title: 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.
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™.
  
  
  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).
  
  
  CONCLUSIONS
  We observed no significant differences in the toxicity, tumor response rates, PFS and OS between the two available brands of rituximab.
authors.affiliation: Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India.
authors.forename: Partha Sarathi
authors.initials: PS
authors.lastname: Roy
authors.affiliation: Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India.
authors.forename: Shiji
authors.initials: S
authors.lastname: John
authors.affiliation: Department of Biostatistics, Tata Memorial Centre, Mumbai, Maharashtra, India.
authors.forename: Sadashiv
authors.initials: S
authors.lastname: Karankal
authors.affiliation: Department of Biostatistics, Tata Memorial Centre, Mumbai, Maharashtra, India.
authors.forename: Sadhana
authors.initials: S
authors.lastname: Kannan
authors.affiliation: Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India.
authors.forename: Preeti
authors.initials: P
authors.lastname: Pawaskar
authors.affiliation: Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India.
authors.forename: Jayanta
authors.initials: J
authors.lastname: Gawande
authors.affiliation: Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India.
authors.forename: Bhausaheb
authors.initials: B
authors.lastname: Bagal
authors.affiliation: Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India.
authors.forename: Navin
authors.initials: N
authors.lastname: Khattry
authors.affiliation: Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India.
authors.forename: Manju
authors.initials: M
authors.lastname: Sengar
authors.affiliation: Department of Medical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India.
authors.forename: Hari
authors.initials: H
authors.lastname: Menon
authors.affiliation: Department of Pathology, Tata Memorial Centre, Mumbai, Maharashtra, India.
authors.forename: Sumeet
authors.initials: S
authors.lastname: Gujral
authors.affiliation: Department of Clinical Hematology, Tata Medical Centre, Kolkata, West Bengal, India.
authors.forename: Reena
authors.initials: R
authors.lastname: Nair
keywords: Anti-CD20; biosimilar; lymphoid neoplasms; monoclonal antibody; observational study; survival outcomes