Assessment of lfosfamide pharmacokinetics, toxicity, and relation to CYP3A4 activity as measured by the erythromycin breath test in patients with sarcoma

Cancer

Volumn 109, Issue 11, 2007, Pages 2315-2322

  Chugh, Rashmi ^a   Wagner, Thomas ^b   Griffith, Kent A ^c   Taylor, Jeremy M G ^c   Thomas, Dafydd G ^a   Worden, Francis P ^a   Leu, Kirsten M ^d   Zalupski, Mark M ^a   Baker, Laurence H ^a,e  

^a UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^b UNIVERSITY OF LÜBECK   (Germany)

^c UNIVERSITY OF MICHIGAN COMPREHENSIVE CANCER CENTER   (United States)

^d Section of Oncology/Hematology   (United States)

^e NONE   (United States)

Author keywords

Cytochrome P450 3A; Erythromycin breath test; Ifosfamide; Pharmacokinetics; Sarcoma

Indexed keywords

2 DICHLOROETHYLIFOSFAMIDE; 3 DICHLOROETHYLIFOSFAMIDE; CARBON 13; CYTOCHROME P450 3A4; DOXORUBICIN; DRUG METABOLITE; ERYTHROMYCIN; GRANULOCYTE COLONY STIMULATING FACTOR; IFOSFAMIDE; MESNA; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; UNCLASSIFIED DRUG; ALKYLATING AGENT; CYP3A4 PROTEIN, HUMAN; CYTOCHROME P450;

ADULT; ANEMIA; AREA UNDER THE CURVE; ARTICLE; BAYES THEOREM; BREATH ANALYSIS; CLINICAL TRIAL; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION ANALYSIS; CREATININE BLOOD LEVEL; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG INFUSION; DRUG MEGADOSE; DRUG URINE LEVEL; ENZYME ACTIVITY; ERYTHROMYCIN BREATH TEST; HUMAN; LEUKOPENIA; LOW DRUG DOSE; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; NEUTROPHIL COUNT; PHASE 2 CLINICAL TRIAL; PHENOTYPE; PREDICTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SOFT TISSUE SARCOMA; THROMBOCYTE COUNT; THROMBOCYTOPENIA; DOSE RESPONSE; ENZYMOLOGY; METABOLISM; REMISSION; SARCOMA; SOFT TISSUE TUMOR; TIME;

ANTINEOPLASTIC AGENTS, ALKYLATING; AREA UNDER CURVE; BREATH TESTS; CYTOCHROME P-450 ENZYME SYSTEM; DOSE-RESPONSE RELATIONSHIP, DRUG; ERYTHROMYCIN; HUMANS; IFOSFAMIDE; REMISSION INDUCTION; SARCOMA; SOFT TISSUE NEOPLASMS; TIME FACTORS;

EID: 34249078591     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.22669     Document Type: Article

References (30)

1. Zalupski M, Baker LH. Ifosfamide. J Natl Cancer Inst. 1988;80:556-566.
2. Van Dyk JJ, Falkson HC, Van der Merwe AM, et al. Unexpected toxicity in patients treated with iphosphamide. Cancer Res. 1972;32:921-924.
3. Kerbusch T, de Kraker J, Keizer HJ, et al. Clinical pharmacokinetics and pharmacodynamics of ifosfamide and its metabolites. Clin Pharmacokinet. 2001;40:41-62.
4. McCune JS, Risler LJ, Phillips BR, et al. Contribution of CYP3A5 to hepatic and renal ifosfamide N-dechloroethylation. DrugMetab Dispos. 2005;33:1074-1081.
5. Walker D, Flinois JP, Monkman SC, et al. Identification of the major human hepatic cytochrome P450 involved in activation and N-dechloroethylation of ifosfamide. Biochem Pharmacol. 1994;47:1157-1163.
6. Huang Z, Roy P, Waxman DJ. Role of human liver microsomal CYP3A4 and CYP2B6 in catalyzing N-dechloroethylation of cyclophosphamide and ifosfamide. Biochem Pharmacol. 2000;59:961-972.
7. Granvil CP, Madan A, Sharkawi M, et al. Role of CYP2B6 and CYP3A4 in the in vitro N-dechloroethylation of (R)-and (S)-ifosfamide in human liver microsomes. Drug Metab Dispos. 1999;27:533-541.
8. Sladek NE. Metabolism of cyclophosphamide by rat hepatic microsomes. Cancer Res. 1971;31:901-908.
9. Sladek NE. Metabolism of oxazaphosphorines. Pharmacol Ther. 1988;37:301-355.
10. Brock N, Hilgard P, Peukert M, et al. Basis and new developments in the field of oxazaphosphorines. Cancer Invest. 1988;6:513-532.
11. Goren MP, Wright RK, Pratt CB, et al. Dechloroethylation of ifosfamide and neurotoxicity. Lancet. 1986;2:1219-1220.
12. Ruzicka JA, Ruenitz PC. Cytochrome P-450-mediated N-dechloroethylation of cyclophosphamide and ifosfamide in the rat. Drug Metab Dispos. 1992;20:770-772.
13. Kerbusch T, Mathjt RA, Keizer HJ, et al. Population pharmacokinetics and exploratory pharmacodynamics of ifosfamide and metabolites after a 72-h continuous infusion in patients with soft tissue sarcoma. Eur J Clin Pharmacol. 2001;57:467-477.
14. Watkins PB, Murray SA, Winkelman LG, et al. Erythromycin breath test as an assay of glucocorticoid-inducible liver cytochromes P-450. Studies in rats and patients. J Clin Invest. 1989;83:688-697.
15. Watkins PB. Noninvasive tests of CYP3A enzymes. Pharmacogenetics. 1994;4:171-184.
16. Hirth J, Watkins PB, Strawderman M, et al. The effect of an individual's cytochrome CYP3A4 activity on docetaxel clearance. Clin Cancer Res. 2000;6:1255-1258.
17. Worden FP, Taylor JM, Biermann JS, et al. Randomized phase II evaluation of 6 g/m2 of ifosfamide plus doxorubicin and granulocyte colony-stimulating factor (G-CSF) compared with 12 g/m2 of ifosfamide plus doxorubicin and G-CSF in the treatment of poor-prognosis soft tissue sarcoma. J Clin Oncol. 2005;23:105-112.
18. Kurowski V, Wagner T. Comparative pharmacokinetics of ifosfamide, 4hydroxyifosfamide, chloroacetaldehyde, and 2-and 3-dechloroethylifosfamide in patients on fractionated intravenous ifosfamide therapy. Cancer Chemother Pharmacol. 1993;33:36-42.
19. Boddy AV, Cole M, Pearson AD, et al. The kinetics of the auto-induction of ifosfamide metabolism during continuous infusion. Cancer Chemother Pharmacol. 1995;36:53-60.
20. Kerbusch T, Huitema AD, Ouwerkerk J, et al. Evaluation of the autoinduction of ifosfamide metabolism by a population pharmacokinetic approach using NONMEM. Br J Clin Pharmacol. 2000;49:555-561.
21. Watkins PB, Hamilton TA, Annesley TM, et al. The erythromycin breath test as a predictor of cyclosporine blood levels. Clin Pharmacol Ther. 1990;48:120-129.
22. McCune JS, Hawke RL, LeCluyse EL, et al. In vivo and in vitro induction of human cytochrome P4503A4 by dexamethasone. Clin Pharmacol Ther. 2000;68:356-366.
23. Singer JM, Hartley JM, Brennan C, et al. The pharmacokinetics and metabolism of ifosfamide during bolus and infusional administration: a randomized cross-over study. Br J Cancer. 1998;77:978-984.
24. Kivisto KT, Kroemer HK, Eichelbaum M. The role of human cytochrome P450 enzymes in the metabolism of anticancer agents: implications for drug interactions. Br J Clin Pharmacol. 1995;40:523-530.
25. Chiou WL, Jeong HY, Wu TC, et al. Use of the erythromycin breath test for in vivo assessments of cytochrome P4503A activity and dosage individualization. Clin Pharmacol Ther. 2001;70:305-310.
26. Krecic-Shepard ME, Barnas CR, Slimko J, et al. In vivo comparison of putative probes of CYP3A4/5 activity: erythromycin, dextromethorphan, and verapamil. Clin Pharmacol Ther. 1999;66:40-50.
27. Kinirons MT, O'Shea D, Kim RB, et al. Failure of erythromycin breath test to correlate with midazolam clearance as a probe of cytochrome P4503A. Clin Pharmacol Ther. 1999;66:224-231.
28. Lown KS, Thummel KE, Benedict PE, et al. The erythromycin breath test predicts the clearance of midazolam. Clin Pharmacol Ther. 1995;57:16-24.
29. Mathijssen RH, de Jong FA, van Schaik RH, et al. Prediction of irinotecan pharmacokinetics by use of cytochrome P450 3A4 phenotyping probes. J Natl Cancer Inst. 2004;96:1585-1592.
30. Roy P, Tretyakov O, Wright J, et al. Stereoselective metabolism of ifosfamide by human P-450s 3A4 and 2B6. Favorable metabolic properties of R-enantiomer. Drug Metab Dispos. 1999;27:1309-1318.