Making TDM work to optimize cancer chemotherapy: A multidisciplinary team approach

Clinical Chemistry

Volumn 44, Issue 2, 1998, Pages 388-400

  Hon, Yuen Yi ^a   Evans, William E ^a  

^a ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTHRACYCLINE; ANTIMETABOLITE; ANTINEOPLASTIC AGENT; CAMPTOTHECIN; EPIPODOPHYLLOTOXIN; FLUOROURACIL; MERCAPTOPURINE; METHOTREXATE; PLATINUM DERIVATIVE; THIOPURINE METHYLTRANSFERASE;

ACUTE LYMPHOBLASTIC LEUKEMIA; BLOOD TOXICITY; BREAST CANCER; CANCER CHEMOTHERAPY; CHEMOPROPHYLAXIS; CONCENTRATION RESPONSE; CONFERENCE PAPER; DIGESTIVE SYSTEM CANCER; DRUG BLOOD LEVEL; DRUG MONITORING; GASTROINTESTINAL SYMPTOM; HEAD AND NECK CANCER; HODGKIN DISEASE; HUMAN; MEDICAL PERSONNEL; OSTEOSARCOMA; PHARMACODYNAMICS; QUANTITATIVE ASSAY; TEAMWORK;

6-MERCAPTOPURINE; ANTINEOPLASTIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG MONITORING; FLUOROURACIL; HUMANS; METHOTREXATE; NEOPLASMS; OUTCOME ASSESSMENT (HEALTH CARE);

EID: 0343090967     PISSN: 00099147     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (96)

1. Rodman JH, Evans WE. Targeted systemic exposure for pediatric cancer therapy. In: D'Argenio D, ed. Advanced methods of pharmacokinetic and pharmacodynamic systems analysis. New York: Plenum Press, 1991:177-83.
2. Spector R, Park GD, Johnson GF, Vesell ES. Therapeutic drug monitoring. Clin Pharmacol Ther 1988;43:345-53.
3. Reynolds DJM, Aronson JK. Making the most of plasma drug concentration measurements. Br Med J 1993;306:48-51.
4. Evans WE, Relling MV. Clinical pharmacokinetics-pharmacodynamics of anticancer drugs. Clin Pharmacokinet 1989;16:327-36.
5. Masson E, Zamboni WC. Pharmacokinetic optimization of cancer chemotherapy. Effect on outcomes. Clin Pharmacokinet 1997;32: 324-43.
6. Galpin AJ, Evans WE. Therapeutic drug monitoring in cancer management. Clin Chem 1993;39(Suppl):2419-30.
7. DeVita VT. Principles of cancer management: chemotherapy. In: DeVita VT, Hellman S, Rosenberg SA, eds. Cancer. Principles and practice of oncology, 5th ed. Philadelphia: Lippincott, 1997;333-47.
8. Moore MJ, Erlichman C. Therapeutic drug monitoring in oncology. Problems and potential in antineoplastic therapy. Clin Pharmacokinet 1987;13:205-27.
9. Ratain MJ. Therapeutic relevance of pharmacokinetics and pharmacodynamics. Semin Oncol 1992;19(Suppl 11):8-13.
10. Ratain MJ. Pharmacology of cancer chemotherapy. In: DeVita VT, Hellman S, Rosenberg SA, eds. Cancer. Principles and practice of oncology, 5th ed. Philadelphia: Lippincott, 1997:375-85.
11. Hryniuk W, Bush H. The importance of dose intensity in chemotherapy of metastatic breast cancer. J Clin Oncol 1984;2:1281-8.
12. Hryniuk WM, Figueredo A, Goodyear M. Applications of dose intensity to problems in chemotherapy of breast and colorectal cancer. Semin Oncol 1987:14(Suppl 4):3-11.
13. Frei E, Canellos GP. Dose. A critical factor in cancer chemotherapy. Am J Med 1980;69:585-94.
14. Evans WE. Clinical pharmacodynamics of anticancer drugs: a basis for extending the concept of dose-intensity. Blut 1988;56:241-8.
15. Collins JM, Zaharko DS, Dedrick RL, Chabner BA. Potential roles for preclinical pharmacology in phase I clinical trials. Cancer Treat Rep 1986;70:73-80.
16. EORTC. Pharmacokinetics and Metabolism Group. Pharmacokinetically guided dose escalation in phase I clinical trials. Commentary and proposed guidelines. Eur J Cancer Clin Oncol 1987; 23:1083-7.
17. Evans WE, Rodman JH, Relling MV, Crom WR, Rivera GK, Pratt CB, Crist WM. Concept of maximum tolerated systemic exposure and its application to phase I-II studies of anticancer drugs. Med Pediatr Oncol 1991;19:153-9.
18. Evans WE. Alternative approaches for phase I studies of anticancer drugs: a role for therapeutic drug monitoring. Ther Drug Monit 1993;15:492-7.
19. Workman P, Graham MA. Pharmacokinetics and cancer chemotherapy, Eur J Cancer 1994;30A:706-10.
20. Evans WE, Petros WP, Relling MV, Crom WR, Madden T, Rodman JH, Sunderland M. Clinical pharmacology of cancer chemotherapy in children. Pediatr Clin North Am 1989;36:1199-230.
21. Knoester PD, Underberg WJM, Beijnen JH. Clinical pharmacokinetics and pharmacodynamics of anticancer agents in pediatric patients [Review]. Anticancer Res 1993;13:1795-808.
22. Plunkett W, Gandhi V. Cellular pharmacodynamics of anticancer drugs. Semin Oncol 1993;20:50-63.
23. Rodman JH, Relling MV, Stewart CF, Synold TW, McLeod H, Kearns C, et al. Clinical Pharmacokinetics and pharmacodynamics of anticancer drugs in children. Semin Oncol 1993;20:18-29.
24. Ratain MJ, Schilsky RL, Conley BA, Egorin MJ. Pharmacodynamics in cancer therapy. J Clin Oncol 1990;8:1739-53.
25. Ratain MJ, Rosner G, Allen SL, Costanza M, Van Echo DA, Henderson IC, Schilsky RL. Population pharmacodynamic study of amonafide: a Cancer and Leukemia Group B study. J Clin Oncol 1995;13:741-7.
26. Hall SW, Friedman J, Legha SS, Benjamin RS, Gutterman JU, Loo TL. Human Pharmacokinetics of a new acridine derivative, 4′-(9-acridinylamino)methanesulfon-m-anisidide (NSC249992). Cancer Res 1983;43:3422-9.
27. Egorin MJ, Van Echo DA, Tipping SJ, Olman EA, Whitacre MY, Thompson BW, Aisner J. Pharmacokinetics and dosage reduction of cis-diammine(1,1-cyclobutanedicarboxylato)platinum in patients with impaired renal function. Cancer Res 1984;44:5432-8.
28. 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;45:6502-6.
29. Sørrensen BT, Strömgren A, Jakobsen P, Jakobsen A. Dose-toxicity relationship of carboplatin in combination with cyclophosphamide in ovarian cancer patients. Cancer Chemother Pharmacol 1991;28:397-401.
30. Egorin MJ, Reyno LM, Canetta RM, Jodrell DI, Swenerton KD, Pater JL, et al. Modeling toxicity and response in carboplatin-based combination chemotherapy. Semin Oncol 1994;21(Suppl 12):7-19.
31. Chatelut E, Chevreau C, Brunner V, Martinez M, Houin G, Bugat R, Canal P. A pharmacologically guided phase I study of carboplatin in combination with methotrexate and vinblastine in advanced urothelial cancer. Cancer Chemother Pharmacol 1995;35:391-6.
32. 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;73:979-84.
33. Campbell AB, Kalman SM, Jacobs C. Plasma platinum levels: relationship to cisplatin dose and nephrotoxicity. Cancer Treat Rep 1983;67:169-72.
34. Schellens JHM, Ma J, Planting ASTh, van der Burg MEL, van Meerten E, de Boer-Dennert M, et al. Relationship between the exposure to cisplatin, DNA-adduct formation in leukocytes and tumor response in patients with solid tumors. Br J Cancer 1996;73:1569-75.
35. Rustum YM, Preisler HD. Correlation between leukemic cell retention of 1-β-arabinofuranosylcytosine 5′-triphosphate and response to therapy. Cancer Res 1979;39:42-9.
36. Rustum YM, Riva C, Preisler HD. Pharmacokinetic parameters of 1-β-D-arabinofuranosylcytosine (ara-C) and their relationship to intracellular metabolism of ara-C, toxicity, and response of patients with acute nonlymphocytic leukemia treated with conventional and high-dose ara-C. Semin Oncol 1987;14(2 Suppl 1):141-8.
37. Preisler HD, Rustum YM, Azarnia N, Priore R. Abrogation of the prognostic significance of low leukemic cell retention of cytosine arabinoside triphosphate by intensification of therapy and by alteration in the dose and schedule of administration of cytosine arabinoside. Cancer Chemother Pharmacol 1987;19:69-74.
38. Piscitelli SC, Rodvold KA, Rushing DA, Tewksbury DA. Pharmacokinetics and pharmacodynamics of doxorubicin in patients with small cell lung cancer. Clin Pharmacol Ther 1993;53:555-61.
39. Bennett CL, Sinkule JA, Schilsky RL, Senekjian E, Choi KE. Phase I clinical and pharmacological study of 72-hour continuous infusion of etoposide in patients with advanced cancer. Cancer Res 1987;47:1952-6.
40. Miller AA, Stewart CF, Tolley EA. Clinical pharmacodynamics of continuous-infusion etoposide. Cancer Chemother Pharmacol 1990;25:361-6.
41. Relling MV, McLeod HL, Bowman LC, Santana VM. Etoposide pharmacokinetics and pharmacodynamics after acute and chronic exposure to cisplatin. Clin Pharmacol Ther 1994;56:503-11.
42. Sonnichsen DS, Ribeiro RC, Luo X, Mathew P, Relling MV. Pharmacokinetics and pharmacodynamics of 21-day continuous oral etoposide in pediatric patients with solid tumors. Clin Pharmacol Ther 1995;58:99-107.
43. Au JLS, Rustum YM, Ledesma EJ, Mittelman A, Creaven PJ. Clinical pharmacological studies of concurrent infusion of 5-fluorouracil and thymidine in treatment of colorectal carcinomas. Cancer Res 1982;42:2930-7.
44. Milano G, Roman P, Khater R, Frenay M, Renée N, Namer M. Dose versus pharmacokinetics for predicting tolerance to 5-day continuous infusion of 5-FU. Int J Cancer 1988;41:537-41.
45. Goldberg JA, Kerr DJ, Willmott N, McKillop JH, McArdle CS. Pharmacokinetics and pharmacodynamics of locoregional 5-fluorouracil (5FU) in advanced colorectal liver metastases. Br J Cancer 1988;57:186-9.
46. Milano G, Namer M, Boublil JL, Khater R, Frenay M, Thyss A, et al. Relationship between systemic 5-FU passage and response in colorectal cancer patients treated with intrahepatic chemotherapy. Cancer Chemother Pharmacol 1987;20:71-4.
47. Thyss A, Milano G, Renée N, Vallicioni J, Schneider M, Demard F. Clinical pharmacokinetic study of 5-FU in continuous 5-day infusions for head and neck cancer. Cancer Chemother Pharmacol 1986;16:64-6.
48. Santini J, Milano G, Thyss A, Renée N, Viens P, Ayela P, et al. 5-FU therapeutic monitoring with dose adjustment leads to an improved therapeutic index in head and neck cancer. Br J Cancer 1989:59: 287-90.
49. Milano G, Etienne MC, Renée N, Thyss A, Schneider M, Ramaioli A, Demard F. Relationship between fluorouracil systemic exposure and tumor response and patient survival. J Clin Oncol 1994;12: 1291-5.
50. Grem JL. Fluorinated pyrimidines. In: Chabner BA, Collins JM, eds. Cancer chemotherapy. Principles and practice. Philadelphia: JB Lippincott Co., 1990:180-224.
51. Barberi-Heyob M, Weber B, Merlin JL, Dittrich C, de Bruijn EA, Luporsi E, Guillemin F. Evaluation of plasma 5-fluorouracil nucleoside levels in patients with metastatic breast cancer: relationships with toxicities. Cancer Chemother Pharmacol 1995;37:110-6.
52. Egorin MJ, Sigman LM, Van Echo DA, Forrest A, Whitacre MY, Aisner J. Phase I clinical and pharmacokinetic study of hexamethylene bisacetamide (NSC 95580) administered as a five-day continuous infusion. Cancer Res 1987;47:617-23.
53. Canal P, Gay C, Dezeuze A, Douillard JY, Bugat R, Brunet R, et al. Pharmacology and Molecular Mechanisms Group of the European Organization for Research and Treatment of Cancer. Pharmacokinetics and pharmacodynamics of irinotecan during a phase II clinical trial in colorectal cancer. J Clin Oncol 1996;14:2688-95.
54. Egorin MJ, Van Echo DA, Whitacre MY, Forrest A, Sigman LM. Engisch KL, Aisner J. Human pharmacokinetics, excretion, and metabolism of the anthracycline antibiotic menogaril (7-OMEN, NSC 269148) and their correlation with clinical toxicities. Cancer Res 1986;46:1513-20.
55. Egorin MJ, Conley BA, Forrest A, Zuhowski EG, Sinibaldi V, Van Echo DA. Phase I study and pharmacokinetics of menogaril (NSC 269148) in patients with hepatic dysfunction. Cancer Res 1987; 47:6104-10.
56. Lennard L, Rees CA, Lilleyman JS, Maddocks JL. Childhood leukemia: a relationship between intracellular 6-mercaptopurine metabolites and neutropenia. Br J Clin Pharmacol 1983;16:359-63.
57. Lennard L, Keen D, Lilleyman JS. Oral 6-mercaptopurine in childhood leukemia: parent drug pharmacokinetics and active metabolite concentrations. Clin Pharmacol Ther 1986;40:287-92.
58. Lennard L, Lilleyman JS. Variable mercaptopurine metabolism and treatment outcome in childhood lymphoblastic leukemia. J Clin Oncol 1989;7:1816-23.
59. Lennard L, Lilleyman JS, Van Loon J, Weinshilboum RM. Genetic variation in response to 6-mercaptopurine for childhood acute lymphoblastic leukemia. Lancet 1990;336:225-9.
60. Krynetski EY, Tai HL, Yates CR, Fessing MY, Loennechen T, Schuetz JD, et al. Genetic polymorphism of thiopurine S-methyltransferase: clinical importance and molecular mechanisms. Pharmacogenetics 1996;6:279-90.
61. Lennard L, Van Loon JA, Lilleyman JS, Weinshilboum RM. Thiopurine pharmacogenetics in leukemia: correlation of erythrocyte thiopurine methyltransferase activity and 6-thioguanine nucleotide concentrations. Clin Pharmacol Ther 1987;41:18-25.
62. McLeod HL, Relling MV, Liu Q, Pui CH, Evans WE. Polymorphic thiopurine methyltransferase in erythrocytes is indicative of activity in leukemic blasts from children with acute lymohoblastic leukemia. Blood 1995;85:1897-902.
63. Evans WE, Horner M, Chu YQ, Kalwinsky D, Roberts WM. Altered mercaptopurine metabolism, toxic effects, and dosage requirement in a thiopurine methyltransferase-deficient child with acute lymphocytic leukemia. J Pediatr 1991;119:985-9.
64. Lennard L, Gibson BE, Nicole T, Lilleyman JS. Congenital thiopurine methyltransferase deficiency and 6-mercaptopurine toxicity during treatment for acute lymphoblastic leukemia. Arch Disease Child 1993;69:577-9.
65. Yates CR, Krynetski EY, Loennechen T, Fessing MY, Tai HL, Pui CH, et al. Molecular diagnosis of thiopurine S-methyltransferase deficiency: genetic basis for azathioprine and mercaptopurine intolerance. Ann Intern Med 1997;126:608-14.
66. Hayder S, Björk O, Lafolie P. The course of biological parameters and 6-mercaptopurine pharmacokinetics during maintenance treatment of children with acute lymphoblastic leukemia. Acta Pediatr Scand 1990;79:832-7.
67. Koren G, Ferrazini G, Sulh H, Langevin AM, Kapelushnik J, Klein J, et al. Systemic exposure to mercaptopurine as a prognostic factor in acute lymphocytic leukemia in children. N Engl J Med 1990; 323:17-21.
68. Adamson PC, Balis FM, Steinberg SM, Poplack DG. Pharmacokinetics of mercaptopurine in children with acute lymphocytic leukemia. N Engl J Med 1990;323:1565-6.
69. Tattersall MHN, Parker LM, Pitman SW, Frei E III. Clinical pharmacology of high-dose methotrexate (NSC-740). Cancer Chemother Rep 1975;6(Pt. 3):25-9.
70. Stoller RG, Hande KR, Jacobs SA, Rosenberg SA, Chabner BA. Use of plasma pharmacokinetics to predict and prevent methotrexate toxicity. N Engl J Med 1977;297:630-4.
71. Evans WE, Pratt CB, Taylor H, Barker LF, Crom WR. Pharmacokinetic monitoring of high-dose methotrexate. Early recognition of high-risk patients. Cancer Chemother Pharmacol 1979;3:161-6.
72. Crom WR, Evans WE. Methotrexate. In: Evans WE, Schentag JJ, Jusko WJ, eds. Applied pharmacokinetics. Principles of therapeutic drug monitoring, 3rd ed. Vancouver, WA: Applied Therapeutics, 1992:29-1-29-42.
73. Evans WE, Crom WR, Stewart CF, Bowman WP, Chen CH, Abromowitch M, Simone JV. Methotrexate systemic clearance influences probability of relapse in children with standard-risk acute lymphocytic leukemia. Lancet 1984;359-62.
74. Evans WE, Crom WR, Abromowitch M, Dodge R, Look AT, Bowman WP, et al. Clinical pharmacodynamics of high-dose methotrexate in acute lymphocytic leukemia. N Engl J Med 1986;314:471-7.
75. Borsi JD, Moe PJ. Systemic clearance of methotrexate in the prognosis of acute lymphoblastic leukemia in children. Cancer 1987;60:3020-4.
76. Camitta B, Leventhal B, Lauer S, Shuster JJ, Adair S, Casper J, et al. Intermediate-dose intravenous methotrexate and mercaptopurine therapy for non-T, non-B acute lymphocytic leukemia of childhood; a Pediatric Oncology Group study. J Clin Oncol 1989; 7:1539-44.
77. Evans WE, Rodman J, Relling MV, Crom WR, Rivera GK, Crist WM, Pui CH. Individualized dosages of chemotherapy as a strategy to improve response for acute lymphocytic leukemia. Semin Hematol 1991;28(Suppl 4):15-21.
78. Sæter G, Alvegard TA, Elomaa I, Stenwig AE, Holmström T, Solheim ØP. Treatment of osteosarcoma of the extremities with the T-10 protocol, with emphasis on the effects of preoperative chemotherapy with single-agent high-dose methotrexate: a Scandinavian Sarcoma Group study. J Clin Oncol 1991;9:1766-75.
79. Graf N, Winkler K, Betlemovic N, Fuchs N, Bode U. Methotrexate pharmacokinetics and prognosis in osteosarcoma. J Clin Oncol 1994;12:1443-51.
80. Galpin AJ, Schuetz JD, Masson E, Yanishevski Y, Synold TW, Barredo JC, et al. Differences in folylpolyglutamate synthetase and dihydrofolate reductase expression in human B-lineage versus T-lineage leukemic lymphoblasts: mechanisms for lineage differences in methotrexate polyglutamylation and cytotoxicity. Mol Pharmacol 1997;52:155-63.
81. Masson E, Relling MV, Synold TW, Liu Q, Schuetz JD, Sandlund JT, et al. Accumulation of methotrexate polyglutamates in lymphoblasts is a determinant of antileukemic effects in vivo. A rationale for high-dose methotrexate. J Clin Invest 1996;97:73-80.
82. Synold TW, Relling MV, Boyett JM, Rivera GK, Sandlund JT, Mahmoud H, et al. Blast cell methotrexate-polyglutamate accumulation in vivo differs by lineage, ploidy, and methotrexate dose in acute lymphoblastic leukemia. J Clin Invest 1994;94:1996-2001.
83. Barredo JC, Synold TW, Laver J, Relling MV, Pui CH, Priest DG, Evans WE. Differences in constitutive and post-methotrexate folylpolyglutamate synthetase activity in B-lineage and T-lineage leukemia. Blood 1994;84:564-9.
84. Rodman JH, Abromowitch M, Sinkule JA, Hayes FA, Rivera GK, Evans WE. Clinical pharmacodynamics of continuous infusion teniposide: systemic exposure as a determinant of response in a phase I trial. J Clin Oncol 1987;5:1007-14.
85. Evans WE, Rodman JH, Relling MV, Petros WP, Stewart CF, Pui CH, Rivera GK. Differences in teniposide disposition and pharmacodynamics in patients with newly diagnosed and relapsed acute lymphocytic leukemia. J Pharmacol Exp Ther 1992;260:71-7.
86. Stewart CF, Baker SD, Heideman RL, Jones D, Crom WR, Pratt CB. Clinical pharmacodynamics of continuous infusion topotecan in children: systemic exposure predicts hematologic toxicity. J Clin Oncol 1994;12:1946-54.
87. Desai ZR, Van den Berg HW, Bridges JM, Shanks RG. Can severe vincristine neurotoxicity be prevented? Cancer Chemother Pharmacol 1982;8:211-4.
88. Charpiat B, Breant V, Pivot-Dumarest C, Maire P, Jelliffe R. Prediction of future serum concentrations with Bayesian fitted pharmacokinetic models: results with data collected by nurses versus trained pharmacy residents. Ther Drug Monit 1994;16:166-73.
89. Jusko WJ. Guidelines for collection and analysis of pharmacokinetic data. In: Evans WE, Schentag JJ, Jusko WJ, eds. Applied pharmacokinetics. Principles of therapeutic drug monitoring, 3rd ed. Vancouver, WA: Applied Therapeutics. 1992:2-1-2-43.
90. Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A, et al. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. J Pharm Sci 1992;81:309-12.
91. Graves DA, Locke CS Jr, Muir KT, Miller RP. The influence of assay variability on pharmacokinetic parameter estimation. J Pharmacokinet Biopharm 1989;17:571-92.
92. Ratain MJ, Staubus AE, Schilsky RL, Malspeis L. Limited sampling models for amonafide (NSC 308847) pharmacokinetics. Cancer Res 1988;48:4127-30.
93. Egorin MJ, Forrest A, Belani CP, Ratain MJ, Abrams JS, Van Echo DA. A limited sampling strategy for cyclophosphamide pharmacokinetics. Cancer Res 1989;49:3129-33.
94. Gentili D, Zucchetti M, Torri V, Sessa C, de Jong J, Cavalli F, D'Incalci M. A limited sampling model for the pharmacokinetics of etoposide given orally. Cancer Chemother Pharmacol 1993;32:482-6.
95. Van Warmerdam UC, Verweij J, Rosing H, Schellens JHM, Maes RAA, Beijnen JH. Limited sampling models for topotecan pharmacokinetics. Ann Oncol 1994;5:259-64.
96. Van Warmerdam LJ, Rodenhuis S, van Tellingen O, Maes RA, Beijen JH. Validation of a limited sampling model for carboplatin in a high-dose chemotherapy combination. Cancer Chemother Pharmacol 1994;35:179-81.