Posted: Tuesday, January 3, 2023
Findings from the ECOG-ACRIN E1411 trial, presented at the 2022 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 77), suggest that lenalidomide plus rituximab therapy may not result in significant survival improvements versus rituximab consolidation following initial bendamustine/rituximab treatment in some patients with mantle cell lymphoma. Lenalidomide has previously been shown to result in activity against mantle cell lymphoma.
“The high [complete response] rate and [median progression-free survival] of 6-plus years from [the] start of [bendamustine/rituximab]-based induction plus [rituximab]-based fixed-duration consolidation support this approach for first-line [mantle cell lymphoma] therapy in individuals not appropriate for more intensive approaches, and as a platform for broader clinical trials,” concluded Mitchell R. Smith, MD, of the Follicular Lymphoma Foundation, Washington, DC, and colleagues.
The study included 373 patients who underwent bendamustine and rituximab induction between 2012 and 2016. Patients were randomly assigned to four arms: six rounds of bendamustine and rituximab induction followed by 2 years of rituximab consolidation (group 1); bendamustine, bortezomib, and rituximab followed by rituximab (group 2); bendamustine and rituximab followed by lenalidomide and rituximab (group 3); or bendamustine, bortezomib, and rituximab followed by lenalidomide and rituximab (group 4). Consolidation treatment was administered only to patients who did not experience disease progression during induction.
Progression-free survival outcomes were slightly better with lenalidomide and rituximab. Respective median progression-free survival and 2-year progression-free survival rates were 6 years and 80.7% in group 1, 6.6 years and 82.8% in group 2, 7.8 years and 83.3% in group 3, and 7.7 years and 94.2% in group 4. A total of 293 patients, 276 of whom constituted the efficacy population, received consolidation treatment.
Overall, 67.9% of the lenalidomide/rituximab group and 66.2% of the rituximab group completed all planned consolidation cycles. Toxicities of at least grade 3 were higher in the lenalidomide/rituximab group (87.0% vs. 64.1%). At data cutoff, more than half of enrolled patients were alive without disease progression.
Disclosure: For full disclosures of the study authors, visit ash.confex.com.