First-line therapy of indolent non-Hodgkin’s lymphoma in routine clinical practice

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Abstract

The aim is to evaluate the efficacy of the first-line rituximab-containing therapy of B-cell lymphoproliferative diseases in Russian clinical practice between 2014 and 2017.

Materials and methods. In the post-authorisation multicenter study EQUILIBRIUM were included 1 thousand patients aged from 21 to 91 with B-cell non-Hodgkin’s lymphoma or chronic lymphatic leukemia who had received at least 4 cycles of rituximab-containing therapy using the drug Acellbia®. This article was devoted to the group of indolent non-Hodgkin’s lymphomas and included 253 patients: follicular lymphoma – 51% of cases, marginal zone lymphoma – 44% of patients, extremely rare were registered lymphoplasmacytic lymphoma and Waldenstrom macroglobulinemia – in 3% and in 2% of cases, respectively. The median age in patients with indolent non-Hodgkin’s lymphomas was 62 years (21–91 years). The vast majority of patients were diagnosed with stage III–IV – 190 (75%) of patients. More than 1/2 (53.4%) of patients in routine practice received R-CHOP therapy as a first-line. BR regimen was applied in 15.4% of cases, 14.2% of patients were treated with R-CVP/R-COP. We indicated rare use of rituximab as monotherapy in induction mode – only 4.4% of patients. And 2.4% of patients were treated with fludarabine-containing therapy.

Results. The final assessment of the effect was carried out after 6–8 cycles of treatment and as a result the overall effect was more than 90%: the frequency of complete remission was 61%, partial responses – 32.9%. The progression admitted only in 17 (6.7%) patients among 253 observed. With a median of 15 months, the median of overall survival and event-free survival was not achieved.

Conclusion. The use of the available and appropriate treatment according to the domestic clinical guidelines with the inclusion of the Russian biosimilar anti-CD20 monoclonal antibody – Acellbia®, demonstrates high direct efficacy and satisfactory long-term treatment results comparable to the retrospective analysis of the previous clinical studies of the original drug rituximab.

About the authors

Lali G. Babicheva

Russian Medical Academy of Continuous Professional Education

Author for correspondence.
Email: ivprectorat@inbox.ru
ORCID iD: 0000-0001-8290-5564

Cand. Sci. (Med.)

Russian Federation, Moscow

Irina V. Poddubnaya

Russian Medical Academy of Continuous Professional Education

Email: ivprectorat@inbox.ru
ORCID iD: 0000-0002-0995-1801

D. Sci. (Med.), Prof., Acad. RAS

Russian Federation, Moscow

References

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  2. Поддубная И.В., Бабичева Л.Г. Роль бендамустина в лечении В-клеточных неходжкинских лимфом. Современная онкология. 2018; 20 (4): 41–8. [Poddubnaya I.V., Babicheva L.G. The role of bendamustine in the treatment of B-cell non-Hodgkin lymphomas. Journal of Modern Oncology. 2018; 20 (4): 41–8 (in Russian).]
  3. Poddubnaya IV, Babicheva LG et al. Comparison of farmacokinetics and pharmacodynamics of BCD-020 with innovator rituximab in patients with indolent non-Hodgkin lymphoma. J Clin Oncology 2014; 32. ASCO Annual Meeting Proceedings. Аbs e19545

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