Influence of HER2 Overexpression on Response to Cetuximab in Patients with Metastatic Colorectal Cancer, Tehran, Iran

Objective: Colorectal cancer (CRC) remains the fourth cause of mortality in the world. HER2, an epidermal growth factor receptor (EGFR) has an influence on prognosis and overall survival in breast and metastatic gastric cancers. We evaluated the prevalence of HER2 positivity among Iranian patients with CRC and determined the response rate to Cetuximab, an EGFRtargeted drug in eligible HER2 positive patients. Methods: HER2 immunohistochemistry staining was carried out in samples of 150 CRC patients and the prevalence of HER2 overexpression was estimated. We also investigated the association of HER2 overexpression with the prognostic factors, overall survival (OS), and progression-free survival (PFS) as well as response to Cetuximab in the patients by reviewing the medical Results: The prevalence of HER2 overexpression was12%. The mean of follow-ups was 40.67 ± 21.57 weeks in the patients with HER2 overexpression. PFS and OS were lower in HER2 overexpressed patient than other. There was only a borderline relation between the distant metastasis and HER2 expression. Considering the response to Cetuximab, there was a significant difference between HER2 positive and HER2 negative groups. Conclusions: Our study provides further evidence in the effect of HER2 overexpression in CRC patients on the OS, PFS, and response to Cetuximab

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

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