Open AccessPB1912 EFFICACY AND SAFETY OF RITUXIMAB BIOSIMILAR TRUXIMA IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND NON‐HODGKIN'S LYMPHOMAS
Author(s) -
Micheva I.,
Useir S.,
Gercheva L.
Publication year - 2019
Publication title -
hemasphere
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.677
H-Index - 11
ISSN - 2572-9241
DOI - 10.1097/01.hs9.0000566152.07666.c7
Subject(s) - medicine , rituximab , biosimilar , chronic lymphocytic leukemia , lymphoma , chop , oncology , hematology , aggressive lymphoma , chemotherapy , leukemia , gastroenterology
Background: Rituximab, an anti‐CD20 monoclonal antibody, is a key therapeutic in the treatment of B cell lymphomas and Chronic lymphocytic leukemia (CLL). Truxima TM is the first biosimilar of the medicine Rituximab to be approved for the treatment of patients non‐Hodgkin's lymphoma (NHL) and CLL, showing similar efficacy, pharmacokinetics, safety and immunogenicity profile. The use of biosimilars may reduce treatment costs andincrease patient access to Rtuximab. Aims: The aim of the study was to assess the efficacy and safety of Truxima TM treatment in combination with chemotherapy in patients NHL and CLL followed for 12 months. Methods: A total of fifty one patients, 28 men and 23 women, were treated with ruxima TM in the Clinic of Hematology at “Sveta Marina” University Hospital, Varna. Truxima TM was applied at a dose of 375 mg/m 2 every 3 weeks in combination with chemotherapy. Response was estimated at treatment completion. Results: Median age was 68,5 years. 22 patients were with CLL, one Richter,s syndrome, 16 with Diffuse large B cell lymphoma (DLBCL), 4 with Mantel cell lymphoma (MCL), 4 with Ssmall cell lymphoma (SCL), 4 with Marginal cell lymphoma (MZL). Truxima TM was combined with different chemotherapeutic regimens: CHOP in 11 patients, Bendamustin in 23, FC in 6, MINE in 3, ACVBP in 1, COP in 3, ICE in 1, and Leukeran in 1. In 34 patients Truxima TM was applied as a first line treatment, in 12 patients as a second line, in 5 cases as a third line. 30 patients have completed their treatment at the time of analysis. Complete response was achieved in 9 (30%) patients, partial response in 17 (56,7%) patients, stable disease in 4 (13,3%). Progressive disease was observed in 1 patient with DLBCL. Grade 3 or 4 hematological toxicity was registered in 5 patients (9,8%). Infusion related reactions were observed in 5,8% of the patientsat grade 1 and 2. Summary/Conclusion: Our experience with the biosimilar over the last year has revealed that Truxima TM is an effective treatment without unexpected side effects. Moreover, cost may be a factor for doctor's choice.