Adding lenalidomide to the cancer drug combination consisting of rituximab plus etoposide, cytarabine, cisplatinum and methylprednisolone (R-ESHAP) “is a feasible salvage regimen with promising efficacy results” in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), according to results from a phase 2 clinical trial published in the British Journal of Haematology.
The trial called GELTAMO tested the safety and efficacy of the new combination called LR-ESHAP in 46 patients.
Read more about DLBCL diagnosis
Participants were given 3 cycles of lenalidomide at a dose of 10 mg per day on days 1 to 14 of every 21-day cycle, in combination with R-ESHAP at standard doses. Patients who responded to this treatment underwent autologous stem-cell transplantation.
The primary objective of the trial was the overall response rate after 3 treatment cycles, which was 67% with 35% of patients achieving complete remission.
The 26 patients who had primary refractory disease had significantly worse overall response rates than those with non-refractory disease.
There were no differences in response rates according to the centralized cell of origin.
A total of 28 patients (61% of all patients) underwent autologous stem-cell transplantation.
At a median follow-up of 41 months, the estimated 3-year progression-free survival was 42% and the overall survival was 48%.
The most common grade 3 or more adverse events were thrombocytopenia seen in 70% of patients, neutropenia seen in 67% of patients, and anemia seen in 35% of patients.
There were no treatment-related deaths during the treatment.
DLBCL is a type of cancer affecting the lymphatic system characterized by the infiltration of B-cells in tissues and organs in a widespread and diffuse pattern.
R-ESHAP is a salvage therapy for relapsed or refractory DLBCL. Lenalidomide is a thalidomide derivative used to treat different cancer types such as multiple myeloma, smoldering myeloma, and myelodysplastic syndromes.
References
Martín García-Sancho A, Baile M, Rodríguez G, et al. Lenalidomide in combination with R-ESHAP in patients with relapsed or refractory diffuse large B-cell lymphoma: a phase 2 study from GELTAMO. Br J Haematol. Published online July 23, 2023. doi:10.1111/bjh.18989
Clinical trial to determinate dose, security and efficacy of lenalidomide and rituximab (LR)-ESHAP in patients with diffuse large B-cell lymphoma. US National Library of Medicine. Updated January 10, 2020. Accessed August 8, 2023.
