A pharmacological study on pegylated asparaginase used in front-line treatment of children with acute lymphoblastic leukemia

Haematologica

Volumn 91, Issue 1, 2006, Pages 24-31

  Rizzari, Carmelo ^a,c   Citterio, Marco ^a   Zucchetti, Massimo ^b   Conter, Valentino ^a   Chiesa, Robert ^a   Colombini, Antonella ^a   Malguzzi, Silvia ^a   Silvestri, Daniela ^c   D'Incalci, Maurizio ^b  

^a SAN GERARDO HOSPITAL   (Italy)

^b MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

^c UNIVERSITY OF MILANO BICOCCA   (Italy)

Author keywords

Acute lymphoblastic leukemia; Asparaginase; Childhood; Pharmacology; Treatment

Indexed keywords

ASPARAGINASE MACROGOL; ASPARAGINE;

ACUTE LYMPHOBLASTIC LEUKEMIA; ADOLESCENT; ALLERGIC REACTION; AMINO ACID BLOOD LEVEL; ARTICLE; BACTERIAL PNEUMONIA; CEREBRAL SINUS THROMBOSIS; CEREBROSPINAL FLUID LEVEL; CHICKENPOX; CHILD; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG CEREBROSPINAL FLUID LEVEL; DRUG EFFECT; DRUG EXPOSURE; DRUG HYPERSENSITIVITY; ENZYME ACTIVITY; FEMALE; HEALTH STATUS; HUMAN; HYPOFIBRINOGENEMIA; LIVER TOXICITY; MALE; NEUTROPENIA; PYREXIA IDIOPATHICA; TREATMENT RESPONSE;

ADOLESCENT; ASPARAGINASE; CHILD; CHILD, PRESCHOOL; FEMALE; HUMANS; LEUKEMIA, LYMPHOCYTIC, ACUTE; MALE; POLYETHYLENE GLYCOLS; REMISSION INDUCTION;

EID: 32544457262     PISSN: 03906078     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (43)

1. th ed, Volume 1, Philadelphia, PA, USA. 1993. p. 387-9.
2. Kidd JG. Regression of transplant lymphomas induced in vivo by means of normal guinea pig serum. J Exp Med 1953;98:565-82.
3. Broome JD. Evidence that the asparaginase of guinea pig serum is responsible for its antilymphoma effects. J Exp Med 1963;118:99-120.
4. Ertel IJ, Nesbit ME, Hammond D, Weiner J, Sather H. Effective dose of asparaginase for induction of remission in previously treated children with lymphocytic leukaemia: a report from Children Cancer's Study Group. Cancer Res 1979;9:3893-6.
5. Muller HJ, Boos J. Use of asparaginase in childhood ALE. Crit Rev Oncol/Hematol 1998;28:97-113.
6. Cao SG, Zhao QY, Ding ZT, Ma L, Yu T, Wang JH. et al. Chemical modification of enzyme molecules to improve their characteristics. Ann NY Acad Sci 1990;613:460-7.
7. Kawashima K, Takeshima H, Higashi Y, Hamaguchi M, Sugie H, Imamura I, et al. High efficacy of monomethoxy-polyethylene glycol-conjugated asparaginase (PEG2-asparaginase) in two patients with hematological malignancies. Leuk Res 1991;15:525-30.
8. Asselin BL, Whitin JC, Coppola DJ, Rupp IP, Sallan SE, Cohen HJ. Comparative pharmacokinetic studies of three asparaginase preparations. J Clin Oncol 1993;1:1780-6.
9. Asselin BL. The three asparaginase s. Comparative pharmacology and optimal use in childhood leukemia. Adv Exp Med Biol 1999;457:621-9.
10. Avramis VI, Sencer S, Penclou AP, Sather H, Bostrom BC, Cohen LJ, 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 leukaemia: a Children's Cancer Group study. Blood 2002;99:1986-94.
11. Silverman LB, Gelber RD, Dalton VK, Asselin BL, Barr RD, Clavell LA, et al. Improved outcome for children with acute lymphoblastic leukaemia: results of Dana-Farber Consortium Protocol 91-01. Blood 2001;97:1211-8.
12. Müller HJ, Loning L, Horn A, Schwabe D, Gunkel M, Schrappe M. 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;110:379-84.
13. Masera G, Conter V, Rizzari C, Arico M, Pession A, Paolucci G. AIEOP Non-B ALL trials. Int J Fed Hematol/Oncol 1999;6:101-11.
14. van Dongen JJ, Seriu T, Panzer-Grumayer ER, Biondi A, Pongers-Willemse MJ, Corral L, et al. Prognostic value of minimal residual disease in acute lymphoblastic leukaemia in childhood. Lancet 1998;352:1731-8.
15. Turnell DC, Cooper JHD. Rapid assay for amino acids in serum or urine by pre-column derivatization and reversed-phase liquid chromatography. Clin Chem 1982;28:527-31.
16. Fukuda K, Nishi Y, Usui T. Free amino acid concentrations in plasma, erythrocytes, gran-ulocytes, and lymphocytes in umbilical cord blood, children, and adults. J Pediatr Gastroenterol Nutr 1984;3:432-9.
17. Heiblim DI, Evans HE, Class L, Agluyani M. Amino acids concentrations in cerebrospinal fluid. Arch Neurol 1978;35:765-8.
18. Boos J, Werber G, Ahlke E, Schulze-Westhoff P, Nowak-Gottl U, Würthwein G, et al. Monitoring of asparaginase activity and asparagine levels in children on different asparaginase preparations. Eur J Cancer 1996;32:1544-50.
19. Vieira Pinheiro JP, Ahlke E, Nowak-Göttl U, Hempel G, Müller HJ, Lumkemann K, et al. Pharmacokinetic dose adjustment of Erwinia asparaginase in protocol II of the paediatric AIL/NHL-BFM treatment protocol. Br J Haematol 1999;104:313-20.
20. Kurtzberg J, Asselin B, Pollack B. PEG-asparaginase vs native E. coli asparaginase for reinduction of relapsed acute lymphoblastic leukaemia: POG #8866 phase II trial. Proceedings of ASCO 1993;12:325.
21. Cheung NK, Chau IY, Coccia PF. Antibody response to Escherichia coli asparaginase. Prognostic significance and clinical utility of antibody measurement. Am J Pediatr Hematol Oncol 1986;8:99-104.
22. Abshire T, Pollock B, Billet A, Bradley P, Buchanan GR. Weekly polyethylene glycolconyugated asparaginase compared with biweekly dosing produces superior induction remission rates in childhood relapsed acute lymphoblastic leukaemia: a Pediatric Oncology Group study. Blood 2000;96:1709-14.
23. Vieira Pinheiro JP, Müller HJ, Schwabe D, Gunkel M, Henze G, von Schutz V, et al. Drug monitoring of low-dose PEG-asparaginase (Oncaspar™) in children with relapsed acute lymphoblastic leucemia. Br J Haematol 2001;113:115-9.
24. Rizzari C. asparaginase treatment. In: ChingHon PUI, Ed. Current clinical oncology: treatment of acute leukemias: new directions for clinical research. Humana Press Inc, Totowa, NJ, USA: 2002. p. 381-91.
25. Ho DH, Wang CY, Lin JR, Brown N, Newman RA, Krakoff IH. Polyethylene glycol-asparaginase and asparaginase studies in rabbits. Drug Metab Dispos 1998;16:27-9.
26. Ettinger LJ, Kurtzberg J, Voute PA, Jurgens H, Halpern SL. An opel-label, multicenter study of polyethylene glycol-asparaginase for the treatment of acute lymphoblastic leukemia. Cancer 1995;75:1176-81.
27. Müller HJ, Beier R, da Palma JC, Lanvers C, Ahlke E, von Schutz VM, et al. PEG-asparaginase (Oncaspar™) 2500 U/m BSA in reinduction of relapse treatment in the ALL(NHL-BFM protocols. Cancer Chemother Pharmacol 2002;49:149-54.
28. Vieira Pinheiro JP, Lanvers C, Wurthwein G, Boos J. Drug monitoring of PEG-asparaginase treatment in childhood acute lymphoblastic leukaemia and non-Hodgkin's lymphoma. Leuk Lymphoma 2002;43:1911-20.
29. Ahlke E, Nowak-Göttl U, Schulze-Westhoff P, Werber G, Borste H, Wurthwein G, et al. Dose reduction of asparaginase under pharmacokinetic and pharmacodynamic control during induction therapy in childhood acute lymphoblastic leukemia. Br J Haematol 1997;96:675-81.
30. Rizzari C, Zucchetti M, Conter V, Diomede L, Bruno A, Gavazzi L, et al. Asparagine depletion and asparaginase activity in children with acute lymphobiastic leukemia receiving i.m. or i.v. Erwinia c. or E. coli asparaginase as first exposure. Ann Oncol 2000;11:189-93.
31. Dibenedetto SP, Di Cataldo A, Ragusa R, Meli C, Lo Nigro L. Levels of asparagine in CSF after intramuscular administration of asparaginase from Erwinia in children with ALL. J Clin Oncol 1995;13:339-44.
32. Gentili D, Corner V, Rizzari C, Tschuemperlin B, Zucchetti M. Asparagine depletion in plasma and cerebro spinal fluid of children with acute lymphoblastic leukaemia during subsequent exposures to Erwinia asparaginase. Ann Oncol 1996;7:725-30.
33. Woo MH, Hak LJ, Storm MC, Gajjar AJ, Sandlund JT, Harrison PL, et al. Cerebrospinal fluid asparagine concentrations after Eschenchia coli asparaginase in children with acute lymphobiastic leukaemia. J Clin Oncol 1999;17:1568-73.
34. Riccardi R, Holcenberg JS, Glaubiger DL, Wood KH, Poplack DG. asparaginase pharmacokinetics and asparagine levels in CSF of Rhesus monkeys and humans. Cancer Res 1981;41:4554-8.
35. Appel IM, Pinheiro JP, den Boer ML, Lanvers C, Reniers NC, Boos JI. Lack of asparagine depletion in the cerebrospinal fluid after intravenous dose of PEG-asparaginase: a window study at initial diagnosis of childhood ALL. Leukemia 2003;17:2254-6.
36. Nowak-Göttl U, Wermes C, Junker R, Koch HG, Schobess R, Fleischhack G, et al. Prospective evaluation of the thrombotic risk in children with acute lymphoblastic leukemia carrying the MTHFR TT 677 genotype, the prothrombin G20210 variant, and further prothrombotic risk factors. Blood 1999;93:1595-9.
37. Nowak-Göttl U, Heinecke A, von Kries R, Nürnberger W, Munchow N, Junker R. Thrombotic events revisited in children with acute lymphobiastic leukemia: impact of concomitant Escherichia coli asparaginase/prednisone administration. Thromb Res 2001;103:165-72.
38. Nowak-Göttl U, Ahlke E, Schulze-Westhoff P, Boos J. Changes in coagulation and fibrinolysis in childhood ALL: a two-step dose reduction of one E. coli asparaginase preparation. Br J Haematol 1996;95:12o-6.
39. Nowak-Göttl U, Werber G, Ziemann D, Ahlke E, Boos J. Influence of two different E. coli asparaginase preparations on fibrinolytic proteins in childhood ALL. Haematologica 1996;81:127-31.
40. Sutor AH, Niemeyer C, Sauter S, Witt I, Kaufmehl K, Rombach A. et al. Gerinnungsveränderungen bei Behandlung mit den Protokollen ALL BFM 90 und NHL-BFM-90. Klin Pädiatr 1992;204:264-73.
41. Nowak-Göttl U, Kuhn N, Wolff JE, Boos J, Kehrel B, Rath B, et al. Inhibition of hypercoagulation by antithrombin substitution in E. coli asparaginase-treated children. Eur J Haematol 1996;56:35-8.
42. Keating MJ, Holmes R, Lerner S, Ho DH. asparaginase and PEG asparaginase-Past, present and future. Leuk Lymphoma 1993;10:153-7.
43. Holle LM, Pegaspargase: an alternative? Ann Pharmacother 1997;31:19-27.