Sunitinib tissue distribution changes after coadministration with ketoconazole in mice

European Journal of Drug Metabolism and Pharmacokinetics

Volumn 41, Issue 3, 2016, Pages 309-319

  Chee, Evelyn Li Ching ^a   Lim, Adeline Yi Ling ^a,c   Modamio, Pilar ^b   Fernandez Lastra, Cecilia ^b   Segarra, Ignacio ^a,b,d  

^a INTERNATIONAL MEDICAL UNIVERSITY   (Malaysia)

^b UNIVERSITY OF BARCELONA   (Spain)

^c ALFRED HOSPITAL   (Australia)

^d NONE   (Spain)

Author keywords

Blood brain barrier; Brain tissue distribution; Drug drug interaction; Ketoconazole; Sunitinib

Indexed keywords

CYTOCHROME P450 3A4; KETOCONAZOLE; SUNITINIB; ANTIFUNGAL AGENT; INDOLE DERIVATIVE; PROTEIN KINASE INHIBITOR; PYRROLE DERIVATIVE;

ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; BRAIN; DRUG ABSORPTION; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG POTENTIATION; DRUG UPTAKE; KIDNEY; LIMIT OF DETECTION; LIMIT OF QUANTITATION; LIVER; MAXIMUM PLASMA CONCENTRATION; MOUSE; NONHUMAN; TIME TO MAXIMUM PLASMA CONCENTRATION; TISSUE DISTRIBUTION; ANIMAL; DRUG INTERACTION; FEMALE; HALF LIFE TIME; INSTITUTE FOR CANCER RESEARCH MOUSE; METABOLISM;

ANIMALS; ANTIFUNGAL AGENTS; AREA UNDER CURVE; DRUG INTERACTIONS; FEMALE; HALF-LIFE; INDOLES; KETOCONAZOLE; MICE; MICE, INBRED ICR; PROTEIN KINASE INHIBITORS; PYRROLES; TISSUE DISTRIBUTION;

EID: 84922424018     PISSN: 03787966     EISSN: 21070180     Source Type: Journal    
DOI: 10.1007/s13318-015-0264-7     Document Type: Article

References (61)

1. Alkharfy KM, Ahmad A, Khan RMA, Al-Shagha WM (2014) Pharmacokinetic plasma behaviors of intravenous and oral bioavailability of thymoquinone in a rabbit model. Eur J Drug Metab Pharmacokinet. doi:10.1007/s13318-014-0207-8
2. Bailer AJ (1988) Testing for the equality of area under the curves when using destructive measurement techniques. J Pharmacokinet Biopharm 16:303–309
3. Bisht S, Feldmann G, Brossart P (2013) Pharmacokinetics and pharmacodynamics of sunitinib for the treatment of advanced pancreatic neuroendocrine tumors. Expert Opin Drug Metab Toxicol 9:777–788
4. Blanchet B, Saboureau C, Benichou AS, Billemont B, Taieb F, Ropert S (2009) Development and validation of an HPLC–UV–visible method for sunitinib quantification in human plasma. Clin Chim Acta 404:134–139
5. Bowlin SJ, Xia F, Wang W, Robinson KD, Stanek EJ (2013) Twelve-month frequency of drug-metabolizing enzyme and transporter-based drug–drug interaction potential in patients receiving oral enzyme-targeted kinase inhibitor antineoplastic agents. Clin Proc Mayo Clin 88:139–148
6. Britten CD, Kabbinavar F, Hecht JR, Bello CL, Li J, Baum C et al (2008) A phase I and pharmacokinetic study of sunitinib administered daily for 2 weeks, followed by a 1-week off period. Cancer Chemother Pharmacol 61:515–524
7. Buxhofer-Ausch V, Secky L, Wlcek K, Svoboda M, Kounnis V, Briasoulis E et al (2013) Tumor-specific expression of organic anion-transporting polypeptides: transporters as novel targets for cancer therapy. J Drug Deliv 2013:863539
8. Caffo M, Barresi V, Caruso G, Cutugno M, La Fata G, Venza M et al (2013) Innovative therapeutic strategies in the treatment of brain metastases. Int J Mol Sci 14:2135–2174
9. Castro LJ, Sahagún AM, Diez MJ, Fernández N, Sierra M, García JJ (2009) Pharmacokinetics of doxycycline in sheep after intravenous and oral administration. Vet J. 180:389–395
10. Chen X, Wang Z, Liu M, Liao M, Wang X, Du H et al (2014) Determination of sunitinib and its active metabolite, N-desethyl sunitinib in mouse plasma and tissues by UPLC–MS/MS: assay development and application to pharmacokinetic and tissue distribution studies. Biomed Chromatogr. doi:10.1002/bmc.3331
11. Chew WK, Segarra I, Ambu S, Mak JW (2012) Significant reduction of brain cysts caused by Toxoplasma gondii after treatment with spiramycin coadministered with metronidazole in a mouse model of chronic toxoplasmosis. Antimicrob Agents Chemother 56:1762–1768
12. Chow LQM, Eckhardt SG (2007) Sunitinib: from rational design to clinical efficacy. J Clin Oncol 25:884–896
13. Chu TF, Rupnick MA, Kerkela R, Dallabrida SM, Zurakowski D, Nguyen L et al (2007) Cardiotoxicity associated with tyrosine kinase inhibitor sunitinib. Lancet 370:2011–2019
14. de Wit D, Gelderblom H, Sparreboom A, den Hartigh J, den Hollander M, König-Quartel JMC et al (2013) Midazolam as a phenotyping probe to predict sunitinib exposure in patients with cancer. Cancer Chemother Pharmacol 73(1):87–96
15. del Fabbro E, Dev R, Cabanillas ME, Busaidy NL, Rodriguez EC, Bruera E (2012) Extreme hypothyroidism associated with sunitinib treatment for metastatic renal cancer. J Chemother 24:221–225
16. Di Gion P, Kanefendt F, Lindauer A, Scheffler M, Doroshyenko O, Fuhr U et al (2011) Clinical pharmacokinetics of tyrosine kinase inhibitors: focus on pyrimidines, pyridines and pyrroles. Clin Pharmacokinet 50:551–603
17. Duckett DR, Cameron MD (2010) Metabolism considerations for kinase inhibitors in cancer treatment. Expert Opin Drug Metab Toxicol 6:1175–1193
18. Dudek AZ, Raza A, Chi M, Singhal M, Oberoi R, Mittapalli RK et al (2013) Brain metastases from renal cell carcinoma in the era of tyrosine kinase inhibitors. Clin Genitourin Cancer 11:155–160
19. Dutreix C, Peng B, Mehring G, Hayes M, Capdeville R, Pokorny R et al (2004) Pharmacokinetic interaction between ketoconazole and imatinib mesylate (Glivec) in healthy subjects. Cancer Chemother Pharmacol 54:290–294
20. Goodman VL, Rock EP, Dagher R, Ramchandani RP, Abraham S, Gobburu JVS et al (2007) Approval summary: sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma. Clin Cancer Res 13:1367–1373
21. Gore ME, Hariharan S, Porta C, Bracarda S, Hawkins R, Bjarnason GA et al (2011) Sunitinib in metastatic renal cell carcinoma patients with brain metastases. Cancer 117:501–509
22. Greenblatt DJ, Zhao Y, Venkatakrishnan K, Duan SX, Harmatz JS, Parent SJ et al (2011) Mechanism of cytochrome P450-3A inhibition by ketoconazole. J Pharm Pharmacol 63:214–221
23. Haznedar JÖ, Patyna S, Bello CL, Peng GW, Speed W, Yu X et al (2009) Single- and multiple-dose disposition kinetics of sunitinib malate, a multitargeted receptor tyrosine kinase inhibitor: comparative plasma kinetics in non-clinical species. Cancer Chemother Pharmacol 64:691–706
24. Hiles JJ, Kolesar JM (2008) Role of sunitinib and sorafenib in the treatment of metastatic renal cell carcinoma. Am J Health Syst Pharm 65:123–131
25. Hu S, Chen Z, Franke R, Orwick S, Zhao M, Rudek MA et al (2009) Interaction of the multikinase inhibitors sorafenib and sunitinib with solute carriers and ATP-binding cassette transporters. Clin Cancer Res 15:6062–6069
26. Joshi AD, Loilome W, Siu I-M, Tyler B, Gallia GL, Riggins GJ (2012) Evaluation of tyrosine kinase inhibitor combinations for glioblastoma therapy. PLoS One 7:e44372
27. Kim A, Balis FM, Widemann BC (2009) Sorafenib and sunitinib. Oncologist 14:800–805
28. Kuhlman JJ, Lalani S, Magluilo J, Levine B, Darwin WD (1996) Human pharmacokinetics of intravenous, sublingual, and buccal buprenorphine. J Anal Toxicol 20:369–378
29. Lacouture ME, Reilly LM, Gerami P, Guitart J (2008) Hand foot skin reaction in cancer patients treated with the multikinase inhibitors sorafenib and sunitinib. Ann Oncol 19:1955–1961
30. Lim AYL, Segarra I, Chakravarthi S, Akram S, Judson JP (2010) Histopathology and biochemistry analysis of the interaction between sunitinib and paracetamol in mice. BMC Pharmacol 10:14
31. Lombardi G, Di Stefano AL, Zagonel V, Tabouret E (2014) Systemic treatments for brain metastases from breast cancer, non-small cell lung cancer, melanoma and renal cell carcinoma: an overview of the literature. Cancer Treat Rev 40:951–959
32. Martínez-Jordá R, Rodriguez-Sasiain JM, Suárez E, Calvo R (1990) Serum binding of ketoconazole in health and disease. Int J Clin Pharmacol Res 10:271–276
33. Mermershtain W, Lazarev I, Shani-Shrem N, Ariad S (2013) Fatal liver failure in a patient treated with sunitinib for renal cell carcinoma. Clin Genitourin Cancer 11:70–72
34. Mouton JW, Theuretzbacher U, Craig WA, Tulkens PM, Derendorf H, Cars O (2008) Tissue concentrations: do we ever learn? J Antimicrob Chemother 61:235–237
35. Nassar I, Pasupati T, Judson JP, Segarra I (2009) Reduced exposure of imatinib after coadministration with acetaminophen in mice. Indian J Pharmacol 41:167–172
36. Nassar I, Pasupati T, Judson JP, Segarra I (2010) Histopathological study of the hepatic and renal toxicity associated with the co-administration of imatinib and acetaminophen in a preclinical mouse model. Malays J Pathol 32:1–11
37. Natarajan K, Xie Y, Baer MR, Ross DD (2012) Role of breast cancer resistance protein (BCRP/ABCG2) in cancer drug resistance. Biochem Pharmacol 83:1084–1103
38. Nishimura M, Naito S (2008) Tissue-specific mRNA expression profiles of human solute carrier transporter superfamilies. Drug Metab Pharmacokinet 23:22–44
39. Otaegui D, Rodríguez-Gascón A, Zubia A, Cossío FP, Pedraz JL (2009) Pharmacokinetics and tissue distribution of Kendine 91, a novel histone deacetylase inhibitor, in mice. Cancer Chemother Pharmacol 64:153–159
40. Pan E, Yu D, Yue B, Potthast L, Chowdhary S, Smith P et al (2012) A prospective phase II single-institution trial of sunitinib for recurrent malignant glioma. J Neurooncol 110:111–118
41. Papaetis GS, Syrigos KN (2009) Sunitinib: a multitargeted receptor tyrosine kinase inhibitor in the era of molecular cancer therapies. BioDrugs 23:377–389
42. Ridruejo E, Cacchione R, Villamil AG, Marciano S, Gadano AC, Mandó OG (2007) Imatinib-induced fatal acute liver failure. World J Gastroenterol 13:6608–6611
43. Segarra I, Movshin DA, Zarif L (2002) Pharmacokinetics and tissue distribution after intravenous administration of a single dose of amphotericin B cochleates, a new lipid-based delivery system. J Pharm Sci 91(8):1827–1837
44. Seneca N, Zoghbi SS, Shetty HU, Tuan E, Kannan P, Taku A et al (2010) Effects of ketoconazole on the biodistribution and metabolism of [11C]loperamide and [11C]N-desmethyl-loperamide in wild-type and P-gp knockout mice. Nucl Med Biol 37:335–345
45. Shah VP, Midha KK, Findlay JW, Hill HM, Hulse JD, McGilveray IJ et al (2000) Bioanalytical method validation—a revisit with a decade of progress. Pharm Res 17:1551–1557
46. Shitara Y, Maeda K, Ikejiri K, Yoshida K, Horie T, Sugiyama Y (2013) Clinical significance of organic anion transporting polypeptides (OATPs) in drug disposition: their roles in hepatic clearance and intestinal absorption. Biopharm Drug Dispos 34:45–78
47. Shukla S, Robey RW, Bates SE, Ambudkar SV (2008) Sunitinib (Sutent, SU11248), a small-molecule receptor tyrosine kinase inhibitor, blocks function of the ATP-binding cassette (ABC) transporters P-glycoprotein (ABCB1) and ABCG2. Drug Metab Dispos 37:359–365
48. Soffietti R, Trevisan E, Rudà R (2012) Targeted therapy in brain metastasis. Curr Opin Oncol 24:679–686
49. Soo GW, Law JHK, Kan E, Tan SY, Lim WY, Chay G et al (2010) Differential effects of ketoconazole and primaquine on the pharmacokinetics and tissue distribution of imatinib in mice. Anticancer Drugs 21:695–703
50. Sykes BW, Underwood C, McGowan CM, Mills PC (2014) Pharmacokinetics of intravenous, plain oral and enteric-coated oral omeprazole in the horse. J Vet Pharmacol Ther. doi:10.1111/jvp.12169
51. Tan SY, Kan E, Lim WY, Chay G, Law JHK, Soo GW et al (2011) Metronidazole leads to enhanced uptake of imatinib in brain, liver and kidney without affecting its plasma pharmacokinetics in mice. J Pharm Pharmacol 63:918–925
52. Tan JR, Chakravarthi S, Judson JP, Haleagrahara N, Segarra I (2013) Potential protective effect of sunitinib after administration of diclofenac: biochemical and histopathological drug–drug interaction assessment in a mouse model. Naunyn Schmiedebergs Arch Pharmacol 386:619–633
53. Tang SC, Lagas JS, Lankheet NAG, Poller B, Hillebrand MJ, Rosing H et al (2012) Brain accumulation of sunitinib is restricted by P-glycoprotein (ABCB1) and breast cancer resistance protein (ABCG2) and can be enhanced by oral elacridar and sunitinib coadministration. Int J Cancer 130:223–233
54. Thomas-Schoemann A, Blanchet B, Bardin C, Noé G, Boudou-Rouquette P, Vidal M et al (2013) Drug interactions with solid tumour-targeted therapies. Crit Rev Oncol Hematol 89:179–196
55. van Erp NP, Gelderblom H, Guchelaar H-J (2009) Clinical pharmacokinetics of tyrosine kinase inhibitors. Cancer Treat Rev 35:692–706
56. Wang E, Lew K, Casciano CN, Clement RP, Johnson WW (2002) Interaction of common azole antifungals with P glycoprotein. Antimicrob Agents Chemother 46:160–165
57. Weise AM, Liu CY, Shields AF (2009) Fatal liver failure in a patient on acetaminophen treated with sunitinib malate and levothyroxine. Ann Pharmacother 43:761–766
58. Yang J, He Y, Du Y-X, Tang L-L, Wang G-J, Fawcett JP (2009) Pharmacokinetic properties of S-adenosylmethionine after oral and intravenous administration of its tosylate disulfate salt: a multiple-dose, open-label, parallel-group study in healthy Chinese volunteers. Clin Ther 31:311–320
59. Yuan J (1993) Estimation of variance for AUC in animal studies. J Pharm Sci 82:761–763
60. Zeitlinger MA, Derendorf H, Mouton JW, Cars O, Craig WA, Andes D et al (2011) Protein binding: do we ever learn? Antimicrob Agents Chemother 55:3067–3074
61. Zimmerman EI, Hu S, Roberts JL, Gibson AA, Orwick SJ, Li L et al (2013) Contribution of OATP1B1 and OATP1B3 to the disposition of sorafenib and sorafenib–glucuronide. Clin Cancer Res 19:1458–1466