DOI QR코드

DOI QR Code

Tyrosine Kinase 억제제와의 약물 상호작용이 약물 혈중농도 변화에 따라 부작용 발생에 미치는 영향: 메타분석 연구

The Impact of Drug Interactions with Tyrosine Kinase Inhibitors on Adverse Event Development based on the changes of drug concentration level: Meta-analysis

  • 황진아 (건양대학교 의약바이오학과) ;
  • 이희영 (인제대학교 약학과)
  • JinAh Hwang (Department of Medicinal Biosciences, Konyang University) ;
  • Heeyoung Lee (Department of Pharmacy, Inje University)
  • 투고 : 2024.03.10
  • 심사 : 2024.03.18
  • 발행 : 2024.03.31

초록

Background: Oral cancer drugs, particularly tyrosine kinase inhibitors (TKIs), are increasingly popular due to their convenience. However, they pose challenges like drug interactions, especially with medications like azole antifungals. While the FDA provides some guidance, more detailed information is needed to manage these interactions effectively. A meta-analysis was conducted to understand the impact of interactions between TKIs and azole antifungals on adverse events during clinical studies. Methods: A meta-analysis followed PRISMA guidelines. Data from PubMed, EMBASE, and references were searched until November 30, 2021. Inclusion criteria encompassed studies on TKI-antifungal interactions in English. Study selection and quality assessment were conducted by two independent investigators. Results: Out of 158 articles, 11 were selected for analysis. Combination therapy showed a slight increase in adverse events but was not statistically significant (OR 1.02, 95% CI 0.49-2.13, p=0.95). AUC and Cmax fold changes did not significantly impact adverse event development. Both itraconazole and ketoconazole showed no significant difference in adverse event development compared to TKI alone. Conclusions: Study finds TKI-DDI not significantly linked to AE increase; azole antifungal types not related to AE. Future DDI research crucial for drug development.

키워드

참고문헌

  1. Prasad V, De Jesus K, Mailankody S. The high price of anticancer drugs: Origins, implications, barriers, solutions. Nat Rev Clin Oncol 2017;14(6):381-90.  https://doi.org/10.1038/nrclinonc.2017.31
  2. Rogala BG, Charpentier MM, Nguyen MK, Landolf KM, Hamad L, Gaertner KM. Oral anticancer therapy: Management of drug interactions. Journal of Oncology Practice 2019;15(2):81-90.  https://doi.org/10.1200/JOP.18.00483
  3. Das A, Sil A, Khan IA, Bandyopadhyay D. Dermatological adverse drug reactions to tyrosine kinase inhibitors: a narrative review. Clin Exp Dermatol. 2023 Jun 5;48(6):599-608.  https://doi.org/10.1093/ced/llad070
  4. Huang L, Jiang S, Shi Y. Tyrosine kinase inhibitors for solid tumors in the past 20 years (2001-2020). Journal of Hematology & Oncology 2020;13(1):143. 
  5. Ismail M, Khan S, Khan F, et al. Prevalence and significance of potential drug-drug interactions among cancer patients receiving chemotherapy. BMC cancer 2020;20(1):335. 
  6. Wang H, Shi H, Wang Y, et al. Potentially hazardous drug-drug interactions associated with oral antineoplastic agents prescribed in chinese tertiary care teaching hospital settings: A multicenter cross-sectional study. Frontiers in pharmacology 2022;13:808848. 
  7. Sudsakorn S, Bahadduri P, Fretland J, Lu C. 2020 fda drug-drug interaction guidance: A comparison analysis and action plan by pharmaceutical industrial scientists. Current Drug Metabolism 2020;21(6):403-26.  https://doi.org/10.2174/1389200221666200620210522
  8. Deodhar M, Al Rihani SB, Arwood MJ, et al. Mechanisms of cyp450 inhibition: Understanding drug-drug interactions due to mechanism-based inhibition in clinical practice. Pharmaceutics 2020;12(9):846. 
  9. Page MJ, McKenzie JE, Bossuyt PM, et al. The prisma 2020 statement: An updated guideline for reporting systematic reviews. BMJ 2021;372:n71. 
  10. Higgins JP, Altman DG, Gotzsche PC, et al. The cochrane collaboration's tool for assessing risk of bias in randomised trials. BMJ 2011;343:d5928. 
  11. Poggesi I, Li LY, Jiao J, et al. Effect of fluconazole and itraconazole on the pharmacokinetics of erdafitinib in healthy adults: A randomized, open-label, drug-drug interaction study. Eur J Drug Metab Pharmacokinet 2020;45(1):101-11.  https://doi.org/10.1007/s13318-019-00581-9
  12. Abbas R, Hug BA, Leister C, Burns J, Sonnichsen D. Pharmacokinetics of oral neratinib during co-administration of ketoconazole in healthy subjects. Br J Clin Pharmacol 2011;71(4):522-7.  https://doi.org/10.1111/j.1365-2125.2010.03845.x
  13. Martin P, Oliver S, Robertson J, Kennedy SJ, Read J, Duvauchelle T. Pharmacokinetic drug interactions with vandetanib during coadministration with rifampicin or itraconazole. Drugs R D 2011;11(1):37-51.  https://doi.org/10.2165/11586980-000000000-00000
  14. Dutreix C, Peng B, Mehring G, et al. Pharmacokinetic interaction between ketoconazole and imatinib mesylate (glivec) in healthy subjects. Chemother Pharmacol 2004;54(4):290-4.  https://doi.org/10.1007/s00280-004-0832-z
  15. Dymond AW, So K, Martin P, et al. Effects of cytochrome p450 (cyp3a4 and cyp2c19) inhibition and induction on the exposure of selumetinib, a mek1/2 inhibitor, in healthy subjects: Results from two clinical trials. Eur J Clin Pharmacol 2017;73(2):175-84.  https://doi.org/10.1007/s00228-016-2153-7
  16. Pithavala YK, Tong W, Mount J, et al. Effect of ketoconazole on the pharmacokinetics of axitinib in healthy volunteers. Invest New Drugs 2012;30(1):273-81.  https://doi.org/10.1007/s10637-010-9511-6
  17. Shumaker R, Aluri J, Fan J, Martinez G, Thompson GA, Ren M. Effects of ketoconazole on the pharmacokinetics of lenvatinib (e7080) in healthy participants. Clin Pharmacol Drug Dev 2015;4(2):155-60.  https://doi.org/10.1002/cpdd.140
  18. Liu Y, Zhang Q, Lu C, Hu W. Multiple administrations of itraconazole increase plasma exposure to pyrotinib in chinese healthy adults. Drug Des Devel Ther 2021;15:2485-93.  https://doi.org/10.2147/DDDT.S312310
  19. Abbas R, Hug BA, Leister C, Burns J, Sonnichsen D. Effect of ketoconazole on the pharmacokinetics of oral bosutinib in healthy subjects. J Clin Pharmacol 2011;51(12):1721-7.  https://doi.org/10.1177/0091270010387427
  20. Narasimhan NI, Dorer DJ, Niland K, Haluska F, Sonnichsen D. Effects of ketoconazole on the pharmacokinetics of ponatinib in healthy subjects. J Clin Pharmacol 2013;53(9):974-81.  https://doi.org/10.1002/jcph.109
  21. Li J, Kankam M, Trone D, Gammon G. Effects of CYP3A inhibitors on the pharmacokinetics of quizartinib, a potent and selective FIT3 inhibitor, and its active metabolite. Br J Clin Pharmacol 2019;85(9):2108-17.  https://doi.org/10.1111/bcp.14022
  22. Ke AB, Zamek-Gliszczynski MJ, Higgins JW, Hall SD. Itraconazole and clarithromycin as ketoconazole alternatives for clinical CYP3A inhibition studies. Clin Pharmacol Ther 2014;95(5):473-6.  https://doi.org/10.1038/clpt.2014.41
  23. Tornio A, Filppula AM, Niemi M, Backman JT. Clinical studies on drug-drug interactions involving metabolism and transport: Methodology, pitfalls, and interpretation. Clin Pharmacol Ther 2019;105(6):1345-61.  https://doi.org/10.1002/cpt.1435
  24. Liu L, Bello A, Dresser MJ, et al. Best practices for the use of itraconazole as a replacement for ketoconazole in drug-drug interaction studies. J Clin Pharmacol 2016;56(2):143-51. https://doi.org/10.1002/jcph.562