Influence of cremophor EL and genetic polymorphisms on the pharmacokinetics of paclitaxel and its metabolites using a mechanism-based model

Drug Metabolism and Disposition

Volumn 39, Issue 2, 2011, Pages 247-255

  Fransson, Martin N ^a   Gréen, Henrik ^b   Litton, Jan Eric ^a   Friberg, Lena E ^c  

^a KAROLINSKA INSTITUTE   (Sweden)

^b LINKÖPING UNIVERSITY   (Sweden)

^c UPPSALA UNIVERSITY   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

4 3' HYDROXYPACLITAXEL; 6ALPHA 4 3' DIHYDROXYPACLITAXEL; 6ALPHA HYDROXYPACLITAXEL; CARBOPLATIN; CREMOPHOR; CYTOCHROME P450 2C8; CYTOCHROME P450 3A4; CYTOCHROME P450 3A5; DOCETAXEL; DRUG METABOLITE; MULTIDRUG RESISTANCE PROTEIN 1; PACLITAXEL; PACLITAXEL DERIVATIVE; UNCLASSIFIED DRUG;

ADULT; AGED; ALLELE; ARTICLE; BLOOD SAMPLING; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG METABOLISM; ENZYME ACTIVITY; FEMALE; GYNECOLOGIC CANCER; HUMAN; MULTIPLE CYCLE TREATMENT; NEUROTOXICITY; OVARY CANCER; PERITONEUM CANCER; PHARMACOGENETICS; PHARMACOKINETICS; POPULATION PHARMACOKINETICS; PRIORITY JOURNAL; SEPTICEMIA; SINGLE NUCLEOTIDE POLYMORPHISM; UTERUS CARCINOMA;

ANALYSIS OF VARIANCE; ANTINEOPLASTIC AGENTS, PHYTOGENIC; ARYL HYDROCARBON HYDROXYLASES; BIOTRANSFORMATION; CHEMISTRY, PHARMACEUTICAL; CYTOCHROME P-450 CYP3A; DRUG CARRIERS; FEMALE; GENITAL NEOPLASMS, FEMALE; GLYCEROL; HUMANS; MIDDLE AGED; MODELS, BIOLOGICAL; P-GLYCOPROTEIN; PACLITAXEL; POLYMORPHISM, SINGLE NUCLEOTIDE;

EID: 79251514312     PISSN: 00909556     EISSN: 1521009X     Source Type: Journal    
DOI: 10.1124/dmd.110.035394     Document Type: Article

References (40)

1. Bergmann TK, Brasch-Andersen C, Green H, Mirza M, Pedersen RS, Nielsen F, Skougaard K, Wihl J, Keldsen N, Damkier P, et al. (2010) Impact of CYP2C8*3 on paclitaxel clearance: a population pharmacokinetic and pharmacogenomic study in 93 patients with ovarian cancer. Pharmacogenomics J doi:10.1038/tpj.2010.19.
2. Bertrand J, Comets E, Laffont CM, Chenel M, and Mentré F (2009) Model-based tests to detect gene effect in pharmacokinetic studies (Abstract). PAGE 18:1464.
3. Calvert AH, Newell DR, Gumbrell LA, O'Reilly S, Burnell M, Boxall FE, Siddik ZH, Judson IR, Gore ME, and Wiltshaw E (1989) Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol 7:1748-1756.
4. Cresteil T, Monsarrat B, Alvinerie P, Tréluyer JM, Vieira I, and Wright M (1994) Taxol metabolism by human liver microsomes: identification of cytochrome P450 isozymes involved in its biotransformation. Cancer Res 54:386-392.
5. Cresteil T, Monsarrat B, Dubois J, Sonnier M, Alvinerie P, and Gueritte F (2002) Regioselective metabolism of taxoids by human CYP3A4 and 2C8: structure-activity relationship. Drug Metab Dispos 30:438-445.
6. Fransson M and Gréen H (2008) Comparison of two types of population pharmacokinetic model structures of paclitaxel. Eur J Pharm Sci 33:128-137.
7. Gianni L, Kearns CM, Giani A, Capri G, Viganó L, Lacatelli A, Bonadonna G, and Egorin MJ (1995) Nonlinear pharmacokinetics and metabolism of paclitaxel and its pharmacokinetic/pharmacodynamic relationships in humans. J Clin Oncol 13:180-190.
8. Gisleskog PO, Karlsson MO, and Beal SL (2002) Use of prior information to stabilize a population data analysis. J Pharmacokinet Pharmacodyn 29:473-505.
9. Gréen H, Söderkvist P, Rosenberg P, Horvath G, and Peterson C (2006a) mdr-1 single nucleotide polymorphisms in ovarian cancer tissue: G2677T/A correlates with response to paclitaxel chemotherapy. Clin Cancer Res 12:854-859. (Pubitemid 43259868)
10. Gréen H, Söderkvist P, Rosenberg P, Mirghani RA, Rymark P, Lundqvist EA, and Peterson C (2009) Pharmacogenetic studies of Paclitaxel in the treatment of ovarian cancer. Basic Clin Pharmacol Toxicol 104:130-137.
11. Gréen H, Vretenbrant K, Norlander B, and Peterson C (2006b) Measurement of paclitaxel and its metabolites in human plasma using liquid chromatography/ion trap mass spectrometry with a sonic spray ionization interface. Rapid Commun Mass Spectrom 20:2183-2189.
12. Harris JW, Katki A, Anderson LW, Chmurny GN, Paukstelis JV, and Collins JM (1994a) Isolation, structural determination, and biological activity of 6 alpha-hydroxytaxol, the principal human metabolite of paclitaxel. J Med Chem 37:706-709.
13. Harris JW, Rahman A, Kim BR, Guengerich FP, and Collins JM (1994b) Metabolism of paclitaxel by human hepatic microsomes and liver slices: participation of cytochrome P450 3A4 and an unknown P450 enzyme. Cancer Res 54:4026-4035.
14. Henningsson A, Karlsson MO, Viganò L, Gianni L, Verweij J, and Sparreboom A (2001) Mechanism-based pharmacokinetic model for paclitaxel. J Clin Oncol 19:4065-4073.
15. Henningsson A, Marsh S, Loos WJ, Karlsson MO, Garsa A, Mross K, Mielke S, Viganò L, Locatelli A, Verweij J, et al. (2005a) Association of CYP2C8, CYP3A4, CYP3A5, and ABCB1 polymorphisms with the pharmacokinetics of paclitaxel. Clin Cancer Res 11:8097-8104. (Pubitemid 41698753)
16. Henningsson A, Sparreboom A, Loos WJ, Verweij J, Silvander M, and Karlsson MO (2005b) Population pharmacokinetic model for Cremophor EL (Abstract). PAGE 13:770.
17. Henningsson A, Sparreboom A, Sandström M, Freijs A, Larsson R, Bergh J, Nygren P, and Karlsson MO (2003) Population pharmacokinetic modelling of unbound and total plasma concentrations of paclitaxel in cancer patients. Eur J Cancer 39:1105-1114.
18. Hooker AC, Staatz CE, and Karlsson MO (2007) Conditional weighted residuals (CWRES): a model diagnostic for the FOCE method. Pharm Res 24:2187-2197.
19. Joerger M, Huitema AD, van den Bongard DH, Schellens JH, and Beijnen JH (2006) Quantitative effect of gender, age, liver function, and body size on the population pharmacokinetics of paclitaxel in patients with solid tumors. Clin Cancer Res 12:2150-2157.
20. Karlsson MO, Molnar V, Freijs A, Nygren P, Bergh J, and Larsson R (1999) Pharmacokinetic models for the saturable distribution of paclitaxel. Drug Metab Dispos 27:1220-1223.
21. Kumar GN, Oatis JE Jr, Thornburg KR, Heldrich FJ, Hazard ES 3rd, and Walle T (1994) 6α-Hydroxytaxol: isolation and identification of the major metabolite of paclitaxel in human liver microsomes. Drug Metab Dispos 22:177-179.
22. Leskelä S, Jara C, Leandro-García LJ, Martínez A, García-Donas J, Hernando S, Hurtado A, Vicario JC, Montero-Conde C, Landa I, et al. (2010) Polymorphisms in cytochromes P450 2C8 and 3A5 are associated with paclitaxel neurotoxicity. Pharmacogenomics J doi:10.1038/tpj.2010.13.
23. Mathijssen RH, de Jong FA, Loos WJ, van der Bol JM, Verweij J, and Sparreboom A (2007) Flat-fixed dosing versus body surface area based dosing of anticancer drugs in adults: does it make a difference? Oncologist 12:913-923.
24. Mirghani RA, Ericsson O, Cook J, Yu P, and Gustafsson LL (2001) Simultaneous determination of quinine and four metabolites in plasma and urine by high-performance liquid chromatography. J Chromatogr B Biomed Sci Appl 754:57-64.
25. Mirghani RA, Hellgren U, Westerberg PA, Ericsson O, Bertilsson L, and Gustafsson LL (1999) The roles of cytochrome P450 3A4 and 1A2 in the 3-hydroxylation of quinine in vivo. Clin Pharmacol Ther 66:454-460.
26. Monsarrat B, Alvinerie P, Wright M, Dubois J, Guéritte-Voegelein F, Guénard D, Donehower RC, and Rowinsky EK (1993) Hepatic metabolism and biliary excretion of Taxol in rats and humans. J Natl Cancer Inst Monogr 15:39-46.
27. Monsarrat B, Chatelut E, Royer I, Alvinerie P, Dubois J, Dezeuse A, Roche H, Cros S, Wright M, and Canal P (1998) Modification of paclitaxel metabolism in a cancer patient by induction of cytochrome P450 3A4. Drug Metab Dispos 26:229-233.
28. Nakajima M, Fujiki Y, Kyo S, Kanaya T, Nakamura M, Maida Y, Tanaka M, Inoue M, and Yokoi T (2005) Pharmacokinetics of paclitaxel in ovarian cancer patients and genetic polymorphisms of CYP2C8, CYP3A4, and MDR1. J Clin Pharmacol 45:674-682.
29. Piszkiewicz D (1977) Positive cooperativity in micelle-catalyzed reactions. J Am Chem Soc 99:1550-1557.
30. Rahman A, Korzekwa KR, Grogan J, Gonzalez FJ, and Harris JW (1994) Selective biotransformation of Taxol to 6α-hydroxytaxol by human cytochrome P450 2C8. Cancer Res 54:5543-5546.
31. Ribbing J and Jonsson EN (2004) Power, selection bias and predictive performance of the Population Pharmacokinetic Covariate Model. J Pharmacokinet Pharmacodyn 31:109-134.
32. Savic RM and Karlsson MO (2009) Importance of shrinkage in empirical Bayes estimates for diagnostics: problems and solutions. AAPS J 11:558-569.
33. Schiff PB, Fant J, and Horwitz SB (1979) Promotion of microtubule assembly in vitro by Taxol. Nature 277:665-667.
34. Sissung TM, Mross K, Steinberg SM, Behringer D, Figg WD, Sparreboom A, and Mielke S (2006) Association of ABCB1 genotypes with paclitaxel-mediated peripheral neuropathy and neutropenia. Eur J Cancer 42:2893-2896.
35. Sonnichsen DS, Hurwitz CA, Pratt CB, Shuster JJ, and Relling MV (1994) Saturable pharmacokinetics and paclitaxel pharmacodynamics in children with solid tumors. J Clin Oncol 12:532-538.
36. Sonnichsen DS, Liu Q, Schuetz EG, Schuetz JD, Pappo A, and Relling MV (1995) Variability in human cytochrome P450 paclitaxel metabolism. J Pharmacol Exp Ther 275:566-575.
37. Sparreboom A, Huizing MT, Boesen JJ, Nooijen WJ, van Tellingen O, and Beijnen JH (1995) Isolation, purification, and biological activity of mono- and dihydroxylated paclitaxel metabolites from human feces. Cancer Chemother Pharmacol 36:299-304.
38. Sparreboom A, van Tellingen O, Nooijen WJ, and Beijnen JH (1996) Nonlinear pharmacokinetics of paclitaxel in mice results from the pharmaceutical vehicle Cremophor EL. Cancer Res 56:2112-2115.
39. Walle T, Walle UK, Kumar GN, and Bhalla KN (1995) Taxol metabolism and disposition in cancer patients. Drug Metab Dispos 23:506-512.
40. Yamaguchi H, Hishinuma T, Endo N, Tsukamoto H, Kishikawa Y, Sato M, Murai Y, Hiratsuka M, Ito K, Okamura C, et al. (2006) Genetic variation in ABCB1 influences paclitaxel pharmacokinetics in Japanese patients with ovarian cancer. Int J Gynecol Cancer 16:979-985.