Analytical validation of a microplate reader-based method for the therapeutic drug monitoring of L-asparaginase in human serum

Analytical Biochemistry

Volumn 309, Issue 1, 2002, Pages 117-126

  Lanvers, Claudia ^a   VieiraPinheiro, Joao Paulo ^a   Hempel, Georg ^a   Wuerthwein, Gudrun ^a   Boos, Joachim ^a  

^a UNIVERSITY HOSPITAL MÜNSTER   (Germany)

Author keywords

Acute lymphoblastic leukemia; L Asparaginase; L Aspartic Hydroxamate; Therapeutic drug monitoring

Indexed keywords

AMINES; AMINO ACIDS; AMMONIA; DISEASES; ENZYMES; ESCHERICHIA COLI;

ACUTE LYMPHOBLASTIC LEUKEMIA; ANALYTICAL VALIDATION; BIOEQUIVALENCE STUDY; COEFFICIENT OF CORRELATION; COEFFICIENTS OF VARIATIONS; HYDROXAMATE; L -ASPARAGINASE; THERAPEUTIC DRUG MONITORING;

PATIENT MONITORING;

ASPARAGINASE; ASPARTIC ACID BETA HYDROXAMIC ACID; ASPARAGINE; BETA ASPARTYLHYDROXAMIC ACID; BETA-ASPARTYLHYDROXAMIC ACID; DRUG DERIVATIVE;

ACUTE LYMPHOBLASTIC LEUKEMIA; ANALYTIC METHOD; ARTICLE; BLOOD SAMPLING; CORRELATION FUNCTION; DRUG DETERMINATION; DRUG MONITORING; ENZYME ACTIVITY; HUMAN; HUMAN CELL; HYDROLYSIS; PRIORITY JOURNAL; QUANTITATIVE ASSAY; VALIDATION PROCESS; BLOOD; CALIBRATION; CHEMISTRY; COMPARATIVE STUDY; DRUG STABILITY; ENZYMOLOGY; ESCHERICHIA COLI; KINETICS; METABOLISM; METHODOLOGY; PECTOBACTERIUM CHRYSANTHEMI; REFERENCE VALUE; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; STATISTICAL MODEL;

ERWINIA; ERWINIA CHRYSANTHEMI; ESCHERICHIA COLI;

ASPARAGINASE; ASPARAGINE; CALIBRATION; DRUG MONITORING; DRUG STABILITY; ESCHERICHIA COLI; HUMANS; HYDROLYSIS; KINETICS; LINEAR MODELS; MICROCHEMISTRY; PECTOBACTERIUM CHRYSANTHEMI; REFERENCE VALUES; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

EID: 0036807796     PISSN: 00032697     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0003-2697(02)00232-4     Document Type: Article

References (32)

1. H.J. Muller, J. Boos, Use of L-asparaginase in childhood ALL, Crit. Rev. Oncol. Hematol. 28 (1998) 97-113.
2. M.J. Keating, R. Holmes, S. Lerner, D.H. Ho, L- asparaginase and PEG asparaginase - Past, present, and future, Leukocyte Lymphoma 10 (Suppl:153-7) (1993) 153-157.
3. B.L. Asselin, J.C. Whitin, D.J. Coppola, I.P. Rupp, S.E. Sallan, H.J. Cohen, Comparative pharmacokinetic studies of three asparaginase preparations, J. Clin. Oncol. 11 (1993) 1780-1786.
4. G. Werber, E. Ahlke, U. Nowak-Gottl, H. Jürgens, E.J. Verspohl, J. Boos, Asparaginase activities are highly sensitive to different buffer conditions, Haematol. Blood Transfusion 38 (1996) 512-516.
5. R. Berg, E. Becker, Ein neuer nachweis von hydroxylamin durch bildung von chinolinchinon-(5,8)-[8-oxy-chinolyl-5-imid]-(5), genannt "Indo-oxin", Ber. Deutsch. Chemi. Ges. 73 (1947) 172-173.
6. D.H. Ho, N.S. Brown, A. Yen, R. Holmes, M. Keating, A. Abuchowski, R.A. Newman, I.H. Krakoff, Clinical pharmacology of polyethylene glycol-L-asparaginase, Drug Metab. Dispos. 14 (1986) 349-352.
7. J. Boos, G. Werber, E. Ahlke, P. Schulze-Westhoff, U. Nowak-Gottl, G. Wurthwein, E.J. Verspohl, J. Ritter, H. Jurgens, Monitoring of asparaginase activity and asparagine levels in children on different asparaginase preparations, Eur. J. Cancer 32A (1996) 1544-1550.
8. E. Ahlke, U. Nowak-Gottl, P. Schulze-Westhoff, G. Werber, H. Borste, G. Wurthwein, H. Jurgens, J. Boos, Dose reduction of asparaginase under pharmacokinetic and pharmacodynamic control during induction therapy in children with acute lymphoblastic leukaemia, Br. J. Haematol. 96 (1997) 675-681.
9. C. Rizzari, M. Zucchetti, V. Conter, L. Diomede, A. Bruno, L. Gavazzi, M. Paganini, P. Sparano, N.L. Lo, M. Arico, M. Milani, M. D'Incalci, 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. 11 (2000) 189-193.
10. P.J. Vieira, E. Ahlke, U. Nowak-Gottl, G. Hempel, H.J. Muller, K. Lumkemann, M. Schrappe, B. Rath, G. Fleischhack, G. Mann, J. Boos, Pharmacokinetic dose adjustment of Erwinia asparaginase in protocol II of the paediatric ALL/NHL-BFM treatment protocols, Br. J. Haematol. 104 (1999) 313-320.
11. R. Miniero, G. Pastore, P. Saracco, M. Messina, M.M. Lange, G. Fiandino, L. Iannacci, E. Madon, Hemostatic changes in children with acute lymphoblastic leukemia treated according to two different L-asparaginase schedules, Am. J. Pediatr. Hematol. Oncol. 8 (1986) 116-120.
12. A. O'Meara, M. Daly, F.H. Hallinan, Increased antithrombin III concentration in children with acute lymphatic leukaemia receiving L-asparaginase therapy, Med. Pediatr. Oncol. 16 (1988) 169-174.
13. O.B. Eden, M.P. Shaw, J.S. Lilleyman, S. Richards, Non-randomised study comparing toxicity of Escherichia coli and Erwinia asparaginase in children with leukaemia, Med. Pediatr. Oncol. 18 (1990) 497-502.
14. U. Nowak-Gottl, E. Ahlke, K. Klosel, H. Jurgens, J. Boos, Changes in coagulation and fibrinolysis in childhood acute lymphoblastic leukaemia re-induction therapy using three different asparaginase preparations, Eur. J. Pediatr. 156 (1997) 848-850.
15. C.T. Dellinger, T.D. Miale, Comparison of anaphylactic reactions to asparaginase derived from Escherichia coli and from Erwinia cultures, Cancer 38 (1976) 1843-1846.
16. P.J. Vieira, H.J. Muller, D. Schwabe, M. Gunkel, d.P. Casimiro, G. Henze, V. von Schutz, M. Winkelhorst, G. Wurthwein, J. Boos, Drug monitoring of low-dose PEG-asparaginase Oncaspar in children with relapsed acute lymphoblastic leukaemia, Br. J. Haematol. 113 (2001) 115-119.
17. H.J. Muller, L. Loning, A. Horn, D. Schwabe, M. Gunkel, M. Schrappe, V. von Schutz, G. Henze, D.P. Casimiro, J. Ritter, J.P. Pinheiro, M. Winkelhorst, J. Boos, Pegylated asparaginase (Oncaspar) in children with ALL: Drug monitoring in reinduction according to the ALL/NHL-BFM95 protocols, Br. J. Haematol. 110 (2000) 379-384.
18. A. Meister, in: Methods in Enzymology, Academic Press, New York, 1955, p. 380.
19. B.L. Asselin, M.Y. Lorenson, J.C. Whitin, D.J. Coppola, A.S. Kende, R.L. Blakley, H.J. Cohen, Measurement of serum L-asparagine in the presence of L-asparaginase requires the presence of an L-asparaginase inhibitor, Cancer Res. 51 (1991) 6568-6573.
20. D.A. Cooney, R.E. Handschumacher, L-asparaginase and L-asparagine metabolism, Annu. Rev. Pharmacol. 10 (1970) 421-440.
21. P. Ylikangas, I. Mononen, A fluorometric assay for L-asparaginase activity and monitoring of L-asparaginase therapy, Anal. Biochem. 280 (2000) 42-45.
22. A. Wehner, E. Harms, M.P. Jennings, I.R. Beacham, C. Derst, P. Bast, K.H. Rohm, Site-specific mutagenesis of Escherichia coli asparaginase II. None of the three histidine residues is required for catalysis, Eur. J. Biochem. 208 (1992) 475-480.
23. V.P. Shah, K.K. Midha, S. Dighe, I.J. McGilveray, J.P. Skelly, A. Yacobi, T. Layloff, C.T. Viswanathan, C.E. Cook, R.D. McDowall, Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies Conference report, Eur. J. Drug Metab. Pharmacokinet. 16 (1991) 249-255.
24. Y. Kamisaki, H. Wada, T. Yagura, A. Matsushima, Y. Inada, Reduction in immunogenicity and clearance rate of Escherichia coli L-asparaginase by modification with monomethoxypolyethylene glycol, J. Pharmacol. Exp. Ther. 216 (1981) 410-414.
25. M.B. Lee, C.D. Bolger, J.M. Bridges, Factors influencing the "in vitro" enhancement of L-asparaginase activity, Biochim. Biophys. Acta 242 (1971) 226-229.
26. M.B. Lee, R.M. Niblock, J.M. Bridges, The influence of human serum on the anti-tumour activity of two L-asparaginases, Br. J. Cancer 23 (1969) 369-376.
27. E. Rauenbusch, K. Bauer, W. Kaufmann, O. Wagner, Isolation and crystallisation of L-asparaginase from E. coli, Recent Results Cancer Res. 33 (1970) 31-38.
28. A.A. Pritsa, K.T. Papazisis; A.H. Kortsaris, G.D. Geromichalos, A. Kyriakidis, Antitumor activity of L-asparaginase from Thermus thermophilus, Anticancer Drugs 12 (2001) 137-142.
29. A.I. Fernandes, G. Gregoriadis, The effect of polysialylation on the immunogenicity and antigenicity of asparaginase: Implication in its pharmacokinetics, Int. J. Pharm. 217 (2001) 215-224.
30. K. Aghaiypour, A. Wlodawer, J. Lubkowski, Structural basis for the activity and substrate specificity of E. chrysanthemi L-asparaginase, Biochemistry 40 (2001) 5655-5664.
31. H.N. Jayaram, D.A. Cooney, S. Jayaram, L. Rosenblum, A simple and rapid method for the estimation of L-asparaginase in chromatographic and electrophoretic effluents: Comparison with other methods, Anal. Biochem. 59 (1974) 327-346.
32. I. Mononen, T. Mononen, P. Ylikangas, V. Kaartinen, K. Savolainen, Enzymatic diagnosis of aspartylglycosaminuria by fluorometric assay of glycosylasparaginase in serum, plasma, or lymphocytes, Clin. Chem. 40 (1994) 385-388.