p 0.13) and interim three-year progression-free survival 77 against 78 percent. Grade 3 or 4 neutropenia (32 against 50 percent) and febrile neutropenia (2 against 7 percent) were more common with chemotherapy; grade 3 or 4 cutaneous reactions (7 against 1 percent) were more common with lenalidomide.
- Complete or unconfirmed complete response at 120 weeks 48 percent (95% CI 44 to 53) versus 53 percent (49 to 57), p 0.13.
- Interim three-year progression-free survival 77 versus 78 percent.
- Grade 3 or 4 neutropenia 32 versus 50 percent; grade 3 or 4 cutaneous reactions 7 versus 1 percent.
Rituximab-lenalidomide is an accepted chemotherapy-free first-line alternative for follicular lymphoma, chosen on toxicity profile and patient preference rather than efficacy.
- Designed to show superiority, which it did not; equivalence was not formally tested.
- Rituximab maintenance was given in both arms.
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