Real-World, Single-Center Data for Lenalidomide Plus Rituximab in Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Transformed Follicular Lymphoma.

Background: This study explored the efficacy of lenalidomide plus rituximab for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) including cases of secondary central nervous system (CNS) involvement and transformed follicular lymphoma (FL) in real-world context because of anti-tumor effect and blood-brain barrier permeability of lenalidomide.

Methods: Twenty-four patients including relapsed or refractory DLBCL (n = 21) including seven patients with secondary CNS involvement and transformed FL (n = 3) were retrospectively analyzed.

Results: Based on the best response, the complete response (CR) rate was 21% (5/24) and the overall response rate (ORR) was 38% (9/24). However, as all cases of transformed FL (n = 3) did not respond, all responders had DLBCL, and the CR and ORR rates of DLBCL were 24% (5/21) and 43% (9/21), respectively. The median number of treatment cycles was only two (range: 1-7) due to frequent occurrence of early progression, and 18 patients died and the cause of death was disease progression. The response rate was not significantly different among patients with and without secondary CNS involvement. The median post-treatment overall and progression-free survival were 7.3 and 1.8 months, respectively. Hematologic toxicities were common adverse events, but most hematologic toxicities were manageable. There were no serious infectious complications or treatment-related mortality.

Conclusion: Lenalidomide plus rituximab might be a salvage therapy for relapsed or refractory DLBCL, especially in case of secondary CNS involvement. However, the addition of other agents should be considered to prolong the duration of response.