285 cases of adverse drug reaction related to new antineoplastic drugs

doi:10.19803/j.1672-8629.20230358

Abstract

Abstract: Objective To study the patterns and characteristics of adverse reaction (ADR) related to new antineoplastic drugs, and provide reference for clinical medication. Methods A total of 285 cases of ADR caused by new antineoplastic drugs were collected in a tertiary general hospital from January 2018 to March 2023. The data on the gender, age, systems-organs involved in ADR, clinical manifestations, off-label medication, grading and outcomes of ADR and correlations was analyzed via the Microsoft Excel and SPSS software. Results Among the 285 cases of ADR, 155 (54.39%) involved males and 130 (45.61%) involved females, and the average age was (54.98±13.175) years. There were 426 cases of clinical manifestations and 12 systems-organs were involved. The digestive system (44.13%) and blood and hematopoietic system(19.01%) were more vulnerable. There were 51 cases of severe ADR, and 6 cases of new general ADR. There were 33 new anti-tumor drugs involved. Macromolecular monoclonal drugs, especially immune checkpoint inhibitors, caused more ADR, among which carrelizumab caused the largest number of cases (66 cases). One hundred and eighteen of these cases involved off-label medication, and the rate was as high as 63.10%. Conclusion ADR associated with novel antineoplastic drugs can occur among patients of any age, and involve multiple organs-systems. New antineoplastic drugs induce more serious ADR than new ADR,and many of these ADR are related to off-label drug use. It is recommended that off-label drug use be adopted, pharmaceutical care provided, and the safety and effectiveness of drug use improved for patients.

Key words: new antineoplastic drugs, adverse drug reaction, off-label medication, national medical insurance negotiation, macromolecular monoclonal drugs, digestive system, blood and hematopoietic system

CLC Number:

XU Weijia, PENG Qi, HUANG Haiyu, ZHANG Leijiao, XIAO Hua, WU Xue. 285 cases of adverse drug reaction related to new antineoplastic drugs[J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 199-203.

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References

[1] National Health Commission Medical Affairs Bureau. Notice of the General Office of the National Health Commission on Printing and Distributing the Guiding Principles for the Clinical Application of New Anti-tumor Drugs (2022 Edition): National Health Office Medical Policy Letter [2022] No. 465[EB/OL].(2020-12-22)[2023-10-18]. http://www.nhc.gov.cn/yzygj/s7659/202212/8df034c9afb44a9d95cd986d4e12fbd8.shtml.
[2] National Health Commission of the People’s Republic of China. The Measures for the Administration of the Clinical Application of Antineoplastic Drugs (for Trial Implementation)[EB/OL].(2020-12-28)[2023-10-18]. http://www.nhc.gov.cn/yzygj/s7659/202012/a7600740bed44d1db7015ca5a1be2cc0.shtml.
[3] NMPA. Measures for the Reporting and Monitoring of Adverse Drug Reactions[EB/OL].(2011-05-04)[2023-10-18]. https://www.nmpa.gov.cn/yaopin/ypfgwj/ypfgbmgzh/20110504162501325.html.
[4] KOU W, GUO DH, TIAN XY, et al.Analysis of 15183 cases of ADR caused by antineoplastic drugs[J]. China Pharmacy(中国药房), 2018, 26(4): 508-511.
[5] YANG L, SHI ZHY, WANG SM.Analysis of adverse drug reaction reports of a class A hospital in Beijing from 2005 to 2021[J]. The Chinese Journal of Clinical Pharmacology(中国临床药理学杂志), 2023, 39(2): 286-289.
[6] CAO MM, CHENG WQ.Epidemiology of cancer in China and the current status of prevention and control[J]. Chin J Clin Oncol(中国肿瘤临床), 2019, 46(3): 145-149.
[7] XU J, ZHANG Y, JIA R, et al.Anti-PD-1 antibody SHR-1210 combined with apatinib for advanced hepatocellular carcinoma, gastric, or esophagogastric junction cancer: an open- label, dose escalation and expansion study[J]. Clin Cancer Res, 2019, 25(2): 515-523.
[8] HUANG J, MO H, ZHANG W, et al.Promising efficacy of SHR-1210, a novel anti programmed cell death 1 antibody, in patients with advanced gastric and gastroesophageal junction cancer in China[J]. Cancer, 2019, 125(5): 742-749.
[9] ZHANG L, TAN L, LU J.Expert consensus on off-label drug use[J]. Journal of Adverse Drug Reactions(药物不良反应杂志), 2015, 17(2): 101-103.
[10] LIU H, LIU Y, HUANG YH, et al.Literature analysis of adverse drug reactions induced by alectinib[J]. China Pharmacy, 2021, 32(16): 2019-2021.
[11] GADOTTI LL, NOGUEIRA ACFS, RIBEIRO MFSA, et al.Successful drug rechallenge following severe acute alectinib-induced interstitial lung disease in a patient with advanced ALK-rearranged lung ade-nocarcinoma[J]. Clin Lung Cancer, 2021, 22(3): e481-e486.
[12] HUANG JR, CHOU CW, CHAO HS.Successful rechallenge of alectinib after remission of severe alectinib-induced interstitial lung disease[J]. J Oncol Pharm Pract, 2021, 27(5): 1311-1314.
[13] HWANG A, ISKANDAR A, DASANU CA.Successful re-introduction of alectinib after inducing interstitial lung disease in a patient with lung cancer[J]. J Oncol Pharm Pract,2019,25(6): 1531-1533.
[14] CAMIDGE DR, DZIADZIUSZKO R, PETERS S, et al.Updated efficacy and safety data and impact of the EML4-ALK fusion variant on the efficacy of alectinib in untreated ALK-positive advanced non-small cell lung cancer in the global phase III ALEX study[J]. J Thorac Oncol, 2019, 14(7): 1233-1243.
[15] TAI XJ, MA HF, LI J, et al.400 reports on adverse drug reactions associated with antineoplastic drugs[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2022, 19(5): 541-549.
[16] Anticancer Drug-induced Interstitial Lung Disease Management Group. Expert consensus on the diagnosis and treatment of anticancer drug-induced interstitial lung disease[J]. Chinese Journal of Oncology(中华肿瘤杂志), 2022, 44(7): 693-702.
[17] ZHU XL.A case of small-cell carcinoma interstitial lung cancer caused by amlotinib[J]. Chinese Journal of Hospital(中国医院药学杂志), 2020, 40(2): 240-241.
[18] Chinese Society of Lung Cancer, Chinese Anti-Cancer Association. EGFR-TKI ADR management Chinese expert consensus[J].Chin J Lung Cancer(中国肺癌杂志), 2019, 22(2): 57-81.
[19] Chinese Society of Clinical Oncology Anti-Tumor Drug safety Management Expert Committee, Chinese society of Clinical Oncology Immunotherapy Expert Committee. Expert consensus on the clinical diagnosis and treatment of RECCP induced by camrelizumab[J]. Chinese Clinical Oncology(临床肿瘤学杂志), 2020, 25(9):840-848.
[20] NAING A, HAJJAR J, GULLEY JL, et al.Strategies for improving the management of immune-related adverse events[J]. J Immunother Cancer, 2020, 8(2): e001754.
[21] Oncologists Branch of the Chinese Medical Association, Expert Committee on Vascular Targeted Therapy of the Chinese Society of Clinical Oncology. Expert consensus on the treatment of advanced non-small cell lung cancer with arotinib hydrochloride[J]. Natl Med J China(中华医学杂志), 2018, 98(44): 3561-3567.
[22] Chinese society of Clinical Oncology Guideline Working Committee. Guidelines for Toxicity Management Related to ICPI(2021) ( ICPi相关的毒性管理指南2021)[M]. Beijing: People’s Health Publishing House, 2021: 41-42.
[23] HOOFNAGLE JH, BJRNSSON ES.Drug-induced liver injury-types and pheno types[J]. The New England Journal of Medicine, 2019, 381: 264-273.
[24] RIELLA LV, PATERSON AM, SHARPE AH, et al.Role of the PD-1 pathway in the immune response[J]. American Society of Transplant Surgeons, 2012, 12(10) : 2575-2587.
[25] MA XQ, CHENG Y, CHEN YX.Research progress of proteinuria associated with vascular endothelial growth factor inhibitors[J]. Chinese Clinical Oncology(临床肿瘤学杂志), 2015, 20(4): 357-362.
[26] XU WJ, GAO Y, WU X.Experience of clinical pharmacists participating in multidisciplinary collaborative diagnosis and treatment and pharmaceutical practice of patients with advanced lung cancer[J]. Chinese Journal of Drug Application and Monitoring(中国药物应用与监测), 2021, 18(4): 242-244.