289 cases of adverse drug reactions associated with monoclonal antibody antitumor drugs

doi:10.19803/j.1672-8629.20210679

Abstract

Abstract: Objective To analyze the patterns and characteristics of adverse drug reactions（ADR）caused by monoclonal antibody anticancer drugs in order to facilitate clinical treatment. Methods A total of 289 cases of ADR induced by monoclonal antibody anticancer drugs between 2016 and 2020 were collected from Shaanxi Province Adverse Drug Reaction Center before being analyzed statistically．Results In these 289 ADR reports, five types of antineoplastic drugs were involved．The majority of the patients with ADR were over 40 years old and female patients outnumbered male ones. Gamage to blood systems was the dominating ADR, followed by damage to the digestive system, systemic reactions, and damage to the skin and accessories. The ADR were similar in that a large proportion of them were induced by bone marrow suppressors. However, many of the symptoms of the digestive tract were caused by bevacizumab and trastuzumab. The skin toxicity of cetuximab and pertuzumab was obvious. Rituximab was likely to cause shivering and high fever. These five types of drugs were mainly given by intravenous drip, but there were still eleven cases of intravenous injection or intrapleural administration. Rituximab caused the large number of severe ADR (34 cases) such as myelosuppression and high fever, followed by bevacizumab (27 cases), the main ADR of which was myelosuppression. 86.51% of the ADR were cured and improved. However, one elderly female patient with colon cancer developed colonic perforation 20 days after bevacizumab treatment and died one month later. Conclusion The incidence of ADR caused by monoclonal antibody anticancer drugs is closely related to the patient's age, route of administration and types of drugs. Some drugs that require special usage and considerations deserve attention. In order to use monoclonal antibody antitumor drugs properly, clinicians should take into account the patient's conditions and the characteristics of drugs in order to prevent ADR.

Key words: anticancer drug, monoclonal antibody, bevacizumab, trastuzumab, cetuximab, pertuzumab, rituximab, adverse drug reaction

CLC Number:

LUO Shishu, QU Jie, ZHOU Nan, XU Cuixiang, LIU Yi, ZHANG Lijie, WANG Jianhua. 289 cases of adverse drug reactions associated with monoclonal antibody antitumor drugs[J]. Chinese Journal of Pharmacovigilance, 2023, 20(4): 444-448.

References

[1] BRUCE AC, LONGO DL.Harrison's Manual of Oncology(哈里森肿瘤学手册)[M]. Second edition. Beijing: Science Press, 2017.
[2] National Health Committee of the People's Republic of China. About the printing of antineoplastic drugs clinical application management approach (trial)[S]. 2020.
[3] The Ministry of Health of the People's Republic of China. Adverse drug reaction report and monitoring measures for the administration[S]. 2011.
[4] ZHANG SG, ZHU JM.The treatment and prevention of adverse drug reactions(药品不良反应的预防与治疗)[M]. Beijing: Beijing Science and Technology Press, 2016.
[5] YANG BF.Pharmacology(药理学) [M]. Ninth Edition. Beijing: People's Medical Publishing House, 2018.
[6] ZENG WH.Clinical analysis and report of adverse drug reactions in elderly patients[J]. Contemporary Medicine(当代医学), 2017, 23(6): 23-24.
[7] CHANG YF, NIU JQ.The analysis of the adverse drug reactions of the aged and the intervention of the rational use[J]. Smart Healthcare(智慧健康), 2020, 6(5): 151-152.
[8] CHENG J, HAN Y, WANG L, et al.Analysis of 54 cases of adverse drug reactions induced by new antitumor drugs[J]. Chinese Journal of New Drugs(中国新药杂志), 2021, 30(3): 280-284.
[9] WANG MM, MA JL, WANG XH, et, al. Analysis of 117 cases of adverse drug reactions induced by bevacizumab injection[J]. Evaluation and Analysis of Drug-use in Hospitals of China(中国医院用药评价与分析), 2020, 20(7): 872-875.
[10] YU WT, WANG YX, JIANG G.Bibliometric analysis of bevacizumab-induced ADR[J]. China Pharmacy(中国药房), 2017, 28(2): 190-193.
[11] LIU XZ, XU ZB, ZHANG XY.Meta-analysis of efficacy and security of bevacizumab combined with platinum in the treatment of advanced non-small-cell lung cancer[J]. Chinese Journal of Modern Applied Pharmacy(中国现代应用药学), 2015, 32(11): 1382-1388.
[12] FARIBA A, NCHARLOTTE OMT, ANTHONIUS DB, et a1. Efficacy and safety assessment of the addition of bevacizumab to adjuvant therapy agents in cancer patients: a systematic review and meta-analysis of randomized controlled trials[J]. Plos one, 2015, 10(9): e0136324.
[13] ZHU D, CAO X, SONG YQ, et al.443 Cases of drug-induced adverse reactions in blood system[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2021, 4(18): 356-360.
[14] NING LJ, SU D, HUANG Y, et al.Analysis of serious adverse drug reactions of patients with malignant tumors in a grade-a class 3 hospital[J]. Pharmaceutical Services, 2020, 2(29): 40-42.
[15] ZHANG F, ZHOU WQ.Management of infusion reactions to systemic anticancer therapy: ESMO clinical practice guidelines-an interpretation[J]. Journal of Nursing Science(护理学杂志), 2018, 9(33): 16-20.
[16] MAGGI E,VUHAGGIO A, MATUCCI. Acute infusion reactions induced by monoclonal antibody therapy[J].Expert Rev Clin Immunol, 2011, 7(1): 55-63.
[17] VUHAGGIO A, CASTELLS MC.Hypersensitivity reactions to biologic agents[J].Immunol Allergy Clin North Am, 2014, 34(3): 615-632.
[18] GUAN M, ZHOU YP, SUN JL, et al.Adverse events of monoclonal antibodies used for cancer therapy[J]. Biomed Res Int, 2015, 2015: 428169.
[19] VOGEL WH.Infusion reactions: diagnosis, assessment, and management[J].Clin J Oncol Nurs, 2010, 14(2):10-21.
[20] TANG YX, FENG XM, ZHANG JX, et al.Therapeutic assessment of Bevacizumab injection into serous cavity in treatment of non -small cell lung cancer with malignant serous cavity effusion and analysis of predictive factors[J]. Journal of Navy Medicine(海军医学杂志), 2021, 3(42): 188-195.
[21] MAO K.Investigation and analysis on adverse reactions induced by antineoplastic drugs in our hospital from 2015 to 2019[J]. China Medicine and Pharmacy(中国医药科学), 2021, 2(11): 165-167.
[22] WANG NN, BAI Y, LIU H, et al.Characteristics of adverse reactions of antineoplastic drugs in 787 cases and the prognosis analysis[J]. Anti-tumor Pharmacy(肿瘤药学), 2019, 2(9): 143-148.