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
Aminat Magomedova, Sergey Kravchenko, Anna Misyurina, Yana Mangasarova, Oleg Margolin, Ekaterina Fastova, Fatima Babaeva, Lilia Gorenkova, Madina Bagova, Ekaterina Nesterova, Ksenia Sychevskaya, Tatyana Moiseeva, Alla Kovrigina, Tatyana Obukhova, Valentina Dvirnyk, Salia Maryina, Irina Galtseva, Vladimir Galuzyak, Karen Danishyan, Irina Kostina, Mikhail Gitis, Andrey Sudarikov, Elena Nikulina, Bella Biderman, Galina Klyasova, Gennady Galstyan, Mikhail Spirin, Sergey Kulikov, Yulia Chabaeva, Elena Zinina, Irina Kryuchkova, Svetlana Sizikova, Vera Sergeyevicheva, Tatyana Ksenzova, Ekaterina Anikina, Tatyana Shelekhova, Olga Arzhanukhina, Kamil Kaplanov, Tatyana Konstantinova, Olga Serdyuk, Tatyana Sychyova, Tatyana Chagorova, Irina Nec hunayeva, Lyudmila Anchukova, Oksana Dzarasova, Valery Savchenko, Elena Parovichnikova
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-HSCT.
Results: 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.
