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7 results on '"Beniwal, Surender Kumar"'

3. Rituximab biosimilar RTXM83 versus reference rituximab in combination with CHOP as first-line treatment for diffuse large B-cell lymphoma: a randomized, double-blind study

Author

Kaplanov, K. D., ÖZCAN, MEHMET ALİ, Udovitsa, D. P., Ilyin, N., Alekseev, S. M., Fadjari, H., Arumugan, V., Chakrabarti, P., Kirushnakumar, K. S., Attili, A. V. S. Suresh, Dantas da Cunha Junior, A., Schmidt Filho, J., Franke, F. A., Sampaio Tavares, R., Pinto Simoes, B., Miguel, C. E., Meton, F., Boquimpani, C., Schaffel, R., Cigno, E. L., Basso, A. C., Jarchum, G., Heller, V. B., Bullorsky, E., Furque, M. L., Jones, L., Bassa, F., Osmanov, D. S., Burdaeva, O. N., Melnichenko, V. Y., Uy, N. A., Keat, C. Teng, Rosales, J. D., Galvez, K., Lazaretti, N., Debiasi, M., Santi, P. Xavier, de Mattos, E. R., Luiz da Silva, R., Rodrigues de Oliveira, J. S., Pereira, J., Salvino de Araujo, A., Fogliatto, L., Beguelin, G. Z., Saslavsky, M. M., Munoz, M., Avila, G. I., Moiseevich, M. G., Viktorovich, P. A., Tiangco, B. J., Molina Barrios, G. R., Martinez-Lapus, F. G. P., Villegas, E. M., Raman, R., Gin, G. Gin, Bermudez, C., Ciliao Munhoz, E., Garcia, J. J., De Stefano, G., Caffaro, J., Syafei, S., da Silva Araujo, S. Shusterschitz, Kowalyszyn, R. D., Jasuja, S., Bhurani, D., Radhakrishnan, V., Salvatierra, A., Mukhopadhyay, A., Bhattacharyya, S., Bhatt, N., Perez Diaz, Luis, Paravisini, Alexandra, Fogliatto, Laura, Nodehi, Sayyed Reza Safaee, Patel, Moosa, Volodicheva, Elena Mikhailovna, Lipatov, Oleg Nikolaevich, Guan, Toh See, Querol, John, Flores, David Hugo, Dasappa, Lokanatha, Beniwal, Surender Kumar, Bar, Daniel Oscar, Delamain, Marcia Torresan, Gonzalez, Derlis E., Candelaria, Myrna, Florez, A., Michiels, S., Leao, D., Loggetto, S. R., Szpak, W., Lifirenko, I. D., Ponomarev, R. S., Lysenko, I. B., and Vladimirov, V.

Subjects
Adult, Male, Cancer Research, medicine.medical_specialty, Adolescent, CHOP, Gastroenterology, law.invention, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, immune system diseases, law, hemic and lymphatic diseases, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Adverse effect, Biosimilar Pharmaceuticals, Cyclophosphamide, Aged, business.industry, Immunogenicity, Hematology, Middle Aged, medicine.disease, Prognosis, Lymphoma, Survival Rate, Oncology, Doxorubicin, Vincristine, 030220 oncology & carcinogenesis, Pharmacodynamics, Prednisone, Rituximab, Female, Lymphoma, Large B-Cell, Diffuse, business, Diffuse large B-cell lymphoma, 030215 immunology, medicine.drug, Follow-Up Studies
Abstract

This multicenter, double-blind, randomized study compared the efficacy, pharmacokinetics (PKs)/pharmacodynamics (PDs), safety and immunogenicity profile of RTXM83 vs. reference rituximab (R-rituximab), both with CHOP, as first-line treatment of diffuse large B-cell lymphoma (DLBCL). A total of 272 patients

Published
2019

4. Rituximab biosimilar RTXM83 versus reference rituximab in combination with CHOP as first-line treatment for diffuse large B-cell lymphoma: a randomized, double-blind study.

Author

Candelaria, Myrna, González, Derlis E., Delamain, Marcia Torresan, Bär, Daniel Oscar, Beniwal, Surender Kumar, Dasappa, Lokanatha, Flores, David Hugo, Querol, John, Guan, Toh See, Lipatov, Oleg Nikolaevich, Volodicheva, Elena Mikhailovna, Patel, Moosa, Safaee Nodehi, Sayyed Reza, Fogliatto, Laura, Paravisini, Alexandra, and Perez Diaz, Luis

Subjects
RITUXIMAB, LYMPHOMAS, CANCER treatment, THERAPEUTICS, ADVERSE health care events
Abstract

This multicenter, double-blind, randomized study compared the efficacy, pharmacokinetics (PKs)/pharmacodynamics (PDs), safety and immunogenicity profile of RTXM83 vs. reference rituximab (R-rituximab), both with CHOP, as first-line treatment of diffuse large B-cell lymphoma (DLBCL). A total of 272 patients <65 years of age, with good prognosis (136 per arm) were randomized (1:1) to receive six cycles of either RTXM83 or R-rituximab. The primary efficacy endpoint was achieved (overall response rate of 83.6% for RTXM83 and 82.9% for R-rituximab) with a difference 0.7% between arms (95%CI: [–8.77% to 10.17%]) fulfilling the predefined non-inferiority margin (–13%). Similar number of patients reported at least one adverse event (AE) (131 per arm) or one serious AE (47 with RTXM83 and 45 with R-rituximab). Anti-drug antibody development was comparable between the arms. PK/PD secondary endpoint results support similarity between the compounds. RTXM83 exhibits non-inferior efficacy and similar safety/immunogenicity to R-rituximab, being an accessible alternative for the treatment of patients with previously untreated DLBCL. [ABSTRACT FROM AUTHOR]

Published
2019
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6. A Randomized, Double-Blind, Phase III Study Comparing Proposed Biosimilar Rituximab (RTXM83) Versus Reference Rituximab, Both in Combination with CHOP, in the First Line Treatment of Patients with Diffuse Large B-Cell Lymphoma (DLBCL)

Author

Candelaria, Myrna, Gonzalez, Derlis Emilio, Beniwal, Surender Kumar, Dasappa, Lokanatha, Bar, Daniel Oscar, Delamain, Marcia Torresan, Mukhopadhyay, Ashis, Flores, David Hugo, Bhurani, Dinesh, Radhakrishnan, Venkatraman, Salvatierra, Alejandro, Kowalyszyn, Ruben Dario, Lipatov, Oleg, Patel, Moosa, Schusterschitz, Sergio, Volodicheva, Elena, and Perez, Luis Antonio

Published
2017
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7. Sociodemographic Parameters of Esophageal Cancer in Northwest India: A Regional Cancer Center Experience of 10 Years.

Author

Kapoor, Akhil, Kumar, Vanita, Singhal, Mukesh Kumar, Nirban, Raj Kumar, Beniwal, Surender Kumar, and Kumar, Harvindra Singh

Subjects
DEMOGRAPHY, ESOPHAGEAL tumors, TIME, SOCIOECONOMIC factors, RETROSPECTIVE studies, DATA analysis software
Abstract

Background: Despite various advances in the treatment of Esophageal Cancer (EC), being one of the least responsive tumors to cancer therapy, the overall prognosis remains poor. Therefore, it is significant to understand various sociodemographic factors associated with EC to find out various schemes for primary prevention of the disease. Materials and Methods: This is a retrospective analysis of medical records of the EC patients registered in the regional cancer center of northwest India from January 2003 to December 2012. The site of the disease and the histology were also recorded in addition to the various sociodemographic parameters. Results: Out of 55,742 patients registered in our hospital; 3,667 were diagnosed to have EC. Male:female ratio was 1.15:1. The mean age was 54.6 ± 11.74 years; 66.15% of the patients were illiterate and 48.6% belonged to the low socioeconomic status. Smoking and alcohol consumption were identified as risk factors in 48 and 25.6% of the patients, respectively. Conclusions: The etiology in majority of the patients is linked to tobacco and alcohol, thus, modification of life style with limiting the use of addictions may be an effective strategy in the prevention of this dreaded and mostly incurable disease. [ABSTRACT FROM AUTHOR]

Published
2015
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