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Rituximab Plus Lenalidomide Treatment Shows Promise for Older Patients with DLBCL
Phase 2 Results From the FIL_ReRi Study
Phase 2 Results From the FIL_ReRi Study
A recent trial demonstrated that the combination of rituximab and lenalidomide was feasible and showed moderate activity in frontline therapy among frail older patients with diffuse large B-cell lymphoma (DLBCL).
The FIL_ReRi study is a 2-stage single-arm trial to investigate the activity and safety of the chemotherapy-free combination of rituximab and lenalidomide among ≥70-year-old untreated frail patients with DLBCL. The primary end point was the overall response rate (ORR) after cycle 6, and the coprimary end point was the rate of grade 3 or 4 extrahematological toxicity.
Patients were administered a maximum of 6 28-day cycles of 20 mg oral lenalidomide from days 2 to 22 and intravenous rituximab 375 mg/m2 on day 1, with response assessment after cycles 4 and 6. Additionally, those with partial response (PR) or complete response (CR) at cycle 6 were administered lenalidomide 10 mg/d from days 1 to 21 for every 28 cycles for a total of 12 cycles or until progression or unacceptable toxicity.
The ORR was 50.8%, with a 27.7% CR. With a median follow-up of 24 months, the median progression-free survival (PFS) was 14 months, and the 2-year duration of response was 64%. A total of 34 patients experienced extrahematological toxicity according to the National Cancer Institute Common Terminology Criteria for Adverse Events grade ≥3.
Study investigators concluded, “The activity of the [rituximab and lenalidomide] combination was observed in a significant proportion of subjects, warranting further exploration of a chemo-free approach in frail older patients with DLBCL.”
Source:
Gini G, Tani M, Tucci A, et al. Lenalidomide plus rituximab for the initial treatment of frail older patients with DLBCL: The FIL_ReRi phase 2 study. Blood. Published online October 26, 2023. doi: 10.1182/blood.2022019173
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