Population pharmacokinetics analysis of cyclophosphamide with genetic effects in patients undergoing hematopoietic stem cell transplantation

European Journal of Clinical Pharmacology

Volumn 69, Issue 8, 2013, Pages 1543-1551

  Kim, In Wha ^a   Yun, Hwi Yeol ^b   Choi, Boyoon ^a   Han, Nayoung ^a   Kim, Myeong Gyu ^a   Park, Seonyang ^c   Oh, Jung Mi ^a  

^a Seoul National University   (South Korea)

^b UPPSALA UNIVERSITY   (Sweden)

^c Seoul National University College of Medicine   (South Korea)

Author keywords

4 hydroxycyclophosphamide; Cyclophosphamide; Hematopoietic stem cell transplantation; Pharmacogenetics; Population pharmacokinetics

Indexed keywords

ASPARTATE AMINOTRANSFERASE; CYCLOPHOSPHAMIDE; CYTOCHROME P450 2B6; CYTOCHROME P450 2C19; CYTOCHROME P450 3A5; DRUG METABOLITE; GLUTATHIONE TRANSFERASE A1; GLUTATHIONE TRANSFERASE M1; GLUTATHIONE TRANSFERASE P1; GLUTATHIONE TRANSFERASE T1; HYDROXYCYCLOPHOSPHAMIDE; MULTIDRUG RESISTANCE PROTEIN 1; UNCLASSIFIED DRUG;

ABCB1 GENE; ABCC2 GENE; ADULT; AREA UNDER THE CURVE; ARTICLE; BLOOD LEVEL; CLINICAL ARTICLE; CONTROLLED STUDY; CYP2B6 GENE; CYP2C19 GENE; CYP3A5 GENE; DRUG CLEARANCE; DRUG EFFECT; DRUG METABOLISM; FEMALE; GENE; GENETIC POLYMORPHISM; GENOTYPING TECHNIQUE; GSTA1 GENE; GSTM1 GENE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HETEROZYGOTE DETECTION; HUMAN; MALE; PRIORITY JOURNAL; SINGLE NUCLEOTIDE POLYMORPHISM; WILD TYPE;

ADOLESCENT; ADULT; ASPARTATE AMINOTRANSFERASES; CYCLOPHOSPHAMIDE; FEMALE; GENOTYPE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; MULTIDRUG RESISTANCE-ASSOCIATED PROTEINS;

EID: 84880511682     PISSN: 00316970     EISSN: 14321041     Source Type: Journal    
DOI: 10.1007/s00228-013-1507-7     Document Type: Article

References (53)

1. van der Wall E, Beijnen JH, Rodenhuis S (1995) High-dose chemotherapy regimens for solid tumors. Cancer Treat Rev 21(2):105-132
2. Timm R, Kaiser R, Lotsch J, Heider U, Sezer O, Weisz K, Montemurro M, Roots I, Cascorbi I (2005) Association of cyclophosphamide pharmacokinetics to polymorphic cytochrome P450 2C19. Pharmacogenomics J 5(6):365-373
3. Rocha V, Franco RF, Porcher R, Bittencourt H, Silva WA Jr, Latouche A, Devergie A, Esperou H, Ribaud P, Socie G, Zago MA, Gluckman E (2002) Host defense and inflammatory gene polymorphisms are associated with outcomes after HLA-identical sibling bone marrow transplantation. Blood 100(12):3908-3918
4. Socie G, Loiseau P, Tamouza R, Janin A, Busson M, Gluckman E, Charron D (2001) Both genetic and clinical factors predict the development of graft-versus-host disease after allogeneic hematopoietic stem cell transplantation. Transplantation 72(4):699-706
5. Chang TK, Weber GF, Crespi CL, Waxman DJ (1993) Differential activation of cyclophosphamide and ifosphamide by cytochromes P-450 2B and 3A in human liver microsomes. Cancer Res 53(23):5629-5637
6. Chang TK, Yu L, Goldstein JA, Waxman DJ (1997) Identification of the polymorphically expressed CYP2C19 and the wild-type CYP2C9-ILE359 allele as low-Km catalysts of cyclophosphamide and ifosfamide activation. Pharmacogenetics 7(3):211-221
7. Bohnenstengel F, Hofmann U, Eichelbaum M, Kroemer HK (1996) Characterization of the cytochrome P450 involved in side-chain oxidation of cyclophosphamide in humans. Eur J Clin Pharmacol 51(3-4):297-301
8. Ren S, Yang JS, Kalhorn TF, Slattery JT (1997) Oxidation of cyclophosphamide to 4-hydroxycyclophosphamide and deschloroethylcyclophosphamide in human liver microsomes. Cancer Res 57(19):4229-4235
9. Dockham PA, Lee MO, Sladek NE (1992) Identification of human liver aldehyde dehydrogenases that catalyze the oxidation of aldophosphamide and retinaldehyde. Biochem Pharmacol 43(11):2453-2469
10. McCune JS, Salinger DH, Vicini P, Oglesby C, Blough DK, Park JR (2009) Population pharmacokinetics of cyclophosphamide and metabolites in children with neuroblastoma: a report from the Children's Oncology Group. J Clin Pharmacol 49(1):88-102
11. de Jonge ME, Huitema AD, van Dam SM, Rodenhuis S, Beijnen JH (2005) Population pharmacokinetics of cyclophosphamide and its metabolites 4-hydroxycyclophosphamide, 2-dechloroethylcyclophosphamide, and phosphoramide mustard in a high-dose combination with Thiotepa and Carboplatin. Ther Drug Monit 27(6):756-765
12. Graham MI, Shaw IC, Souhami RL, Sidau B, Harper PG, McLean AE (1983) Decreased plasma half-life of cyclophosphamide during repeated high-dose administration. Cancer Chemother Pharmacol 10(3):192-193
13. Moore MJ, Hardy RW, Thiessen JJ, Soldin SJ, Erlichman C (1988) Rapid development of enhanced clearance after high-dose cyclophosphamide. Clin Pharmacol Ther 44(6):622-628
14. Brock N, Stekar J, Pohl J, Niemeyer U, Scheffler G (1979) Acrolein, the causative factor of urotoxic side-effects of cyclophosphamide, ifosfamide, trofosfamide and sufosfamide. Arzneimittelforschung 29(4):659-661
15. McDonald GB, Sharma P, Matthews DE, Shulman HM, Thomas ED (1984) Venocclusive disease of the liver after bone marrow transplantation: diagnosis, incidence, and predisposing factors. Hepatology 4(1):116-122
16. de Jonge ME, Huitema AD, Rodenhuis S, Beijnen JH (2005) Clinical pharmacokinetics of cyclophosphamide. Clin Pharmacokinet 44(11):1135-1164
17. McDonald GB, Slattery JT, Bouvier ME, Ren S, Batchelder AL, Kalhorn TF, Schoch HG, Anasetti C, Gooley T (2003) Cyclophosphamide metabolism, liver toxicity, and mortality following hematopoietic stem cell transplantation. Blood 101(5):2043-2048
18. Balasubramanian P, Desire S, Panetta JC, Lakshmi KM, Mathews V, George B, Viswabandya A, Chandy M, Krishnamoorthy R, Srivastava A (2012) Population pharmacokinetics of cyclophosphamide in patients with thalassemia major undergoing HSCT. Bone Marrow Transplant 47(9):1178-1185
19. Nakajima M, Komagata S, Fujiki Y, Kanada Y, Ebi H, Itoh K, Mukai H, Yokoi T, Minami H (2007) Genetic polymorphisms of CYP2B6 affect the pharmacokinetics/pharmacodynamics of cyclophosphamide in Japanese cancer patients. Pharmacogenet Genomics 17(6):431-445
20. Rossi D, Rasi S, Franceschetti S, Capello D, Castelli A, De Paoli L, Ramponi A, Chiappella A, Pogliani EM, Vitolo U, Kwee I, Bertoni F, Conconi A, Gaidano G (2009) Analysis of the host pharmacogenetic background for prediction of outcome and toxicity in diffuse large B-cell lymphoma treated with R-CHOP21. Leukemia 23(6):1118-1126
21. Dasgupta RK, Adamson PJ, Davies FE, Rollinson S, Roddam PL, Ashcroft AJ, Dring AM, Fenton JA, Child JA, Allan JM, Morgan GJ (2003) Polymorphic variation in GSTP1 modulates outcome following therapy for multiple myeloma. Blood 102(7):2345-2350
22. Hohaus S, Di Ruscio A, Di Febo A, Massini G, D'Alo F, Guidi F, Mansueto G, Voso MT, Leone G (2005) Glutathione S-transferase P1 genotype and prognosis in Hodgkin's lymphoma. Clin Cancer Res 11(6):2175-2179
23. Stanulla M, Schrappe M, Brechlin AM, Zimmermann M, Welte K (2000) Polymorphisms within glutathione S-transferase genes (GSTM1, GSTT1, GSTP1) and risk of relapse in childhood B-cell precursor acute lymphoblastic leukemia: a case-control study. Blood 95(4):1222-1228
24. Yang G, Shu XO, Ruan ZX, Cai QY, Jin F, Gao YT, Zheng W (2005) Genetic polymorphisms in glutathione-S-transferase genes (GSTM1, GSTT1, GSTP1) and survival after chemotherapy for invasive breast carcinoma. Cancer 103(1):52-58
25. Ekhart C, Doodeman VD, Rodenhuis S, Smits PH, Beijnen JH, Huitema AD (2008) Influence of polymorphisms of drug metabolizing enzymes (CYP2B6, CYP2C9, CYP2C19, CYP3A4, CYP3A5, GSTA1, GSTP1, ALDH1A1 and ALDH3A1) on the pharmacokinetics of cyclophosphamide and 4-hydroxycyclophosphamide. Pharmacogenet Genomics 18(6):515-523
26. Qiu R, Yao A, Vicini P, McDonald GB, Batchelder AL, Bouvier ME, Cole SL, Slattery JT (2004) Diminishing the risk of nonrelapse mortality in hematopoietic stem cell transplantation: Prediction of exposure to the cyclophosphamide metabolite carboxyethylphosphoramide mustard. Clin Pharmacol Ther 76(3):270-280
27. Vesell ES (1977) Genetic and environmental factors affecting drug disposition in man. Clin Pharmacol Ther 22(5 Pt 2):659-679
28. World Medical Association (2008) WMA Declaration of Helsinki - Ethical principles for medical research involving human subjects (2002). At: 59th WMA General Assembly. Seoul. Available (pdf file) at: http://www.wma.net/en/ 30publications/10policies/b3/
29. Ekhart C, Gebretensae A, Rosing H, Rodenhuis S, Beijnen JH, Huitema AD (2007) Simultaneous quantification of cyclophosphamide and its active metabolite 4-hydroxycyclophosphamide in human plasma by high-performance liquid chromatography coupled with electrospray ionization tandem mass spectrometry (LC-MS/MS). J Chromatogr B Analyt Technol Biomed Life Sci 854(1-2):345-349
30. Cockcroft DW, Gault MH (1976) Prediction of creatinine clearance from serum creatinine. Nephron 16(1):31-41
31. Beal S, Sheiner L, Boeckmann A, Bauer R (2009) NONMEM user's guides 1989-2009. Icon Development Solutions, Dublin
32. Jonsson EN, Karlsson MO (1999) Xpose-an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM. Comput Methods Programs Biomed 58(1):51-64
33. Lindbom L, Ribbing J, Jonsson EN (2004) Perl-speaks-NONMEM (PsN)-a Perl module for NONMEM related programming. Comput Methods Programs Biomed 75(2):85-94
34. Keizer RJ, van Benten M, Beijnen JH, Schellens JH, Huitema AD (2011) Pirana and PCluster: a modeling environment and cluster infrastructure for NONMEM. Comput Methods Programs Biomed 101(1):72-79
35. Huitema AD, Mathot RA, Tibben MM, Rodenhuis S, Beijnen JH (2001) A mechanism-based pharmacokinetic model for the cytochrome P450 drug-drug interaction between cyclophosphamide and thioTEPA and the autoinduction of cyclophosphamide. J Pharmacokinet Pharmacodyn 28(3):211-230
36. Hassan M, Svensson US, Ljungman P, Bjorkstrand B, Olsson H, Bielenstein M, Abdel-Rehim M, Nilsson C, Johansson M, Karlsson MO (1999) A mechanism-based pharmacokinetic-enzyme model for cyclophosphamide autoinduction in breast cancer patients. Br J Clin Pharmacol 48(5):669-677
37. Kumar S, Wolf RC, Chen MG, Gastineau DA, Gertz MA, Inwards DJ, Lacy MQ, Tefferi A, Litzow MR (2002) Omission of day +11 methotrexate after allogeneic bone marrow transplantation is associated with increased risk of severe acute graft-versus-host disease. Bone Marrow Transplant 30(3):161-165
38. Choi SW, Levine JE, Ferrara JL (2010) Pathogenesis and management of graft-versus-host disease. Immunol Allergy Clin North Am 30(1):75-101
39. Hill GR, Ferrara JL (2000) The primacy of the gastrointestinal tract as a target organ of acute graft-versus-host disease: rationale for the use of cytokine shields in allogeneic bone marrow transplantation. Blood 95(9):2754-2759
40. Johansson JE, Brune M, Ekman T (2001) The gut mucosa barrier is preserved during allogeneic, haemopoietic stem cell transplantation with reduced intensity conditioning. Bone Marrow Transplant 28(8):737-742
41. Salinger DH, McCune JS, Ren AG, Shen DD, Slattery JT, Phillips B, McDonald GB, Vicini P (2006) Real-time dose adjustment of cyclophosphamide in a preparative regimen for hematopoietic cell transplant: a Bayesian pharmacokinetic approach. Clin Cancer Res 12(16):4888-4898
42. Qiu R, Kalhorn TF, Slattery JT (2004) ABCC2-mediated biliary transport of 4-glutathionylcyclophosphamide and its contribution to elimination of 4-hydroxycyclophosphamide in rat. J Pharmacol Exp Ther 308(3):1204-1212
43. Zhang WX, Chen B, Jin Z, Yu Z, Wang X, Chen H, Mao A, Cai W (2008) Influence of uridine diphosphate (UDP)-glucuronosyltransferases and ABCC2 genetic polymorphisms on the pharmacokinetics of mycophenolic acid and its metabolites in Chinese renal transplant recipients. Xenobiotica 38(11):1422-1436
44. Fujita K, Nagashima F, Yamamoto W, Endo H, Sunakawa Y, Yamashita K, Ishida H, Mizuno K, Matsunaga M, Araki K, Tanaka R, Ichikawa W, Miya T, Narabayashi M, Akiyama Y, Kawara K, Ando Y, Sasaki Y (2008) Association of ATP-binding cassette, sub-family C, number 2 (ABCC2) genotype with pharmacokinetics of irinotecan in Japanese patients with metastatic colorectal cancer treated with irinotecan plus infusional 5-fluorouracil/leucovorin (FOLFIRI). Biol Pharm Bull 31(11):2137-2142
45. Lai Y, Xing L, Poda GI, Hu Y (2007) Structure-activity relationships for interaction with multidrug resistance protein 2 (ABCC2/MRP2): the role of torsion angle for a series of biphenyl-substituted heterocycles. Drug Metab Dispos 35(6):937-945
46. Ito K (2008) ABCC2/Abcc2 transport property in different species and its modulation by heterogeneous factors. Drug Metab Pharmacokinet 23(6):394-405
47. Chen TL, Kennedy MJ, Anderson LW, Kiraly SB, Black KC, Colvin OM, Grochow LB (1997) Nonlinear pharmacokinetics of cyclophosphamide and 4-hydroxycyclophosphamide/aldophosphamide in patients with metastatic breast cancer receiving high-dose chemotherapy followed by autologous bone marrow transplantation. Drug Metab Dispos 25(5):544-551
48. Beckett GJ, Foster GR, Hussey AJ, Oliveira DB, Donovan JW, Prescott LF, Proudfoot AT (1989) Plasma glutathione S-transferase and F protein are more sensitive than alanine aminotransferase as markers of paracetamol (acetaminophen)-induced liver damage. Clin Chem 35(11):2186-2189
49. Bagley CM Jr, Bostick FW, DeVita VT Jr (1973) Clinical pharmacology of cyclophosphamide. Cancer Res 33(2):226-233
50. De Bruijn EA, Slee PH, Van Oosterom AT, Lameijer DW, Roozendaal KJ, Tjaden UR (1988) Pharmacokinetics of intravenous and oral cyclophosphamide in the presence of methotrexate and fluorouracil. Pharm Weekbl Sci 10(5):200-206
51. Xie H, Griskevicius L, Stahle L, Hassan Z, Yasar U, Rane A, Broberg U, Kimby E, Hassan M (2006) Pharmacogenetics of cyclophosphamide in patients with hematological malignancies. Eur J Pharm Sci 27(1):54-61
52. Ljungman P, Hassan M, Bekassy AN, Ringden O, Oberg G (1997) High busulfan concentrations are associated with increased transplant-related mortality in allogeneic bone marrow transplant patients. Bone Marrow Transplant 20(11):909-913
53. Slattery JT, Sanders JE, Buckner CD, Schaffer RL, Lambert KW, Langer FP, Anasetti C, Bensinger WI, Fisher LD, Appelbaum FR et al (1995) Graft-rejection and toxicity following bone marrow transplantation in relation to busulfan pharmacokinetics. Bone Marrow Transplant 16(1):31-42