RELEVANCE
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.
Overview
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.
- 48 vs 53 out of 100 had no sign of cancer on scans or tests with Rituximab + lenalidomide compared with Rituximab + chemotherapy; 5 fewer per 100.
- On this measure the first group did worse, not better.
- The p-value (0.13) means the difference could plausibly be due to chance.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- 77 vs 78 out of 100 alive without the cancer growing at 3 years with Rituximab + lenalidomide compared with Rituximab + chemotherapy; 1 fewer per 100.
- On this measure the first group did worse, not better.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- Median 120.2 vs 123.8 months with Rituximab + lenalidomide compared with Rituximab + chemotherapy; about 3.6 months shorter for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 8 percent lower chance of the event at any given time (hazard ratio 0.92, likely range 0.756 to 1.12).
- The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- 32 vs 50 out of 100 reached this endpoint with Rituximab + lenalidomide compared with Rituximab + chemotherapy; 18 fewer per 100.
- On this measure the first group did worse, not better.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- 7 vs 1 out of 100 reached this endpoint with Rituximab + lenalidomide compared with Rituximab + chemotherapy; 6 more per 100.
- Roughly one extra person helped for every 17 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Previously untreated advanced follicular lymphoma needing treatment: rituximab plus lenalidomide (R2) against rituximab plus the investigator's chemotherapy (R-CHOP, R-CVP or R-bendamustine), both followed by rituximab maintenance, with complete response at 120 weeks and progression-free survival as co-primary endpoints. People in a different situation may not see the same effect.
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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