AUTHOR=Nair Reena , Bhat Gull Mohammad , Agrawal Narendra , Sengar Manju , Malhotra Pankaj , Nityanand Soniya , Lele Chitra , Reddy Pramod , Kankanwadi Suresh , Maharaj Narendra 

TITLE=Real-world outcomes of diffuse large B-cell lymphoma in the biosimilar era

JOURNAL=Frontiers in Oncology

VOLUME=Volume 13 - 2023

YEAR=2023

URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1248723

DOI=10.3389/fonc.2023.1248723

ISSN=2234-943X

ABSTRACT=Background: Diffuse Large B-Cell lymphoma (DLBCL) is an aggressive and the most common type of non-Hodgkin lymphoma (NHL). The clinical use of rituximab has improved the treatment response and survival of patients with DLBCL. The introduction of rituximab biosimilar into healthcare system has helped in providing a cost-effective treatment to B-cell lymphoid malignancies as standard of care and has improved access to patients worldwide. The aim of this study was to observe the real-world effectiveness and safety of Reditux TM and Ristova ® in DLBCL patients.Methods: Observational study in adults with DLBCL receiving Reditux TM or Ristova ® across 29 centers in India (2015)(2016)(2017)(2018)(2019)(2020)(2021)(2022). Effectiveness and safety were assessed up to 2 years after first dose.Results: Out of 1365 patients considered for analysis, 1250 (91.6%) were treated with Reditux TM and 115 (8.42%) with Ristova ® . At 2 years, PFS 69% (HR, 1.16; 95% CI, 0.80 to 1.67), OS 78.7% (HR, 1.20; 95% CI, 0.78 to 1.86), response rates, quality of life (QoL) and overall safety in both the cohorts were comparable. The best overall response rate (BORR) at 6 months was comparable with no statistically significant differences between the Reditux TM and the Ristova ® cohorts (89.2% vs 94.3%). In multivariate analysis, BCL-2 and VAS were significant prognostic factors for PFS.Reditux TM and Ristova ® were comparable in real-world setting.