Multicenter Randomized Controlled (Comparative) Open Prospective Study to Evaluate The Efficacy of The R-DA-EPOCH-21 And R-mNHL-BFM-90 ± Autologous Hematopoietic Stem Cell Transplantation Programs in Untreated Patients With De Novo Diffuse B-Cell Large Cell Lymphoma With Signs of Poor Prognosis - DLBCL-2015 Protocol

Background: NHL-BFM-90 chemotherapy is highly effective in pediatric aggressive B-cell lymphomas. Purpose: To evaluate the efficacy and toxicity of the R-mNHL-BFM-90 and R-DAEPOCH-21 programs in adult patients with de novo DLBCL. Patients and methods: Inclusion criteria: newly diagnosed DLBCL (NOS), no previous chemotherapy, 2 or more signs of poor prognosis, age 18-60. The protocol included 140 patients from 13 medical centers in Russia: R-DA-EPOCH-21 – 33; R-DAEPOCH-21+auto-HSCT - 29; R-mNHL-BFM-90 - 33; R-mNHL-BFM-90+ auto-HSCT -35 patients. R-DA-EPOCH-21 branch: 6 courses were performed. If CR was not achieved, 2 courses of R-DHAP were performed ± auto-HSCT. Branch R-mNHL-BFM-90 included 6 cycles: RA-RB-RA-RB-RA-RB. If CR was not achieved, 2 courses of R-DHAP ± auto-HSCTResults: Of 62 patients on R-DA-EPOCH-21±auto-HSCT, CR was achieved in 36 (58.1%) patients, PR was achieved in 14 (22.6%) patients, progression was reported in 6 (9.7%) patients, 3 (4.8%) patients had died, and treatment continued in 3 (4.8%) patients. Of 68 patients on R-mNHL-BFM-90±autoHSCT CR was achieved in 63 (92.7%) patients, PR was achieved in 2 (2.9%) patients, progression was not reported, 2 (2.9%) patients had died, and treatment continued in 1 (1.5%) patient. The 4-year OS of patients in the high-risk group 94% on R-mNHL-BFM-90 therapy, 81% on R-DA-EPOCH-21 therapy;. the 4-year EFS of patients in the high-risk group was 78% and 43%, respectively (p = 0.0004). Conclusion: R-mNHL-BFM-90 program is highly effective in de novo DLBCL NOS adult patients; toxicity is acceptable.