Lenalidomide in combination with R-ESHAP in patients with relapsed or refractory diffuse large B-cell lymphoma: A phase 2 study from GELTAMO.

Abstract

Diffuse large B-cell lymphoma (DLBCL) patients with relapsed or refractory (RR) disease have poor outcomes with current salvage regimens. We conducted a phase 2 trial to analyse the safety and efficacy of adding lenalidomide to R-ESHAP (LR-ESHAP) in patients with RR DLBCL. Subjects received 3 cycles of lenalidomide 10 mg/day on days 1-14 of every 21-day cycle, in combination with R-ESHAP at standard doses. Responding patients underwent autologous stem-cell transplantation (ASCT). The primary endpoint was the overall response rate (ORR) after 3 cycles. Centralized cell-of-origin (COO) classification was performed. Forty-six patients were included. The ORR after LR-ESHAP was 67% (35% of patients achieved complete remission). Patients with primary refractory disease (n = 26) had significantly worse ORR than patients with non-refractory disease (54% vs. 85%, p = 0.031). No differences in response rates according to the COO were observed. Twenty-eight patients (61%) underwent ASCT. At a median follow-up of 41 months, the estimated 3-year PFS and OS were 42% and 48%, respectively. The most common grade ≥3 adverse events were thrombocytopenia (70% of patients), neutropenia (67%) and anaemia (35%). There were no treatment-related deaths during LR-ESHAP cycles. In conclusion, LR-ESHAP is a feasible salvage regimen with promising efficacy results for patients with RR DLBCL.

• Authors: A Martín García-Sancho, M Baile, G Rodríguez, I Dlouhy, J M Sancho, I Jarque, E González-Barca, A Salar, M Espeso, C Grande, J Bergua, S Montes-Moreno, A Redondo, A Enjuanes, E Campo, A López-Guillermo, D Caballero
• Journal: British journal of haematology (Br J Haematol) Vol. 203 Issue 2 Pg. 202-211 (10 2023) ISSN: 1365-2141 [Electronic] England
• PMID: 37485564 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2023 British Society for Haematology and John Wiley & Sons Ltd.

Chemical References

• Lenalidomide
• Rituximab

Topics

• Humans
• Lenalidomide (adverse effects)
• Lymphoma, Non-Hodgkin (drug therapy)
• Lymphoma, Large B-Cell, Diffuse (pathology)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)
• Neutropenia (etiology)
• Thrombocytopenia (chemically induced)
• Rituximab (therapeutic use)