[1]李萍,庄捷,孙红,等.间变性淋巴瘤激酶抑制剂的遴选量化评估[J].福建医药杂志,2025,47(01):1-5.[doi:10.20148/j.fmj.2025.01.001]
　LI Ping,ZHUANG Jie,SUN Hong,et al.Selection and quantitative evaluation of anaplastic lymphoma kinase inhibitors[J].FUJIAN MEDICAL JOURNAL,2025,47(01):1-5.[doi:10.20148/j.fmj.2025.01.001]
点击复制

间变性淋巴瘤激酶抑制剂的遴选量化评估()
分享到：

《福建医药杂志》[ISSN:1002-2600/CN:35-1071/R]

卷:
47
期数:
2025年01期
页码:
1-5
栏目:
临床研究
出版日期:
2025-01-20

文章信息/Info

Title:
Selection and quantitative evaluation of anaplastic lymphoma kinase inhibitors
文章编号:
1002-2600(2025)01-0001-05
作者:
李萍; 庄捷; 孙红; 冯彩萍; 魏晓霞; 蔡加琴
福州大学附属省立医院药学部,福州 350001
Author(s):
LI Ping;  ZHUANG Jie;  SUN Hong;  FENG Caiping;  WEI Xiaoxia;  CAI Jiaqin
Department of Pharmacy, Fuzhou University Affiliated Provincial Hospital, Fuzhou, Fujian 350001, China
关键词:
克唑替尼;  塞瑞替尼;  阿来替尼;  布格替尼;  恩沙替尼;  洛拉替尼;  药品遴选
Keywords:
crizotinib;  ceritinib;  alectinib;  brigatinib;  ensartinib;  lorlatinib;  drug selection
分类号:
R979.1
DOI:
10.20148/j.fmj.2025.01.001
文献标志码:
B
摘要:
目的 通过对克唑替尼、塞瑞替尼、阿来替尼、布格替尼、恩沙替尼和洛拉替尼进行量化评估,为医疗机构遴选间变性淋巴瘤激酶抑制剂(ALK-TKIs)提供依据。方法 应用《中国医疗机构药品评价与遴选快速指南》的评价维度、评价细则及评价方法,对克唑替尼、塞瑞替尼、阿来替尼、布格替尼、恩沙替尼和洛拉替尼进行药品评价。结果 克唑替尼、塞瑞替尼、阿来替尼、布格替尼、恩沙替尼和洛拉替尼的遴选量化评估总分分别为79.12、80.50、79.99、82.00、70.14、79.31分。结论 根据评分结果,医疗机构在引入ALK-TKIs时,建议遴选的顺序依次为布格替尼、塞瑞替尼、阿来替尼、洛拉替尼、克唑替尼、恩沙替尼。
Abstract:
Objective To perform quantitative evaluation for crizotinib, ceritinib, alectinib, brigatinib, ensartinib and lorlatinib, so as to provide a basis for selecting anaplastic lymphoma kinase inhibitors(ALK-TKIs)for medical institutions. Methods The drug evaluation of crizotinib, ceritinib, alectinib, brigatinib, ensartinib and lorlatinib was carried out by using the evaluation dimensions, evaluation rules and evaluation methods of the " Quick Guidelines for Drug Evaluation and Selection in Chinese Medical Institutions". Results The overall score of crizotinib, ceritinib, alectinib, brigatinib, ensartinib and loratinib was 79.12, 80.50, 79.99, 82.00, 70.14, 79.31. Conclusion According to the score results, when introducing ALK-TKIs in medical institutions, the recommended selection order is brigatinib, ceritinib, alectinib, lorlatinib, crizotinib,and ensartinib.

参考文献/References:

[1] Duma N, Santana-Davila R, Molina J R. Non-small cell lung cancer: epidemiology, screening, diagnosis, and treatment[J]. Mayo Clin Proc, 2019, 94(8): 1623-1640.
[2] 赵志刚, 董占军, 刘建平. 中国医疗机构药品评价与遴选快速指南(第二版)[J]. 医药导报, 2023, 42(4): 447-456.
[3] 徐子钧, 胡继繁, 刘子玲. ALK阳性非小细胞肺癌靶向治疗耐药机制及治疗管理的研究进展[J]. 中国肿瘤临床, 2022, 49(5): 254-258.
[4] Zhao D, Chen J, Chu M, et al. Pharmacokinetic-based drug-drug interactions with anaplastic lymphoma kinase inhibitors: a review[J]. Drug Des Devel Ther, 2020, 14: 1663-1681.
[5] Gupta N, Wang X, Offman E, et al. Population pharmacokinetics of brigatinib in healthy volunteers and patients with cancer[J]. Clin Pharmacokinet, 2021, 60(2): 235-247.
[6] Horn L, Infante J R, Reckamp K L, et al. Ensartinib(X-396)in ALK-positive non-small cell lung cancer: results from a first-in-human phase Ⅰ/Ⅱ, multicenter study[J]. Clin Cancer Res, 2018, 24(12): 2771-2779.
[7] Ma Y, Pan H, Liu Y, et al. Ensartinib in advanced ALK-positive non-small cell lung cancer: a multicenter, open-label, two-staged, phase 1 trial[J]. J Thorac Dis, 2022, 14(12): 4751-4762.
[8] Chen J, OGorman M T, James L P, et al. Pharmacokinetics of lorlatinib after single and multiple dosing in patients with anaplastic lymphoma kinase(ALK)-positive non-small cell lung cancer: results from a global phase Ⅰ/Ⅱ Study[J]. Clin Pharmacokinet, 2021, 60(10): 1313-1324.
[9] Riely G J, Wood D E, Ettinger D S,et al.Non-small cell lung cancer, version 4.2024, NCCN clinical practice guidelines in oncology[J]. Journal of the National Comprehensive Cancer Network, 2024,22(4): 249-274.
[10] 中国临床肿瘤学会指南工作委员会. CSCO非小细胞肺癌诊疗指南2024[M]. 北京: 人民卫生出版社, 2024: 95-99.
[11] Solomon B J, Mok T, Kim D W, et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer[J]. N Engl J Med, 2014, 371(23): 2167-2177.
[12] Soria J C, Tan D S W, Chiari R, et al. First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer(ASCEND-4): a randomised, open-label, phase 3 study[J]. Lancet, 2017, 389(10072): 917-929.
[13] Mok T, Camidge D R, Gadgeel S M, et al. Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study[J]. Ann Oncol, 2020, 31(8): 1056-1064.
[14] Camidge D R, Kim H R, Ahn M J, et al. Brigatinib versus crizotinib in ALK inhibitor-naive advanced ALK-positive NSCLC: Final results of phase 3 ALTA-1L trial[J]. J Thorac Oncol, 2021, 16(12): 2091-2108.
[15] Horn L, Wang Z, Wu G, et al. Ensartinib vs crizotinib for patients with anaplastic lymphoma kinase-positive non-small cell lung cancer: a randomized clinical trial[J]. JAMA Oncol, 2021, 7(11): 1617-1625.
[16] Solomon B J, Bauer T M, Mok T S K, et al. Efficacy and safety of first-line lorlatinib versus crizotinib in patients with advanced, ALK-positive non-small-cell lung cancer: updated analysis of data from the phase 3, randomised, open-label CROWN study[J]. Lancet Respir Med, 2023, 11(4): 354-366.
[17] Jiang J, Zhao C, Zhang F, et al. ALK inhibitors in ALK-rearranged non-small cell lung cancer with and without brain metastases: systematic review and network meta-analysis[J]. BMJ Open, 2022, 12(9): e060782.
[18] Tao Y, Zhou Y, Tang L, et al. Toxicity profile of anaplastic lymphoma kinase tyrosine kinase inhibitors for patients with non-small cell lung cancer: a systematic review and meta-analysis[J]. Invest New Drugs, 2022, 40(4): 831-840.
[19] Gupta N, Hanley M J, Kerstein D, et al. Effect of severe renal impairment on the pharmacokinetics of brigatinib[J]. Invest New Drugs, 2021, 39(5): 1306-1314.
[20] Hanley M J, Kerstein D, Tugnait M, et al. Brigatinib pharmacokinetics in patients with chronic hepatic impairment[J]. Invest New Drugs, 2023, 41(3): 402-410.
[21] Morcos P N, Cleary Y, Sturm-Pellanda C, et al. Effect of hepatic impairment on the pharmacokinetics of alectinib[J]. J Clin Pharmacol, 2018, 58(12): 1618-1628.
[22] Lin S, Gong J, Canas G C, et al. A phase I study to evaluate the pharmacokinetics and safety of lorlatinib in adults with mild, moderate, and severe renal impairment[J]. Eur J Drug Metab Pharmacokinet, 2022, 47(2): 235-245.
[23] Team R. Lorlatinib(Lorbrena)[J]. Can J Health Technol, 2022, 2(4): 1-21.
[24] Zhao D, Chen J, Long X, et al. Dose adjustment for tyrosine kinase inhibitors in nonsmall cell lung cancer patients with hepatic or renal function impairment(Review)[J]. Oncol Rep, 2021, 45(2): 413-426.
[25] Tugnait M, Gupta N, Hanley M J, et al. Effects of strong CYP2C8 or CYP3A inhibition and CYP3A induction on the pharmacokinetics of brigatinib, an oral anaplastic lymphoma kinase inhibitor, in healthy volunteers[J]. Clin Pharmacol Drug Dev, 2020, 9(2): 214-223.
[26] Patel M, Chen J, McGrory S, et al. The effect of itraconazole on the pharmacokinetics of lorlatinib: results of a phase I, open-label, crossover study in healthy participants[J]. Invest New Drugs, 2020, 38(1): 131-139.
[27] Chen J, Xu H, Pawlak S, et al. The effect of rifampin on the pharmacokinetics and safety of lorlatinib: results of a phase one, open-label, crossover study in healthy participants[J]. Adv Ther, 2020, 37(2): 745-758.
[28] Morcos P N, Cleary Y, Guerini E, et al. Clinical drug-drug interactions through cytochrome P450 3A(CYP3A)for the selective ALK inhibitor alectinib[J]. Clin Pharmacol Drug Dev, 2017, 6(3): 280-291.
[29] 申越, 王睿, 高婧, 等. 非小细胞肺癌小分子的靶向治疗研究进展[J].世界肿瘤研究, 2022, 12(2): 90-98.
[30] 许佳艺,代展菁,卢钰琼,等.ALK-TKIs治疗ALK阳性非小细胞肺癌药物经济学的系统评价[J].中国循证医学杂志,2022,22(12):1428-1435.

更新日期/Last Update: 2025-01-20