Efficacy and safety of therapy with biosimilar bevacizumab in the treatment of patients with metastatic colon cancer -a series of clinical observations


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Abstract

Background. Currently, anti-angiogenic therapy is firmly established in the treatment regimen for patients with metastatic colon cancer (MCC). In 2015, a bioanalogue of bevacizumab, produced by the pharmaceutical Biocad company, was registered in the Russian Federation; however, oncologists have little data on the effectiveness of the biovalogue of bevacizumab at MCC. Objective: to evaluate the efficacy and tolerability of a combination of chemotherapy and biosimilar beanacizumab, Biocad company, in patients with metastatic colon cancer (MCC). Methods. A retrospective analysis of a prospective database of patients with MCC treated at the Department of Clinical Pharmacology and Chemotherapy of the N.N. Blokhin NMRCO of the Ministry of Health of the Russian Federation was performed. A description of a series of clinical observations is presented. The statistical hypothesis was not intended. Statistical analysis is represented by descriptive statistics. Results. In the department darabase, 13 patients with MCC were identified; they were treated in in 2017-2018 with the inclusion of the biosimilar bevacizumab; 84.6% of patients had a history of adjuvant therapy, mutation in the BRAF gene was revealed in 15.4%, localization of the primary tumor in the right colon - in 46.2% of patients. More often, biosimilar bevacizumab was added to first-line chemotherapy (53.8%), mainly with oxaliplatin-containing regimens (61.5%). The median follow-up period was only 6 months, so the median patient life expectancy has not yet been reached. Bevacizumab-associated toxicity was limited only to arterial hypertension. The latter was registered in four patients, and only one of them had degree 3 hypertension. Conclusion. With insufficient median follow-up period, it is impossible to speak about the real survival of patients who received chemotherapy in combination with biosimilar bevacizumab manufactured by Biocad company. Biosimilar bevacizumab has acceptable toxicity. Observational study with a larger number of patients is required.

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About the authors

Mikhail Yu. Fedyanin

N.N. Blokhin National Medical Research Center of Oncology

Email: fedianinmu@mail.ru
MD, Senior Researcher at the Department of Clinical Pharmacology and Chemotherapy

Kh. Kh.-M Elsnukaeva

N.N. Blokhin National Medical Research Center of Oncology

I. A Pokataev

N.N. Blokhin National Medical Research Center of Oncology

O. V Sekhina

N.N. Blokhin National Medical Research Center of Oncology

D. A Chekini

N.N. Blokhin National Medical Research Center of Oncology

A. A Bulanov

N.N. Blokhin National Medical Research Center of Oncology

A. A Tryakin

N.N. Blokhin National Medical Research Center of Oncology

S. A Tyulyandin

N.N. Blokhin National Medical Research Center of Oncology

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