Development of a physiologically based pharmacokinetic model of actinomycin D in children with cancer

British Journal of Clinical Pharmacology

Volumn 81, Issue 5, 2016, Pages 989-998

  Walsh, Christopher ^a   Bonner, Jennifer J ^a   Johnson, Trevor N ^b   Neuhoff, Sibylle ^b   Ghazaly, Essam A ^c   Gribben, John G ^c   Boddy, Alan V ^d   Veal, Gareth J ^a  

^a NEWCASTLE UNIVERSITY   (United Kingdom)

^b CERTARA UK LIMITED   (United Kingdom)

^c QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^d UNIVERSITY OF SYDNEY   (Australia)

Author keywords

actinomycin D; cancer; paediatrics; pharmacokinetics; physiologically based pharmacokinetic modelling

Indexed keywords

DACTINOMYCIN; MULTIDRUG RESISTANCE PROTEIN 1; ABCB1 PROTEIN, HUMAN; ANTINEOPLASTIC ANTIBIOTIC; MULTIDRUG RESISTANCE PROTEIN;

ADOLESCENT; ADULT; AREA UNDER THE CURVE; ARTICLE; BILIARY CLEARANCE; CANCER PATIENT; CHILD; CHILDHOOD CANCER; DRUG EXPOSURE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; PARTITION RATIO; PRIORITY JOURNAL; RENAL CLEARANCE; ANIMAL; BIOLOGICAL MODEL; CHEMICAL AND DRUG INDUCED LIVER INJURY; COHORT ANALYSIS; COMPUTER SIMULATION; DOG; INFANT; MDCK CELL LINE; METABOLISM; NEOPLASMS; PRESCHOOL CHILD; YOUNG ADULT;

ADOLESCENT; ADULT; ANIMALS; ANTIBIOTICS, ANTINEOPLASTIC; CHEMICAL AND DRUG INDUCED LIVER INJURY; CHILD; CHILD, PRESCHOOL; COHORT STUDIES; COMPUTER SIMULATION; DACTINOMYCIN; DOGS; FEMALE; HUMANS; INFANT; MADIN DARBY CANINE KIDNEY CELLS; MALE; MODELS, BIOLOGICAL; NEOPLASMS; P-GLYCOPROTEINS; YOUNG ADULT;

EID: 84959450131     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/bcp.12878     Document Type: Article

References (33)

1. Goldberg IH, Rabinowitz M, Reich E,. Basis of actinomycin action. I. DNA binding and inhibition of RNA-polymerase synthetic reactions by actinomycin. Proc Natl Acad Sci U S A 1962; 48: 2094-101.
2. White L, Tobias V, Hughes DW,. Actinomycin D-induced hepatotoxicity. Pediatr Hematol Oncol 1989; 6: 53-7.
3. Arndt C, Hawkins D, Anderson JR, Breitfeld P, Womer R, Meyer W,. Age is a risk factor for chemotherapy-induced hepatopathy with vincristine, dactinomycin, and cyclophosphamide. J Clin Oncol 2004; 22: 1894-901.
4. Bisogno G, de Kraker J, Weirich A, Masiero L, Ludwig R, Tournade MF, Carli M,. Veno-occlusive disease of the liver in children treated for Wilms tumor. Med Pediatr Oncol 1997; 29: 245-51.
5. Tattersall MH, Sodergren JE, Sengupta SK, Trites DH, Modest EJ, Frei E III,. Pharmacokinetics of actinomycin D in patients with malignant melanoma. Clin Pharmacol Ther 1975; 17: 701-8.
6. Shamash J, Powles T, Ansell W, Berney D, Stebbing J, Mutsvangwa K, Wilson P, Asterling S, Liu S, Wyatt P, Joel SP, Oliver RT,. GAMEC-a new intensive protocol for untreated poor prognosis and relapsed or refractory germ cell tumours. Br J Cancer 2007; 97: 308-14.
7. Galbraith WM, Mellett LB,. Tissue disposition of 3 H-actinomycin D (NSC-3053) in the rat, monkey, and dog. Cancer Chemother Rep 1975; 59: 1601-9.
8. Hill CR, Cole M, Errington J, Malik G, Boddy AV, Veal GJ,. Characterisation of the clinical pharmacokinetics of actinomycin D and the influence of ABCB1 pharmacogenetic variation on actinomycin D disposition in children with cancer. Clin Pharmacokinet 2014; 53: 741-51.
9. Mondick JT, Gibiansky L, Gastonguay MR, Skolnik JM, Cole M, Veal GJ, Boddy AV, Adamson PC, Barrett JS,. Population pharmacokinetic investigation of actinomycin-D in children and young adults. J Clin Pharmacol 2008; 48: 35-42.
10. Veal GJ, Cole M, Errington J, Parry A, Hale J, Pearson AD, Howe K, Chisholm JC, Beane C, Brennan B, Waters F, Glaser A, Hemsworth S, McDowell H, Wright Y, Pritchard-Jones K, Pinkerton R, Jenner G, Nicholson J, Elsworth AM, Boddy AV, Kingdom Children's Cancer Study Group Pharmacology Working Group. Pharmacokinetics of dactinomycin in a pediatric patient population: a United Kingdom Children's Cancer Study Group study. Clin Cancer Res 2005; 11: 5893-9.
11. Gurney JG, Smith MA, Smith JA,. Cancer among infants. In: Cancer Incidence and Survival among Children and Adolescents: United States SEER Program 1975-1995, eds, Ries GLA, Smith MA, Gurney JG, Linet M, Tamra T, Young JL, Bunin GR,. Bethesda, MD: National Cancer Institute, SEER Program NIH Pub No 99-4649, 1999; 149-56.
12. Langholz B, Skolnik JM, Barrett JS, Renbarger J, Seibel NL, Zajicek A, Arndt CA,. Dactinomycin and vincristine toxicity in the treatment of childhood cancer: a retrospective study from the Children's Oncology Group. Pediatr Blood Cancer 2011; 57: 252-7.
13. Tournade MF, Com-Nougue C, de Kraker J, Ludwig R, Rey A, Burgers JM, Sandstedt B, Godzinski J, Carli M, Potter R, Zucker JM,. Optimal duration of preoperative therapy in unilateral and nonmetastatic Wilms' tumor in children older than 6 months: results of the Ninth International Society of Pediatric Oncology Wilms' Tumor Trial and Study. J Clin Oncol 2001; 19: 488-500.
14. Jamei M, Bajot F, Neuhoff S, Barter Z, Yang J, Rostami-Hodjegan A, Rowland-Yeo K,. A mechanistic framework for in vitro-in vivo extrapolation of liver membrane transporters: prediction of drug-drug interaction between rosuvastatin and cyclosporine. Clin Pharmacokinet 2014; 53: 73-87.
15. Neuhoff S, Gaohua L, Burt H, Jamei M, Li L, Tucker GT, Rostami-Hodjegan A,. Accounting for transporters in renal clearance: towards a mechanistic kidney model (Mech KiM). In: Transporters in Drug Development: Discovery, Optimization, Clinical Study and Regulation, eds, Sugiyama Y, Steffansen B,. New York: Springer, 2013; 155-77.
16. Jiang X, Zhao P, Lesko LJ, Schmidt S,. Application of physiologically-based pharmacokinetic (PBPK) model in predicting drug metabolism and pharmacokinetics in pediatric populations-a case study of acetaminophen. Clin Pharmacol Ther 2013; 93: S8.
17. Johnson TN, Rostami-Hodjegan A, Tucker GT,. Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children. Clin Pharmacokinet 2006; 45: 931-56.
18. Johnson TN, Boussery K, Rowland-Yeo K, Tucker GT, Rostami-Hodjegan A,. A semi-mechanistic model to predict the effects of liver cirrhosis on drug clearance. Clin Pharmacokinet 2010; 49: 189-206.
19. Adam K, Schmiedl S, Szymanski J, Imschweiler T, Voelpel S, Niehues T, Sinha K, Wirth S, Abuhejleh A, Willmann S, Lippert J, Thuermann PA,. Evaluation of the physiology-based pharmacokinetic (PBPK) model PK-SIM in children receiving high-dose methotrexate. Basic Clin Pharmacol Toxicol 2009; 105: 129-30.
20. Kersting G, Willmann S, Wurthwein G, Lippert J, Boos J, Hempel G,. Physiologically based pharmacokinetic modelling of high- and low-dose etoposide: from adults to children. Cancer Chemother Pharmacol 2012; 69: 397-405.
21. Alexander SP, Mathie A, Peters JA,. Guide to Receptors and Channels (GRAC), 5th edition. Br J Pharmacol 2011; 164: S1-324.
22. Zhao Y, Jona J, Chow DT, Rong H, Semin D, Xia X, Zanon R, Spancake C, Maliski E,. High-throughput logP measurement using parallel liquid chromatography/ultraviolet/mass spectrometry and sample-pooling. Rapid Commun Mass Spectrom 2002; 16: 1548-55.
23. Hill CR, Jamieson D, Thomas HD, Brown CD, Boddy AV, Veal GJ,. Characterisation of the roles of ABCB1, ABCC1, ABCC2 and ABCG2 in the transport and pharmacokinetics of actinomycin D in vitro and in vivo. Biochem Pharmacol 2013; 85: 29-37.
24. Veal GJ, Errington J, Sludden J, Griffin MJ, Price L, Parry A, Hale J, Pearson AD, Boddy AV, Group UPW,. Determination of anti-cancer drug actinomycin D in human plasma by liquid chromatography-mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2003; 795: 237-43.
25. Rodgers T, Rowland M,. Mechanistic approaches to volume of distribution predictions: understanding the processes. Pharm Res 2007; 24: 918-33.
26. Hansch C, Leo A, Hoekman D,. Exploring QSAR-Hydrophobic, Electronic, and Steric Constants. Washington, DC: American Chemical Society 1995; p. 20.
27. Lombardo F, Shalaeva MY, Tupper KA, Gao F,. ElogDoct: A tool for lipophilicity determination in drug discovery. 2. Basic and neutral compounds (2001) Journal of Medicinal Chemistry, 14: 2490-97.
28. Lutz RJ, Galbraith WM, Dedrick RL, Shrager R, Mellett LB,. A model for the kinetics of distribution of actinomycin-D in the beagle dog. J Pharmacol Exp Ther 1977; 200: 469-78.
29. Jones HM, Mayawala K, Poulin P,. Dose selection based on physiologically based pharmacokinetic (PBPK) approaches. AAPS J 2013; 15: 377-87.
30. Cheeti S, Budha NR, Rajan S, Dresser MJ, Jin JY,. A physiologically based pharmacokinetic (PBPK) approach to evaluate pharmacokinetics in patients with cancer. Biopharm Drug Dispos 2013; 34: 141-54.
31. Rivory LP, Slaviero KA, Clarke SJ,. Hepatic cytochrome P450 3A drug metabolism is reduced in cancer patients who have an acute-phase response. Br J Cancer 2002; 87: 277-80.
32. Sukhai M, Yong A, Pak A, Piquette-Miller M,. Decreased expression of P-glycoprotein in interleukin-1beta and interleukin-6 treated rat hepatocytes. Inflamm Res 2001; 50: 362-70.
33. Bonner J, Walsh C, Johnson T, Neuhoff S, Greystoke A, Veal G,. Building of a paediatric cancer population for physiologically-based pharmacokinetic modelling and simulation in neonates, infants and children. Abstracts of the Annual Meeting of the Population Approach Group in Europe, 2015.