TY  - JOUR
TI  - Biosimilar Rituximab (Redditux) Added to CHOP Chemotherapy for De Novo Diffuse Large B-Cell Lymphoma Patients: Real-Life Single-Center Experience
AB  - Objective: Redditux® (RED), as a biosimilar rituximab, was approved in Turkey for all indications of the original Mabthera® (MAB) in March 2018. The aim of our study was to evaluate the efficacy and safety of RED in de novo diffuse large B-cell lymphoma. Materials and Methods: Fifty-one patients received RED combined with the CHOP regimen. The median follow-up was 31 months. The historical control group included 219 patients treated with the MAB-CHOP regimen and the median follow-up time was 38 months. We compared the response rates and survival outcomes of these RED-CHOP and MAB-CHOP cohorts. Results: In the RED cohort, the overall response rate (ORR) at the end of the treatment protocol was 86%, with 37 (72.5%) cases of complete response (CR) and 7 (13.5%) cases of partial response (PR). In the historical MAB cohort, the ORR was 84%, with CR and PR rates of 82% and 2%, respectively. The 24-month progression-free survival (PFS) rates were 73.76% (95% confidence interval [CI]: 0.59-0.84) and 85.2% (95% CI: 0.79-0.90) for the RED and MAB cohorts, respectively (p=0.0106). The 24-month overall survival rates were 78.4% (95% CI: 0.64-0.87) and 81.4% (95% CI: 0.75-0.86) for the RED and MAB cohorts, respectively (p=0.7461). For patients with high revised International Prognostic Index scores, 24-month PFS was 45.5% (95% CI: 0.17-0.71) and 63% (95% CI: 0.37-0.80) for the RED and MAB cohorts, respectively (p=0.0711). In the RED cohort, central nervous system (CNS) relapse was significantly increased compared to the MAB cohort (10% vs. 1.83%, p=0.004). Among the RED cohort, bone involvement at the time of diagnosis was a risk factor for CNS relapse (p=0.028). Thirteen patients died in follow-up. There were no serious adverse events causing the cessation of the drugs. Conclusion: RED has an ORR similar to that of MAB. However, PFS rates were worse in the RED cohort. Additionally, CNS relapse ratio was a major concern for our RED cohort. Large prospective controlled studies and real-life data with longer follow-up are needed to document the non-inferiority of RED compared to MAB.
AU  - Eşkazan, Ahmet Emre
AU  - Soysal, Teoman
AU  - tiryaki, tarık onur
AU  - PINAR OZBALAK, EZGI
AU  - Yonal-Hindilerden, Ipek
AU  - Mastanzade, Metban
AU  - Ar, Muhlis Cem
AU  - Özlük, Dilek Özden
AU  - Yenerel, Mustafa Nuri
AU  - Erdem, Simge
AU  - Ozbalak, Murat
AU  - ELVERDİ, TUĞRUL
AU  - Altay, Ali Yılmaz
AU  - Yegen, Gulcin
AU  - Nalcaci, Meliha
AU  - Ferhanoğlu, Burhan
AU  - Kalayoglu Besisik, Sevgi
DO  - 10.4274/tjh.galenos.2022.2022.0142
PY  - 2022
JO  - Turkish Journal of Hematology
VL  - 39
IS  - 4
SN  - 1300-7777
SP  - 254
EP  - 261
DB  - TRDizin
UR  - http://search/yayin/detay/1174302
ER  -