Clinical Oncology
Volume 19, Issue 2 , Pages 99-107 , March 2007

Chemotherapy Dosing Part II: Alternative Approaches and Future Prospects

  • S.A. Kaestner

      Affiliations

    • Department of Pharmacy and Pharmacology, 5W, University of Bath, Claverton Down, Bath BA2 7AY, UK
    • ,
  • G.J. Sewell

      Affiliations

    • Department of Pharmacy, Kingston University, Penrhyn Road, Kingston upon Thames, Surrey KT1 2EE, UK
    • Corresponding Author InformationAuthor for correspondence: G. J. Sewell, Department of Pharmacy, Kingston University, Penrhyn Road, Kingston upon Thames, Surrey KT1 2EE, UK. Tel: +44-20-85477577.

Received 15 September 2006 ,Accepted 9 October 2006.

References 

  1. Kaestner SA, Sewell GJ. Chemotherapy dosing part I: scientific basis for current practice and use of body surface area (BSA). Clin Oncol 2006;19.
  2. Calvert AH, Newell DR, Gumbrell LA, et al. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol. 1989;7:1748–1756
  3. Ghazal-Aswad S, Calvert AH, Newell DR. A single-sample assay for the estimation of the area under the free carboplatin plasma concentration versus time curve. Cancer Chemother Pharmacol. 1996;37:429–434
  4. Allsopp MA, Sewell GJ. A pharmacokinetic–pharmacodynamic study on carboplatin administered in prolonged continuous infusion regimens with synchronous radiotherapy. J Oncol Pharm Pract. 1995;1:25–32
  5. Duffull SB, Robinson BA. Clinical pharmacokinetics and dose optimisation of carboplatin. Clin Pharmacokinet. 1997;33:161–183
  6. Calvert AH, Harland SJ, Newell DR, Siddik ZH, Harrap KR. Phase I studies with carboplatin at the Royal Marsden Hospital. Cancer Treat Rev. 1985;12(Suppl A):51–57
  7. Huitema ADR, Mathot RAA, Tibben MM, Schellens JHM, Rodenhuis S, Beijnen JH. Validation of techniques for the prediction of carboplatin exposure: application of Bayesian methods. Clin Pharmacol Ther. 2000;67:621–630
  8. Egorin MJ, Van Echo DA, Tipping SJ, et al. Pharmacokinetics and dosage reduction of cis-diammine(1,1-cyclobutanedicarboxylato)platinum in patients with impaired renal function. Cancer Res. 1984;44:5432–5438
  9. Egorin MJ, Van Echo DA, Olman EA, Whitacre MY, Forrest A, Aisner J. Prospective validation of a pharmacologically based dosing scheme for the cis-diamminedichloroplatinum (II) analogue diamminecyclobutanedicarboxylatoplatinum. Cancer Res. 1985;45:6502–6506
  10. Jodrell DI, Egorin MJ, Canetta RM, et al. Relationships between carboplatin exposure and tumour response and toxicity in patients with ovarian cancer. J Clin Oncol. 1992;10:520–528
  11. Harland SJ, Newell DR, Siddik ZH, Chadwick R, Calvert AH, Harrap KR. Pharmacokinetics of cis-diammine-1,1-cyclobutane dicarboxylate platinum(II) in patients with normal and impaired renal function. Cancer Res. 1984;44:1693–1697
  12. Calvert H, Judson I, van der Vijgh WJF. Platinum complexes in cancer medicine: pharmacokinetics and pharmacodynamics in relation to toxicity and therapeutic activity. Cancer Surv. 1993;17:189–217
  13. Sørensen BT, Strömgren A, Jakobsen P, Nielsen JT, Smedegaard Andersen L, Jakobsen A. Renal handling of carboplatin. Cancer Chemother Pharmacol. 1992;30:317–320
  14. van Warmerdam LJC, Rodenhuis S, ten Bokkel Huinink WW, Maes RAA, Beijnen JH. The use of the Calvert formula to determine the optimal carboplatin dosage. J Cancer Res Clin Oncol. 1995;121:478–486
  15. Jeyabalan N, Hirte HW, Moens F. Treatment of advanced ovarian carcinoma with carboplatin in a patient with renal failure. Int J Gynecol Cancer. 2000;10:463–468
  16. de Jonge ME, Huitema ADR, Tukker AC, van Dam SM, Rodenhuis S, Beijnen JH. Accuracy, feasibility, and clinical impact of prospective Bayesian pharmacokinetically guided dosing of cyclophosphamide, thiotepa, and carboplatin in high-dose chemotherapy. Clin Cancer Res. 2005;11:273–283
  17. de Jonge ME, van den Bongard HJGD, Huitema ADR, et al. Bayesian pharmacokinetically guided dosing of paclitaxel in patients with non-small cell lung cancer. Clin Cancer Res. 2004;10:2237–2244
  18. Millward MJ, Webster LK, Toner GC, et al. Carboplatin dosing based on measurement of renal function — experience at the Peter MacCallum Cancer Institute. Aust N Z J Med. 1996;26:372–379
  19. van Warmerdam LJC, Rodenhuis S, van der Wall E, Maes RAA, Beijnen JH. Pharmacokinetics and pharmacodynamics of carboplatin administered in a high-dose combination regimen with thiotepa, cyclophosphamide and peripheral stem cell support. Br J Cancer. 1996;73:979–984
  20. Calvert AH. Dose optimisation of carboplatin in adults. Anticancer Res. 1994;14:2273–2278
  21. Rowland M, Tozer TN. Clinical pharmacokinetics, concepts and applications. Philadelphia: Lippincott Williams and Wilkins; 1995;
  22. Payne RB. Creatinine clearance and glomerular filtration rate. Ann Clin Biochem. 2000;37:98–99
  23. Bostom AG, Kronenberg F, Ritz E. Predictive performance of renal function equations for patients with chronic kidney disease and normal serum creatinine levels. J Am Soc Nephrol. 2002;13:2140–2144
  24. Murray PT, Ratain MJ. Estimation of the glomerular filtration rate in cancer patients: a new formula for new drugs. J Clin Oncol. 2003;21:2633–2635
  25. Keir MJ, Morris KP, Skinner R. The direct measurement of glomerular filtration rate from the continuous monitoring of DTPA clearance. Physiol Meas. 1993;14:71–78
  26. Levey AS, Greene T, Schluchter MD, et al. Glomerular filtration rate measurements in clinical trials. Modification of Diet in Renal Disease Study Group and the Diabetes Control and Complications Trial Research Group. J Am Soc Nephrol. 1993;4:1159–1171
  27. van Warmerdam LJ, Rodenhuis S, ten Bokkel Huinink WW, Maes RAA, Beijnen JH. Evaluation of formulas using the serum creatinine level to calculate the optimal dosage of carboplatin. Cancer Chemother Pharmacol. 1996;37:266–270
  28. Ando M, Minami H, Ando Y, et al. Multi-institutional validation study of carboplatin dosing formula using adjusted serum creatinine level. Clin Cancer Res. 2000;6:4733–4738
  29. van den Bongard HJGD, Mathôt RAA, Beijnen JH, Schellens JHM. Pharmacokinetically guided administration of chemotherapeutic agents. Clin Pharmacokinet. 2000;39:345–367
  30. Alberts DS, Dorr RT. New perspectives on an old friend: optimizing carboplatin for the treatment of solid tumours. Oncologist. 1998;3:15–34
  31. Chatelut E, Canal P, Brunner V, et al. Prediction of carboplatin clearance from standard morphological and biological patient characteristics. J Natl Cancer Inst. 1995;87:573–580
  32. Dowling TC, Frye RF, Fraley DS, Matzke GR. Comparison of iothalamate clearance methods for measuring GFR. Pharmacotherapy. 1999;19:943–950
  33. Wright JG, Calvert AH, Highley MS, et al. Accurate prediction of renal function for carboplatin dosing. Proc Am Assoc Cancer Res. 1999;40:384
  34. Itoh K. Comparison of methods for determination of glomerular filtration rate: Tc-99m-DTPA renography, predicted creatinine clearance method and plasma sample method. Ann Nucl Med. 2003;17:561–565
  35. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of diet in renal disease study group. Ann Intern Med. 1999;130:461–470
  36. Marx GM, Blake GM, Galani E, et al. Evaluation of the Cockroft–Gault, Jelliffe and Wright formulae in estimating renal function in elderly cancer patients. Ann Oncol. 2004;15:291–295
  37. Wright JG, Boddy AV, Highley M, Fenwick J, McGill A, Calvert AH. Estimation of glomerular filtration rate in cancer patients. Br J Cancer. 2001;84:452–459
  38. Lewis J, Agodoa L, Cheek D-A, et al. Comparison of cross-sectional renal function measurements in African Americans with hypertensive nephrosclerosis and of primary formulas to estimate glomerular filtration rate. Am J Kidney Dis. 2001;38:744–753
  39. Dooley MJ, Poole SG, Rischin D, Webster LK. Carboplatin dosing: gender bias and inaccurate estimates of glomerular filtration rate. Eur J Cancer. 2002;38:44–51
  40. Filler G, Foster J, Acker A, Lepage N, Akbari A, Ehrich JHH. The Cockroft–Gault formula should not be used in children. Kidney Int. 2005;67:2321–2324
  41. Beddhu S, Samore MH, Roberts MS, Stoddard GJ, Pappas LM, Cheung AK. Creatinine production, nutrition, and glomerular filtration rate estimation. J Am Soc Nephrol. 2003;14:1000–1005
  42. Rule AD, Larson TS, Bergstralh EJ, Slezak JM, Jacobsen SJ, Cosio FG. Using serum creatinine to estimate glomerular filtration rate: accuracy in good health and chronic kidney disease. Ann Intern Med. 2004;141:929–937
  43. Herrington JD, Tran HT, Riggs MW. Prospective evaluation of carboplatin AUC dosing in patients with a BMI >27 or cachexia. Cancer Chemother Pharmacol. 2006;57:241–247
  44. Lin J, Knight EL, Hogan ML, Singh AK. A comparison of prediction equations for estimating glomerular filtration rate in adults without kidney disease. J Am Soc Nephrol. 2003;14:2573–2580
  45. Calvert AH, Egorin MJ. Carboplatin dosing formulae: gender bias and the use of creatinine-based methodologies. Eur J Cancer. 2002;38:11–16
  46. Keevil BG, Kilpatrick ES, Nichols SP, Maylor PW. Biological variation of cystatin C: implications for the assessment of glomerular filtration rate. Clin Chem. 1998;44:1535–1539
  47. Hoppe A, Séronie-Vivien S, Thomas F, et al. Serum cystatin C is a better marker of topotecan clearance than serum creatinine. Clin Cancer Res. 2005;11:3038–3044
  48. Tonkin KS, Levin L, Powe J. Neither toxicity nor dose intensity of carboplatin is affected by glomerular filtration rate versus body surface area dose calculation in gynecologic malignancy. Int J Gynecol Cancer. 1994;4:315–319
  49. Ratain MJ, Schilsky RL, Conley BA, Egorin MJ. Pharmacodynamics in cancer therapy. J Clin Oncol. 1990;8:1739–1753
  50. Thomson A. Why do therapeutic drug monitoring. Pharm J. 2004;273:153–155
  51. Oellerich M, Armstrong VW. Prodrug metabolites: implications for therapeutic drug monitoring. Clin Chem. 2001;47:805–806
  52. Hon YY, Evans WE. Making TDM work to optimize cancer chemotherapy: a multidisciplinary team approach. Clin Chem. 1998;44:388–400
  53. Bates DW, Soldin SJ, Rainey PM, Micelli JN. Strategies for physician education in therapeutic drug monitoring. Clin Chem. 1998;44:401–407
  54. Reyno LM, Egorin MJ, Eisenberger MA, Sinibaldi VJ, Zuhowski EG, Sridhara R. Development and validation of a pharmacokinetically based fixed dosing scheme for suramin. J Clin Oncol. 1995;13:2187–2195
  55. Lowis SP, Price L, Pearson ADJ, Newell DR, Cole M. A study of the feasibility and accuracy of pharmacokinetically guided etoposide dosing in children. Br J Cancer. 1998;77:2318–2323
  56. Levitt NC, Propper DJ, Madhusudan S, et al. Pharmacokinetically guided phase I trial of topotecan and etoposide phosphate in recurrent ovarian cancer. Br J Cancer. 2005;93:60–69
  57. Young AM, Daryanani S, Kerr DJ. Can pharmacokinetic monitoring improve clinical use of fluorouracil?. Clin Pharmacokinet. 1999;36:391–398
  58. Lennard L. Therapeutic drug monitoring of antimetabolic cytotoxic drugs. Br J Clin Pharmacol. 1999;47:131–143
  59. Fety R, Rolland F, Barberi-Heyob M, et al. Clinical impact of pharmacokinetically-guided dose adaptation of 5-fluorouracil: results from a multicentric randomised trial in patients with locally advanced head and neck carcinomas. Clin Cancer Res. 1998;4:2039–2045
  60. Rousseau A, Marquet P. Application of pharmacokinetic modelling to the routine therapeutic drug monitoring of anticancer drugs. Fundam Clin Pharmacol. 2002;16:253–262
  61. Evans WE, Relling MV, Rodman JH, Crom WR, Boyett JM, Pui C-H. Conventional compared with individualized chemotherapy for childhood acute lymphoblastic leukemia. N Engl J Med. 1998;338:499–505
  62. Jelliffe RW, Schumitzky A, Leary R, et al. Optimizing individualized dosage regimens of potentially toxic drugs. Applications of pharmacokinetic principles in drug development. London: Kluwer Academic/Plenum Publishers; 2003;477–528
  63. de Jongh FE, Verweij J, Loos WJ, et al. Body-surface area-based dosing does not increase accuracy of predicting cisplatin exposure. J Clin Oncol. 2001;19:3733–3739
  64. Lowis SP, Pearson ADJ, Newell DR, Cole M. Etoposide pharmacokinetics in children: the development and prospective validation of a dosing equation. Cancer Res. 1993;53:4881–4889
  65. Eksborg S. Anthracycline pharmacokinetics. Limited sampling model for plasma level monitoring with special reference to epirubicin (Farmorubicin). Acta Oncol. 1990;29:339–342
  66. Gusella M, Ferrazzi E, Ferrari M, Padrini R. New limited sampling strategy for determining 5-fluorouracil area under the concentration-time curve after rapid intravenous bolus. Ther Drug Monit. 2002;24:425–431
  67. Moore MJ, Bunting P, Yuan S, Thiessen JJ. Development and validation of a limited sampling strategy for 5-fluorouracil given by bolus intravenous administration. Ther Drug Monit. 1993;15:394–399
  68. Panday VR, van Warmerdam LJ, Huizing MT, Rodenhuis S, Schellens JH, Beijnen JH. A single 24-hour plasma sample does not predict the carboplatin AUC from carboplatin–paclitaxel combinations or from a high-dose carboplatin–thiotepa–cyclophosphamide regimen. Cancer Chemother Pharmacol. 1999;43:435–438
  69. Hirth J, Watkins PB, Strawderman M, Schott A, Bruno R, Baker LH. The effect of an individual's cytochrome CYP3A4 activity on docetaxel clearance. Clin Cancer Res. 2000;6:1255–1258
  70. Milano G, Etienne MC, Pierrefite V, Barberi-Heyob M, Deporte-Fety R, Renée N. Dihydropyrimidine dehydrogenase deficiency and fluorouracil-related toxicity. Br J Cancer. 1999;79:627–630
  71. Milano G, Etienne MC. Individualizing therapy with 5-fluorouracil related to dihydropyrimidine dehydrogenase: theory and limits. Ther Drug Monit. 1996;18:335–340
  72. Lim W-T, McLeod HL. Should screening for DPD deficiency be mandatory before 5-FU exposure?. Onkologie. 2004;27:531–533
  73. Grem JL. Screening for dihydropyrimidine dehydrogenase deficiency. Clin Cancer Res. 2005;11:5067–5068
  74. Allegra CJ. Dihydropyrimidine dehydrogenase activity: prognostic partner of 5-fluorouracil?. Clin Cancer Res. 1999;5:1947–1949
  75. Gamelin E, Boisdron-Celle M, Guerin-Meyer V, et al. Correlation between uracil and dihydrouracil plasma ratio, fluorouracil (5-FU) pharmacokinetic parameters, and tolerance in patients with advanced colorectal cancer: a potential interest for predicting 5-FU toxicity and determining optimal 5-FU dosage. J Clin Oncol. 1999;17:1105–1110
  76. Chazal M, Etienne MC, Renée N, Bourgeon A, Richelme H, Milano G. Link between dihydropyrimidine dehydrogenase activity in peripheral blood mononuclear cells and liver. Clin Cancer Res. 1996;2:507–510
  77. Lu Z, Zhang R, Diasio RB. Dihydropyrimidine dehydrogenase activity in human peripheral blood mononuclear cells and liver: population characteristics, newly identified deficient patients, and clinical implication in 5-fluorouracil chemotherapy. Cancer Res. 1993;53:5433–5438
  78. Van Kuilenburg ABP, van Lenthe H, Blom MJ, Mul EPJ, Van Gennip AH. Profound variation in dihydropyrimidine dehydrogenase activity in human blood cells: major implications for the detection of partly deficient patients. Br J Cancer. 1999;79:620–626
  79. Fleming RA, Milano G, Thyss A, et al. Correlation between dihydropyrimidine dehydrogenase activity in peripheral mononuclear cells and systemic clearance of fluorouracil in cancer patients. Cancer Res. 1992;52:2899–2902
  80. Mattison LK, Ezzeldin H, Carpenter M, Modak A, Johnson MR, Diasio RB. Rapid identification of dihydropyrimidine dehydrogenase deficiency by using a novel 2-13C-uracil breath test. Clin Cancer Res. 2004;10:2652–2658
  81. Remaud G, Boisdron-Celle M, Hameline C, Morel A, Gamelin E. An accurate dihydrouracil/uracil determination using improved high performance liquid chromatography method for preventing fluoropyrimidines-related toxicity in clinical practice. J Chromatogr B Analyt Technol Biomed Life Sci. 2005;823:98–107
  82. Relling MV, Hancock ML, Rivera GK, et al. Mercaptopurine therapy intolerance and heterozygosity at the thiopurine S-methyltransferase gene locus. J Natl Cancer Inst. 1999;91:1983–1985
  83. Black AJ, McLeod HL, Capell HA, et al. Thiopurine methyltransferase genotype predicts therapy-limiting severe toxicity from azathioprine. Ann Intern Med. 1998;129:716–718
  84. Ando Y, Saka H, Ando M, et al. Polymorphisms of UDP-glucuronosyltransferase gene and irinotecan toxicity: a pharmacogenetic analysis. Cancer Res. 2000;60:6921–6926
  85. Maitland ML, Vasisht K, Ratain MJ. TPMT, UGT1A1 and DPYD: genotyping to ensure safer cancer therapy?. Trends Pharmacol Sci. 2006;27:432–437
  86. Henningsson A, Sparreboom A, Sandström M, et al. Population pharmacokinetic modelling of unbound and total plasma concentrations of paclitaxel in cancer patients. Eur J Cancer. 2003;39:1105–1114
  87. Rivera E, Erder MH, Fridman M, Frye D, Hortobagyi GN. First-cycle absolute neutrophil count can be used to improve chemotherapy-dose delivery and reduce the risk of febrile neutropenia in patients receiving adjuvant therapy: a validation study. Breast Cancer Res. 2003;5:R114–R120
  88. Nieboer P, Vries EGE, Mulder NH, van der Graaf WTA. Relevance of high-dose chemotherapy in solid tumours. Cancer Treat Rev. 2005;31:210–225
  89. Alberts DS, Garcia DJ. Total platinum versus platinum dose intensification in ovarian cancer treatment. Semin Oncol. 1994;21:11–15
  90. Bergh J, Wiklund T, Erikstein B, et al. Tailored fluorouracil, epirubicin, and cyclophosphamide compared with marrow-supported high-dose chemotherapy as adjuvant treatment for high-risk breast cancer: a randomized trial. Lancet. 2000;356:1384–1391
  91. Hryniuk W. Dosage parameters in chemotherapy of breast cancer. Breast Dis. 2001;14:21–30
  92. Plumridge R, Sewell GJ. Dose-banding of cytotoxic drugs: a new concept in cancer chemotherapy. Am J Health Syst Pharm. 2001;58:1760–1764
  93. Baker JP, Jones SE. Rationalisation of chemotherapy services in the University Hospital Birmingham NHS Trust. J Oncol Pharm Pract. 1998;4:10–14
  94. MacLean F, MacIntyre J, McDade J, Moyes D. Dose banding of chemotherapy in the Edinburgh Cancer Centre. Pharm J. 2003;270:691–693
  95. Goffredo F. The role of the oncology pharmacist in 1999. J Oncol Pharm Pract. 1999;5:140–142
  96. Vincent C, Taylor-Adams S, Chapman EJ, et al. How to investigate and analyse clinical incidents: Clinical Risk Unit and Association of Litigation and Risk Management protocol. Br Med J. 2000;320:777–781
  97. Taxis K, Barber N. Causes of intravenous medication errors: an ethnographic study. Qual Saf Health Care. 2003;12:343–348
  98. Taxis K, Barber N. Ethnographic study of incidence and severity of intravenous drug errors. Br Med J. 2003;326:684–687
  99. Attilio RM. Caring enough to understand: the road to oncology medication error prevention. Hosp Pharm. 1996;31:17–26
  100. Connor TH, Sessink PJM, Harrison BR, et al. Surface contamination of chemotherapy drug vials and evaluation of new vial-cleaning techniques: results of three studies. Am J Health-Syst Pharm. 2005;62:475–484
  101. Sewell GJ. Oncology pharmacy in the new millennium. J Oncol Pharm Pract. 1999;5:143–144
  102. Needle R. Putting a price on the service. Costing of the work of the pharmacy production unit. Hosp Pharm Pract. 1991;1:55–57
  103. Dooley MJ, Singh S, Michael M. Implications of dose rounding of chemotherapy to the nearest vial size. Support Care Cancer. 2004;12:653–656
  104. So J. Improving the lives of patients with cancer. Pharm Manage. 2002;18:27–29
  105. Goldspiel BR. Global advances in oncology pharmacy practice. J Oncol Pharm Pract. 1995;1:3–5
  106. Heck G, Berger G, Kiemen U, Latscha N. Aspects of quality management: accuracy in dosing antineoplastic drugs. J Oncol Pharm Practice. 1996;2:29–34
  107. Tran M. The impact of introducing pre-printed chemotherapy medication charts to a day chemotherapy unit. J Oncol Pharm Pract. 2000;6:64–69
  108. Kaestner S, Walker V, Roberts S, Perren T, Sewell G. Clinical and pharmacokinetic (pk) study on “dose-banded” and individual-dose chemotherapy: an interim report. J Oncol Pharm Pract. 2004;10:100
  109. Xeloda®: Dose modification guidelines; Colorectal and breast cancer. Welwyn Garden City: Roche, 2002.
  110. National Institute for Health and Clinical Excellence. Guidance on the use of capecitabine for the treatment of locally advanced or metastatic breast cancer. NICE Technology Appraisal 62. London: National Institute for Health and Clinical Excellence, 2003.
  111. Ratain MJ. Dear doctor: We really are not sure what dose of capecitabine you should prescribe for your patient. J Clin Oncol. 2002;20:1434–1435
  112. Joint Formulary Committee . British National Formulary 50. London: British Medical Association and Royal Pharmaceutical Society of Great Britain; 2005;
  113. Van Ummersen L, Binger K, Volkman J, et al. A phase I trial of perifosine (NSC 639966) on a loading dose/maintenance dose schedule in patients with advanced cancer. Clin Cancer Res. 2004;10:7450–7456
  114. Akbulut H, Tang Y, Maynard J, Zhang L, Pizzorno G, Deisseroth A. Vector targeting makes 5-fluorouracil chemotherapy less toxic and more effective in animal models of epithelial neoplasms. Clin Cancer Res. 2004;10:7738–7746

PII: S0936-6555(06)00368-2

doi: 10.1016/j.clon.2006.10.003

Clinical Oncology
Volume 19, Issue 2 , Pages 99-107 , March 2007

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