Pharmacokinetics and pharmacodynamics of protein-unbound docetaxel in cancer patients

Cancer Science

Volumn 97, Issue 3, 2006, Pages 235-241

  Minami, Hironobu ^a   Kawada, Kenji ^a   Sasaki, Yasutsuna ^a   Igarashi, Tadahiko ^a   Saeki, Toshiaki ^a   Tahara, Makoto ^a   Itoh, Kuniaki ^a   Fujii, Hirofumi ^a  

^a NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

DOCETAXEL; MITOMYCIN; NITROSOUREA; OROSOMUCOID; PLASMA PROTEIN;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CALCULATION; CANCER CHEMOTHERAPY; CANCER PATIENT; CONTROLLED STUDY; DRUG ACTIVITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG INFUSION; DRUG PROTEIN BINDING; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTIVARIATE LOGISTIC REGRESSION ANALYSIS; NEUTROPENIA; PHARMACODYNAMICS; PREDICTION; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; SOLID TUMOR; ULTRAFILTRATION;

ADULT; AGED; ANTINEOPLASTIC AGENTS, PHYTOGENIC; AREA UNDER CURVE; BLOOD PROTEINS; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; NEUTROPENIA; TAXOIDS;

EID: 33645971606     PISSN: 13479032     EISSN: 13497006     Source Type: Journal    
DOI: 10.1111/j.1349-7006.2006.00166.x     Document Type: Article

References (34)

1. Lima JJ, Boudoulas H, Blanford MF. Concentration dependence of disopyramide binding to serum protein and its influence on kinetics and dynamics. J Pharmacol Exp Ther 1981; 219: 741-7.
2. Stewart CF, Arbuck SG, Fleming RA, Evans WE. Relation of systemic exposure to unbound etoposide and hematologic toxicity. Clin Pharmacol Ther 1991; 50: 385-93.
3. Rowland M. Protein binding and drug clearance. Clin Pharmacokinet 1984; 9 (Suppl. 1): 10-17.
4. Wilkinson GR. Clearance approaches in pharmacology. Pharmacol Rev 1987; 39: 1-47.
5. Shargel L, Yu ABC. Physiologic drug distribution and protein binding. In: Shargel L, Yu ABC, eds. Applied Biopharmaceutics and Pharmacokinetics, 4th edn. Stamford: Appleton and Lange, 1999; 281-324.
6. Chan S, Friedrichs K, Noel D et al. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol 1999; 17: 2341-54.
7. Nabholtz J-M, Senn HJ, Bezwoda WR et al. Prospective randomized trial of docetaxel versus mitomycin plus vinblastine in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy. J Clin Oncol 1999; 17: 1413-24.
8. Sjöström J, Blomqvist C, Mouridsen H et al. Docetaxel compared with sequential methotrexate and 5-fluorouracil in patients with advanced breast cancer after anthracycline failure: A randomised phase III study with crossover on progression by the Scandinavian Breast Group. Eur J Cancer 1999; 35: 1194-201.
9. Fossella FV, DeVore R, Kerr RN et al. Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. J Clin Oncol 2000; 18: 2354-62.
10. Shepherd FA, Dancey J, Ramlau R et al. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 2000; 18: 2095-103.
11. Francis P, Schneider J, Hann L et al. Phase II trial of docetaxel in patients with platinum-refractory advanced ovarian cancer. J Clin Oncol 1994; 12: 2301-8.
12. Vasey PA. Role of docetaxel in the treatment of newly diagnosed advanced ovarian cancer. J Clin Oncol 2003; 21: 136S-44S.
13. Dreyfuss AI, Clark JR, Norris CM et al. Docetaxel: An active drug for squamous cell carcinoma of the head and neck. J Clin Oncol 1996; 14: 1672-8.
14. Muro K, Hamaguchi T, Ohtsu A et al. A phase II study of single-agent docetaxel in patients with metastatic esophageal cancer. Ann Oncol 2004; 15: 955-9.
15. Bang Y-J, Kang WK, Kang Y-K et al. Docetaxel 75 mg/m 2 is active and well tolerated in patients with metastatic or recurrent gastric cancer, a phase II trial. Jpn J Clin Oncol 2002; 32: 248-54.
16. Sulkes A, Smyth J, Sessa C et al. Docetaxel (Taxotere) in advanced gastric cancer: Results of a phase II clinical trial. EORTC Early Clinical Trials Group. Br J Cancer 1994; 70: 380-3.
17. Tannock IF, Wit RD, Berry WR et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004; 351: 1502-12.
18. Beer TM, Pierce WC, Lowe BA, Henner WD. Phase II study of weekly docetaxel in symptomatic androgen-independent prostate cancer. Ann Oncol 2001; 12: 1273-9.
19. Urien S, Barre J, Morin C, Paccaly A, Montay G, Tillement J-P. Docetaxel serum protein binding with high affinity to alpha 1 -acid glycoprotein. Invest New Drugs 1996; 14: 147-51.
20. Bruno R, Hille D, Riva A et al. Population pharmacokinetics/ pharmacodynamics of docetaxel in phase II studies in patients with cancer. J Clin Oncol 1998; 16: 187-96.
21. 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: 364-71.
22. Minami H, Ohe Y, Niho S et al. Comparison of pharmacokinetics and pharmacodynamics of docetaxel and cisplatin in elderly and non-elderly patients: Why is toxicity increased in elderly patients? J Clin Oncol 2004; 22: 2901-8.
23. Baker SD, Li J, Tije AJT et al. Relationship of systemic exposure to unbound docetaxel and neutropenia. Clin Pharmacol Ther 2005; 77: 43-53.
24. Bruno R, Vivier N, Vergniol JC, Phillips SLD, Montay G, Sheiner LB. A population pharmacokinetic model for docetaxel (Taxotere), model building and validation. J Pharmacokin Biopharm 1996; 24: 153-72.
25. Rivory L, Slaviero K, Clarke S. Hepatic cytochrome P450 3A drug metabolism is reduced in cancer patients who have an acute-phase response. Br J Cancer 2002; 87: 277-80.
26. Baker SD, Schaik RH, Nv Rivory LP et al. Factors affecting cytochrome P-450 3A activity in cancer patients. Clin Cancer Res 2004; 10: 8341-50.
27. Vergniol J, Bruno R, Montay G, Frydman A. Determination of Taxotere in human plasma by a semi-automated high-performance liquid chromatographic method. J Chromatogr 1992; 582: 273-8.
28. Extra J-M, Rousseau F, Bruno R, Clavel M, Bail NL, Marty M. Phase I and pharmacokinetic study of taxotere (RP 56976; NSC 628503) given as a short intravenous infusion. Cancer Res 1993; 53: 1037-42.
29. Bissett D, Setanoians A, Cassidy J et al. Phase I and pharmacokinetic study of taxotere (RP 56976) administered as a 24-hour infusion. Cancer Res 1993; 53: 523-7.
30. Pazdur R, Newman RA, Newman BM et al. Phase I trial of Taxotere, five-day schedule. J Natl Cancer Inst 1992; 84: 1781-8.
31. Bruno R, Olivares R, Berille J et al. α-1-Acid glycoprotein as an independent predictor for treatment effects and a prognostic factor of survival in patients with non-small cell lung cancer treated with docetaxel. Clin Cancer Res 2003; 9: 1077-82.
32. Baumann H, Gauldie J. The acute response. Immunol Today 1994; 15: 74-80.
33. Koeffler P, Gasson J, Ranyard J, Souza L, Shepard M, Munker R. Recombinant human TNF a stimulates production of granulocyte colony-stimulating factor. Blood 1987; 70: 55-9.
34. Seelentag WK, Mermod JJ, Montesano R, Vassalli P. Additive effects of interleukin 1 and tumour necrosis factor-α on the accumulation of the three granulocyte and macrophage colony-stimulating factor mRNAs in human endothelial cells. EMBO J 1987; 6: 2261-5.