Lenalidomide in combination with R-ESHAP (rituximab, etoposide, cisplatin, cytarabine, methylprednisolone) is feasible and demonstrated encouraging outcomes in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), a study published in the British Journal of Haematology has shown.1
Because patients with DLBCL who fail rituximab-containing therapy have a poor outcome with the current salvage regimens, researchers sought to evaluate the feasibility, efficacy, and tolerability of lenalidomide plus R-ESHAP in a phase 1b study.
For the study, researchers enrolled 19 patients with relapsed or refractory DLBCL. Participants received lenalidomide at escalating doses on days 1 to 14 of every 21-day cycle for 3 cycles, in combination with R-ESHAP. Patients who responded then received treatment with BEAM (carmustine, etoposide, cytarabine, melphalan) followed by autologous hematopoietic cell transplantation.
Lenalidomide at a dose of 10 mg per day was identified as the maximum tolerated dose after 1 patient who received 15 mg daily experienced dose-limited grade 3 angioedema and 2 patients experienced mobilization failure.
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Results showed that all toxicities associated with the first regimen resolved and no grade 4 or 5 non-hematologic toxicities were reported.
In terms of efficacy, the complete remission rate was 47.4% and the overall response rate was 78.9%. Researchers found that the 2-year progression-free survival and 2-year overall survival rate was 44% and 63%, respectively, after a median of 24.6 months of follow-up.
- Martin A, Redondo AM, Dlouhy I, et al. Lenalidomide in combination with R-ESHAP in patients with relapsed or refractory diffuse large B-cell lymphoma: a phase 1b study from GELTAMO group [published online ahead of print February 5, 2016]. Brit J Haematol. doi: 10.1111/bjh.13945.