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


如何引用文章

全文:

开放存取 开放存取
受限制的访问 ##reader.subscriptionAccessGranted##
受限制的访问 订阅或者付费存取

详细

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.

全文:

受限制的访问

作者简介

Mikhail 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. Elsnukaeva

N.N. Blokhin National Medical Research Center of Oncology

I. Pokataev

N.N. Blokhin National Medical Research Center of Oncology

O. Sekhina

N.N. Blokhin National Medical Research Center of Oncology

D. Chekini

N.N. Blokhin National Medical Research Center of Oncology

A. Bulanov

N.N. Blokhin National Medical Research Center of Oncology

A. Tryakin

N.N. Blokhin National Medical Research Center of Oncology

S. Tyulyandin

N.N. Blokhin National Medical Research Center of Oncology

参考

  1. Hurwitz H., Fehrenbacher L., Novotny W., et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N. Engl J. Med. 2004;350(23):2335-42.
  2. Jang H.J., Kim B.J., Kim J.H., Kim H. The addition of bevacizumab in the first-line treatment for metastatic colorectal cancer: an updated metaanalysis of randomized trials. Oncotarget. 2017;8(42):73 009-16. Doi: 10.18632/ oncotarget.20314.
  3. Орлов С.В., Фогт С.Н., Шустовр М.С. Успешная регистрация отечественного биоаналога бевацизумаба - новые возможности эффективной терапии больных неплоскоклеточным немелкоклеточным раком легкого. Исследования и практика в медицине. 2015;2(4):132-36.
  4. Reinacher-Schick A.C., Arnold D., Dietrich G., et al. Activity of the combination of bevacizumab (Bev) with capecitabine/irinotecan (CapIri/Bev) or capecitabine/oxaliplatin (CapOx/Bev) in advanced colorectal cancer (ACRC): A randomized phase II study of the AIO Colorectal Study Group (AIO trial 0604). J Clin Oncol. 2008;26:A4030.
  5. Giantonio B.J., Catalano P.J., Meropol N.J., et al. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol. 2007;25(12):1539-44
  6. Jain R.K. Normalization of tumor vasculature: An emerging concept in antiangiogenic therapy. Science. 2005;307:58-62
  7. Aparicio T., Ghiringhelli F., Boige V., et al. Bevacizumab maintenance Versus No Maintenance During Chemotherapy-Free Intervals in metastatic colorectal cancer: a randomized phase III trial (PRODIGE 9). J Clin Oncol. 2018 Mar 1,36(7): 674-81. doi: 10.1200/JCO.2017.75.2931.
  8. Hurwitz H.I., Tebbutt N.C., Kabbinavar F., et al. Efficacy and safety of bevacizumab in metastatic colorectal cancer: pooled analysis from seven randomized controlled trials. Oncologist. 2013;18(9):1004-12. Doi: 10.1634/ theoncologist.2013-0107.
  9. Venook A.P., Niedzwiecki D., Innocents F., et al. Impact of primary (1°) tumor location on overall survival (OS) and progression-free survival (PFS) in patients (pts) with metastatic colorectal cancer (mCRC): Analysis of CALGB/SWOG 80405 (Alliance). J Clin Oncol. 2016;34:3504.
  10. Hiret S., Christophe B., Bertaut A, et al. Bevacizumab or cetuximab plus chemotherapy after progression with bevacizumab plus chemotherapy in patients with wtKRAS metastatic colorectal cancer: A randomized phase II study (Prodige 18 - UNICANCER GI). J Clin Oncol. 2016,34:3514.

补充文件

附件文件
动作
1. JATS XML

版权所有 © Bionika Media, 2018
##common.cookie##