Efferent therapy in the first-line drug treatment of metastatic colorectal cancer

Abstract

The aim of this study is to analyse the efficacy of efferent therapy (hemosorption) as part of drug treatment in patients with metastatic colorectal cancer (mCRC) based on the use of standard first-line chemotherapy combined with the bevacizumab biosimilar. The study included 54 patients with histologically verified mCRC who received the first-line FOLFOX + bevacizumab therapy in combination with and without hemosorption. All patients of the FOLFOX + bevacizumab (+) hemosorption group (n = 32) received the hemosorption using Hemophoenix apparatus on Day 4 of the cycle during the first 6 cycles. A total of 182 hemosorption procedures were performed. The control group included 22 patients receiving the FOLFOX + bevacizumab regimen without hemosorption. The bevacizumab biosimilar was introduced in both groups throughout the treatment at standard doses once every 2 weeks. There was no statistically significant difference between the study groups in the main clinical, pathomorphological, molecular genetic characteristics (sex, age, ECOG status, localization of primary tumor, tumor differentiation, RAS, BRAF mutations, microsatellite instability, etc.).Blood sampling to evaluate the effect of hemosorption on the pharmacokinetics (PK) of bevacizumab biosimilar was performed during the 2nd cycle before (PK1) and after (PK2) hemosorption procedures. The bevacizumab biosimilar concentration in the blood of patients before and after hemosorption showed no statistically significant difference (p = 0,423).The use of pharmaceutical treatment in the FOLFOX + bevacizumab (+) hemosorption group contributed to the achievement of an objective response (OR) in 62% of patients (p = 0.001). Median progression-free survival (PFS) was 10 ± 0.9 months [95% CI 8.3-11.7] in the FOLFOX + bevacizumab (+) hemosorption group, and 7 ± 0.5 months [95% CI 4.4-11.6] in the FOLFOX + bevacizumab (-) hemosorption group. There was no significant difference in PFS between the groups of patients treated with FOLFOX + bevacizumab regimen with and without hemosorption (p = 0.445).There were statistically significant differences in the frequency of nausea, diarrhoea and asthenia in the FOLFOX + bevacizumab (+) hemosorption group. The analysis of the dynamics of the quality of life (QoL) level before and after treatment showed that QoL level related to health (p = 0.0001) as well as the emotional (p = 0.0001) and social (p = 0,04) functioning increased in patients receiving the FOLFOX + bevacizumab regimen in combination with hemosorption, 0,039).Thus, the addition of hemosorption to the first-line drug treatment according to the FOLFOX + bevacizumab regimen does not affect bevacizumab pharmacokinetics, increases the frequency of objective response, reduces toxicity of the therapy and improves the quality of patients’ life indicators.

Keywords

• metastatic colorectal cancer
• hemosorption
• bevacizumab biosimilar
• first-line treatment