Quantitative effect of gender, age, liver function, and body size on the population pharmacokinetics of paclitaxel in patients with solid tumors

Clinical Cancer Research

Volumn 12, Issue 7 I, 2006, Pages 2150-2157

  Joerger, Markus ^a   Huitema, Alwin D R ^a   Van Den Bongard, Desiree H J G ^a   Schellens, Jan H M ^a,b   Beijnen, Jos H ^a,b  

^a NETHERLANDS CANCER INSTITUTE   (Netherlands)

^b UTRECHT UNIVERSITY   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

BILIRUBIN; CARBOPLATIN; PACLITAXEL;

ADULT; AGE; AGED; ANTHROPOMETRY; ARTICLE; BODY SIZE; BODY SURFACE; CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG ELIMINATION; FEMALE; HUMAN; LIVER FUNCTION; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; OVARY CANCER; PRIORITY JOURNAL; QUANTITATIVE STUDY; SEX DIFFERENCE; SOLID TUMOR;

AGE FACTORS; ANTINEOPLASTIC AGENTS; BODY SIZE; FEMALE; HUMANS; LIVER; LIVER FUNCTION TESTS; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; NEOPLASMS; PACLITAXEL; POPULATION; SEX FACTORS;

EID: 33646252500     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-05-2069     Document Type: Article

References (44)

1. Sonnichsen DS, Hurwitz CA, Pratt CB, Shuster JJ, Relling MV. Saturable pharmacokinetics and paclitaxel pharmacodynamics in children with solid tumors. J Clin Oncol 1994;12:532-8.
2. Gianni L, Kearns CM, Gianni A, et al. Nonlinear pharmacokinetics and metabolism of paclitaxel and its pharmacokinetic/pharmacodynamic relationships in humans. J Clin Oncol 1995;13:180-90.
3. van Tellingen O, Huizing MT, Panday VR, Schellens JH, Nooijen WJ, Beijnen JH. Cremophor EL causes (pseudo-) non-linear pharmacokinetics of paclitaxel in patients. Br J Cancer 1999;81:330-5.
4. Sparreboom A, van Tellingen O, Nooijen WJ, Beijnen JH. Nonlinear pharmacokinetics of paclitaxel in mice results from the pharmaceutical vehicle Cremophor EL. Cancer Res 1996;56:2112-5.
5. Sparreboom A, van Zuylen L, Brouwer E, et al. Cremophor EL-mediated alteration of paclitaxel distribution in human blood: clinical pharmacokinetic implications. Cancer Res 1999;59:1454-7.
6. van Zuylen L, Karlsson MO, Verweij J, et al. Pharmacokinetic modeling of paclitaxel encapsulation in Cremophor EL micelles. Cancer Chemother Pharmacol 2001;47:309-18.
7. van Huylen L, Gianni L, Verweij J, et al. Inter-relationships of paclitaxel disposition, infusion duration and Cremophor EL kinetics in cancer patients. Anticancer Drugs 2000;11:331-7.
8. Henningsson A, Karlsson MO, Vigano L, Gianni L, Verweij J, Sparreboom A. Mechanism-based pharmacokinetic model for paclitaxel. J Clin Oncol 2001;19:4065-73.
9. Panday VR, Huizing MT, Willemse PH, et al. Hepatic metabolism of paclitaxel and its impact in patients with altered hepatic function. Semin Oncol 1997;24:S11.
10. Brown T, Havlin K, Weiss G, et al. A phase I trial of taxol given by a 6-hour intravenous infusion. J Clin Oncol 1991;9:1261-7.
11. Wiernik PH, Schwartz EL, Einzig A, Strauman JJ, Lipton RB, Dutcher JP. Phase I trial of taxol given as a 24-hour infusion every 21 days: responses observed in metastatic melanoma. J Clin Oncol 1987;5:1232-9.
12. Rowinsky EK, Burke PJ, Karp JE, Tucker RW, Ettinger DS, Donehower RC. Phase I and pharmacodynamic study of taxol in refractory acute leukemias. Cancer Res 1989;49:4640-7.
13. Rowinsky EK, Gilbert MR, McGuire WP, et al. Sequences of taxol and cisplatin: a phase I and pharmacologic study. J Clin Oncol 1991;9:1692-703.
14. Kojima T, Matsui T, Uemura T, Fujimitsu Y, Kato J, Kojima H. [A case of advanced gastric cancer treated with weekly paclitaxel with measurement of paclitaxel concentrations in blood and ascites]. Gan To Kagaku Ryoho 2003;30:1529-31.
15. Takahashi Y, Hara A, Tokuhara T, Izumi N, Iwamoto S, Satake K. [A case of inoperable scirrhous gastric cancer that responded remarkably to a combination of TS-1 + paclitaxel and showed complete loss of ascites]. Gan To Kagaku Ryoho 2004;31:1093-5.
16. Ishida T, Shimokawa H, Kawaguchi K, et al. [Effective weekly paclitaxel administration for gastric cancer with malignant ascites-a case report]. Gan To Kagaku Ryoho 2002;29:1643-6.
17. Matsui T, Kojima H, Kato J, et al. [A case report of unresectable gastric cancer that responded to 5-FU plus paclitaxel (FT) therapy]. Gan To Kagaku Ryoho 2004;31:939-42.
18. Hikino H, Yamada T, Hata T, et al. [Efficacy of weekly administration of paclitaxel for advanced or recurrent gastric cancer with peritoneal dissemination]. Gan To Kagaku Ryoho 2004;31:759-61.
19. Kato K, Koide A, Oobu M, et al. [A case of gastric cancer with peritoneal dissemination which shows a remarkable efficacy by a weekly administration of paclitaxel intraperitoneally]. Gan To Kagaku Ryoho 2004;31:1852-4.
20. Rowinsky EK, Wright M, Monsarrat B, Donehower RC. Clinical pharmacology and metabolism of Taxol (paclitaxel): update 1993. Ann Oncol 1994;5 Suppl 6:S7-16.
21. Ohtsu T, Sasaki Y, Tamura T, et al. Clinical pharmacokinetics and pharmacodynamics of paclitaxel: a 3-hour infusion versus a 24-hour infusion. Clin Cancer Res 1995;1:599-606.
22. Kearns CM, Gianni L, Egorin MJ. Paclitaxel pharmacokinetics and pharmacodynamics. Semin Oncol 1995;22:16-23.
23. Rowinsky EK, Donehower RC. The clinical pharmacology of paclitaxel (Taxol). Semin Oncol 1993;20:16-25.
24. Karlsson MO, Molnar V, Freijs A, Nygren P, Bergh J, Larsson R. Pharmacokinetic models for the saturable distribution of paclitaxel. Drug Metab Dispos 1999;27:1220-3.
25. Henningsson A, Sparreboom A, Sandstrom M, et al. Population pharmacokinetic modelling of unbound and total plasma concentrations of paclitaxel in cancer patients. Eur J Cancer 2003;39:1105-14.
26. Wilson WH, Berg SL, Bryant G, et al. Paclitaxel in doxorubicin-refractory or mitoxantrone-refractory breast cancer: a phase I/II trial of 96-hour infusion. J Clin Oncol 1994;12:1621-9.
27. Venook AP, Egorin M, Brown T. Paclitaxel (Taxol) in patients with liver dysfunction (CALGB 9264). Proc Am Soc Clin Oncol 1994;13:139.
28. Huizing MT, Vermorken JB, Rosing H, et al. Pharmacokinetics of paclitaxel and three major metabolites in patients with advanced breast carcinoma refractory to anthracycline therapy treated with a 3-hour paclitaxel infusion: a European Cancer Centre (ECC) trial. Ann Oncol 1995;6:699-704.
29. Huizing MT, Keung AC, Rosing H, et al. Pharmacokinetics of paclitaxel and metabolites in a randomized comparative study in platinum-pretreated ovarian cancer patients. J Clin Oncol 1993;11:2127-35.
30. Huizing MT, Giaccone G, van Warmerdam LJ, et al. Pharmacokinetics of paclitaxel and carboplatin in a dose-escalating and dose-sequencing study in patients with non-small-cell lung cancer. The European Cancer Centre. J Clin Oncol 1997;15:317-29
31. de Jonge ME, van den Bongard HJ, Huitema AD, et al. Bayesian pharmacokinetically guided dosing of paclitaxel in patients with non-small cell lung cancer. Clin Cancer Res 2004;10:2237-44.
32. Eisenhauer EA, Bokkel Huinink WW, Swenerton KD, et al. European-Canadian randomized trial of paclitaxel in relapsed ovarian cancer: high-dose versus low-dose and long versus short infusion. J Clin Oncol 1994;12:2654-66.
33. Malingre MM, Terwogt JM, Beijnen JH, et al. Phase I and pharmacokinetic study of oral paclitaxel. J Clin Oncol 2000;18:2468-75.
34. Willey TA, Bekos EJ, Gaver RC, et al. High-performance liquid chromatographic procedure for the quantitative determination of paclitaxel (Taxol) in human plasma. J Chromatogr 1993;621:231-8.
35. Huizing MT, Sparreboom A, Rosing H, van Tellingen O, Pinedo HM, Beijnen JH. Quantification of paclitaxel metabolites in human plasma by high-performance liquid chromatography. J Chromatogr B Biomed Appl 1995;674:261-8.
36. Beal SL, Sheiner LB. NONMEM Users Guide University of California at San Francisco: NONMEM Project Group: 1998.
37. 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.
38. Fetterly GJ, Tamburlin JM, Straubinger RM. Paclitaxel pharmacodynamics: application of a mechanism-based neutropenia model. Biopharm Drug Dispos 2001;22:251-61.
39. Miller AA, Rosner GL, Egorin MJ, Hollis D, Lichtman SM, Ratain MJ. Prospective evaluation of body surface area as a determinant of paclitaxel pharmacokinetics and pharmacodynamics in women with solid tumors: cancer and Leukemia Group B Study 9763. Clin Cancer Res 2004;10:8325-31.
40. Venook AP, Egorin MJ, Rosner GL, et al. Phase I and pharmacokinetic trial of paclitaxel in patients with hepatic dysfunction: Cancer and Leukemia Group B 9264. J Clin Oncol 1998;16:1811-9.
41. Nakamura Y, Sekine I, Furuse K, Saijo N. Retrospective comparison of toxicity and efficacy in phase II trials of 3-h infusions of paclitaxel for patients 70 years of age or older and patients under 70 years of age. Cancer Chemother Pharmacol 2000;46:114-8.
42. Smorenburg CH, ten Tije AJ, Verweij J, et al. Altered clearance of unbound paclitaxel in elderly patients with metastatic breast cancer. Eur J Cancer 2003;39:196-202.
43. Lichtman SM, Egorin M, Rosner GL, et al. Clinical pharmacology of paclitaxel in relation to patient age: CALGB 9762 [abstr 265]. Proc Am Soc Clin Oncol 2001;20:67a.
44. Smorenburg CH, Sparreboom A, Bontenbal M, Stoter G, Nooter K, Verweij J. Randomized cross-over evaluation of body-surface area-based dosing versus flat-fixed dosing of paclitaxel. J Clin Oncol 2003;21:197-202.