Factors affecting pharmacokinetic variability following doxorubicin and docetaxel-based therapy

European Journal of Cancer

Volumn 40, Issue 8, 2004, Pages 1170-1178

  Rudek, M A ^a   Sparreboom, A ^a,c   Garrett Mayer, E S ^a   Armstrong, D K ^a   Wolff, A C ^a   Verweij, J ^b   Baker, S D ^a  

^a JOHNS HOPKINS UNIVERSITY   (United States)

^b ERASMUS MEDICAL CENTER   (Netherlands)

^c NATIONAL CANCER INSTITUTE   (United States)

Author keywords

Docetaxel; Doxorubicin; Pharmacokinetics; Variability

Indexed keywords

ANTINEOPLASTIC AGENT; CAPECITABINE; CISPLATIN; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; LANIQUIDAR; MARIMASTAT; METHOTREXATE; PACLITAXEL; UNCLASSIFIED DRUG;

ADULT; AGED; BODY SIZE; BODY SURFACE; CANCER COMBINATION CHEMOTHERAPY; CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG CLEARANCE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MALIGNANT NEOPLASTIC DISEASE; PRIORITY JOURNAL; SEX DIFFERENCE;

ADULT; AGE FACTORS; AGED; AGED, 80 AND OVER; ANTIBIOTICS, ANTINEOPLASTIC; ANTINEOPLASTIC AGENTS, PHYTOGENIC; BODY CONSTITUTION; BODY MASS INDEX; DOXORUBICIN; DRUG ADMINISTRATION SCHEDULE; DRUG INTERACTIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; REGRESSION ANALYSIS; TAXOIDS;

EID: 1942488208     PISSN: 09598049     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejca.2003.12.026     Document Type: Conference Paper

References (45)

1. Calvert A.H., Newell D.R., Gumbrell L.A.et al. Carboplatin dosage. prospective evaluation of a simple formula based on renal function J. Clin. Oncol. 7:1989;1748-1756.
2. Evans W.E., Relling M.V., Rodman J.H., Crom W.R., Boyett J.M., Pui C.H. Conventional compared with individualized chemotherapy for childhood acute lymphoblastic leukemia. N. Engl. J. Med. 338:1998;499-505.
3. Gurney H. Dose calculation of anticancer drugs. a review of the current practice and introduction of an alternative J. Clin. Oncol. 14:1996;2590-2611.
4. Gurney H. How to calculate the dose of chemotherapy. Br. J. Cancer. 86:2002;1297-1302.
5. Felici A., Verweij J., Sparreboom A. Dosing strategies for anticancer drugs. the good, the bad and body-surface area Eur. J. Cancer. 38:2002;1677.
6. Grochow L.B., Baraldi C., Noe D. Is dose normalization to weight or body surface area useful in adults? J. Natl. Cancer Inst. 82:1990;323-325.
7. Ratain M.J. Body-surface area as a basis for dosing of anticancer agents. science, myth, or habit? J. Clin. Oncol. 16:1998;2297-2298.
8. Sawyer M., Ratain M.J. Body surface area as a determinant of pharmacokinetics and drug dosing. Invest New Drugs. 19:2001;171-177.
9. Baker S.D., Verweij J., Rowinsky E.K.et al. Role of body-surface area in dosing of investigational anticancer agents in adults. 1991-2001 J. Natl. Cancer Inst. 94:2002;1883-1888.
10. Miller A.A. Body surface area in dosing anticancer agents. scratch the surface! J. Natl. Cancer Inst. 94:2002;1822-1823.
11. Egorin M.J. Horseshoes, hand grenades, and body-surface area-based dosing. aiming for a target J. Clin. Oncol. 21:2003;182-183.
12. van den Bongard H.J., Mathot R.A., Beijnen J.H., Schellens J.H. Pharmacokinetically guided administration of chemotherapeutic agents. Clin. Pharmacokinet. 39:2000;345-367.
13. Sparreboom A., Planting A.S., Jewell R.C.et al. Clinical pharmacokinetics of doxorubicin in combination with GF120918, a potent inhibitor of MDR1 P-glycoprotein. Anticancer Drugs. 10:1999;719-728.
14. Dees E.C., O'Reilly S., Goodman S.N.et al. A prospective pharmacologic evaluation of age-related toxicity of adjuvant chemotherapy in women with breast cancer. Cancer Invest. 18:2000;521-529.
15. Baker S.D., Kennedy M.J., Wolff A.C.et al. Pharmacokinetics (PK) of doxorubicin (A) and docetaxel (T) combinations in patients with advanced cancer. Proc. Amer. Soc. Clin. Oncol. 20:2001;109a.
16. Gianni L., Vigano L., Locatelli A.et al. Human pharmacokinetic characterization and in vitro study of the interaction between doxorubicin and paclitaxel in patients with breast cancer. J. Clin. Oncol. 15:1997;1906-1915.
17. Pronk L.C., Schellens J.H., Planting A.S.et al. Phase I and pharmacologic study of docetaxel and cisplatin in patients with advanced solid tumors. J. Clin. Oncol. 15:1997;1071-1079.
18. Pronk L.C., Vasey P., Sparreboom A.et al. A phase I and pharmacokinetic study of the combination of capecitabine and docetaxel in patients with advanced solid tumours. Br. J. Cancer. 83:2000;22-29.
19. Louwerens M., Smorenburg C., Sparreboom A., Loos W.J., Verweij J., de Wit R. Phase I pharmacokinetic and sequence finding study of the combination of docetaxel and methotrexate in patients with solid tumours. Eur. J. Cancer. 38:2002;497-504.
20. van Zuylen L., Sparreboom A., van der Gaast A.et al. Disposition of docetaxel in the presence of P-glycoprotein inhibition by intravenous administration of R101933. Eur. J. Cancer. 38:2002;1090-1099.
21. van Zuylen L., Sparreboom A., van der Gaast A.et al. The orally administered P-glycoprotein inhibitor R101933 does not alter the plasma pharmacokinetics of docetaxel. Clin. Cancer Res. 6:2000;1365-1371.
22. Wolff A.C., Krishnamurthi S., Sparano J.A., Armstrong D.A., Donehower R.C., Baker S.D. A pharmacokinetic (PK) and pharmacodynamic study of doxorubicin and docetaxel combinations plus marimastat (AT/M) in metastatic breast cancer (MBC). Proc. Amer. Soc. Clin. Oncol. 20:2001;98a.
23. de Bruijn P., Verweij J., Loos W.J.et al. Determination of doxorubicin and doxorubicinol in plasma of cancer patients by high-performance liquid chromatography. Anal. Biochem. 266:1999;216-221.
24. Loos W.J., Verweij J., Nooter K., Stoter G., Sparreboom A. Sensitive determination of docetaxel in human plasma by liquid-liquid extraction and reversed-phase high-performance liquid chromatography. J. Chromatogr. B Biomed. Sci. Appl. 693:1997;437-441.
25. D'Argenio D.Z., Schumitzky A. A program package for simulation and parameter estimation in pharmacokinetic systems. Comput. Programs Biomed. 9:1979;115-134.
26. Danesi R., Fogli S., Gennari A., Conte P., Del Tacca M. Pharmacokinetic-pharmacodynamic relationships of the anthracycline anticancer drugs. Clin. Pharmacokinet. 41:2002;431-444.
27. Bruno R., Hille D., Riva A.et al. Population pharmacokinetics/ pharmacodynamics of docetaxel in phase II studies in patients with cancer. J. Clin. Oncol. 16:1998;187-196.
28. DuBois D., DuBois E.F. A formula to estimate the approximate surface area if height and weight be known. Arch. Intern. Med. 17:1916;863-871.
29. Morgan D.J., Bray K.M. Lean body mass as a predictor of drug dosage. Implications for drug therapy Clin. Pharmacokinet. 26:1994;292-307.
30. Gibbs J.P., Gooley T., Corneau B.et al. The impact of obesity and disease on busulfan oral clearance in adults. Blood. 93:1999;4436-4440.
31. Robert J. Anthracyclines. Grochow L.B., Ames M.M. A clinician's guide to chemotherapy pharmacokinetics and pharmacodynamics. 1998;93-173 Williams & Wilkins, Baltimore.
32. Baker S.D., Grochow L.B., Donehower R.C. Should anticancer drug doses be adjusted in the obese patient? J. Natl. Cancer Inst. 87:1995;333-3334.
33. Cosolo W.C., Morgan D.J., Seeman E., Zimet A.S., McKendrick J.J., Zalcberg J.R. Lean body mass, body surface area and epirubicin kinetics. Anticancer Drugs. 5:1994;293-297.
34. Erttmann R., Erb N., Steinhoff A., Landbeck G. Pharmacokinetics of doxorubicin in man. dose and schedule dependence J. Cancer Res. Clin. Oncol. 114:1988;509-513.
35. Bronchud M.H., Margison J.M., Howell A., Lind M., Lucas S.B., Wilkinson P.M. Comparative pharmacokinetics of escalating doses of doxorubicin in patients with metastatic breast cancer. Cancer Chemother. Pharmacol. 25:1990;435-439.
36. Evans W.E., Crom W.R., Yee G.C.et al. Adriamycin pharmacokinetics in children. Proc. Amer. Assoc. Cancer Res. 21:1980;176.
37. Dodion P., Riggs C.E., Akman S.R., Tamburini J.M., Colvin O.M., Bachur N.R. Interactions between cyclophosphamide and adriamycin metabolism in rats. J. Pharmacol. Exp. Ther. 229:1984;51-57.
38. Nabholtz J.M., Pienkowski T., Mackey J.et al. Phase III trial comparing TAC (docetaxel, doxorubicin, cyclophosphamide) with FAC (5-fluorouracil, doxorubicin, cyclophosphamide) in the adjuvant treatment of node positive breast cancer (BC) patients. interim analysis of the BCIRG 001 study Proc. Amer. Soc. Clin. Oncol. 21:2002;36a.
39. Rodvold K.A., Rushing D.A., Tewksbury D.A. Doxorubicin clearance in the obese. J. Clin. Oncol. 6:1988;1321-1327.
40. Eksborg S., Strandler H.S., Edsmyr F., Naslund I., Tahvanainen P. Pharmacokinetic study of i.v. infusions of adriamycin. Eur. J. Clin. Pharmacol. 28:1985;205-212.
41. Li J., Gwilt P.R. The effect of age on the early disposition of doxorubicin. Cancer Chemother. Pharmacol. 51:2003;395-402.
42. Bruno R., Vivier N., Veyrat-Follet C., Montay G., Rhodes G.R. Population pharmacokinetics and pharmacokinetic-pharmacodynamic relationships for docetaxel. Invest. New Drugs. 19:2001;163-169.
43. Bruno R., Vivler N., Vergniol J.C., De Phillips S.L., Montay G., Sheiner L.B. A population pharmacokinetic model for docetaxel (Taxotere). model building and validation J. Pharmacokinet. Biopharm. 24:1996;153-172.
44. Sotaniemi E.A., Arranto A.J., Pelkonen O., Pasanen M. Age and cytochrome P450-linked drug metabolism in humans. an analysis of 226 subjects with equal histopathologic conditions Clin. Pharmacol. Ther. 61:1997;331-339.
45. Dooley M.J., Poole S.G., Toner G.C.et al. Predicted normal weight as a potential tool for adjusting chemotherapy doses in obese patients. Proc. Amer. Soc. Clin. Oncol. 22:2003;142.