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RELEVANCE tested whether a chemotherapy-free combination of rituximab and the pill lenalidomide could beat standard chemo-immunotherapy for untreated follicular lymphoma; it was not better, but it was just as effective with a different set of side effects, so it became an accepted alternative.
RELEVANCE was an open-label phase 3 superiority trial run by Celgene with the French LYSA group that randomised 1,030 patients with previously untreated follicular lymphoma to rituximab plus lenalidomide or rituximab plus chemotherapy (R-CHOP in most), each followed by rituximab maintenance. The co-primary endpoints were confirmed or unconfirmed complete response at 120 weeks by independent review and progression-free survival.
Complete response at 120 weeks was 48 percent with rituximab-lenalidomide against 53 percent with rituximab-chemotherapy, and interim three-year progression-free survival was 77 against 78 percent, so superiority was not shown. In the final registry results median progression-free survival was 120.2 against 123.8 months (hazard ratio 0.92). Grade 3 or 4 neutropenia and febrile neutropenia were more common with chemotherapy and grade 3 or 4 skin reactions with lenalidomide. The corpus's follicular lymphoma page lists lenalidomide-rituximab as an alternative first-line option on this evidence.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,030 enrolled.
95% CI 44 to 53 · 95% CI 49 to 57
Source95% CI 72 to 80 · 95% CI 74 to 82
Source95% CI 104.9 to 126.3 · 95% CI 107.4 to not reached
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Complete or unconfirmed complete response at 120 weeks (independent review)primary | Rituximab + lenalidomide | 513 | 48% | - | 0.13 | link |
| Rituximab + chemotherapy | 517 | 53% | ||||
| Progression-free survival at 3 years (interim)primary | Rituximab + lenalidomide | 513 | 77% | - | - | link |
| Rituximab + chemotherapy | 517 | 78% | ||||
| Progression-free survival, final (registry results)primary | Rituximab + lenalidomide | - | 120.2 months | 0.92 (0.756 to 1.12) | 0.406 | link |
| Rituximab + chemotherapy | - | 123.8 months | ||||
| Grade 3 or 4 neutropenia | Rituximab + lenalidomide | - | 32% | - | - | link |
| Rituximab + chemotherapy | - | 50% | ||||
| Grade 3 or 4 cutaneous reactions | Rituximab + lenalidomide | - | 7% | - | - | link |
| Rituximab + chemotherapy | - | 1% |
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