1074P - A retrospective single centre analysis of safety, toxicity and efficacy of rituximab (original) and its biosimilar in diffuse large B-cell lymphoma...

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Anti-Cancer Agents & Biologic Therapy
Cancer Immunology and Immunotherapy
Presenter Partha Roy
Authors P.S. Roy1, M. Sengar2, H. Menon2, B. Bagal2, N. Khattry2, E. Shridhar3, S. Gujral3, S. Laskar4, V. Rangarajan5, R. Nair6
  • 1Medical Oncology, Tata Memorial Hospital, 400012 - Mumbai/IN
  • 2Medical Oncology, Tata Memorial Hospital, Mumbai/IN
  • 3Pathology, Tata Memorial Hospital, 400012 - Mumbai/IN
  • 4Radiation Oncology, Tata Memorial Hospital, 400012 - Mumbai/IN
  • 5Radiology, Tata Memorial Hospital, 400012 - Mumbai/IN
  • 6Tata Memorial Hospital Centre, IN-400012 - Mumbai/IN



Rituximab with chemotherapy (CHOP regimen) has been the standard of care for diffuse large B-cell lymphoma (DLBCL). Mabthera® is being used in India since early 2000. Reditux®, a biosimilar molecule of Rituximab, was developed in India & approved for use since March 2007. This retrospective audit aims to compare the safety, toxicity and efficacy of Mabthera® with Reditux®.


Two hundred twenty-three patients aged ≥ 18 years who underwent treatment from January 2004 to June 2010 were included. All patients received 4-8 cycles of R-CHOP. CT scan of chest & abdomen was done at baseline and within 4 weeks of completion of treatment. Grade 3-4 hematological and non-hematological toxicities according to CTC version 3.0 were recorded. Response rates [complete response (CR), partial response (PR)] in both groups were evaluated as per Cheson's criteria & compared by Chi-Square test. Overall survival (OS) and progression-free survival (PFS) were estimated by Kaplan-Meier method & compared by two-sided log rank test.


One hundred one patients received Mabthera®, 72 received Reditux®. In 17 patients, the brand used was unknown and 33 patients received both. Baseline characteristics such as, age, gender, performance status, stage of disease & revised IPI score at presentation were similar in both groups. Median number of treatment cycle received was 6 in each group. Overall response rate (CR + PR) was 88% (Mabthera®) and 90% (Reditux®). OS at 5 years was 85% (Mabthera®) and 93% (Reditux®); P = 0.13. PFS at 5 years was 76% (Mabthera®) and 84% (Reditux®); P = 0.44. At a median follow-up of 35 months (18 to 58 months) treatment related death was seen in 3 in Mabthera® and 2 in Reditux® group. Grade 3-4 febrile neutropenia was observed in 23% (Mabthera®) & 20% (Reditux®); grade 3-4 oral mucositis and diarrhea was seen in 25% (Mabthera®) & 10% (Reditux®). No difference in infusional reactions were observed.


Reditux® is as efficacious as Mabthera® in terms of response rates, OS & PFS with comparable toxicity. However, randomized prospective trial is needed to validate these results.


All authors have declared no conflicts of interest.