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Efficacy and safety of bevacizumab biosimilars versus original drugs for patients with metastatic colorectal cancer: a Meta-analysis

Published on Dec. 30, 2023Total Views: 1105 times Total Downloads: 514 times Download Mobile

Author: En-Hui WEN 1 Ying LI 2 Zhi-Ying WANG 3 Li-Hui LONG 1

Affiliation: 1. Clinical Pharmaceutics Room, the First Afiliated Hospital of Xi’an Medical University, Xi’an 710077, China 2. Department of Traditional Chinese Medicine, Xi’an Mental Health Center, Xi’an 710061, China 3. College of Pharmacy, Xi’an Medical University, Xi’an 710021, China

Keywords: Bevacizumab Biosimilar Metastatic colorectal cancer Meta-analysis Randomized controlled trial

DOI: 10.19960/j.issn.1005-0698.202312010

Reference: En-Hui WEN, Ying LI, Zhi-Ying WANG, Li-Hui LONG.Efficacy and safety of bevacizumab biosimilars versus original drugs for patients with metastatic colorectal cancer: a Meta-analysis[J].Yaowu Liuxingbingxue Zazhi,2023, 32(12):1401-1407.DOI: 10.19960/j.issn.1005-0698.202312010.[Article in Chinese]

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Abstract

Objective  To systematically review the efficacy and safety of bevacizumab biosimilars versus original drugs in treatment of  metastatic colorectal cancer.

Methods  PubMed, Embase, Cochrane Library, CNKI, WanFang Data, VIP and SinoMed databases were electronically searched to collect the randomized controlled trials (RCTs) of bevacizumab biosimilar in patients with metastatic colorectal cancer from inception to June 18, 2023. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies, and a meta-analysis was conducted using Stata 17.0 software.

Results  A total of 4 RCTs involving 1 052 patients were included. The results of meta-analysis showed that no significant difference was found in overall response rate (RD=﹣0.01, 95%CI ﹣0.06 to 0.05, P=0.86), progression free survival (HR=1.00, 95%CI 0.91 to 1.09, P=0.94), the total incidence of adverse drug reactions (RR=1.05, 95%CI 0.85 to 1.31, P=0.91) and the incidence of severe adverse events (RR=0.886, 95%CI 0.377 to 2.081, P=0.60) between bevacizumab biosimilars group and original drugs group.

Conclusion  The current evidence shows that bevacizumab biosimilar is equivalent to original drugs in treatment of  metastatic colorectal cancer. Due to limited quality and quantity of the included studies, more high quality studies are required to verify the above conclusions.

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References

1.Cervantes A, Adam R, Roselló S, et al. Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up[J]. Ann Oncol, 2023, 34(1): 10-32. DOI: 10.1016/j.annonc.2022.10.003.

2.Casak SJ, Lemery SJ, Chung J, et al. FDA's approval of the first biosimilar to bevacizumab[J]. Clin Cancer Res, 2018, 24(18): 4365-4370. DOI: 10.1158/1078-0432.CCR-18-0566.

3.中国临床肿瘤学会(CSCO)抗淋巴瘤联盟. 生物类似药临床应用专家共识[J]. 白血病·淋巴瘤, 2021, 30(3): 129-136. DOI: 10.3760/cma.j.cn115356-20210117-00018.

4.姜时雨, 石远凯. 生物类似药在肿瘤领域中的发展现状[J]. 中华肿瘤杂志, 2017, 39(10): 721-725. [Jiang SY, Shi YK. The development of biosimilars in oncology[J]. Chinese Journal of Oncology, 2017, 39(10): 721-725.] DOI: 10.3760/cma.j.issn.0253-3766.2017.10.001.

5.周莉婷, 胡莹莹, 徐隆昌, 等. 贝伐珠单抗生物类似药质量相似性评价探讨[J]. 中国生物工程杂志, 2020, 40(11): 102-109. [Zhou LT, Hu YY, Xu LC, et al. Discussion on the quality similarity assessment of bevacizumab biosimilar[J]. China Biotechnology, 2020, 40(11): 102-109.] DOI: 10.13523/j.cb.2007024.

6.王变珍, 文勇, 卢剑锋, 等. 贝伐珠单抗生物类似药临床前药代动力学的相似性评价[J]. 中国生物制品学杂志, 2020, 33(4): 402-409. [Wang BZ, Wen Y, Lu JF, et al. Preclinical evaluation on similarity of pharmacokinetic of bevacizumab biosimilar[J]. Chinese Journal of Biologicals, 2020, 33(4): 402-409.] DOI: 10.13200/j.cnki.cjb.003032.

7.王攀, 孙瑞芳. 贝伐珠单抗生物类似药与Avastin药代动力学对比研究分析[J]. 中国临床药理学杂志, 2020, 36(7): 880-882, 886. [Wang P, Sun RF. Comparative study on the pharmacokinetics of bevacizumab and Avastin[J]. The Chinese Journal of Clinical Pharmacology, 2020, 36(7): 880-882, 886.] DOI: 10.13699/j.cnki.1001-6821. 2020.07.044.

8.中国药品综合评价指南项目组. 中国药品综合评价指南参考大纲(第二版) [J]. 药品评价, 2015, 12(8): 6. DOI: 10.3969/j.issn.1672-2809.2015.08.001.

9.Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1) [J]. Eur J Cancer, 2009, 45(2): 228-247. DOI: 10.1016/j.ejca.2008.10.026.

10.National Cancer Institute. Common terminology criteria for adverse events v.5.0 (CTCAE)[EB/OL]. (2017-11-27)[2022-10-10]. http:// ctep.cancer.gov/protocol Development/electronic_.

11.Higgins JP, Altman DG, Gøtzsche PC, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials[J]. BMJ, 2011, 343: d5928. DOI: 10.1136/bmj.d592.

12.李柄辉, 訾豪, 李路遥, 等. 医学领域一次研究和二次研究的方法学质量(偏倚风险)评价工具[J].医学新知, 2021, 31(1): 51-58. [Li BH, Zi H, Li LY, et al. Methodological quality (risk of bias) assessment tools for primary and secondary medical studies: what are they and which is better?[J]. New Medicine, 2021, 31(1): 51-58.]DOI: 10.12173/j.issn.1004-5511.2021.01.07.

13.Advani S, Biswas G, Sinha S, et al. A prospective, randomized, multiple-dose, multi-center, comparative clinical study to evaluate the efficacy, safety, immunogenicity of a biosimilar bevacizumab (Test product, Hetero) and reference medicinal product (Bevacizumab, Roche) in patients of metastatic colorectal cancer[J]. J Assoc Physicians India, 2018, 66(6): 55-59. https://pubmed.ncbi.nlm.nih.gov/31331137/.

14.Qin S, Li J, Bai Y, et al. Efficacy, safety, and immunogenicity of HLX04 versus reference bevacizumab in combination with XELOX or mFOLFOX6 as first-line treatment for metastatic colorectal cancer: results of a randomized, double-blind phase III study[J]. BioDrugs, 2021, 35(4): 445-458. DOI: 10.1007/s40259-021-00484-9.

15.Romera A, Peredpaya S, Shparyk Y, et al. Bevacizumab biosimilar BEVZ92 versus reference bevacizumab in combination with FOLFOX or FOLFIRI as first-line treatment for metastatic colorectal cancer: a multicentre, open-label, randomised controlled trial[J]. Lancet Gastroenterol Hepatol, 2018, 3(12): 845-855. DOI: 10.1016/S2468-1253(18)30269-3.

16.Rezvani H, Mortazavizadeh SM, Allahyari A, et al. Efficacy and safety of proposed bevacizumab biosimilar BE1040V in patients with metastatic colorectal cancer: a phase Ⅲ, randomized, double-blind, noninferiority clinical trial [J]. Clin Ther, 2020, 42(5): 848-859. DOI: 10.1016/j.clinthera.2020.03.009.

17.Tebbutt NC, Wilson K, Gebski VJ, et al. Capecitabine, bevacizumab, and mitomycin in first-line treatment of meta-static colorectal cancer: results of the Australasian gastro-intestinal trials group randomized phaseⅢ MAX study[J]. J Clin Oncol, 2010, 28(19): 3191-3198. DOI: 10.1200/JCO.2009.27.7723.

18.Cunningham D, Lang I, Marcuello E, et al. Bevacizumab plus capecitabine versus capecitabine alone in elderly patients with previously untreated metastatic colorectal cancer (AVEX): an open- label, randomised phase 3 trial[J]. Lancet Oncol, 2013, 14(11): 1077-1085. DOI: 10.1016/S1470-2045(13)70154-2.

19.Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for meta-static colorectal cancer[J]. N Engl J Med, 2004, 350(23): 2335-2342. DOI: 10.1056/NEJMoa032691.

20.国家药品监督管理局药品审评中心. 晚期结直肠癌新药临床试验设计指导原则[EQ/OL]. (2021-12-29)[2022-09-12]. https://www.cde.org.cn/zdyz/domesticinfopage?zdyzIdCODE=6b8ecd73163f0f8679280f7b002e74db.

21.谢曌璐, 张卿, 杨雪, 等. 贝伐珠单抗首次使用后出现肠梗阻1例[J]. 肿瘤药学, 2021, 11(3): 378-380, 384. [Xie ZL, Zhang Q, Yang X, et al. A case of intestinal obstruction after the first use of bevacizumab[J]. Anti-tumor Pharmacy, 2021, 11(3): 378-380, 384.] DOI: 10.3969/j.issn.2095-1264.2021.03.25.

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