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

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-Hodgkins 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-Hodgkins 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-Hodgkins lymphomas was 62 years (2191 years). The vast majority of patients were diagnosed with stage IIIIV 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 68 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.