A population pharmacokinetic model for doxorubicin and doxorubicinol in the presence of a novel MDR modulator, zosuquidar trihydrochloride (LY335979)

Cancer Chemotherapy and Pharmacology

Volumn 51, Issue 2, 2003, Pages 107-118

  Callies, Sophie ^a   De Alwis, Dinesh P ^b   Wright, James G ^b   Sandler, Alan ^c   Burgess, Michael ^b   Aarons, Leon ^a  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

^b ELI LILLY AND COMPANY   (United States)

^c VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Doxorubicin; Doxorubicinol; LY335979; NONMEM; Pharmacokinetics

Indexed keywords

2,4 BIS(ALLYLAMINO) 6 [4 [[2,2 BIS(4 FLUOROPHENYL)ETHYL]AMINO]PIPERIDINO] 1,3,5 TRIAZINE; 5 [3 (4 DIPHENYLACETYL 1 PIPERAZINYL) 2 HYDROXYPROPOXY]QUINOLINE; BIRICODAR; DOXORUBICIN; DOXORUBICINOL; ELACRIDAR; ZOSUQUIDAR;

ADULT; AGED; ARTICLE; CHEMOTHERAPY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG CLEARANCE; DRUG DISTRIBUTION; FEMALE; HUMAN; MALE; POPULATION MODEL; PRIORITY JOURNAL;

EID: 0037330465     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-002-0542-3     Document Type: Article

References (50)

1. Advani R, Fisher GA, Lum BL, Hausdorff J, Halsey J, Litchman M, Sikic BI (2001) A phase I trial of doxorubicin, paclitaxel, and Valspodar (PSC833), a modulator of multidrug resistance. Clin Cancer Res 7:1221-1229
2. Ambukar SV, Dey S, Hrycyna CA, Ramachandra M, Pastan I, Gottesman MM (1999) Biochemical, cellular and pharmacological aspects of the multidrug transporter. Annu Rev Pharmacol Toxicol 39:361-368
3. Biedler JL, Riehm H (1970) Cellular resistance to actinomycin D in Chinese hamster cells in vitro: cross-resistance, radio-autographic and cytogenetic studies. Cancer Res 30:1174-1184
4. Boeckmann AJ, Sheiner LB, Beal SL (1994) NONMEM users guide. NONMEM Project Group, University of California, San Francisco
5. Borst P, Evers R, Kool M, Wijnholds J (2000) A family of drug transporters: the multidrug resistance-associated proteins. J Natl Cancer Inst 92:1295-1302
6. Chico I, Kang MH, Bergan R, Abraham J, Bakke S, Meadows B, Rutt A, Robey R, Choyke P, Merino M, Goldspiel B, Smith T, Steinberg S, Figg WD, Fojo T, Bates S (2001) Phase I study of infusional paclitaxel in combination with the P-glycoprotein antagonist PSC833. J Clin Oncol 19:832-842
7. 2) for hepatocellular carcinoma: clinical and pharmacokinetic results. Cancer Treat Rep 68:487-491
8. Dantzig AH, Shepard RL, Cao J, Law KL, Ehlhardt WJ, Baughman TM, Bumol TF, Starling JJ (1996) Reversal of P-glycoprotein-mediated multidrug resistance by a potent cyclopropyldibenzosuberane modulator, LY335979. Cancer Res 56:4171-4179
9. Dantzig AH, Shepard RL, Law KL, Tabas L, Pratt S, Gillespie JS, Binkley SN, Kuhfeld MT, Starling JJ, Wrighton SA (1999) Selectivity of the multidrug resistance modulator, LY335979, for P-glycoprotein and effect on cytochrome P-450 activities. J Pharmacol Exp Ther 290:854-862
10. Dantzig AH, Law KL, Cao J, Starling JJ (2001) Reversal of multidrug resistance by the P-glycoprotein modulator LY335979, from the bench to the clinic. Curr Med Chem 8:39-50
11. De Alwis DP, Pouliquen I, Burgess M, Green L, Chaudhary A, Jordan C, et al (2001) A phase I dose escalating study of LY335979, a novel Pgp modulator - administered intravenously in combination with doxorubicin (abstract 284). Proc ASCO 20 (part 1)
12. Ferry D, Price L, Atsmon J, Inbar M, Merimsy O, Telligen O, et al (2001) A phase IIA pharmacokinetic and pharmacodynamic study of the P-glycoprotein inhibitor, XR9576, in patients treated with doxorubicin chemotherapy. Proc Am Assoc Cancer Res 42:950-5160
13. Ford JM, Hait WN (1990) Pharmacology of drugs that alter multidrug resistance in cancer. Pharmacol Rev 42:155-199
14. Germann UA, Ford PJ, Shlyakhter D, Mason VS, Harding MW (1997) Chemosensitization and drug accumulation effects of VX-170, verapamil, cyclosporin A, MS-209 and GF120918 in multidrug resistant HL60/ADR cells expressing the multidrug resistance-associated protein MRP. Anticancer Drugs 8:141-155
15. Giaccone G, Linn SC, Welink J, Catimel G, Stieltjes H, van der Vijgh WJF, Ecltink C, Vermorken JB, Pinedo HM (1997) A dose-finding and pharmacokinetic study of reversal of multidrug resistance with SDZ PSC 833 in combination with doxorubicin in patients with solid tumors. Clin Cancer Res 3:2005-2015
16. Green LJ, Marder P, Slapak CA (2001) Modulation by LY335979 of P-glycoprotein function in multidrug-resistant cell lines and human natural killer cells. Biochem Pharmacol 61:1393-1399
17. Grochow LB, Ames MM (1998) A clinician's guide to chemotherapy pharmacokinetics and pharmacodynamics, 1st edn. Williams & Wilkins, Baltimore, pp 93-122
18. Hyafil F, Vergely C, du Vignaud P, Grand-Perret T (1993) In vitro and in vivo reversal of multidrug resistance by GF120918, an acridonecarboxamide derivative. Cancer Res 53:4595-4602
19. Jacquet JM, Bressolle F, Galtier M, Bourrier M, Donadio D, Jourdan J, Rossi JF (1990) Doxorubicin and doxorubicinol: intra and inter-individual variation of PK parameters. Cancer Chemother Pharmacol 27:219-225
20. Jonson N, Karlsson M (1998) Xpose 2.0 user's manual. Department of Pharmacy, Uppsala University, Sweden
21. Juliano RL, Ling V (1976) A surface glycoprotein modulating drug permeability in chinese hamster ovary cell mutants. Biochim Biophys Acta 455:152-162
22. Krishna R, Mayer LD (1997) Liposomal doxorubicin circumvents PSC 833-free drug interactions, resulting in effective therapy of multidrug resistance solid tumor. Cancer Res 57:5246-5253
23. Krishna R, Mayer LD (2000) Multidrug resistance (MDR) in cancer; mechanisms, reversal using modulators of MDR and the role of MDR modulators in influencing the pharmacokinetics of anticancer drugs. Eur J Pharm Sci 11:265-283
24. Krishna R, St-Louis M, Mayer LD (2000) Increased intracellular drug accumulation and complete chemosensitization achieved in multidrug-resistant solid tumours by coadministering valspodar (PSC 833) with sterically stabilized liposomal doxorubicin. Int J Cancer 85:131-141
25. Leca F, Marchiset-Leca D, Noble A, Antonetti M (1991) New data on the pharmacokinetics of adriamycin and its major metabolite, adriamycinol. Eur J Drug Metab Pharmacokinet 16:107-111
26. Lee BH, Shin HS, Lee CO, Park SH, Yoo SE, Yi KY, Jung NP, Choi Su (2000) Effect of KR30035, a novel multidrug-resistance modulator, on the cardiovascular system of rat in vivo and on the cell cycle of human cancer cells in vitro. Anticancer Drugs 11:55-61
27. Massart C, Gibassier J, Raoul M, Pourquier P, Leclech G, Robert J, Lucas C (1995) Cyclosporin A, verapamil, and S9788 reverse doxorubicin resistance in human medullary thyroid carcinoma cell line. Anticancer Drugs 6:135-146
28. Nakanishi O, Baba M, Saito A, Yamashita T, Sato W, Abe H, Fukazawa N, Suzuki T, Sato S, Naito M, Tsuruo T (1997) Potentiation of the antitumor activity by a novel quinoline compound, MS-209, in multidrug-resistant solid tumor cell lines. Oncol Res 9:61-69
29. Peck RA, Hewett J, Harding MW, Wang YM, Chaturvedi PR, Bhatnagar A, Zeissman H, Atkins F, Hawkins MJ (2001) Phase I and pharmacokinetic study of the novel MDR1 and MRP1 inhibitor Biricodar administered alone and in combination with doxorubicin. J Clin Oncol 19:3130-3141
30. Piscitelli SC, Rodvold KA, Rushing DA, Tewksbury DA (1993) Pharmacokinetics and pharmacodynamics of doxorubicin in patients with small cell lung cancer. Clin Pharmacol Ther 53:555-561
31. Preiss R, Sohr R, Kittelman B, Muller E, Hasse D (1989) Investigations on the dose-dependent pharmacokinetics of adriamycin and its metabolites. Int J Clin Pharmacol Ther Toxicol 27:156-164
32. Punt CJ, Voest EE, Tueni E, Van Oosterom AT, Backx A, De Mulder PH, Hecquet B, Lucas C, Gerard B, Bleiberg H (1997) Phase IB study of doxorubicin in combination with the multidrug resistance reversing agent S9788 in advance colorectal and renal cancer. Br J Cancer 76:1376-1381
33. Rosenberg MF, Callaghan R, Ford RC, Higgins CF (1997) Structure of the multidrug resistance P-glycoprotein to 2.5 nm resolution determined by electron microscopy and image analysis. J Biol Chem 272:1065
34. Rowinsky EK, Smith L, Wang YM, Chaturvedi P, Villalona M, Campbell E, Aylesworth C, Eckhard SG, Hammond L, Kraynak M, Drengler R, Stephenson J, Harding MW, Von Hoff DD (1998) Phase I and pharmacokinetic study of paclitaxel in combination with biricodar, a novel agent that reverses multi-drug resistance conferred by over expression of both MDR and MRP. J Clin Oncol 16:2964-2976
35. Schott B, Robert J (1989) Comparative activity of anthracycline 13-dihydrometabolites against rat glioblastoma cells in culture. Biochem Pharmacol 38:4069-4074
36. Schuetz EG, Beck WT, Schuetz JD (1996) Modulators and substrates of P-glycoprotein and cytochrome P4503A coordinately up-regulate these proteins in human colon carcinoma cells. Mol Pharmacol 49:311-318
37. Sheiner LB (1984) Population pharmacokinetics: the population approach to pharmacokinetic data analysis: rational and standard data analysis methods. Drug Metab Rev 15:153-171
38. Sonneveld P, Marie J, Huisman C (1996) Reversal of multidrug resistance by SDZ-PSC833, combined with VAD (vincristine, doxorubicin, dexamethasone) in refractory multiple myeloma. A phase I study. Leukemia 10:1741-1750
39. Spahn-langguth H, Baktir G, Radschuweit A, Okyar A, Terhaag B, Ader P, Hanafy A, Langguth P (1998) P-Glyco-protein transporters and the gastrointestinal tract: evaluation of the potential in vivo relevance of in vitro data employing talinolol as a model compound. Int J Clin Pharmacol Ther 36:16-24
40. Sparreboom A, Planting AST, Jewell RC, van der Burg ME, van der Gaast A, de Bruijn P, Loos WJ, Nooter K, Chandler LH, Paul EM, Wissel PS, Verweij J (1999) Clinical pharmacokinetics of doxorubicin in combination with GF120918, a potent inhibitor of MDR1 P-glycoprotein. Anticancer Drugs 10:719-728
41. Stewart A, Steiner J, Mellows G, Laguda B, Norris D, Bevan P (2000) Phase I trial of XR9576 in healthy volunteers demonstrates modulation of P-glycoprotein in CD56+ lymphocytes after oral and intravenous administration. Clin Cancer Res 6:4186-4191
42. Sun H, Fadiran EO, Jones CD, Lesko L, Huang S-M, Higgins K, Hu C, Machado S, Maldonado S, Williams R, Hossain M, Ette EI (1999) Population pharmacokinetics - a regulatory perspective. Clin Pharmacokinet 37:41-51
43. Sweatam TW, Lokich JJ, Israel M (1989) Clinical pharmacology of continuous infusion doxorubicin. Ther Drug Monit 11:3-9
44. Tan B, Piwnica-Worms D, Ratner L (2000) Multidrug resistance transporters and modulation. Curr Opin Oncol 12:450-458
45. Tranchand B, Catimel G, Lucas C, Sarkany M, Bastian G, Evene E, Guastalla JP, Negrier S, Rebattu P, Dumortier A, Foy M, Grossin F, Mazier B, Froudarakis M, Barbet N, Clavel M, Ardiet C (1998) Phase I clinical and pharmacokinetic study of S9788, a new multidrug-resistance reversal agent given alone and in combination with doxorubicin to patients with advanced solid tumors. Cancer Chemother Pharmacol 41:281-291
46. Troconiz IF, de Alwis DP, Tillmann C, Callies S, Mitchell M, Schaefer HG (2000) Comparison of manual versus ambulatory blood pressure measurements with pharmacokinetic-pharmacodynamic modeling of antihypertensive compounds: application. Clin Pharmacol Ther 68:18-27
47. Van Zuylen L, Sparreboom A, van der Gaast A, van der Burg ME, van Beurden V, Bol CJ, Woestenborghs R, Palmer PA, Verweij J (2000) The orally administered P-glycoprotein inhibitor R101933 does not alter the plasma pharmacokinetics of docetaxel. Clin Cancer Res 6:1365-1371
48. Wacher VJ, Wu CY, Benet LZ (1995) Overlapping substrate specificities and tissue distribution of cytochrome P4503A and P-glycoprotein: implications for drug delivery and activity in cancer chemotherapy. Mol Carcinog 13:129-134
49. Wade JR, Beal SL, Sambol NC (1994) Interaction between structural, statistical and covariates models in population pharmacokinetic analysis. J Pharmacokinet Biopharm 22:165-177
50. Wang GX, Wang YX, Zhou XB, Korth M (2001) Effect of doxorubicinol on excitation-contraction coupling in guinea pig ventricular myocytes. Eur J Pharmacol 423:99-107