Lenalidomide appears active and safe as maintenance therapy after response to second-line therapy in patients with relapsed diffuse large B cell lymphoma (DLBCL) ineligible for high-dose chemotherapy and autologous hematopoietic cell transplantation (HCT), according to a study published in The Lancet Haematology.1
Patients with relapsed DLBCL who are not eligible for autologous HCT or have relapsed after HCT have a low likelihood of cure. Therefore, single-agent maintenance after salvage therapy might be a promising approach to prolong survival in this population.
Because lenalidomide can be safely taken for years with an acceptable safety profile, researchers sought to evaluate the safety and efficacy of lenalidomide maintenance in patients with chemosensitive relapse of DLBCL ineligible to undergo autologous HCT or who have relapsed after HCT.
For the multicenter, open-label, phase 2 trial (ClinicalTrials.gov Identifier: NCT00799513), investigators enrolled 48 HIV-negative adults with de novo or transformed DLBCL and relapsed disease responsive to standard rituximab-containing salvage therapy. All participants received oral lenalidomide for 3 weeks of each 4-week cycle until lymphoma progression or unacceptable toxicity.
After a median follow-up of 25 months, results showed that 70% (95% CI, 57-83) of patients were progression-free at 1 year. Researchers found that 19 patients experienced progressive lymphoma, 1 patient died due to toxicity, and 1 patient died while off therapy.
Grade 3 to 4 adverse events were uncommon, with the exception of neutropenia. Nine patients experienced 10 cases of severe adverse events, including 4 cases of febrile neutropenia and 2 cases of diarrhea; all but 1 patient recovered and 6 of these patients continued with lenalidomide maintenance.
Notably, 1 patient died due to treatment-related intestinal infarction.
Although this study is limited by its nonrandomized design, the trial appears to support the use of lenalidomide maintenance in this population. Further investigation of immunomodulatory agents as maintenance therapy in high-risk patients with DLBCL is warranted.
1. Ferreri AJ, Sassone M, Zaja F, et al. Lenalidomide maintenance in patients with relapsed diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplantation: an open label, single-arm, multicentre phase 2 trial. Lancet Haematol. 2017 Feb 16. doi: 10.1016/S2352-3026(17)30016-9 [Epub ahead of print]