Dept of Medical Oncology, 2 Dept of Pathology, 3 Dept of Radiation Oncology, 4. Dept of Nuclear Medicine; Tata Memorial Hospital, Mumbai, India

Transcription

1 A Retrospective Single Centre Analysis Of Efficacy, Safety And Toxicity of Rituximab (Original) And Its Biosimilar In Diffuse Large B-Cell Lymphoma Patients Treated With Chemo-immunotherapy Dr Partha Sarathi Roy 1, Dr Manju Sengar 1, Dr Hari Menon 1, Dr Bhausaheb Bagal 1, Dr Navin Khattry 1, Dr Epari Shridhar 2, Dr Sumeet Gujral 2, Dr Siddhartha Laskar 3, Dr V Rangarajan 4, Dr Reena Nair 1 1 Dept of Medical Oncology, 2 Dept of Pathology, 3 Dept of Radiation Oncology, 4 Dept of Nuclear Medicine; Tata Memorial Hospital, Mumbai, India

2 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 Reditux TM, a biosimilar molecule of Rituximab, was developed in India & approved for use since March 2007 We report a retrospective audit that compares the efficacy and safety of Mabthera TM with Reditux TM

3 Methodology Retrospective, observational single-centre study of treatment naïve DLBCL patients above 18 years treated with CHOP-R at Tata Memorial Hospital between 2004 to 2010 The study was approved by the Hospital Ethics Committee Pharmacy records were obtained for all patients who had taken treatment with Rituximab All epidemiological & treatment details were retrieved from case record files. Follow up information were recorded from the hospital electronic medical records system

4 Methodology Patients were grouped as those who received all cycles of Mabthera TM (101), all cycles of Reditux TM (72). A third group included 50 patients who received both brands of Rituximab (33) or took treatment at other centres (17), in whom we did not have information about the brands used The primary outcome was to compare the progression free survival (PFS) of patients receiving CHOP with Reditux TM versus Mabthera TM The secondary outcome was to compare the response rates, incidence of grade 3-4 haematological and all non-haematological toxicities and overall survival (OS)

5 Results: Characteristics of 223 DLBCL patients treated with CHOP-R according to treatment groups CHARECTERISTICS TOTAL (n=223) Mabthera TM Group #101 Reditux TM Group #72 Both Brands or Brand not known #50 Gender: Male Female 156 (70%) 67 (30%) 67 (66%) 34 (34%) 55 (76%) 17 (24%) 33 (66%) 16 (32%) Age (years): <60 > (79%) 46 (21%) 79 (78%) 22 (22%) 56 (78%) 16 (22%) 41 (82%) 09 (18%) Stage: I II III IV 35 (16%) 76 (34%) 47 (21%) 65 (29%) 13 (13%) 32 (31%) 25 (25%) 31(31%) 14 (19%) 26 (36%) 16 (22%) 16 (22%) 08 (16%) 18 (36%) 06 (12%) 18 (36%) B symptoms: 73 (33%) 35 (35%) 20 (28%) 18 (36%) ECOG PS: 0 & 1 >2 192 (86%) 31 (14%) 82 (81%) 20 (19%) 63 (86%) 09 (14%) 46 (92%) 02 (04%) R-IPI score: 0 1,2 3,4,5 29 (13%) 150 (67%) 44 (20%) 12 (12%) 66 (65%) 23 (23%) 09 (13%) 52 (72%) 11 (15%) 08 (16%) 32 (64%) 10 (20%)

6 Results: Progression free survival

7 Results: Response and Status of 223 DLBCL patients treated with CHOP-R according to treatment groups RESPONSE TOTAL (n=223) Mabthera TM Group #101 Reditux TM Group #72 Complete Response 168 (75%) 76 (75%) 59 (82%) 33 (66%) (CR) Partial 34 (15%) 14 (14%) 09 (13%) 11 (22%) Response (PR) Progressive disease on 09 (04%) 05 (05%) (08%) Treatment (PD) Not evaluated 12 (05%) 06 (06%) 04 (06%) 02 (04%) STATUS Relapse after CR 15 (07%) 06 (06%) 04 (06%) 05 (10%) Progressive disease 19 (09%) 06 (06%) 06 (08%) 07 (14%) (PD) after PR DEATH 22 (10%) 13 (13%) 05 (07%) 05 (10%) on Treatment 12 (05%) 06 (06%) 03 (04%) 03 (06%) on Follow up 10 (04%) 07 (07%) 02 (03%) 01 (02%) Both Brands or Brand not known #50

8 Results: Toxicity of DLBCL patients treated with CHOP-R according to treatment groups TOXICITY (Data on toxicity is limited) TOTAL (n=93) Mabthera TM Group #40 Reditux TM Group # 30 Febrile Neutropenia Mucositis-Grade III/IV Gastrointestinal-Grade III/IV Peripheral neuropathy- all grades Infusional reactions (Severe) Dilated cardiomyopathy CMV viremia Herpes zoster reactivation Pneumonia DEATH on Treatment Both Brands or Brand not known #23

9 Results: Overall Survival

10 Conclusions In our experience, Reditux TM was as efficacious as Mabthera TM in terms of PFS, response rates, and OS Due to the retrospective nature of the study toxicity details were available in limited patients. However toxicity was comparable Thus randomized prospective trials are needed to compare the efficacy and toxicity of biosimilar versus original molecules