Therapeutic drug monitoring of imatinib: Bayesian and alternative methods to predict trough levels

Clinical Pharmacokinetics

Volumn 51, Issue 3, 2012, Pages 187-201

  Gotta, Verena ^a,b   Widmer, Nicolas ^a   Montemurro, Michael ^a   Leyvraz, Serge ^a   Haouala, Amina ^a   Decosterd, Laurent A ^a   Csajka, Chantal ^a,b   Buclin, Thierry ^a  

^a LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

^b UNIVERSITY OF LAUSANNE   (Switzerland)

Author keywords

Drug monitoring; Imatinib; Pharmacokinetic modelling; Pharmacokinetics; Pharmacology.

Indexed keywords

IMATINIB;

ACUTE LYMPHOBLASTIC LEUKEMIA; ADULT; AGED; ARTICLE; BAYES THEOREM; CHRONIC MYELOID LEUKEMIA; DRUG CLEARANCE; DRUG MONITORING; FEMALE; GASTROINTESTINAL STROMAL TUMOR; HUMAN; LIMIT OF QUANTITATION; LIQUID CHROMATOGRAPHY; MALE; PREDICTION; PRIORITY JOURNAL; TANDEM MASS SPECTROMETRY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; BAYES THEOREM; DRUG MONITORING; FEMALE; GASTROINTESTINAL STROMAL TUMORS; HUMANS; LINEAR MODELS; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; NONLINEAR DYNAMICS; PIPERAZINES; PROTEIN KINASE INHIBITORS; PYRIMIDINES; REPRODUCIBILITY OF RESULTS; YOUNG ADULT;

EID: 84857073563     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.2165/11596990-000000000-00000     Document Type: Article

References (58)

1. Alnaim L. Therapeutic drug monitoring of cancer chemotherapy. J Oncol Pharm Pract 2007; 13: 207-21
2. Rousseau A, Marquet P, Debord J, et al. Adaptive control methods for the dose individualisation of anticancer agents. Clin Pharmacokinet 2000; 38: 315-53 (Pubitemid 30229470)
3. de Jonge ME, Huitema AD, Schellens JH, et al. Individualised cancer chemotherapy: strategies and performance of prospective studies on therapeutic drug monitoring with dose adaptation. A review. Clin Pharmacokinet 2005; 44: 147-73 (Pubitemid 40188938)
4. Evans WE, Crom WR, Abromowitch M, et al. Clinical pharmacodynamics of high-dose methotrexate in acute lymphocytic leukemia: identification of a relation between concentration and effect. N Engl J Med 1986; 314: 471-7
5. Gamelin E, Delva R, Jacob J, et al. Individual fluorouracil dose adjustment based on pharmacokinetic follow-up compared with conventional dosage: results of a multicenter randomized trial of patients with metastatic colorectal cancer. J Clin Oncol 2008; 26: 2099-105
6. Klumpen HJ, Samer CF, Mathijssen RH, et al. Moving towards dose individualization of tyrosine kinase inhibitors. Cancer Treat Rev 2010; 37: 251-60
7. Houk BE, Bello CL, Poland B, et al. Relationship between exposure to sunitinib and efficacy and tolerability endpoints in patients with cancer: results of a pharmacokinetic/pharmacodynamic meta-analysis. Cancer Chemother Pharmacol 2010; 66: 357-71
8. Thomas F, Rochaix P, White-Koning M, et al. Population pharmacokinetics of erlotinib and its pharmacokinetic/pharmacodynamic relationships in head and neck squamous cell carcinoma. Eur J Cancer 2009; 45: 2316-23
9. 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: 4022-8
10. Widmer N, Decosterd LA, Csajka C, et al. Population pharmacokinetics of imatinib and the role of alpha-acid glycoprotein. Br J Clin Pharmacol 2006; 62: 97-112 (Pubitemid 44195246)
11. Bilgi N, Bell K, Ananthakrishnan AN, et al. Imatinib and Panax ginseng: a potential interaction resulting in liver toxicity. Ann Pharmacother 2010; 44: 926-8
12. 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: 102-6 (Pubitemid 38186987)
13. Burger H, Nooter K. Pharmacokinetic resistance to imatinib mesylate: role of the ABC drug pumps ABCG2 (BCRP) and ABCB1 (MDR1) in the oral bioavailability of imatinib. Cell Cycle 2004; 3: 1502-5 (Pubitemid 40521401)
14. Gambacorti-Passerini C, Zucchetti M, Russo D, et al. Alpha1 acid glycoprotein binds to imatinib (STI571) and substantially alters its pharmacokinetics in chronic myeloid leukemia patients. Clin Cancer Res 2003; 9: 625-32 (Pubitemid 36182594)
15. Peng B, Lloyd P, Schran H. Clinical pharmacokinetics of imatinib. Clin Pharmacokinet 2005; 44: 879-94 (Pubitemid 41252840)
16. Delbaldo C, Chatelut E, Re M, et al. Pharmacokinetic-pharmacodynamic relationships of imatinib and its main metabolite in patients with advanced gastrointestinal stromal tumors. Clin Cancer Res 2006; 12: 6073-8 (Pubitemid 44703771)
17. Widmer N, Decosterd LA, Leyvraz S, et al. Relationship of imatinib-free plasma levels and target genotype with efficacy and tolerability. Br J Cancer 2008; 98: 1633-40 (Pubitemid 351684684)
18. Widmer N, Decosterd LA, Csajka C, et al. Imatinib plasma levels: correlation with clinical benefit in GIST patients. Br J Cancer 2010; 102: 1198-9
19. Cortes JE, Egorin MJ, Guilhot F, et al. Pharmacokinetic/pharmacodynamic correlation and blood-level testing in imatinib therapy for chronic myeloid leukemia. Leukemia 2009; 23: 1537-44
20. 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: 3141-7
21. 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: 3496-9 (Pubitemid 46572540)
22. Kantarjian HM, Cortes J, La RP, et al. Optimizing therapy for patients with chronic myelogenous leukemia in chronic phase. Cancer 2010; 116: 1419-30
23. Awidi A, Ayed AO, Bsoul N, et al. Relationship of serum imatinib trough level and response in CML patients: long termfollow-up. LeukRes 2010; 34: 1573-5
24. Li-Wan-Po A, Farndon P, Craddock C, et al. Integrating pharmacogenetics and therapeutic drug monitoring: optimal dosing of imatinib as a caseexample. Eur J Clin Pharmacol 2010 Apr; 66 (4): 369-74
25. SinghN,Kumar L,MeenaR, et al. Drug monitoring of imatinib levels in patients undergoing therapy for chronic myeloid leukaemia: comparing plasma levels of responders and non-responders. Eur J Clin Pharmacol 2009; 65: 545-9
26. Baccarani M, Rosti G, Castagnetti F, et al. Comparison of imatinib 400mg and 800mg daily in the front-line treatment of high-risk, Philadelphia-positive chronic myeloid leukemia: a European Leukemia Net Study. Blood 2009; 113: 4497-504
27. Blanke CD, Demetri GD, von Mehren M, et al. Long-term results from a randomized phase II trial of standard-versus higher-dose imatinib mesylate for patients with unresectable or metastatic gastrointestinal stromal tumors expressing KIT. J Clin Oncol 2008; 26: 620-5 (Pubitemid 351264357)
28. Blanke CD, Rankin C, Demetri GD, et al. Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the Kit receptor tyrosine kinase: S0033. J Clin Oncol 2008; 26: 626-32 (Pubitemid 351264358)
29. Demetri GD, vonMM,Antonescu CR, et al.NCCNTask Force report: update on the management of patients with gastrointestinal stromal tumors. J Natl Compr Canc Netw 2010; 8 Suppl. 2: S1-41
30. Wang Y, Chia YL, Nedelman J, et al.Atherapeutic drug monitoring algorithm for refining the imatinib trough level obtained at different sampling times. Ther Drug Monit 2009; 31: 579-84
31. Rousseau A, Marquet P. Application of pharmacokinetic modelling to the routine therapeutic drug monitoring of anticancer drugs. Fundam Clin Pharmacol 2002; 16: 253-62 (Pubitemid 35205335)
32. Rodman JH, D'Argenio DZ, Peck CC. Analysis of pharmacokinetic data for individualizing drug dosage regimens. In: Burton ME, Shaw LM, Schentag JJ, et al., editors. Applied pharmacokinetics& pharmacodynamics-principles of therapeutic drug monitoring. 4th ed. Baltimore (MD): Lippincott Williams & Wilkins; 2006
33. Sheiner LB, Beal S, Rosenberg B, et al. Forecasting individual pharmacokinetics. Clin Pharmacol Ther 1979; 26: 294-305 (Pubitemid 10194671)
34. Beal SL, Sheiner LB. NONMEM user's guide: part VII. Hanover (MD): Globomax, Inc., 1992
35. US Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research (CBER), Center for Biologics Evaluation and Research (CBER). Guidance for industry on population pharmacokinetics. Fed Regist 1999; 64: 6663-4
36. Haouala A, Zanolari B, Rochat B, et al. Therapeutic drug monitoring of the new targeted anticancer agents imatinib, nilotinib, dasatinib, sunitinib, sorafenib and lapatinib by LC tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2009; 877: 1982-96
37. Wessa P. Testing sample variance-confidence intervals (v1.0.2) in free statistics software (v1.1.23-r6). Office for Research Development and Education [online]. Available fromURL:http://www.wessa.net/rwasp-hypothesisvariance3. wasp/[Accessed 2011 Mar 4]
38. Wessa P. Testing variance-p-value (v1.0.3) in free statistics software (v1.1.23-r6). Office forResearchDevelopment and Education [online].Available fromURL: http://www.wessa.net/rwasp-hypothesisvariance2.wasp/[Accessed 2011Mar 4]
39. Sheiner LB, Beal SL. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm 1981; 9: 503-12
40. Beal SL, Sheiner LB. Part VII: conditional estimation methods. In: Beal SL, Sheiner LB, Boeckmann A, et al., editors. NONMEM user's guides. Ellicott City (MD): Icon Development Solutions, 1989-2009
41. Menon-Andersen D, Mondick JT, Jayaraman B, et al. Population pharmacokinetics of imatinib mesylate and its metabolite in children and young adults. Cancer Chemother Pharmacol 2009; 63: 229-38
42. PetainA,KattygnarathD, Azard J, et al. Population pharmacokinetics and pharmacogenetics of imatinib in children and adults.ClinCancer Res 2008; 14: 7102-9
43. 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: 35-44 (Pubitemid 40942779)
44. European pharmacopoeia, supplement 5.2 (chapter 2.9.40). 5th ed. Strasbourg: Council of Europe, 2005
45. US pharmacopoeia (USP) 29-National Formularium (NF) 24. General chapter 905: uniformity of dosage units. Rockville (MD): United States Pharmacopeial Convention, 2005
46. US Department ofHealth andHuman Services, Food and DrugAdministration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM). Guidance for industry-bioanalytical method validation [online]. Available from URL: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf [Accessed 2012 Jan 18]
47. Tsang J, Rudychev I, Pescatore SL. Prescription compliance and persistency in chronic myelogenous leukemia (CML) and gastrointestinal stromal tumor (GIST) patients (pts) on imatinib (IM) [abstract no. 6119]. J Clin Oncol 2006; 24 (18S): 6119 [online]. Available from URL http://meeting.ascopubs.org/ cgi/con tent/abstract/24/18-suppl/6119?sid=65d28164-2c6c-4d34-8abf-90845f8ef806 [Accessed 2012 Jan 18]
48. Noens L, van Lierde MA, De BR, et al. Prevalence, determinants, and outcomes of nonadherence to imatinib therapy in patients with chronic myeloid leukemia: the ADAGIO study. Blood 2009 May 28; 113 (22): 5401-11
49. Karlsson MO, Sheiner LB. The importance of modeling interoccasion variability in population pharmacokinetic analyses. J Pharmacokinet Pharmacodyn 1993; 21: 735-50 (Pubitemid 24052760)
50. Tong WG, Kantarjian H, O'Brien S, et al. Imatinib front-line therapy is safe and effective in patients with chronic myelogenous leukemia with pre-existing liver and/or renal dysfunction. Cancer 2010; 116: 3152-9
51. Atkinson AJ, ReidenbergMM.Effect of renal disease on pharmacokinetics. In: Atkinson AJ, Abernethy DR, Daniels CE, et al., editors. Principles of clinical pharmacology. 2nd ed. New York: Elsevier Inc., 2011
52. Susla GM, Atkinson AJ. Effect of liver disease on pharmacokinetics. In: Atkinson AJ, Abernethy DR, Daniels CE, et al., editors. Principles of clinical pharmacology. 2nd ed. New York: Elsevier Inc., 2011
53. Widmer N, Gotta V, Haouala A, et al. Tyrosine kinase inhibitors concentration monitoring in chronic myeloid leukemia. Leuk Res 2010; 34: 698-9
54. Buclin T, Widmer N, Biollaz J, et al. Who is in charge of assessing therapeutic drug monitoring? The case of imatinib. Lancet Oncol 2011; 12: 9-11
55. 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: 2381-8
56. Ravaud A, Bello CL. Exposure-response relationships in patients with metastatic renal cell carcinoma receiving sunitinib: maintaining optimum efficacy in clinical practice. Anticancer Drugs 2011; 22: 377-83
57. Trent J, Molimard M. Pharmacokinetics and pharmacodynamics of nilotinib in gastrointestinal stromal tumors. Semin Oncol 2011; 38: S28-33
58. Luo FR, Yang Z, Camuso A, et al. Dasatinib (BMS-354825) pharmacokinetics and pharmacodynamic biomarkers in animal models predict optimal clinical exposure. Clin Cancer Res 2006; 12: 7180-6 (Pubitemid 44974520)