Vol. 17 No. 2 (2024), LYMPHOID TUMORS
Vol. 17 No. 2 (2024)
LYMPHOID TUMORS

Therapy Optimization in Newly Diagnosed Diffuse Large B-Cell Lymphoma: Efficacy and Safety of the R-SD-EPOCH ± HDMTX Program Under Single-Center Non-Randomized Prospective Clinical Trial (Preliminary Results)

Published 01.04.2024
Marat Albertovich Mingalimov
City Clinical Hospital No. 52, 3 Pekhotnaya ul., Moscow, Russian Federation, 123182; IM Sechenov First Moscow State Medical University, 2 korp. 4 Bolshaya Pirogovskaya ul., Moscow, Russian Federation, 119435
PDF_2024-17-2_173-179 (Russian)

Keywords

diffuse large B-cell lymphoma
first-line therapy
intensified programs
toxicity
safety profile

How to Cite

1.
Mingalimov M.A. Therapy Optimization in Newly Diagnosed Diffuse Large B-Cell Lymphoma: Efficacy and Safety of the R-SD-EPOCH ± HDMTX Program Under Single-Center Non-Randomized Prospective Clinical Trial (Preliminary Results). Клиническая онкогематология. 2024;17(2):173-179. doi:10.21320/2500-2139-2024-17-2-173-179
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Abstract

Aim. To assess clinical efficacy and safety of the intensified program R-SD-EPOCH ± HDMTX (R-split-dose-EPOCH ± high-dose MTX) in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL).

Materials & Methods. From October 2022 to August 2023, 25 newly diagnosed DLBCL patients were enrolled into the trial protocol. Data of 23 patients were analyzed. The age of patients was 46–70 years (median 63 years); there were 13 women and 10 men. Stage II with bulky tumor lesion was registered in 7 patients; 16 patients showed advanced stages (III and IV). The IPI stratification yielded 13 high-risk, 7 intermediate-high risk, and 3 intermediate-low risk patients. In accordance with the CNS-IPI criteria, 14 patients were listed as high-risk. All 23 patients were treated with R-SD-EPOCH (rituximab, prednisolone, and cyclophosphamide; etoposide, vincristine, and doxorubicin were administered in fractionated doses). High-dose methotrexate as part of R-SD-EPOCH (continuous 3 g/m2 infusion over 12 hours) was administered exclusively to the CNS-IPI high-risk patients. They received it on Day 16 of R-SD-EPOCH ± HDMTX cycles 2, 4, and 6.

Results. The methotrexate-free R-SD-EPOCH regimen was administered throughout the whole program to 9 patients, whereas 14 patients received R-SD-EPOCH ± HDMTX (methotrexate was administered only in cycles 2, 4, and 6). Overall response in the whole cohort (n = 23) was 95 %. Interim PET-CTs were performed after chemotherapy cycles 2 and 4 in 21 patients. Complete metabolic response was achieved in 20 (95 %) patients, whereas partial metabolic response was registered in 1 (5 %) patient. One of the remaining 2 patients was undergoing initial treatment by the time of analysis. The other one with partial response assessed by contrast-enhanced CT, died after surgery for colon perforation followed by localized peritonitis. The patients in the present trial showed equal 10-month PFS and OS rates of 85 % (median not reached; 95% CI 66.4–100.0 %). Hematologic toxicity grade 3/4 was identified in 14 (60 %) patients, and non-hematologic toxicity was observed in 9 (35 %) patients.

Conclusion. The preliminary results of the present clinical trial of the intensified program R-SD-EPOCH ± HDMTX as the first method for the drug treatment of DLBCL demonstrate high efficacy and acceptable safety profile. The data obtained point towards the feasibility of continuing this clinical trial.

PDF_2024-17-2_173-179 (Russian)

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