Download PDF
CC BY-NC-ND 4.0 · Indian J Med Paediatr Oncol 2013; 34(04): 292-298
DOI: 10.4103/0971-5851.125248
ORIGINAL ARTICLE

Comparison of the efficacy and safety of Rituximab (Mabthera™) and its biosimilar (Reditux™) in diffuse large B-cell lymphoma patients treated with chemo-immunotherapy: A retrospective analysis

Partha Sarathi Roy
Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India
,
Shiji John
Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India
,
Sadashiv Karankal
Department of Biostatistics, Tata Memorial Centre, Mumbai, Maharashtra, India
,
Sadhana Kannan
Department of Biostatistics, Tata Memorial Centre, Mumbai, Maharashtra, India
,
Preeti Pawaskar
Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India
,
Jayanta Gawande
Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India
,
Bhausaheb Bagal
Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India
,
Navin Khattry
Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India
,
Manju Sengar
Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India
,
Hari Menon
Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India
,
Sumeet Gujral
Department of Pathology, Tata Memorial Centre, Mumbai, Maharashtra, India
,
Reena Nair
Department of Clinical Hematology, Tata Medical Centre, Kolkata, West Bengal, India
› Author Affiliations
› Further Information
  PDF Download Permissions and Reprints

Abstract

Background: Rituximab (Mabthera™) have been in use in India since 2000. A biosimilar molecule of rituximab (Reditux™) was approved in India in 2007. This retrospective audit was done to compare the efficacy and safety of Mabthera™ with Reditux™. Materials and Methods: We reviewed the charts of 223 adult diffuse large B-cell lymphoma patients who had received cyclophosphamide, doxorubicin, vincristine and prednisolone with rituximab chemotherapy. Tumor recurrence, survival and toxicities experienced during chemotherapy were obtained from the patient charts. The survival analysis was restricted to patients who received at least 4 cycles of the same brand. Results: Of the 223 patients evaluated, 101 received Mabthera™, 72 received Reditux™. There were no differences in the infusional reaction rates, grades 3 and 4 neutropenia and oral mucositis between the two brands. Complete-remission (CR) rates were similar with Mabthera™ and Reditux™ (75% and 82%, respectively; P = 0.294). The progression free survival (PFS) rate at 5 years were 72% in Mabthera™ and 81% in Reditux™ (P = 0.382). The overall survival (OS) at 5 years were comparable in the two groups (66% in Mabthera™ and 76% in Reditux™; P = 0.264). Conclusion: We observed no significant differences in the toxicity, tumor response rates, PFS and OS between the two available brands of rituximab.

Keywords

Anti-CD20 - biosimilar - lymphoid neoplasms - monoclonal antibody - observational study - survival outcomes


Publication History

Article published online:
19 July 2021

© 2013. Indian Society of Medical and Paediatric Oncology. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/.)

Thieme Medical and Scientific Publishers Pvt. Ltd.
A-12, 2nd Floor, Sector 2, Noida-201301 UP, India

 

  • References

  • 1 Feugier P, Van Hoof A, Sebban C, Solal-Celigny P, Bouabdallah R, Fermé C, et al. Long-term results of the R-CHOP study in the treatment of elderly patients with diffuse large B-cell lymphoma: A study by the Groupe d′Etude des Lymphomes de l′Adulte. J Clin Oncol 2005;23:4117-26.
  • 2 Habermann TM, Weller EA, Morrison VA, Gascoyne RD, Cassileth PA, Cohn JB, et al. Rituximab-CHOP versus CHOP alone or with maintenance rituximab in older patients with diffuse large B-cell lymphoma. J Clin Oncol 2006;24:3121-7.
  • 3 Pfreundschuh M, Trümper L, Osterborg A, Pettengell R, Trneny M, Imrie K, et al. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: A randomised controlled trial by the MabThera International Trial (MInT) Group. Lancet Oncol 2006;7:379-91.
  • 4 Biswas G, Parikh PM, Nair R, Bhagwat R, Bakshi A, Prabhash K, et al. Rituximab (anti-CD20 monoclonal antibody) in lymphoproliferative malignancies: Tata Memorial experience. J Assoc Physicians India 2006;54:29-33.
  • 5 Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Giezen TJ, et al. Biosimilars: What clinicians should know. Blood 2012;120:5111-7.
  • 6 Minghetti P, Rocco P, Cilurzo F, Vecchio LD, Locatelli F. The regulatory framework of biosimilars in the European Union. Drug Discov Today 2012;17:63-70.
  • 7 Harris RJ. Heterogeneity of recombinant antibodies: Linking structure to function state of the art analytical methods for characterization of biological products and assessment of comparability. Karger 2005;122:117-27.
  • 8 Kamoda S, Ishikawa R, Kakehi K. Capillary electrophoresis with laser-induced fluorescence detection for detailed studies on N-linked oligosaccharide profile of therapeutic recombinant monoclonal antibodies. J Chromatogr A 2006;1133:332-9.
  • 9 Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, et al. Revised response criteria for malignant lymphoma. J Clin Oncol 2007;25:579-86.
  • 10 Simoens S. Biosimilar medicines and cost-effectiveness. Clinicoecon Outcomes Res 2011;3:29-36.
  • 11 Vallabhajosyula S, Baijal G, Vadhiraja BM, Fernandes DJ, Vidyasagar MS. Non-Hodgkin′s lymphoma: Is India ready to incorporate recent advances in day to day practice? J Cancer Res Ther 2010;6:36-40.