Lenalidomide plus rituximab (R2) may be just as safe and effective among patients with previously untreated follicular lymphoma (FL) compared with the standard combination chemotherapy regimen, according to a study during Presidential Symposium at the 23rd Annual Congress of the European Hematology Association in Sweden.1
For the phase 3 RELEVANCE study (ClinicalTrials.gov Identifier: NCT01650701), researchers randomly assigned 1030 patients with grade 1 to 3a FL to receive lenalidomide plus rituximab or rituximab plus investigator’s choice chemotherapy of CHOP, CVP, or bendamustine (R-chemo); responding patients in both study arms received rituximab maintenance therapy. Eligible patients required systemic therapy, had a median age of 59 years old, and both study groups had comparable baseline characteristics.
After a median follow-up of 37.9 months, the superiority of one regimen versus the other was not established.
The complete response (CR)/CR unconfirmed (CRu) at 120 weeks among patients in the lenalidomide arm was 48% compared with 53% among patients who received standard therapy (P= .38).
Rates of 3-year progression-free survival (PFS) in the R2arm and R-chemo arm was 77% and 78%, respectively, and the 3-year overall survival (OS) rate was 94% in both groups.
Although survival outcomes and regimen activity was similar, the toxicity profiles of the 2 regimens were very different. Patients treated with standard combination chemotherapy had higher rates of fatigue, nausea, peripheral neuropathy, neutropenia, febrile neutropenia, vomiting, stomatitis, and alopecia, but lower rates of cutaneous reactions, diarrhea, and tumor flare reactions compared with patients treated with R2. Thromboembolic events occurred at similar rates among both groups.
Grade 5 adverse events (AEs) occurred in 1% of patients in both treatment arms, and second primary malignancies were reported in 7% of patients in the R2arm compared with 9% in the R-chemo arm. AEs led to 11% and 3% of patients discontinuing treatment in the R2arm and R-chemo arms, respectively.
The authors concluded that “the superiority of R2 over R-chemo was not demonstrated in this phase 3 trial, however, compared with R-chemo, R2 appeared to show similar efficacy with a different toxicity profile.”
- Morschhauser F, Fowler NH, Feugier P, et al. RELEVANCE: Phase III efficacy and safety study of lenalidomide plus rituximab (R2) versus rituximab plus chemotherapy, followed by rituximab, in previously untreated follicular lymphoma. Oral presentation at: 2018 European Hematology Association 23rd Annual Congress; June 2018; Stockholm, Sweden.