Analysis of post-marketing adverse reactions of ametinib

doi:10.19803/j.1672-8629.20240089

Abstract

Abstract: Objective To analyze the incidence of adverse reactions of the third-generation EGFR-TKI aumolertinib, and to provide reference for rational use of the drug in clinic. Methods PubMed, Embase, Web of Science, The Cochrane Library, CNKI, and WanFang Data and SinoMed database were searched to retrieve the literature on post-marketing adverse reactions of aumolertinib that was published from the inception to 16 January 2024 and to perform statistical analyses. Results A total of 12 articles were included in the study, and data on safety was collected from 263 patients. There were 246 adverse reactions caused by ametinib, which were mainly manifested as rash/acne-like rash (17.9%), increased transaminases (12.6%), onychomycosis (7.3%), haematological and lymphatic system disorders (6.1%), and generalized malaise (5.7%). A total of 11 adverse reactions ≥ grade 3 occurred, and the prognosis was good. Conclusion The adverse reactions of aumolertinib have diverse manifestations, and the effect on the skin and liver function is more obvious. Clinicians are advised to be alert to the occurrence of adverse reactions.

Key words: aumolertinib, EGFR-TKI, non-small cell lung cancer, adverse reactions, literature analysis, rational drug use

CLC Number:

R994.11

SUN Xuelin, DU Jiao, TAN Qin, HU Xin, ZHANG Yatong, ZHENG Li. Analysis of post-marketing adverse reactions of ametinib[J]. Chinese Journal of Pharmacovigilance, 2024, 21(6): 683-686.

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References

[1] Oncology Society of Chinese Medical Association, Chinese Medical Association Publishing House. Chinese Medical Association guideline for clinical diagnosis and treatment of lung cancer (2023 edition)[J]. Chin J Oncol, 2023, 45(7): 539-574.
[2] LAHIRI A, MAJI A, POTDAR PD, et al.Lung cancer immunotherapy: progress, pitfalls, and promises[J]. Mol Cancer, 2023, 22(1): 40.
[3] SHI Y, AU JS, THONGPRASERT S, et al.A prospective, molecular epidemiology study of EGFR mutations in Asian patients with advanced non-small-cell lung cancer of adenocarcinoma histology (PIONEER)[J]. J Thorac Oncol, 2014, 9(2): 154-162.
[4] HUANG JX, WANG H.Targeted therapy and mechanism of drug resistance in non-small cell lung cancer with epidermal growth factor receptor gene mutation[J]. Chin J Lung Cancer(中国肺癌杂志), 2022, 25(3): 183-192.
[5] HOU J, SUN J, DENG XY, et al.Application of aumolertinib for epidermal growth factor receptor mutationpositive non-small cell lung cancer[J]. Central South Pharmacy, 2022, 20(8): 1856-1860.
[6] YANG J CH, CAMIDGE D R, YANG CT, et al.Safety, Efficacy, and pharmacokinetics of almonertinib (HS-10296) in pretreated patients with EGFR-mutated advanced NSCLC: a multicenter, open-label, Phase 1 Trial[J]. Journal of Thoracic Oncology, 2020, 15(12): 1907-1918.
[7] LU S, WANG Q, ZHANG G, et al.Efficacy of aumolertinib (HS-10296) in patients with advanced EGFR T790M + NSCLC: updated post-national medical products administration approval results from the APOLLO registrational trial[J]. J Thorac Oncol, 2022, 17(3): 411-422.
[8] YANG GX, CHENG YT, LIU LL, et al.Clinical trial of ametinib tablets combined with bevacizumab injection in the treatment of advanced non - small cell lung cancer patients with epidermal growth factor receptor mutation[J]. Chin J Clin Pharmoco, 2023, 39(11): 1528-1532.
[9] WANG HF, WANG Y, LI YR, et al.A case of Stevens-Johnson syndrome caused by almonertinib[J]. Chin J Hosp Pharm, 2023, 11: 1296-1298.
[10] OUYANG LH, HE GF, HUANG JJ, et al.A medication analysis of rhabdomyolysis after amitinib in patients with lung cancer[J]. Central South Pharmacy, 2022, 20(6): 1463-1466.
[11] LI TX, GUO XX, CHEN Y.A case of interstitial lung disease in a patient with non-small cell lung cancer due to targeted therapy with alectinib[J]. China Pharmacist, 2022, 25(11): 2000-2001.
[12] JIAO CC, ZHOU F, CHEN WX, et al.The efficacy of almonertinib in the second line treatment of patients with NSCLC harbo-ring EGFR mutations[J]. Modern Oncology, 2022, 30(24): 4462-4466.
[13] HUANG ZD.Neoadjuvant aumonertinib in potential resectable stage III EGFRmutation-positive lung adenocarcinom[D]. Nanchang: Nanchang University, 2023.
[14] HUANG JX.To observe the clinical efficacy of almonertinib in the treatment of patients with advanced lung adenocarcinoma[D]. Guangzhou: Southern Medical University, 2023.
[15] HAN SS, CAI J, MA JA.Analysis of cutaneous adverse drug reactions induced by epidermal growth factor receptor inhibitors in 116 patients with non small cell lung cancer[J]. Pharmaceutical and Clinical Research, 2023, 31(5): 458-461.
[16] HAN Q, SU FY, SONG ZC, et al.Clinical trial of amitinib tablets in the treatment of patients with advanced non-small cell lung cancer[J]. Chin J Clin Pharmacol, 2022, 38(15): 1723-1726.
[17] ZHOU Q, HU Z, LI X, et al.Almonertinib-induced interstitial lung disease in a lung adenocarcinoma patient complicated with interstitial lung abnormality[J]. BMC Pulm Med, 2023, 23(1): 79.
[18] LI T, CHANG KJ, QIU X, et al.A pilot study of anlotinib with third-generation epidermal growth factor receptor tyrosine kinase inhibitors in untreated EGFR-mutant patients with advanced non-small cell lung cancer[J]. Translational Lung Cancer RESEARCH, 2023, 12(6):1256-1263.
[19] JIANG T, LUO YY, WANG BB.Almonertinib-induced interstitial lung disease A case report[J]. Medicine, 2021, 100(3): e24393.
[20] Chinese Society of Clinical Oncology. The 2023 edition of the Chinese Society of Clinical Oncology (CSCO) guidelines for the diagnosis and treatment of NSCLC(中国临床肿瘤学会(CSCO)非小细胞肺癌诊疗指南2023年版)[M]. Beijing: People’s Medical Publishing House, 2023.
[21] U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE) v5.0[EB/OL]. (2017-11-27)[2024-04-24]. https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_50.
[22] CHANG HC, WANG TJ, LIN MH, et al.A review of the systemic treatment of Stevens-Johnson syndrome and toxic epidermal Necrolysis[J]. Biomedicines, 2022, 10(9): 2105.
[23] GARG VK, BUTTAR HS, BHAT SA, et al.stevens-johnson Syndrome and toxic epidermal necrolysis: an overview of diagnosis, Therapy Options and Prognosis of Patients[J]. Recent Adv Inflamm Allergy Drug Discov, 2023, 17(2): 110-120.
[24] TORRES PA, HELMSTETTER JA, KAYE AM, et al.Rhabdomyolysis: pathogenesis, diagnosis, and treatment[J]. Ochsner J, 2015, 15(1): 58-69.
[25] GUPTA A, THORSON P, PENMATSA KR, et al.Rhabdomyolysis: revisited[J]. Ulster Med J, 2021, 90(2): 61-69.