Multicenter randomized controlled (comparative) open prospective study to evaluate the efficacy of the R-DA-EPOCH-21 and R-mNHL-BFM-90 with and without autologous hematopoietic stem cell transplantation programs in untreated patients with de novo diffuse B-cell large cell lymphoma with signs of poor prognosis (final results)

A. U. Magomedova; Ya. K. Mangasarova; S. K. Kravchenko; A. M. Kovrigina; O. V. Margolin; E. A Fastova; F. E. Babaeva; M. J. Bagova; L. G. Gorenkova; E. S. Nesterova; T. N. Moiseeva; T. N. Obukhova; E. E. Nikulina; B. V. Biderman; V. N. Dvirnyk; I. V. Galtseva; G. A. Klyasova; G. M. Galstyan; Yu. A. Chabaeva; E. E. Zvonkov

doi:10.35754/0234-5730-2024-69-4-392-409

Multicenter randomized controlled (comparative) open prospective study to evaluate the efficacy of the R-DA-EPOCH-21 and R-mNHL-BFM-90 with and without autologous hematopoietic stem cell transplantation programs in untreated patients with de novo diffuse B-cell large cell lymphoma with signs of poor prognosis (final results)

https://doi.org/10.35754/0234-5730-2024-69-4-392-409

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Abstract

Introduction. The R-NHL-BFM-90 protocol has been successfully used for the treatment of Burkitt’s lymphoma and diffuse large B-cell lymphoma (DLBCL) in children and adolescents, as well as adult T-cell lymphomas. The protocol was modified for the treatment of adult patients with de novo nodal DLBCL.

Aim: to evaluate the efficacy and toxicity of the R-mNHL-BFM-90 and R-DA-EPOCH-21 protocols in adult patients with de novo nodal DLBCL with 2 or more signs of poor prognosis, as well as to determine the role of auto-HSCT in the consolidation of remission.

Materials and methods. From 2015 to 2021, 164 patients were evaluated for randomization. The study included 140 patients from 13 Russian medical centers. 89 (76 %) patients with de novo nodal DLBCL: R-DAEPOCH-21 20 (22.5 %) patients; R-DAEPOCH-21 + auto-HSCT 21 (23.5 %) patients; R-mNHL-BFM-90 20 (22.5 %) patients; R-mNHL-BFM-90 performed + auto-HSCT 28 (31.5 %) patients. In the high-intermediate and high-risk group, there were 12 (29.3 %) and 29 (70.7 %) patients on the R-DA-EPOCH-21 + auto-HSCT protocol and 15 (31.2 %) and 32 (66.7 %) on the R-mNHL-BFM-90 protocol + auto-HSCT, respectively.

Results. The R-mNHL-BFM-90 protocol proved to be more effective. Complete remission in the high-risk group was achieved in 30 (93.7 %) patients versus 18 (62.0 %), there was no progression versus 3 (10.3 %) patients treated according to R-DA-EPOCH-21 (p = 0.0167). The five-year overall and event-free survival in the high-risk group was 97 % vs. 75 % (p = 0.01) and 97 % vs. 72 % (p = 0.0026), respectively. In the intermediate risk group, the results of therapy did not differ. The toxicity of the R-mNHL-BFM-90 protocol exceeded the toxicity of R-DA-EPOCH-21 only in neutropenic fever (p = 0.04) and grade 3–4 thrombocytopenia (p = 0.0009).

Conclusion. The R-mNHL-BFM-90 protocol is effective for the treatment of patients with nodal de novo DLBCL diffuse large B-cell lymphoma of high-risk adults; its toxicity is acceptable. However, on the R-DA-EPOCH-21 therapy, the results of therapy are unsatisfactory. The R-DA-EPOCH-21 protocol with auto-HSCT was more effective than without auto-HSCT, however, due to the small number of patients, the results were unpresentative. The results of therapy according R-mNHL-BFM-90 protocol with auto-HSCT and without auto-HSCT were not differ.