Population pharmacokinetics of intravenously and orally administered docetaxel with or without co-administration of ritonavir in patients with advanced cancer

British Journal of Clinical Pharmacology

Volumn 69, Issue 5, 2010, Pages 465-474

  Koolen, Stijn L W ^a,b   Oostendorp, Roos L ^a,b   Beijnen, Jos H ^a,b,c   Schellens, Jan H M ^a,b,c   Huitema, Alwin D R ^a,b  

^a SLOTERVAART HOSPITAL   (Netherlands)

^b NETHERLANDS CANCER INSTITUTE   (Netherlands)

^c UTRECHT UNIVERSITY   (Netherlands)

Author keywords

CYP3A4; Docetaxel; Oral administration; Population pharmacokinetics; Ritonavir

Indexed keywords

CYCLOSPORIN A; CYTOCHROME P450; DEXAMETHASONE; DOCETAXEL; GLYCOPROTEIN P; GRANISETRON; RITONAVIR;

ADULT; ADVANCED CANCER; AGED; ARTICLE; CANCER PATIENT; CLINICAL ARTICLE; COMPARTMENT MODEL; CONCENTRATION RESPONSE; DATA ANALYSIS; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ELIMINATION; DRUG INHIBITION; FEMALE; HUMAN; INTESTINE; LIVER BLOOD FLOW; MALE; POPULATION MODEL; PRIORITY JOURNAL;

ADMINISTRATION, ORAL; ADULT; AGED; ANTINEOPLASTIC AGENTS; BIOLOGICAL AVAILABILITY; CYTOCHROME P-450 CYP3A; ENZYME INHIBITORS; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; NEOPLASMS; P-GLYCOPROTEIN; RITONAVIR; TAXOIDS;

EID: 77950651521     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2010.03621.x     Document Type: Article

References (31)

1. Di Maio M, Perrone F, Chiodini P, Gallo C, Camps C, Schuette W, Quoix E, Tsai CM, Gridelli C. Individual patient data meta-analysis of docetaxel administered once every 3 weeks compared with once every week second-line treatment of advanced non-small-cell lung cancer. J Clin Oncol 2007 25 : 1377 1382.
2. Schellens JHM, Malingre MM, Kruijtzer CM, Bardelmeijer HA, Van Tellingen O, Schinkel AH, Beijnen JH. Modulation of oral bioavailability of anticancer drugs: from mouse to man. Eur J Pharm Sci 2000 12 : 103 110.
3. Bardelmeijer HA, Ouwehand M, Buckle T, Huisman MT, Schellens JHM, Beijnen JH, Van Tellingen O. Low systemic exposure of oral docetaxel in mice resulting from extensive first-pass metabolism is boosted by ritonavir. Cancer Res 2002 62 : 6158 6164.
4. Malingre MM, Richel DJ, Beijnen JH, Rosing H, Koopman FJ, Bokkel Huinink WW, Schot ME, Schellens JH. Co-administration of cyclosporine strongly enhances the oral bioavailability of docetaxel. J Clin Oncol 2001 19 : 1160 1166.
5. Oostendorp RL, Huitema A, Rosing H, Jansen RS, Ter Heine R, Keessen M, Beijnen JH, Schellens JH. Co-administration of ritonavir strongly enhances the apparent oral bioavailability of docetaxel in patients with solid tumors. Clin Cancer Res 2009 15 : 4228.
6. Washington CB, Duran GE, Man MC, Sikic BI, Blaschke TF. Interaction of anti-HIV protease inhibitors with the multidrug transporter P-glycoprotein (P-gp) in human cultured cells. J Acquir Immune Defic Syndr Hum Retrovirol 1998 19 : 203 209.
7. Kempf DJ, Marsh KC, Kumar G, Rodrigues AD, Denissen JF, McDonald E, Kukulka MJ, Hsu A, Granneman GR, Baroldi PA, Sun E, Pizzuti D, Plattner JJ, Norbeck DW, Leonard JM. Pharmacokinetic enhancement of inhibitors of the human immunodeficiency virus protease by co-administration with ritonavir. Antimicrob Agents Chemother 1997 41 : 654 660.
8. Kappelhoff BS, Huitema ADR, Crommentuyn KML, Mulder JW, Meenhorst PL, van Gorp ECM, Mairuhu AT, Beijnen JH. Development and validation of a population pharmacokinetic model for ritonavir used as a booster or as an antiviral agent in HIV-1-infected patients. Br J Clin Pharmacol 2005 59 : 174 182.
9. Gridelli C, Gallo C, Di Maio M, Barletta E, Illiano A, Maione P, Salvagni S, Piantedosi FV, Palazzolo G, Caffo O, Ceribelli A, Falcone A, Mazzanti P, Brancaccio L, Capuano MA, Isa L, Barbera S, Perrone F. A randomized clinical trial of two docetaxel regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study. Br J Cancer 2004 91 : 1996 2004.
10. Schuette W, Nagel S, Blankenburg T, Lautenschlaeger C, Hans K, Schmidt EW, Dittrich I, Schweisfurth H, von Weikersthal LF, Raghavachar A, Reissig A, Serke M. Phase III study of second-line chemotherapy for advanced non-small-cell lung cancer with weekly compared with 3-weekly docetaxel. J Clin Oncol 2005 20 : 8389 8395.
11. Camps C, Massuti B, Jimenez A, Maestu I, Gomez RG, Isla D, Gonzalez JL, Almenar D, Blasco A, Rosell R, Carrato A, Vinolas N, Batista N, Giron CG, Galan A, Lopez M, Blanco R, Provencio M, Diz P, Felip E. Randomized phase III study of 3-weekly versus weekly docetaxel in pretreated advanced non-small-cell lung cancer: a Spanish Lung Cancer Group trial. Ann Oncol 2006 17 : 467 472.
12. Kuppens IE, van Maanen MJ, Rosing H, Schellens JHM, Beijnen JH. Quantitative analysis of docetaxel in human plasma using liquid chromatography coupled with tandem mass spectrometry. Biomed Chromatogr 2005 19 : 355 361.
13. Rosing H, Lustig V, Koopman FP, Bokkel Huinink WW, Beijnen JH. Bio-analysis of docetaxel and hydroxylated metabolites in human plasma by high-performance liquid chromatography and automated solid-phase extraction. J Chromatogr B Biomed Sci Appl 1997 696 : 89 98.
14. van Heeswijk RPG, Hoetelmans RMW, Harms R, Meenhorst PL, Mulder JW, Lange JM, Beijnen JH. Simultaneous quantitative determination of the HIV protease inhibitors amprenavir, indinavir, nelfinavir, ritonavir and saquinavir in human plasma by ion-pair high-performance liquid chromatography with ultraviolet detection. J Chromatogr B Biomed Sci Appl 1998 719 : 159 168.
15. Beal SL, Boeckman AJ, Scheiner LB. NONMEM User's Guides.
16. Keizer RJ, Zandvliet AS, Huitema ADR. A simple infrastructure and graphical user interface (GUI) for distributed NONMEM analysis on standard network environments. PAGE Abstracts of the Annual Meeting of the Population Approach Group in Europe, 2008.
17. Launay-Iliadis MC, Bruno R, Cosson V, Vergniol JC, Oulid-Aissa D, Marty M, Clavel M, Aapro M, Le Bail N, Iliadis A. Population pharmacokinetics of docetaxel during phase I studies using nonlinear mixed-effect modeling and nonparametric maximum-likelihood estimation. Cancer Chemother Pharmacol 1995 37 : 47 54.
18. Bruno R, Vivler N, Vergniol JC, De Phillips SL, Montay G, Sheiner LB. A population pharmacokinetic model for docetaxel (Taxotere): model building and validation. J Pharmacokinet Biopharm 1996 24 : 153 172.
19. Lu JF, Blaschke TF, Flexner C, Rosenkranz SL, Sheiner LB. Model-based analysis of the pharmacokinetic interactions between ritonavir, nelfinavir, and saquinavir after simultaneous and staggered oral administration. Drug Metab Dispos 2002 30 : 1455 1461.
20. Wilkinson GR, Shand DG. Commentary: a physiological approach to hepatic drug clearance. Clin Pharmacol Ther 1975 18 : 377 390.
21. Jonsson EN, Karlsson MO. Xpose - an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM. Comput Methods Programs Biomed 1999 58 : 51 64.
22. Karlsson MO, Savic RM. Diagnosing model diagnostics. Clin Pharmacol Ther 2007 82 : 17 20.
23. Savic RM, Karlsson MO. Importance of shrinkage in empirical bayes estimates for diagnostics: problems and solutions. AAPS J 2009 11 : 558.
24. Holford NHG. The visual predictive check - superiority to standard diagnostic (Rorschach) plots. PAGE Abstracts of the Annual Meeting of the Population Approach Group in Europe, 2005 164.
25. Lindbom L, Ribbing J, Jonsson EN. Perl-speaks-NONMEM (PsN) - a Perl module for NONMEM related programming. Comput Methods Programs Biomed 2004 75 : 85 94.
26. Loos WJ, Baker SD, Verweij J, Boonstra JG, Sparreboom A. Clinical pharmacokinetics of unbound docetaxel: role of polysorbate 80 and serum proteins. Clin Pharmacol Ther 2003 74 : 364 371.
27. Van Tellingen O, Beijnen JH, Verweij J, Scherrenburg EJ, Nooijen WJ, Sparreboom A. Rapid esterase-sensitive breakdown of polysorbate 80 and its impact on the plasma pharmacokinetics of docetaxel and metabolites in mice. Clin Cancer Res 1999 5 : 2918 2924.
28. van Zuylen L, Verweij J, Sparreboom A. Role of formulation vehicles in taxane pharmacology. Invest New Drugs 2001 19 : 125 141.
29. Bruno R, Hille D, Riva A, Vivier N, Bokkel Huinnink WW, van Oosterom AT, Kaye SB, Verweij J, Fossella FV, Valero V, Rigas JR, Seidman AD, Chevallier B, Fumoleau P, Burris HA, Ravdin PM, Sheiner LB. Population pharmacokinetics/ pharmacodynamics of docetaxel in phase II studies in patients with cancer. J Clin Oncol 1998 16 : 187 196. (Pubitemid 28041598)
30. Bosch TM, Huitema ADR, Doodeman VD, Jansen R, Witteveen E, Smit WM, Jansen RL, van Herpen CM, Soesan M, Beijnen JH, Schellens JHM. Pharmacogenetic screening of CYP3A and ABCB1 in relation to population pharmacokinetics of docetaxel. Clin Cancer Res 2006 12 : 5786 5793.
31. Tran A, Jullien V, Alexandre J, Rey E, Rabillon F, Girre V, Dieras V, Pons G, Goldwasser F, Treluyer JM. Pharmacokinetics and toxicity of docetaxel: role of CYP3A, MDR1, and GST polymorphisms. Clin Pharmacol Ther 2006 79 : 570 580.