The 1st Annual Meeting of the International Academy for Clinical Hematology (IACH) took place in Paris, France, on September 27–29, 2018. On Thursday 27 September, a hematology hot news session was held, with an abstract presented entitled “The RELEVANCE study” by Professor Gandhi Damaj from the University of Caen Normandy, Caen, France.
The RELEVANCE study (NCT01476787) is a multicenter, open label, randomized, phase III trial evaluating the combination of lenalidomide plus rituximab (R2) versus chemotherapy plus rituximab (R-chemo) followed by rituximab maintenance for the treatment of patients with previously untreated follicular lymphoma (FL).
- N = 1030 patients
- R2 arm, n = 513 patients (median age = 59 years; range 30–89)
- R-chemo arm, n = 517 patients (median age = 59 years; range 23–83)
- Treatment period 1 (6 months): lenalidomide (20 mg per day on Day 2-22/28) and rituximab (375 mg/m2) or chemotherapy (R-CHOP 72%, R-B 23% and R-CVP 5%)
- Treatment period 2 (~1 year): R² arm patients received lenalidomide po and rituximab every two months; R-chemo arm patients received rituximab every two months
- Treatment period 3 (1 year): both treatment arms receive rituximab maintenance
- Co-primary endpoints: complete remission rate (CR) or CRu at 120 weeks and progression-free survival (PFS)
- 120-week CR/Cru: 48% in the R2 arm vs 53% in the R-chemo arm
- Best overall response rate: 84% in the R2 arm vs 89% in the R-chemo arm, not significantly different
- 3-year overall survival (OS): 94% in both arms
- IRC interim PFS: 77% in the R2 arm vs 78% in the R-chemo arm at a median follow-up of 37.9 months; HR = 1.10 (95% CI, 0.85–1.43), P = 0.48
- Safety: there was more grade 3/4 neutropenia in the R-chemo arm (50%) compared to the R2 arm (32%) and less no hematologic toxicities in R² arm except for rash
- More dose reduction and treatment discontinuation were prevalent in the R2 arm
Professor Damaj concluded his talk highlighting that R2 did not meet the primary objectives at the first interim analysis and R2 treatment did not show superior efficacy in comparison with R-chemo at 120 weeks. Therefore, R-chemo remains the standard of care for patients with untreated follicular lymphoma. R² could be proposed for some selected profile of patients, however, longer follow up and medico-economic data are necessary to help physician decision-making.