Potential Clinical Benefit of Therapeutic Drug Monitoring of Imatinib in Oncology
Authors:
Turjap M. 1 3; J. Juřica 2,3; R. Demlová 2,4
Authors place of work:
Oddělení klinické farmacie, FN Ostrava
1; Farmakologický ústav, LF MU, Brno
2; Skupina experimentální a aplikované neuropsychofarmakologie, CEITEC – Středoevropský technologický institut, MU, Brno
3; Oddělení klinických hodnocení, Masarykův onkologický ústav, Brno
4
Published in the journal:
Klin Onkol 2015; 28(2): 105-111
Category:
Review
doi:
https://doi.org/10.14735/amko2015105
Summary
Imatinib mesylate is a competitive inhibitor of BCR/ ABL tyrosine kinase and inhibits also several receptor tyrosin kinases. Since its launch to the market, imatinib has proven to be very valuable in the treatment of Philadelphia chromosome (BCR/ ABL) – positive (Ph+) chronic myeloid leukemia and Kit (CD117) positive gastrointestinal stromal tumors. The drug is metabolized by cytochrome P450, and there are many clinically important pharmacokinetic drug‑drug interactions described in the literature. Frequent polypharmacy in oncological patients increases probability of such interactions, and also adherence may play its role during long‑term treatment. Fixed dosing therapeutic regimens fail to respect known interindividual variability in pharmacokinetics of the drug and thus, some patients may not achieve sufficient plasma concentrations. Based on current evidence, there seems to be a relationship between plasma concentration and clinical response to imatinib. Therefore, imatinib appears to be suitable candidate for therapeutic drug monitoring. Here, we present an overview of pharmacokinetics, drug‑drug interactions and current knowledge and suggestions on therapeutic drug monitoring of imatinib, its potential benefits and limitations.
Key words:
imatinib – pharmacokinetics – drug interactions – therapeutic drug monitoring – chronic myeloid leukemia – gastrointestinal stromal tumors
The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study.
The Editorial Board declares that the manuscript met the ICMJE “uniform requirements” for biomedical papers.
Submitted:
8. 12. 2014
Accepted:
4. 2. 2015
Zdroje
1. Klener P, Klener P Jr. ABL1, SRC a další nereceptorové tyrozinkinázy jako nové cíle specifické protinádorové léčby. Klin Onkol 2010; 23(4): 203– 209.
2. National Comprehensive Cancer Network [homepage on the Internet]. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Chronic Myelogenous Leukemia, Version 1.2015 [cited 2015 Jan 18]. Available from: http:/ / www.nccn.org/ professionals/ physician_gls/ pdf/ cml.pdf.
3. National Comprehensive Cancer Network [homepage on the Internet]. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Soft Tissue Sarcoma, Version 2.2014 [cited 2015 Feb 1]. Available from: http:/ / www.nccn.org/ professionals/ physician_gls/ pdf/ sarcoma.pdf.
4. Baccarani M, Deininger MW, Rosti G et al. European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood 2013; 122(6): 872– 884. doi: 10.1182/ blood‑ 2013‑ 05‑ 501569.
5. Liu Y, Ramírez J, Ratain MJ. Inhibition of paracetamol glucuronidation by tyrosine kinase inhibitors. Br J Clin Pharmacol 2011; 71(6): 917– 920. doi: 10.1111/ j.1365‑ 2125.2011.03911.x.
6. Schmidli H, Peng B, Riviere GJ et al. Population pharmacokinetics of imatinib mesylate in patients with chronic‑ phase chronic myeloid leukaemia: results of a phase III study. Br J Clin Pharmacol 2005; 60(1): 35– 44.
7. SPC GLIVEC 400 MG [online]. [citováno 8. prosince 2014]. Dostupné z: http:/ / www.ema.europa.eu/ docs/ cs_CZ/ document_library/ EPAR_– _Product_Information/ human/ 000406/ WC500022207.pdf.
8. Lexi‑ Comp, Inc. (Lexi‑ Drugs®) [online]. Lexi‑ Comp, Inc. [cited 2014 Jul 28]. Available from: http://online.lexi.com/.
9. Filppula AM, Laitila J, Neuvonen PJ et al. Potent mechanism‑based inhibition of CYP3A4 by imatinib explains its liability to interact with CYP3A4 substrates. Br J Clin Pharmacol 2012; 165(8): 2787– 2798. doi: 10.1111/ j.1476‑ 5381.2011.01732.x.
10. Haouala A, Widmer N, Duchosal MA et al. Drug interactions with the tyrosine kinase inhibitors imatinib, dasatinib, and nilotinib. Blood 2011; 117(8): E75– E87. doi: 10.1182/ blood‑ 2010‑ 07‑ 294330.
11. Dutreix C, Peng B, Mehring G et al. Pharmacokinetic interaction between ketoconazole and imatinib mesylate (Glivec) in healthy subjects. Cancer Chemother Pharmacol 2004; 54(4): 290– 294.
12. White DL, Saunders VA, Dang PO et al. OCT‑ 1- mediated influx is a key determinant of the intraceflular uptake of imatinib but not nilotinib, (AMN107): reduced OCT‑ 1 activity is the cause of low in vitro sensitivity to imatinib. Blood 2006; 108(2): 697– 704.
13. Bolton AE, Peng B, Hubert M et al. Effect of rifampicin on the pharmacokinetics of imatinib mesylate (Gleevec, STI571) in healthy subjects. Cancer Chemother Pharmacol 2004; 53(2): 102– 106.
14. Houghton PJ, Germain GS, Harwood FC et al. Imatinib mesylate is a potent inhibitor of the ABCG2 (BCRP) transporter and reverses resistance to topotecan and SN‑ 38 in vitro. Cancer Res 2004; 64(7): 2333– 2337.
15. Breccia M, Santopietro M, Loglisci G et al. Concomitant use of imatinib and warfarin in chronic phase chronic myeloid leukemia patients does not interfere with drug efficacy. Leuk Res 2010; 34(8): e224– e225. doi: 10.1016/ j.leukres.2010.03.015.
16. Lin AM, Rini BI, Derynck MK et al. A phase I trial of docetaxel/ estramustine/ imatinib in patients with hormone‑ refractory prostate cancer. Clin Genitourin Cancer 2007; 5(5): 323– 328.
17. MacKichan JJ. Interpretation of serum drug concentrations. In: Lee M (ed.). Basic skills in interpreting laboratory data. 5th ed. Bethesda: American Society of Health‑ System Pharmacists 2013: 71– 117.
18. Baccarani M, Dreyling M, Group EG. Chronic myeloid leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow‑up. Ann Oncol 2010; 21 (Suppl 5): v165– 167. doi: 10.1093/ annonc/ mdq201.
19. Teng JF, Mabasa VH, Ensom MH. The role of therapeutic drug monitoring of imatinib in patients with chronic myeloid leukemia and metastatic or unresectable gastrointestinal stromal tumors. Ther Drug Monit 2012; 34(1): 85– 97. doi: 10.1097/ FTD.0b013e31823cdec9.
20. Gao B, Yeap S, Clements A et al. Evidence for therapeutic drug monitoring of targeted anticancer therapies. J Clin Oncol 2012; 30(32): 4017– 4025. doi: 10.1200/ JCO.2012.43.5362.
21. Gotta V, Buclin T, Csajka C et al. Systematic review of population pharmacokinetic analyses of imatinib and relationships with treatment outcomes. Ther Drug Monit 2013; 35(2): 150– 167. doi: 10.1097/ FTD.0b013e318284ef11.
22. Gotta V, Widmer N, Decosterd LA et al. Clinical usefulness of therapeutic concentration monitoring for imatinib dosage individualization: results from a randomized controlled trial. Cancer Chemother Pharmacol 2014; 74(6): 1307– 1319. doi: 10.1007/ s00280‑ 014‑ 2599‑ 1.
23. Picard S, Titier K, Etienne G et al. Trough imatinib plasma levels are associated with both cytogenetic and molecular responses to standard‑dose imatinib in chronic myeloid leukemia. Blood 2007; 109(8): 3496– 3499.
24. Larson RA, Druker BJ, Guilhot F et al. Imatinib pharmacokinetics and its correlation with response and safety in chronic‑ phase chronic myeloid leukemia: a subanalysis of the IRIS study. Blood 2008; 111(8): 4022– 4028. doi: 10.1182/ blood‑ 2007‑ 10‑ 116475.
25. Takahashi N, Wakita H, Miura M et al. Correlation between imatinib pharmacokinetics and clinical response in Japanese patients with chronic‑ phase chronic myeloid leukemia. Clin Pharmacol Ther 2010; 88(6): 809– 813. doi: 10.1038/ clpt.2010.186.
26. Koren‑ Michowitz M, Volchek Y, Naparstek E et al. Imatinib plasma trough levels in chronic myeloid leukaemia: results of a multicentre study CSTI571AIL11TGLIVEC. Hematol Oncol 2012; 30(4): 200– 205. doi: 10.1002/ hon.2005.
27. Marin D, Bazeos A, Mahon FX et al. Adherence is the critical factor for achieving molecular responses in patients with chronic myeloid leukemia who achieve complete cytogenetic responses on imatinib. J Clin Oncol 2010; 28(14): 2381– 2388. doi: 10.1200/ JCO.2009.26.3087.
28. Bouchet S, Titier K, Moore N et al. Therapeutic drug monitoring of imatinib in chronic myeloid leukemia: experience from 1216 patients at a centralized laboratory. Fundam Clin Pharmacol 2013; 27(6): 690– 697. doi: 10.1111/ fcp.12007.
29. Gotta V, Bouchet S, Widmer N et al. Large‑ scale imatinib dose‑concentration‑ effect study in CML patients under routine care conditions. Leuk Res 2014; 38(7): 764– 772. doi: 10.1016/ j.leukres.2014.03.023.
30. Yu H, Steeghs N, Nijenhuis CM et al. Practical guidelines for therapeutic drug monitoring of anticancer tyrosine kinase inhibitors: focus on the pharmacokinetic targets. Clin Pharmacokinet 2014; 53(4): 305– 325. doi: 10.1007/ s40262‑ 014‑ 0137‑ 2.
31. OPTIM IMATINIB. A prospective randomized phase IIstudy evaluating the monitoring of imatinib mesylate (Gliveec®) plasmatic through level in patients newly diagnosed with chronic phase chronic myelogenous leukaemia (CP‑ CML) [cited 2015 Jan 25]. Available from: https:/ / www.clinicaltrialsregister.eu/ ctr‑ search/ trial/ 2010- 019568- 35/ FR.
32. Demetri GD, Wang Y, Wehrle E et al. Imatinib plasma levels are correlated with clinical benefit in patients with unresectable/ metastatic gastrointestinal stromal tumors. J Clin Oncol 2009; 27(19): 3141– 3147. doi: 10.1200/ JCO.2008.20.4818.
33. SARC019. A randomized, phase 3 study of dose escalation versus no dose escalation of Imatinib in metastatic GIST patients with Imatinib trough levels less than 1100 nanograms/ mL [cited 2015 Jan 27]. Available from: https:/ / clinicaltrials.gov/ ct2/ show/ study/ NCT01031628.
34. Bardin C, Veal G, Paci A et al. Therapeutic drug monitoring in cancer – are we missing a trick? Eur J Cancer 2014; 50(12): 2005– 2009. doi: 10.1016/ j.ejca.2014.04.013.
Štítky
Paediatric clinical oncology Surgery Clinical oncologyČlánok vyšiel v časopise
Clinical Oncology
2015 Číslo 2
- Spasmolytic Effect of Metamizole
- Metamizole at a Glance and in Practice – Effective Non-Opioid Analgesic for All Ages
- Metamizole in perioperative treatment in children under 14 years – results of a questionnaire survey from practice
- Current Insights into the Antispasmodic and Analgesic Effects of Metamizole on the Gastrointestinal Tract
- Obstacle Called Vasospasm: Which Solution Is Most Effective in Microsurgery and How to Pharmacologically Assist It?
Najčítanejšie v tomto čísle
- Malignant Tumors of Thyroid Gland
- Vitamin D During Cancer Treatment
- Glomus Tumor of the Finger – Case Report
- The Importance of Early Tumor Shrinkage and Deepness of Response in Assessing the Efficacy of Systemic Anticancer Treatment with Metastatic Colorectal Cancer