A limited sampling schedule to estimate individual pharmacokinetic parameters of fludarabine in hematopoietic cell transplant patients

Clinical Cancer Research

Volumn 15, Issue 16, 2009, Pages 5280-5287

  Salinger, David H ^a,e   Blough, David K ^b,c   Vicini, Paolo ^a,f   Anasetti, Claudio ^d   O'Donnell, Paul V ^b,c   Sandmaier, Brenda M ^b,c   McCune, Jeannine S ^b,c  

^a University of Washington   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c Fred Hutchinson Cancer Research Center   (United States)

^d H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^e AMGEN INC   (United States)

^f PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

2 FLUOROADENINE; BUSULFAN; DRUG METABOLITE; FLUDARABINE; THYMOCYTE ANTIBODY; UNCLASSIFIED DRUG;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CLINICAL ARTICLE; DRUG BLOOD LEVEL; FEMALE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMAN; MALE; PATIENT COMPLIANCE; POPULATION MODEL; PRIORITY JOURNAL; REDUCED INTENSITY CONDITIONING; SIMULATION;

ADOLESCENT; ADULT; AGED; BLOOD SPECIMEN COLLECTION; CHILD; FEMALE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; RETROSPECTIVE STUDIES; TIME FACTORS; TRANSPLANTATION CONDITIONING; VIDARABINE PHOSPHATE; YOUNG ADULT;

EID: 69449094889     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-09-0427     Document Type: Article

References (37)

1. Copelan EA. Hematopoietic stem-cell transplantation. N Engl J Med 2006;354:1813-1826
2. Deeg HJ, Maris MB, Scott BL, Warren EH. Optimization of allogeneic transplant conditioning: not the time for dogma. Leukemia 2006;20: 1701-1705
3. Baron F, Storb R, Little MT. Hematopoietic cell transplantation: five decades of progress. Arch Med Res 2003;34:528-544 (Pubitemid 38084707)
4. Aoudjhane M, Labopin M, Gorin NC, et al. Comparative outcome of reduced intensity and myeloablative conditioning regimen in HLA identical sibling allogeneic haematopoietic stem cell transplantation for patients older than 50 years of age with acute myeloblastic leukaemia: a retrospective survey from the Acute Leukemia Working Party (ALWP) of the European group for Blood and Marrow Transplantation (EBMT). Leukemia 2005;19:2304-2312 (Pubitemid 41748028)
5. Maris MB, Niederwieser D, Sandmaier BM, et al. HLA-matched unrelated donor hematopoietic cell transplantation after nonmyeloablative conditioning for patients with hematologic malignancies. Blood 2003;102:2021-2030 (Pubitemid 37122375)
6. Mielcarek M, Burroughs L, Leisenring W, et al. Prognostic relevance of 'early-onset' graft-versushost disease following non-myeloablative haematopoietic cell transplantation. Br J Haematol 2005;129:381-391
7. Danhauser L, Plunkett W, Liliemark J, Gandhi V, Iacoboni S, Keating M. Comparison between the plasma and intracellular pharmacology of 1-β-D-arabinofuranosylcytosine and 9-β-D-arabinofuranosyl- 2-fluoroadenine 5'-monophosphate in patients with relapsed leukemia. Leukemia 1987;1:638-643 (Pubitemid 17154182)
8. Gandhi V, Plunkett W. Cellular and clinical pharmacology of fludarabine. Clin Pharmacokinet 2002;41:93-103.
9. Robak T, Lech-Maranda E, Korycka A, Robak E. Purine nucleoside analogs as immunosuppressive and antineoplastic agents: mechanism of action and clinical activity. Current medicinal chemistry 2006;13:3165-3189 (Pubitemid 44680862)
10. Seymour L, Eisenhauer E. A review of doselimiting events in phase I trials: antimetabolites show unpredictable relationships between dose and toxicity. Cancer Chemother Pharmacol 2001;47:2-10. (Pubitemid 32664505)
11. Hersh MR, Kuhn JG, Phillips JL, Clark G, Ludden TM, Von Hoff DD. Pharmacokinetic study of fludarabine phosphate (NSC 312887). Cancer Chemother Pharmacol 1986;17:277-280
12. Jacobson PA, Rogosheske J, Green K, et al. Fludarabine pharmacokinetics in nonmyeloablative hematopoietic cell transplantation (HCT): association with engraftment and neurotoxicty [abstract 3673]. Blood 2005;106.
13. Bornhauser M, Storer B, Slattery JT, et al. Conditioning with fludarabine and targeted busulfan for transplantation of allogeneic hematopoietic stem cells. Blood 2003;102:820-826 (Pubitemid 36917770)
14. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976;16:31-41.
15. Plunkett W, Gandhi V, Huang P, et al. Fludarabine: pharmacokinetics, mechanisms of action, and rationales for combination therapies. Semin Oncol 1993;20:2-12. (Pubitemid 23333771)
16. Malspeis L, Grever MR, Staubus AE, Young D. Pharmacokinetics of 2-F-ara-A (9-β-D-arabinofuranosyl- 2-fluoroadenine) in cancer patients during the phase I clinical investigation of fludarabine phosphate. Semin Oncol 1990;17(5 Suppl. 8):18-32. (Pubitemid 20356425)
17. Bonin M, Pursche S, Bergeman T, et al. F-ara-A pharmacokinetics during reduced-intensity conditioning therapy with fludarabine and busulfan. Bone Marrow Transplant 2007;39:201-206 (Pubitemid 46243261)
18. NONMEM Users Guides. In: Beal SL, Sheiner LB, Boeckmann AJ, editors. NONMEM users guides. Ellicott City: Icon Development Solutions; 1989-2006.
19. Wahlby U, Jonsson EN, Karlsson MO. Assessment of actual significance levels for covariate effects in NONMEM. J Pharmacokinet Pharmacodyn 2001;28:231-252 (Pubitemid 32643366)
20. Holford NHG. The visual predictive checksuperiority to standard diagnostic (Rorschach) plots [abstract 738]. Abstracts of the Annual Meeting of the Population Approach Group in Europe (PAGE) 2005;14.
21. Giralt S, Logan B, Rizzo D, et al. Reducedintensity conditioning for unrelated donor progenitor cell transplantation: long-term follow-up of the first 285 reported to the national marrow donor program. Biol Blood Marrow Transplant 2007;13:844-852 (Pubitemid 46902440)
22. Mielcarek M, Sandmaier BM, Maloney DG, et al. Nonmyeloablative hematopoietic cell transplantation: status quo and future perspectives. J Clin Immunol 2002;22:70-74 (Pubitemid 34252612)
23. McCune JS, Gibbs JP, Slattery JT. Plasma concentration monitoring of busulfan: does it improve clinical outcome? Clin Pharmacokinet 2000;39:155-165
24. Slattery JT, Sanders JE, Buckner CD, et al. Graftrejection and toxicity following bone marrow transplantation in relation to busulfan pharmacokinetics. Bone Marrow Transplant 1995;16:31-42.
25. McDonald GB, Slattery JT, Bouvier ME, et al. Cyclophosphamide metabolism, liver toxicity, and mortality following hematopoietic stem cell transplantation. Blood 2003;101:2043-2048
26. McCune J, Batchelder A, Guthrie K, et al. Personalized dosing of cyclophosphamide in the total body irradiation-cyclophosphamide conditioning regimen: a phase II trial in patients with hematologic malignancy. Clin Pharmacol Ther 1990;17(5 Suppl 8):18-32.
27. Bornhauser M, Schuler U, Porksen G, et al. Mycophenolate mofetil and cyclosporine as graft-versus-host disease prophylaxis after allogeneic blood stem cell transplantation. Transplantation 1999;67:499-504. (Pubitemid 29114207)
28. Jacobson P, Rogosheske J, Barker JN, et al. Relationship of mycophenolic acid exposure to clinical outcome after hematopoietic cell transplantation. Clin Pharmacol Ther 2005;78: 486-500. (Pubitemid 41698903)
29. Barker JN, Weisdorf DJ, DeFor TE, Blazar BR, Miller JS,Wagner JE. Rapid and complete donor chimerism in adult recipients of unrelated donor umbilical cord blood transplantation after reduced- intensity conditioning. Blood 2003;102: 1915-1919
30. Woodahl EL, Wang J, Heimfeld S, et al. A novel phenotypic method to determine fludarabine triphosphate accumulation in Tlymphocytes from hematopoietic cell transplantation patients. Cancer Chemother Pharmacol 2009;63:391-401.
31. Borthakur G, Kantarjian H, Wang X, et al. Treatment of core-binding-factor in acute myelogenous leukemia with fludarabine, cytarabine, and granulocyte colony-stimulating factor results in improved event-free survival. Cancer 2008;113:3181-3185
32. Luminari S, Marcheselli L, Sacchi S, et al. Anthracycline-fludarabine- containing regimens with or without rituximab in the treatment of patients with advanced follicular lymphoma. Cancer 2009;115:1906-1913
33. McDonald GB, McCune JS, Batchelder A, et al. Metabolism-based cyclophosphamide dosing for hematopoietic cell transplant. Clin Pharmacol Ther 2005;78:298-308. (Pubitemid 41254114)
34. Salinger DH, McCune JS, Ren AG, et al. Real-time dose adjustment of cyclophosphamide in a preparative regimen for hematopoietic cell transplant: a Bayesian pharmacokinetic approach. Clin Cancer Res 2006;12:4888-4898
35. US DHHS, FDA CDER and CBER. FDA guidance for industry on population pharmacokinetics. February 1999.
36. Salinger DH, McCune JS, Blough DK, Vicini P. Mean squared error as criterion for sampling schedule optimization for individual dose targeting in IV busulfan [abstract 1413]. Abstracts of the Annual Meeting of the Population Approach Group in Europe (PAGE) 2008;17.
37. Monteleone J, Duffull SB. Choice of best design. In: Kimko HC, Duffull SB, editors. Simulation for designing clinical trials: a pharmacokinetic- pharmacodynamic modeling perspective. 1st ed. New York: Marcel Dekker; 2003, p. 173-200.