A population pharmacokinetic/pharmacodynamic model of methotrexate and mucositis scores in osteosarcoma

Therapeutic Drug Monitoring

Volumn 33, Issue 6, 2011, Pages 711-718

  Johansson, Åsa M ^a   Hill, Nicola ^b   Perisoglou, Martha ^b   Whelan, Jeremy ^b   Karlsson, Mats O ^a   Standing, Joseph F ^a,c  

^a UPPSALA UNIVERSITY   (Sweden)

^b UNIVERSITY COLLEGE HOSPITAL   (United Kingdom)

^c GREAT ORMOND STREET HOSPITAL   (United Kingdom)

Author keywords

Methotrexate; Mucositis; NONMEM; Osteosarcoma; Pharmacokinetics pharmacodynamics; Therapeutic drug monitoring

Indexed keywords

CREATININE; METHOTREXATE;

ADOLESCENT; ADULT; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; BODY WEIGHT; CHILD; CLINICAL ARTICLE; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DRUG CLEARANCE; DRUG MEGADOSE; DRUG METABOLISM; DRUG MONITORING; FEMALE; FILTRATION; HUMAN; MALE; MUCOSA INFLAMMATION; OSTEOSARCOMA; PHARMACODYNAMICS; PHYSIOLOGY; POPULATION RESEARCH; PRESCHOOL CHILD; PRIORITY JOURNAL; PROBABILITY; SCHOOL CHILD; SCORING SYSTEM;

ADOLESCENT; ADULT; ANTIMETABOLITES, ANTINEOPLASTIC; BONE NEOPLASMS; CHILD; CHILD, PRESCHOOL; DRUG MONITORING; FEMALE; HUMANS; MALE; METABOLIC CLEARANCE RATE; METHOTREXATE; MIDDLE AGED; MODELS, BIOLOGICAL; MUCOSITIS; OSTEOSARCOMA; PROSPECTIVE STUDIES; SEVERITY OF ILLNESS INDEX; YOUNG ADULT;

EID: 84856117057     PISSN: 01634356     EISSN: 15363694     Source Type: Journal    
DOI: 10.1097/FTD.0b013e31823615e1     Document Type: Article

References (41)

1. Tang N, Song WX, Luo J, et al. Osteosarcoma development and stem cell differentiation. Clin Orthop Relat Res. 2008;466:2114-2130.
2. Ferguson WS, Goorin AM. Current treatment of osteosarcoma. Cancer Invest. 2001;19:292-315. (Pubitemid 32374371)
3. Maia MB, Saivin S, Chatelut E, et al. In vitro and in vivo protein binding of methotrexate assessed by microdialysis. Int J Clin Pharmacol Ther. 1996;34:335-341. (Pubitemid 26271000)
4. Bleyer WA. The clinical pharmacology of methotrexate: new applications of an old drug. Cancer. 1978;41:36-51. (Pubitemid 8286409)
5. Groninger E, Proost JH, de Graaf SS. Pharmacokinetic studies in children with cancer. Crit Rev Oncol Hematol. 2004;52:173-197. (Pubitemid 39593753)
6. Widemann BC, Balis FM, Kempf-Bielack B, et al. High-dose methotrexateinduced nephrotoxicity in patients with osteosarcoma. Cancer. 2004;100:2222-2232. (Pubitemid 38580344)
7. Borsi JD, Sagen E, Romslo I, et al. Rescue after intermediate and highdose methotrexate: background, rationale, and current practice. Pediatr Hematol Oncol. 1990;7:347-363. (Pubitemid 20376683)
8. Cutler C, Li S, Kim HT, et al. Mucositis after allogeneic hematopoietic stem cell transplantation: a cohort study of methotrexate-and nonmethotrexate-containing graft-versus-host disease prophylaxis regimens. Biol Blood Marrow Transplant. 2005;11:383-388. (Pubitemid 40542931)
9. Rousseau A, Sabot C, Delepine N, et al. Bayesian estimation of methotrexate pharmacokinetic parameters and area under the curve in children and young adults with localised osteosarcoma. Clin Pharmacokinet. 2002;41:1095-1104. (Pubitemid 35246783)
10. Evans WE, Pratt CB, Taylor RH, et al. Pharmacokinetic monitoring of high-dose methotrexate. Early recognition of high-risk patients. Cancer Chemother Pharmacol. 1979;3:161-166. (Pubitemid 10203329)
11. Monjanel S, Rigault JP, Cano JP, et al. High-dose methotrexate: preliminary evaluation of a pharmacokinetic approach. Cancer Chemother Pharmacol. 1979;3:189-196. (Pubitemid 10203334)
12. Monjanel-Mouterde S, Lejeune C, Ciccolini J, et al. Bayesian population model of methotrexate to guide dosage adjustments for folate rescue in patients with breast cancer. J Clin Pharm Ther. 2002;27:189-195. (Pubitemid 34748143)
13. Christophidis N, Louis WJ, Lucas I, et al. Renal clearance of methotrexate in man during high-dose oral and intravenous infusion therapy. Cancer Chemother Pharmacol. 1981;6:59-64. (Pubitemid 11044313)
14. Winograd B, Lippens RJ, Oosterbaan MJ, et al. Renal excretion and pharmacokinetics of methotrexate and 7-hydroxy-methotrexate following a 24-h high dose infusion of methotrexate in children. Eur J Clin Pharmacol. 1986;30:231-238. (Pubitemid 16166076)
15. Rhodin MM, Anderson BJ, Peters AM, et al. Human renal function maturation: a quantitative description using weight and postmenstrual age. Pediatr Nephrol. 2009;24:67-76.
16. Ceriotti F, Boyd JC, Klein G, et al. Reference intervals for serum creatinine concentrations: assessment of available data for global application. Clin Chem. 2008;54:559-566. (Pubitemid 351359026)
17. Junge W, Wilke B, Halabi A, et al. Determination of reference intervals for serum creatinine, creatinine excretion and creatinine clearance with an enzymatic and a modified Jaffe method. Clin Chim Acta. 2004;344:137-148. (Pubitemid 38626148)
18. Janmahasatian S, Duffull SB, Ash S, et al. Quantification of lean bodyweight. Clin Pharmacokinet. 2005;44:1051-1065. (Pubitemid 41356391)
19. Karlsson MO, Sheiner LB. The importance of modeling interoccasion variability in population pharmacokinetic analyses. J Pharmacokinet Biopharm. 1993;21:735-750. (Pubitemid 24052760)
20. Aarons L, Graham G. Methodological approaches to the population analysis of toxicity data. Toxicol Lett. 2001;120:405-410. (Pubitemid 32375108)
21. Beal SL, Sheiner LB, Boeckmann AJ. NONMEM User's Guides. Ellicot City, MD: Icon Development Solutions; 1989-2006.
22. Efron B. Bootstrap methods: another look at the jackknife. Ann Stat. 1979;7:1-26.
23. Karlsson MO, Holford N. A tutorial on visual predictive checks. PAGE. 2008;17:Abstract 1434. Available at: wwwpage-meetingorg/?abstract=1434.
24. Bergstrand M, Hooker AC, Karlsson MO. Visual predictive checks for censored and categorical data. PAGE. 2009;18:abstract 1604. Available at: wwwpage-meetingorg/?abstract=1604.
25. Lindbom L, Ribbing J, Jonsson EN. Perl-speaks-NONMEM (PsN)-a Perl module for NONMEM related programming. Comput Methods Programs Biomed. 2004;75:85-94. (Pubitemid 38798039)
26. Lindbom L, Pihlgren P, Jonsson N. PsN-Toolkit-a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. Comput Methods Programs Biomed. 2005;79:241-257. (Pubitemid 41196689)
27. Jonsson EN, Karlsson MO. Xpose-an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM. Comput Methods Programs Biomed. 1999;58:51-64. (Pubitemid 29049052)
28. Johansson Å M, Mayne N, Hennig S, et al. Pharmacokinetics of high-dose methotrexate in adults and children. PAGE. 2009;18:abstract 1605. Available at: wwwpage-meetingorg/?abstract=1605.
29. Byon W, Fletcher CV, Brundage RC. Impact of censoring data below an arbitrary quantification limit on structural model misspecification. J Pharmacokinet Pharmacodyn. 2008;35:101-116. (Pubitemid 351420764)
30. Colom H, Farre R, Soy D, et al. Population pharmacokinetics of high-dose methotrexate after intravenous administration in pediatric patients with osteosarcoma. Ther Drug Monit. 2009;31:76-85.
31. Pignon T, Lacarelle B, Duffaud F, et al. Pharmacokinetics of high-dose methotrexate in adult osteogenic sarcoma. Cancer Chemother Pharmacol. 1994;33:420-424. (Pubitemid 24057695)
32. Aumente D, Buelga DS, Lukas JC, et al. Population pharmacokinetics of high-dose methotrexate in children with acute lymphoblastic leukaemia. Clin Pharmacokinet. 2006;45:1227-1238. (Pubitemid 44904825)
33. Crews KR, Liu T, Rodriguez-Galindo C, et al. High-dose methotrexate pharmacokinetics and outcome of children and young adults with osteosarcoma. Cancer. 2004;100:1724-1733. (Pubitemid 38456352)
34. Plard C, Bressolle F, Fakhoury M, et al. A limited sampling strategy to estimate individual pharmacokinetic parameters of methotrexate in children with acute lymphoblastic leukemia. Cancer Chemother Pharmacol. 2007;60:609-620. (Pubitemid 47084260)
35. Wall AM, Gajjar A, Link A, et al. Individualized methotrexate dosing in children with relapsed acute lymphoblastic leukemia. Leukemia. 2000;14:221-225. (Pubitemid 30095374)
36. Aquerreta I, Aldaz A, Giraldez J, et al. Methotrexate pharmacokinetics and survival in osteosarcoma. Pediatr Blood Cancer. 2004;42:52-58. (Pubitemid 38180429)
37. Evans WE, Relling MV, Rodman JH, et al. Conventional compared with individualized chemotherapy for childhood acute lymphoblastic leukemia. N Engl J Med. 1998;338:499-505. (Pubitemid 28103133)
38. Odoul F, Le Guellec C, Lamagnere JP, et al. Prediction of methotrexate elimination after high dose infusion in children with acute lymphoblastic leukaemia using a population pharmacokinetic approach. Fundam Clin Pharmacol. 1999;13:595-604.
39. Aarons L. Physiologically based pharmacokinetic modelling: a sound mechanistic basis is needed. Br J Clin Pharmacol. 2005;60:581-583. (Pubitemid 41705376)
40. Naidu MU, Ramana GV, Rani PU, et al. Chemotherapy-induced and/or radiation therapy-induced oral mucositis-complicating the treatment of cancer. Neoplasia. 2004;6:423-431. (Pubitemid 39411078)
41. Fujita Y, Nakamura T, Aomori T, et al. Pharmacokinetic individualisation of high-dose methotrexate chemotherapy for the treatment of localised osteosarcoma. J Chemother. 2010;22:186-190.