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.


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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

Russian Federation, Moscow

Cand. Sci. (Med.)

Irina V. Poddubnaya

Russian Medical Academy of Continuous Professional Education

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

Russian Federation, Moscow

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

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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