Abstract
This study compared the efficacy and safety of the modified BEAM (mitoxantrone hydrochloride liposome replacing melphalan) versus BEAM/BEAC as a conditioning regimen for autologous hematopoietic stem cell transplantation (auto-HSCT) in patients with non-Hodgkin lymphoma (NHL). The data source for the modified BEAM regimen was obtained from a prospective, single-arm study (NCT05681403), while the BEAM/BEAC regimen was retrospectively collected from an electronic health record-derived external control group. Primary endpoint was the cumulative incidence of relapse (CIR). Eighty-three patients were included, with 34 in the modified BEAM group, 23 in the BEAM group, and 26 in the BEAC group. The median times were 10.5, 9.0, and 9.0 days for neutrophil engraftment, and 10.5, 10.0, and 10.0 days for platelet engraftment, respectively. Oral mucositis (14.7%, 21.7%, and 7.7%), nausea (8.8%, 17.4%, and 0.0%), and diarrhea (5.9%, 8.2%, and 0.0%) were the most common grade 3-4 non-hematologic toxicities in three groups. No treatment-related death was reported. Besides, no significant differences were observed in 2-year CIR (9.4%, 26.6%, and 23.6%), progression-free survival (90.6%, 73.4%, and 76.4%), and overall survival (97.1%, 87.0%, and 88.5%) rates among three groups (all P > 0.05). The modified BEAM conditioning regimen may have comparable efficacy and safety with the BEAM/BEAC regimen in treating patients with NHL.