التفاصيل البيبلوغرافية
| العنوان: |
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. |
| المؤلفون: |
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, Perez Diaz, Luis |
| المصدر: |
Leukemia & Lymphoma; Dec2019, Vol. 60 Issue 14, p3375-3385, 11p |
| مصطلحات موضوعية: |
RITUXIMAB, LYMPHOMAS, CANCER treatment, THERAPEUTICS, ADVERSE health care events |
| مستخلص: |
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] |
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| قاعدة البيانات: |
Complementary Index |
