Abstract:

Objective To analyze and compare the effect and safety of the rituximab researched drug （Rituxan® ）and domestic biosimilar（Hanlikang® ）combined with CHOP regimen in the treatment of patients with newly diagnosed diffuse large B⁃cell lymphoma（DLBCL）. Methods The newly diagnosed DLBCL patients who received R⁃CHOP treatment were collected into our study and divided into 3 groups：R group（Rituxan® treatment group）（n = 40），H group（Hanlikang® treatment group）（n = 34），R/H group（Rituxan®/Hanlikang® treatment group）（n = 27）. The main indicators were collected［complete remission rate（CR），partial remission rate（PR） were recorded at the 4th cycle（C4）and at the end of chemotherapy，and the overall response rate（overall response rate，ORR）］and secondary indicators［2 years after treatment，the progression free survival rate（PFS）and total survival（overall survival，OS），adverse events］were recorded and compared. Results The patients in the group R，group H and group R/H were followed upfor at least 2 years，the follow⁃up rates were 100.00%.There was no significant difference in CR，PR，ORR in the middle and end of treatment，2 year⁃PFS，2⁃year OS and adverse events within 3 groups（all P > 0.05）. Conclusion Both the original research drug rituximab（Rituxan® ）and the domestic biosimilar（Hanlikang® ）can be used in combination with CHOP regimen in the treatment of newly diag⁃ nosed DLBCL patients，the efficacy and safety of both are comparable.

Key words:

rituximab, biosimilars, CHOP, diffuse large B?cell lymphoma