Multiple-pool cell lifespan models for neutropenia to assess the population pharmacodynamics of unbound paclitaxel from two formulations in cancer patients

Cancer Chemotherapy and Pharmacology

Volumn 63, Issue 6, 2009, Pages 1035-1048

  Bulitta, Jürgen B ^a   Zhao, Ping ^b   Arnold, Robert D ^a,f   Kessler, Dean R ^b   Daifuku, Richard ^b   Pratt, James ^b   Luciano, Gabriel ^b   Hanauske, Axel R ^c   Gelderblom, Hans ^d   Awada, Ahmad ^e   Jusko, William J ^a  

^a UNIVERSITY AT BUFFALO   (United States)

^b Sonus Pharmaceuticals   (United States)

^c DEPARTMENT OF CARDIOLOGY   (Germany)

^d LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^e JULES BORDET INSTITUTE   (Belgium)

^f UNIVERSITY OF GEORGIA   (United States)

Author keywords

LC MS MS; Monte Carlo simulation; Multiple pool cell lifespan model; Neutrophils toxicity; Non hematological malignancies; Paclitaxel; Population pharmacokinetics and pharmacodynamics

Indexed keywords

CREMOPHOR; PACLITAXEL; PACLITAXEL TOCOSOL;

ARTICLE; CANCER PATIENT; CELL MATURATION; CELL SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; CYTOTOXICITY; DRUG EXPOSURE; DRUG FORMULATION; HUMAN; LIQUID CHROMATOGRAPHY; MULTICENTER STUDY; NEUTROPENIA; NEUTROPHIL COUNT; PHARMACODYNAMICS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TANDEM MASS SPECTROMETRY;

ANTINEOPLASTIC AGENTS, PHYTOGENIC; CELL SURVIVAL; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, LIQUID; CROSS-OVER STUDIES; FEMALE; HUMANS; LEUKOCYTE COUNT; LINEAR MODELS; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; NEOPLASMS; NEUTROPENIA; NEUTROPHILS; PACLITAXEL; STEM CELLS; STRUCTURE-ACTIVITY RELATIONSHIP; TANDEM MASS SPECTROMETRY;

EID: 63949087251     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-008-0828-1     Document Type: Article

References (51)

1. Beal SL, Sheiner LB, Boeckmann AJ (2006) NONMEM Users Guides (1989-2006). Icon Development Solutions, Ellicott City
2. Bogdanova N, Lissianskaya A, Gorelov A, Moiseyenko V, Golubeva O, Weiden P (2003) Paclitaxel vitamin E emulsion: phase I/II study of weekly administration in patients with non-small cell lung (NSCLC), transitional Cell (TCC), ovarian or colorectal cancer. Proc Am Soc Clin Oncol 22: abstract No. 988
3. Bogdanova N, Karaseva N, Ognerubov N, Golubeva O, Weiden P (2004) Paclitaxel injectable emulsion: phase 2a study of weekly administration in patients with non-small cell lung cancer (NSCLC). Journal of Clinical Oncology (ASCO Annual Meeting Proceedings) 22: abstract No. 7133
4. PP Constantinides KJ Lambert AK Tustian B Schneider S Lalji W Ma B Wentzel D Kessler D Worah SC Quay 2000 Formulation development and antitumor activity of a filter-sterilizable emulsion of paclitaxel Pharm Res 17 175 182
5. PP Constantinides A Tustian DR Kessler 2004 Tocol emulsions for drug solubilization and parenteral delivery Adv Drug Deliv Rev 56 1243 1255
6. EA Eisenhauer WW Ten Bokkel Huinink KD Swenerton L Gianni J Myles ME van der Burg I Kerr JB Vermorken K Buser N Colombo 1994 European-Canadian randomized trial of paclitaxel in relapsed ovarian cancer: high-dose versus low-dose and long versus short infusion J Clin Oncol 12 2654 2666
7. LE Friberg A Henningsson H Maas L Nguyen MO Karlsson 2002 Model of chemotherapy-induced myelosuppression with parameter consistency across drugs J Clin Oncol 20 4713 4721
8. M Gardmark MO Karlsson F Jonsson M Hammarlund-Udenaes 1998 Morphine-3-glucuronide has a minor effect on morphine antinociception. Pharmacodynamic modeling J Pharm Sci 87 813 820
9. M Gardmark L Brynne M Hammarlund-Udenaes MO Karlsson 1999 Interchangeability and predictive performance of empirical tolerance models Clin Pharmacokinet 36 145 167
10. H Gelderblom K Mross AJ Ten Tije D Behringer S Mielke DM van Zomeren J Verweij A Sparreboom 2002 Comparative pharmacokinetics of unbound paclitaxel during 1- and 3-hour infusions J Clin Oncol 20 574 581
11. L Gianni CM Kearns A Giani G Capri L Vigano A Lacatelli G Bonadonna MJ Egorin 1995 Nonlinear pharmacokinetics and metabolism of paclitaxel and its pharmacokinetic/pharmacodynamic relationships in humans J Clin Oncol 13 180 190
12. Gorelov A, Gorelov S, Karlov P, Golubeva O, Stewart M (2004) Paclitaxel injectable emulsion: phase 2a study of weekly administration in patients with metastatic or locally advanced unresectable or recurrent urothelial transitional cell cancer (TCC). J Clin Oncol (ASCO Annual Meeting Proceedings) 22: abstract No. 4586
13. Hanauske AR, Goedhals L, Gelderblom H, Lee Y, Awada A, Vermorken JB, Lübbing C, Ruiz-Garcia A, Pratt J, Stewart MB (2005) Pharmacokinetics (PK) of free and total paclitaxel after equal doses of Paclitaxel Injectable Emulsion and Paclitaxel Injection. J Clin Oncol (ASCO Annual Meeting Proceedings) 23: abstract No. 2045
14. A Henningsson MO Karlsson L Vigano L Gianni J Verweij A Sparreboom 2001 Mechanism-based pharmacokinetic model for paclitaxel J Clin Oncol 19 4065 4073
15. A Henningsson A Sparreboom M Sandstrom A Freijs R Larsson J Bergh P Nygren MO Karlsson 2003 Population pharmacokinetic modelling of unbound and total plasma concentrations of paclitaxel in cancer patients Eur J Cancer 39 1105 1114
16. A Henningsson S Marsh WJ Loos MO Karlsson A Garsa K Mross S Mielke L Vigano A Locatelli J Verweij A Sparreboom HL McLeod 2005 Association of CYP2C8, CYP3A4, CYP3A5, and ABCB1 polymorphisms with the pharmacokinetics of paclitaxel Clin Cancer Res 11 8097 8104
17. J Hing JJ Perez-Ruixo K Stuyckens A Soto-Matos L Lopez-Lazaro P Zannikos 2008 Mechanism-based pharmacokinetic/pharmacodynamic meta-analysis of trabectedin (ET-743, Yondelis) induced neutropenia Clin Pharmacol Ther 83 130 143
18. NH Holford 1999 Target concentration intervention: beyond Y2 K Br J Clin Pharmacol 48 9 13
19. NH Holford 2001 Target concentration intervention: beyond Y2 K Br J Clin Pharmacol 52 Suppl 1 55S 59S
20. MT Huizing AC Keung H Rosing V van der Kuij WW Ten Bokkel Huinink IM Mandjes AC Dubbelman HM Pinedo JH Beijnen 1993 Pharmacokinetics of paclitaxel and metabolites in a randomized comparative study in platinum-pretreated ovarian cancer patients J Clin Oncol 11 2127 2135
21. AK Iyer G Khaled J Fang H Maeda 2006 Exploiting the enhanced permeability and retention effect for tumor targeting Drug Discov Today 11 812 818
22. SH Jang MG Wientjes JL Au 2001 Kinetics of P-glycoprotein-mediated efflux of paclitaxel J Pharmacol Exp Ther 298 1236 1242
23. M Joerger AD Huitema DH van den Bongard JH Schellens JH Beijnen 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
24. M Joerger AD Huitema DJ Richel C Dittrich N Pavlidis E Briasoulis JB Vermorken E Strocchi A Martoni R Sorio HP Sleeboom MA Izquierdo DI Jodrell H Calvert AV Boddy H Hollema R Fety WJ Van der Vijgh G Hempel E Chatelut M Karlsson J Wilkins B Tranchand AH Schrijvers C Twelves JH Beijnen JH Schellens 2007 Population pharmacokinetics and pharmacodynamics of Paclitaxel and Carboplatin in ovarian cancer patients: a study by the European organization for research and treatment of cancer-pharmacology and molecular mechanisms group and new drug development group Clin Cancer Res 13 6410 6418
25. MO Karlsson V Molnar J Bergh A Freijs R Larsson 1998 A general model for time-dissociated pharmacokinetic-pharmacodynamic relationship exemplified by paclitaxel myelosuppression Clin Pharmacol Ther 63 11 25
26. MO Karlsson V Molnar A Freijs P Nygren J Bergh R Larsson 1999 Pharmacokinetic models for the saturable distribution of paclitaxel Drug Metab Dispos 27 1220 1223
27. MO Karlsson T Anehall LE Friberg A Henningsson C Kloft M Sandstrom R Xie 2005 Pharmacokinetic/pharmacodynamic modelling in oncological drug development Basic Clin Pharmacol Toxicol 96 206 211
28. CM Kearns L Gianni MJ Egorin 1995 Paclitaxel pharmacokinetics and pharmacodynamics Semin Oncol 22 16 23
29. C Kloft J Wallin A Henningsson E Chatelut MO Karlsson 2006 Population pharmacokinetic-pharmacodynamic model for neutropenia with patient subgroup identification: comparison across anticancer drugs Clin Cancer Res 12 5481 5490
30. I Kola J Landis 2004 Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov 3 711 715
31. Kompella UB, Lee VHL (1991) Pharmacokinetics of peptide and protein drugs. In: Lee VHL (ed) Peptide and protein drug delivery. Marcel Dekker, New York, pp 391-484
32. W Krzyzanski WJ Jusko 2002 Multiple-pool cell lifespan model of hematologic effects of anticancer agents J Pharmacokinet Pharmacodyn 29 311 337
33. W Krzyzanski S Woo WJ Jusko 2006 Pharmacodynamic models for agents that alter production of natural cells with various distributions of lifespans J Pharmacokinet Pharmacodyn 33 125 166
34. W Krzyzanski JJ Perez-Ruixo A Vermeulen 2008 Basic pharmacodynamic models for agents that alter the lifespan distribution of natural cells J Pharmacokinet Pharmacodyn 35 349 377
35. T Licht I Pastan MM Gottesman F Herrmann 1996 The multidrug-resistance gene in gene therapy of cancer and hematopoietic disorders Ann Hematol 72 184 193
36. Lissianskaya A, Gershanovich M, Ognerubov N, Golubeva O, Pratt J (2004) Paclitaxel injectable emulsion: phase 2a study of weekly administration in patients with platinum-resistant ovarian cancer. J Clin Oncol (ASCO Annual Meeting Proceedings) 22: abstract No. 5047
37. H Minami Y Sasaki N Saijo T Ohtsu H Fujii T Igarashi K Itoh 1998 Indirect-response model for the time course of leukopenia with anticancer drugs Clin Pharmacol Ther 64 511 521
38. DR Mould GF Fleming KM Darcy D Spriggs 2006 Population analysis of a 24-h paclitaxel infusion in advanced endometrial cancer: a gynaecological oncology group study Br J Clin Pharmacol 62 56 70
39. H Onishi Y Machida 2005 Macromolecular and nanotechnological modification of camptothecin and its analogs to improve the efficacy Curr Drug Discov Technol 2 169 183
40. K Ozawa H Minami H Sato 2007 Population pharmacokinetic and pharmacodynamic analysis for time courses of docetaxel-induced neutropenia in Japanese cancer patients Cancer Sci 98 1985 1992
41. JJ Perez-Ruixo HC Kimko AT Chow V Piotrovsky W Krzyzanski WJ Jusko 2005 Population cell life span models for effects of drugs following indirect mechanisms of action J Pharmacokinet Pharmacodyn 32 767 793
42. EK Rowinsky M Wright B Monsarrat GJ Lesser RC Donehower 1993 Taxol: pharmacology, metabolism and clinical implications Cancer Surv 17 283 304
43. EK Rowinsky EA Eisenhauer V Chaudhry SG Arbuck RC Donehower 1993 Clinical toxicities encountered with paclitaxel (Taxol) Semin Oncol 20 1 15
44. AH Schinkel U Mayer E Wagenaar CA Mol L van Deemter JJ Smit MA van der Valk AC Voordouw H Spits O van Tellingen JM Zijlmans WE Fibbe P Borst 1997 Normal viability and altered pharmacokinetics in mice lacking mdr1-type (drug-transporting) P-glycoproteins Proc Natl Acad Sci USA 94 4028 4033
45. Skubitz KM (1999) Neutrophilic Leukocytes. In: Lee GR, Foerster J, Lukens J, Paraskevas F, Greer JP, Rodgers GM, Wintrobe MM (eds) Wintrobe's Clinical Hematology. Lippincott Williams & Wilkins, Philadelphia
46. DS Sonnichsen CA Hurwitz CB Pratt JJ Shuster MV Relling 1994 Saturable pharmacokinetics and paclitaxel pharmacodynamics in children with solid tumors J Clin Oncol 12 532 538
47. A Sparreboom O van Tellingen WJ Nooijen JH Beijnen 1996 Nonlinear pharmacokinetics of paclitaxel in mice results from the pharmaceutical vehicle Cremophor EL Cancer Res 56 2112 2115
48. A Sparreboom L van Zuylen E Brouwer WJ Loos P de Bruijn H Gelderblom M Pillay K Nooter G Stoter J Verweij 1999 Cremophor EL-mediated alteration of paclitaxel distribution in human blood: clinical pharmacokinetic implications Cancer Res 59 1454 1457
49. Taylor AE, Granger GN (1984) Handbook of physiology. In: Renkin EM (ed). American Physiological Society, Bethesda, pp 467-520
50. S Woo W Krzyzanski WJ Jusko 2008 Pharmacodynamic model for chemotherapy-induced anemia in rats Cancer Chemother Pharmacol 62 123 133
51. L Zhang SL Beal LB Sheiner 2003 Simultaneous vs. sequential analysis for population PK/PD data I: best-case performance J Pharmacokinet Pharmacodyn 30 387 404