Key clinical point: Front-line chemo-free combination therapy with rituximab and lenalidomide was moderately active in elderly frail patients with diffuse large B-cell lymphoma (DLBCL) who were ineligible for conventional cytotoxic therapy.
Major finding: The overall response rate was 50.8% (95% CI 38.1%-63.4%), with 27.7% of patients achieving a complete response. After a 24-month median follow-up, the median progression-free survival was 14.0 months (95% CI 6.8-not reached) and the 2-year duration of response rate was 64.6% (95% CI 42.1%-80.1%). The grade ≥3 extra-hematological toxicity event rate was 52.3%.
Study details: Findings are from the prospective phase 2 FIL_ReRi trial including 65 frail patients aged ≥70 years with untreated DLBCL who received ≤6 cycles of lenalidomide+rituximab; patients with partial or complete response at cycle 6 received lenalidomide for 12 cycles or until progression or unacceptable toxicity.
Disclosures: This study was sponsored by Fondazione Italiana Linfomi (FIL), Alessandria, Italy. Some authors declared participating on data safety monitoring or advisory boards of, serving in leadership roles in, or receiving consulting fees or speaker honoraria from various sources, including FIL.
Source: Gini G et al. Lenalidomide plus rituximab for the initial treatment of elderly frail patients with DLBCL: The FIL_ReRi phase 2 study. Blood. 2023 (Jul 7). Doi: 10.1182/blood.2022019173