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 Cytotoxic agents
Lymphomas
Immunotherapy
Therapy
Biological therapy
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

Abstract

Background

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®.

Methods

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.

Results

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.

Conclusion

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.

Disclosure

All authors have declared no conflicts of interest.