Asparaginase pharmacokinetics and implications of therapeutic drug monitoring

References

• Muller HJ, Boos J. Use of L-asparaginase in childhood ALL. Crit Rev Oncol Hematol 1998;28:97–113.
   PubMed Web of Science ®Google Scholar
• Pieters R, Hunger SP, Boos J, et al. L-asparaginase treatment in acute lymphoblastic leukemia:a focus on Erwinia asparaginase. Cancer 2011;117:238–249.
   PubMed Web of Science ®Google Scholar
• Pui CH, Mullighan CG, Evans WE, et al. Pediatric acute lymphoblastic leukemia: where are we going and how do we get there? Blood 2012;120:1165–1174.
   PubMed Web of Science ®Google Scholar
• Boos J, Werber G, Ahlke E, et al. Monitoring of asparaginase activity and asparagine levels in children on different asparaginase preparations. Eur J Cancer 1996;32A:1544–1550.
   PubMed Web of Science ®Google Scholar
• Vieira Pinheiro JP, Ahlke E, Nowak-Gottl U, et al. Pharmacokinetic dose adjustment of Erwinia asparaginase in protocol II of the paediatric ALL/NHL-BFM treatment protocols. Br J Haematol 1999;104:313–320.
   PubMed Web of Science ®Google Scholar
• Appel IM, Kazemier KM, Boos J, et al. Pharmacokinetic, pharmacodynamic and intracellular effects of PEG-asparaginase in newly diagnosed childhood acute lymphoblastic leukemia: results from a single agent window study. Leukemia 2008;22:1665–1679.
   PubMed Web of Science ®Google Scholar
• Jarrar M, Gaynon PS, Periclou AP, et al. Asparagine depletion after pegylated E. coli asparaginase treatment and induction outcome in children with acute lymphoblastic leukemia in first bone marrow relapse: a Children's Oncology Group study (CCG-1941). Pediatr Blood Cancer 2006;47:141–146.
   PubMed Web of Science ®Google Scholar
• Dinndorf PA, Gootenberg J, Cohen MH, et al. FDA drug approval summary:pegaspargase (oncaspar) for the first-line treatment of children with acute lymphoblastic leukemia (ALL). Oncologist 2007;12:991–998.
   PubMed Web of Science ®Google Scholar
• Douer D, Yampolsky H, Cohen LJ, et al. Pharmacodynamics and safety of intravenous pegaspargase during remission induction in adults aged 55 years or younger with newly diagnosed acute lymphoblastic leukemia. Blood 2007;109:2744–2750.
   PubMed Web of Science ®Google Scholar
• Covini D, Tardito S, Bussolati O, et al. Expanding targets for a metabolic therapy of cancer: L-asparaginase. Recent Pat Anticancer Drug Discov 2012;7:4–13.
   PubMed Web of Science ®Google Scholar
• Grigoryan RS, Panosyan EH, Seibel NL, et al. Changes of amino acid serum levels in pediatric patients with higher-risk acute lymphoblastic leukemia (CCG-1961). In Vivo 2004;18:107–112.
   PubMed Web of Science ®Google Scholar
• Avramis VI, Panosyan EH. Pharmacokinetic/pharmacodynamic relationships of asparaginase formulations: the past, the present and recommendations for the future. Clin Pharmacokinet 2005;44: 367–393.
   PubMed Web of Science ®Google Scholar
• Panosyan EH, Grigoryan RS, Avramis IA, et al. Deamination of glutamine is a prerequisite for optimal asparagine deamination by asparaginases in vivo (CCG-1961). Anticancer Res 2004;24:1121–1125.
   PubMed Web of Science ®Google Scholar
• Willems L, Jacque N, Jacquel A, et al. Inhibiting glutamine uptake represents an attractive new strategy for treating acute myeloid leukemia. Blood 2013;122:3521–3532.
   PubMed Web of Science ®Google Scholar
• Moola ZB, Scawen MD, Atkinson T, et al. Erwinia chrysanthemi L-asparaginase:epitope mapping and production of antigenically modified enzymes. Biochem J 1994;302:921–927.
   PubMed Web of Science ®Google Scholar
• Kotzia GA, Labrou NE. L-Asparaginase from Erwinia chrysanthemi 3937: cloning, expression and characterization. J Biotechnol 2007;127:657–669.
   PubMed Web of Science ®Google Scholar
• Derst C, Henseling J, Rohm KH. Engineering the substrate specificity of Escherichia coli asparaginase. II. Selective reduction of glutaminase activity by amino acid replacements at position 248. Protein Sci 2000;9:2009–2017.
   PubMed Web of Science ®Google Scholar
• Panosyan EH, Seibel NL, Martin-Aragon S, et al. Asparaginase antibody and asparaginase activity in children with higher-risk acute lymphoblastic leukemia: Children's Cancer Group Study CCG-1961. J Pediatr Hematol Oncol 2004;26:217–226.
   PubMed Web of Science ®Google Scholar
• Rizzari C, Conter V, Stary J, et al. Optimizing asparaginase therapy for acute lymphoblastic leukemia. Curr Opin Oncol 2013; 25(Suppl. 1):S1–S9.
   PubMed Web of Science ®Google Scholar
• Keding R. Discontinuation of Elspar (asparaginase for injection) 10,000 IU [Internet]. Deerfield, IL: Lundbeck LLC; 3 August 2012. Available from: www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM321556.pdf
   Google Scholar
• Riccardi R, Holcenberg JS, Glaubiger DL, et al. L-asparaginase pharmacokinetics and asparagine levels in cerebrospinal fluid of rhesus monkeys and humans. Cancer Res 1981;41:4554–4558.
   PubMed Web of Science ®Google Scholar
• Avramis VI, Sencer S, Periclou AP, et al. A randomized comparison of native Escherichia coli asparaginase and polyethylene glycol conjugated asparaginase for treatment of children with newly diagnosed standard-risk acute lymphoblastic leukemia: a Children's Cancer Group study. Blood 2002;99:1986–1994.
   PubMed Web of Science ®Google Scholar
• Asselin BL, Kreissman S, Coppola DJ, et al. Prognostic significance of early response to a single dose of asparaginase in childhood acute lymphoblastic leukemia. J Pediatr Hematol Oncol 1999;21:6–12.
   PubMed Web of Science ®Google Scholar
• Ahlke E, Nowak-Gottl U, Schulze-Westhoff P, et al. Dose reduction of asparaginase under pharmacokinetic and pharmacodynamic control during induction therapy in children with acute lymphoblastic leukaemia. Br J Haematol 1997;96:675–681.
   PubMed Web of Science ®Google Scholar
• Rizzari C, Zucchetti M, Conter V, et al. L-asparagine depletion and L-asparaginase activity in children with acute lymphoblastic leukemia receiving IM or IV Erwinia C. or E. coli L-asparaginase as first exposure. Ann Oncol 2000;11:189–193.
   PubMed Web of Science ®Google Scholar
• Wetzler M, Sanford BL, Kurtzberg J, et al. Effective asparagine depletion with pegylated asparaginase results in improved outcomes in adult acute lymphoblastic leukemia: Cancer and Leukemia Group B Study 9511. Blood 2007;109:4164–4167.
   PubMed Web of Science ®Google Scholar
• Silverman LB, Gelber RD, Dalton VK, et al. Improved outcome for children with acute lymphoblastic leukemia: results of Dana-Farber Consortium Protocol 91-01. Blood 2001;97:1211–1218.
   PubMed Web of Science ®Google Scholar
• Pession A, Valsecchi MG, Masera G, et al. Long-term results of a randomized trial on extended use of high dose L-asparaginase for standard risk childhood acute lymphoblastic leukemia. J Clin Oncol 2005;23:7161–7167.
   PubMed Web of Science ®Google Scholar
• Amylon MD, Shuster J, Pullen J, et al. Intensive high-dose asparaginase consolidation improves survival for pediatric patients with T cell acute lymphoblastic leukemia and advanced stage lymphoblastic lymphoma: a Pediatric Oncology Group study. Leukemia 1999;13: 335–342.
   PubMed Web of Science ®Google Scholar
• Asselin BL. The three asparaginases. Comparative pharmacology and optimal use in childhood leukemia. Adv Exp Med Biol 1999;457: 621–629.
   PubMed Web of Science ®Google Scholar
• Asselin BL, Whitin JC, Coppola DJ, et al. Comparative pharmacokinetic studies of three asparaginase preparations. J Clin Oncol 1993;11:1780–1786.
   PubMed Web of Science ®Google Scholar
• Tong WH, Pieters R, Kaspers GJ, et al. A prospective study on drug monitoring of PEGasparaginase and Erwinia asparaginase and asparaginase antibodies in pediatric acute lymphoblastic leukemia. Blood 2014;123:2026–2033.
   PubMed Web of Science ®Google Scholar
• Salzer WL, Asselin B, Supko JG, et al. Erwinia asparaginase achieves therapeutic activity after pegaspargase allergy: a report from the Children's Oncology Group. Blood 2013;122:507–514.
   PubMed Web of Science ®Google Scholar
• Vrooman LM, Supko JG, Neuberg DS, et al. Erwinia asparaginase after allergy to E. coli asparaginase in children with acute lymphoblastic leukemia. Pediatr Blood Cancer 2010;54:199–205.
   PubMed Web of Science ®Google Scholar
• Rizzari C, Citterio M, Zucchetti M, et al. A pharmacological study on pegylated asparaginase used in front-line treatment of children with acute lymphoblastic leukemia. Haematologica 2006;91:24–31.
   PubMed Web of Science ®Google Scholar
• Albertsen BK, Schroder H, Jakobsen P, et al. Monitoring of Erwinia asparaginase therapy in childhood ALL in the Nordic countries. Br J Clin Pharmacol 2001;52:433–437.
   PubMed Web of Science ®Google Scholar
• Moghrabi A, Levy DE, Asselin B, et al. Results of the Dana-Farber Cancer Institute ALL Consortium Protocol 95-01 for children with acute lymphoblastic leukemia. Blood 2007;109:896–904.
   PubMed Web of Science ®Google Scholar
• Duval M, Suciu S, Ferster A, et al. Comparison of Escherichia coli-asparaginase with Erwinia-asparaginase in the treatment of childhood lymphoid malignancies: results of a randomized European Organisation for Research and Treatment of Cancer-Children's Leukemia Group phase 3 trial. Blood 2002;99:2734–2739.
   PubMed Web of Science ®Google Scholar
• Rizzari C, Valsecchi MG, Arico M, et al. Effect of protracted high-dose L-asparaginase given as a second exposure in a Berlin-Frankfurt-Munster-based treatment: results of the randomized 9102 intermediate-risk childhood acute lymphoblastic leukemia study--a report from the Associazione Italiana Ematologia Oncologia Pediatrica. J Clin Oncol 2001;19:1297–1303.
   PubMed Web of Science ®Google Scholar
• Salzer W, Seibel N, Smith M. Erwinia asparaginase in pediatric acute lymphoblastic leukemia. Expert Opin Biol Ther 2012;12: 1407–1414.
   PubMed Web of Science ®Google Scholar
• ClinicalTrials.gov. International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia; NLM Identifier: NCT01117441 [Internet]. Bethesda, MD: National Library of Medicine (US)/University of Schleswig-Holstein; 2010. Available from: http://clinicaltrials.gov/show/NCT01117441
   Google Scholar
• Schrey D, Borghorst S, Lanvers-Kaminsky C, et al. Therapeutic drug monitoring of asparaginase in the ALL-BFM 2000 protocol between 2000 and2007. Pediatr Blood Cancer 2010;54:952–958.
   Google Scholar
• Vrooman LM, Kirov I, Dreyer ZE, et al. Preliminary results of a pharmacokinetic study of intravenous asparaginase Erwinia chrysanthemi following allergy to E coli-derived asparaginase in children, adolescents, and young adults with acute lymphoblastic leukemia or lymphoblastic lymphoma. Blood 2013;122(Suppl. 1): Abstract 3904.
   Google Scholar
• Zalewska-Szewczyk B, Andrzejewski W, Mlynarski W, et al. The anti-asparagines antibodies correlate with L-asparagines activity and may affect clinical outcome of childhood acute lymphoblastic leukemia. Leuk Lymphoma 2007;48:931–936.
   PubMed Web of Science ®Google Scholar
• Woo MH, Hak LJ, Storm MC, et al. Anti-asparaginase antibodies following E. coli asparaginase therapy in pediatric acute lymphoblastic leukemia. Leukemia 1998;12:1527–1533.
   PubMed Web of Science ®Google Scholar
• Kurtzberg J, Asselin B, Bernstein M, et al. Polyethylene glycol-conjugated L-asparaginase versus native L-asparaginase in combination with standard agents for children with acute lymphoblastic leukemia in second bone marrow relapse: a Children's Oncology Group Study (POG 8866). J Pediatr Hematol Oncol 2011;33:610–616.
   PubMed Web of Science ®Google Scholar
• Willer A, Gerss J, Konig T, et al. Anti-Escherichia coli asparaginase antibody levels determine the activity of second-line treatment with pegylated E coli asparaginase: a retrospective analysis within the ALL-BFM trials. Blood 2011;118:5774–5782.
   PubMed Web of Science ®Google Scholar
• Vrooman LM, Stevenson KE, Supko JG, et al. Postinduction dexamethasone and individualized dosing of Escherichia coli L-asparaginase each improve outcome of children and adolescents with newly diagnosed acute lymphoblastic leukemia: results from a randomized study--Dana-Farber Cancer Institute ALL Consortium Protocol 00–01. J Clin Oncol 2013;31:1202–1210.
   PubMed Web of Science ®Google Scholar
• Hawkins DS, Park JR, Thomson BG, et al. Asparaginase pharmacokinetics after intensive polyethylene glycol-conjugated L-asparaginase therapy for children with relapsed acute lymphoblastic leukemia. Clin Cancer Res 2004;10:5335–5341.
   PubMed Web of Science ®Google Scholar
• Albertsen BK, Schroder H, Jakobsen P, et al. Antibody formation during intravenous and intramuscular therapy with Erwinia asparaginase. Med Pediatr Oncol 2002;38:310–316.
   PubMedGoogle Scholar
• Wang B, Relling MV, Storm MC, et al. Evaluation of immunologic crossreaction of antiasparaginase antibodies in acute lymphoblastic leukemia (ALL) and lymphoma patients. Leukemia 2003;17:1583–1588.
   PubMed Web of Science ®Google Scholar
• Liu C, Kawedia JD, Cheng C, et al. Clinical utility and implications of asparaginase antibodies in acute lymphoblastic leukemia. Leukemia 2012;26:2303–2309.
   PubMed Web of Science ®Google Scholar
• Zalewska-Szewczyk B, Gach A, Wyka K, et al. The cross-reactivity of anti-asparaginase antibodies against different L-asparaginase preparations. Clin Exp Med 2009;9:113–116.
   PubMed Web of Science ®Google Scholar
• Albertsen BK, Schroder H, Ingerslev J, et al. Comparison of intramuscular therapy with Erwinia asparaginase and asparaginase Medac: pharmacokinetics, pharmacodynamics, formation of antibodies and influence on the coagulation system. Br J Haematol 2001;115:983–990.
   PubMed Web of Science ®Google Scholar
• Muller HJ, Loning L, Horn A, et al. Pegylated asparaginase (Oncaspar) in children with ALL: drug monitoring in reinduction according to the ALL/NHL-BFM 95 protocols. Br J Haematol 2000;110:379–384.
   PubMed Web of Science ®Google Scholar
• Evans WE, Tsiatis A, Rivera G, et al. Anaphylactoid reactions to Escherichia coli and Erwinia asparaginase in children with leukemia and lymphoma. Cancer 1982;49:1378–1383.
   PubMed Web of Science ®Google Scholar
• Albertsen BK, Jakobsen P, Schroder H, et al. Pharmacokinetics of Erwinia asparaginase after intravenous and intramuscular administration. Cancer Chemother Pharmacol 2001;48:77–82.
   PubMed Web of Science ®Google Scholar
• Ho DH, Yap HY, Brown N, et al. Clinical pharmacology of intramuscularly administered L-asparaginase. J Clin Pharmacol 1981;21:72–78.
   PubMed Web of Science ®Google Scholar
• Plourde PV, Jeha S, Hijiya N, et al. Safety profile of asparaginase Erwinia chrysanthemi in a large compassionate-use trial. Pediatr Blood Cancer 2014;61:1232–1238.
   PubMed Web of Science ®Google Scholar
• AIBioTech Inc. L-asparaginase assay for leukemia patients [Internet]. 2013. Available from: www.aibiotech.com/l-asparaginase-assay-leukemia-patients
   Google Scholar
• EU Clinical Trials Register. Dutch Childhood Oncology Group. Treatment study protocol of the Dutch Childhood Oncology Group for children and adolescents (1–19 year) with newly diagnosed acute lymphoblastic leukemia. EudraCT Number: 2012-000067-25 [Internet]. London, UK: European Medicines Agency; 2012. Available from: www.clinicaltrialsregister.eu/ctr-search/search?query = 2012-000067-25
   Google Scholar
• Boissel N, Auclerc MF, Lhéritier V, et al. Should adolescents with acute lymphoblastic leukemia be treated as old children or young adults? Comparison of the French FRALLE-93 and LALA-94 trials. J Clin Oncol 2003;21:774–780.
   PubMed Web of Science ®Google Scholar
• de Bont JM, Holt B, Dekker AW, et al. Significant difference in outcome for adolescents with acute lymphoblastic leukemia treated on pediatric vs adult protocols in the Netherlands. Leukemia 2004;18:2032–2035.
   PubMed Web of Science ®Google Scholar
• Hallbook H, Gustafsson G, Smedmyr B, et al. Treatment outcome in young adults and children > 10 years of age with acute lymphoblastic leukemia in Sweden: a comparison between a pediatric protocol and an adult protocol. Cancer 2006;107:1551–1561.
   PubMed Web of Science ®Google Scholar
• Ramanujachar R, Richards S, Hann I, et al. Adolescents with acute lymphoblastic leukaemia: outcome on UK national paediatric (ALL97) and adult (UKALLXII/E2993) trials. Pediatr Blood Cancer 2007;48: 254–261.
   PubMed Web of Science ®Google Scholar
• Stock W, La M, Sanford B, et al. What determines the outcomes for adolescents and young adults with acute lymphoblastic leukemia treated on cooperative group protocols? A comparison of Children's Cancer Group and Cancer and Leukemia Group B studies. Blood 2008;112:1646–1654.
   PubMed Web of Science ®Google Scholar
• Rizzari C. Shedding light on the asparaginase galaxy. Blood 2014;123:1976–1978.
   PubMed Web of Science ®Google Scholar