Pharmacodynamics and safety of intravenous pegaspargase during remission induction in adults aged 55 years or younger with newly diagnosed acute lymphoblastic leukemia

Blood

Volumn 109, Issue 7, 2007, Pages 2744-2750

  Douer, Dan ^a,b   Yampolsky, Henry ^a   Cohen, Lewis J ^a   Watkins, Kristy ^a   Levine, Alexandra M ^a   Periclou, Antonia P ^a   Avramis, Vassilios I ^a  

^a UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^b UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ASPARAGINASE; ASPARAGINASE ANTIBODY; ASPARAGINASE MACROGOL; ASPARAGINE; CYCLOPHOSPHAMIDE; CYTARABINE; DAUNORUBICIN; ENZYME ANTIBODY; MERCAPTOPURINE; NEUTRALIZING ANTIBODY; PREDNISONE; UNCLASSIFIED DRUG; VINCRISTINE;

ACUTE LYMPHOBLASTIC LEUKEMIA; ADOLESCENT; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CANCER REGRESSION; CLINICAL ARTICLE; CONSTIPATION; CONTROLLED STUDY; CORRELATION ANALYSIS; DEAMINATION; DEEP VEIN THROMBOSIS; DIARRHEA; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; ENZYME ACTIVITY; ENZYME BLOOD LEVEL; FATIGUE; FEMALE; FEVER; HUMAN; HYPERBILIRUBINEMIA; HYPERGLYCEMIA; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROPATHY; PANCREATITIS; POST HOC ANALYSIS; PRIORITY JOURNAL; SIDE EFFECT; SINGLE DRUG DOSE; TREATMENT RESPONSE; VOMITING;

EID: 33947600985     PISSN: 00064971     EISSN: 00064971     Source Type: Journal    
DOI: 10.1182/blood-2006-07-035006     Document Type: Article

References (59)

1. Capizzi RL. Asparaginase revisited. Leuk Lymph. 1993;10:147-150.
2. Kurtzberg J. Asparaginase. In: Holland JF, Frei E III, Bast RC Jr, et al, eds. Cancer Medicine. 4th ed. Philadelphia, PA: Williams & Wilkens; 1997: 1027-1035.
3. Ortega JA, Nesbit ME Jr, Donaldson MH, et al. L-asparaginase, vincristine, and prednisone for induction of first remission in acute lymphocytic leukemia. Cancer Res. 1977;37:535-540.
4. Chessells JM, Cornbleet M. Combination chemotherapy for bone marrow relapse in childhood lymphoblastic leukaemia (ALL). Med Pediatr Oncol. 1979;6:359-365.
5. Ertel IJ, Nesbit ME, Hammond D, Weiner J, Sather H. Effective dose of L-asparaginase for induction of remission in previously treated children with acute lymphocytic leukemia: a report from Childrens Cancer Study Group. Cancer Res. 1979;39:3893-3896.
6. Sallan SE, Hitchcock-Bryan S, Gelber R, Cassady JR, Frei E III, Nathan DG. Influence of intensive asparaginase in the treatment of childhood non-T-cell acute lymphoblastic leukemia. Cancer Res. 1983;43:5601-6507.
7. Clavell LA, Gelber RD, Cohen HJ, et al. Four agent induction and intensive asparaginase therapy for the treatment of childhood acute lymphoblastic leukemia. N Engl J Med. 1986;315:657-663.
8. Nachman JB, Sather HN, Sensel MG, et al. Augmented post-induction therapy for children with high-risk acute lymphoblastic leukemia and a slow response to initial therapy. N Engl J Med. 1998;338:1663-1671.
9. Capizzi RL, Bertino JR, Skeel RT, et al. L-asparaginase: clinical, biochemical, pharmacological, and immunological studies. Ann Intern Med 1971; 74:893-901.
10. Gahrton G, Engstedt L, Franzen S, et al. Induction of remission with L-asparaginase, cyclophosphamide, cytosine arabinoside, and prednisolone in adult patients with acute leukemia. Cancer. 1974;34:472-479.
11. Hoelzer D, Thiel E, Loffler H, et al. Prognostic factors in a multicenter study for treatment of acute lymphoblastic leukemia in adults. Blood. 1988;71: 123-131.
12. Linker C, Damon L, Ries, Navarro W. Intensified and shortened cyclical chemotherapy for adult acute lymphoblastic leukemia. J Clin Oncol. 2002;20:2464-2471.
13. Larson RA, Dodge RK, Burns CP, et al. A five-drug remission induction regimen with intensive consolidation for adults with acute lymphoblastic leukemia: cancer and leukemia group B study 8811. Blood. 1995;85:2025-2037.
14. Rowe JM, Buck G, Burnett AK, et al, for ECOG and the MRC/NCRI Adult Leukemia Working Party. Induction therapy for adults with acute lymphoblastic leukemia: results of more than 1500 patients from the international ALL trial: MRC UKALL XII/ECOG E2993. Blood. 2005;106:3760-3767.
15. Haskell CM, Canellos GP. L-asparaginase resistance in human leukemia: asparagine synthetase. Bioch Pharm. 1969;18:2578-2580.
16. Cooney DA, Handschumacher RE. L-asparaginase and L-asparagine metabolism. Ann Rev Pharm. 1970;10:421-440.
17. Nandy P, Periclou AP, Avramis VI. The synergism of 6-mercaptopurine (6-MP) plus cytosine arabinoside (ara-C) followed by PEG-asparaginase (PEG-asparaginase) in human leukemia cell lines (CCRF/CEM/0 and CCRG/CEM/ara-C/7A) is due to increased cell apoptosis. Anticancer Res. 1998;18:727-738.
18. 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.
19. Silverman LB, Gelber GB, 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.
20. 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.
21. Pession A, Valsecchi MG, Masera G, et al. Longterm results of a randomized trial on extended use of high dose L-asparaginase for standard risk childhood acute lymphoblastic leukemia J Clin Oncol. 2005;28:7161-7167.
22. Ogawa C, Ohara A, Manabe A, et al. Treatment outcome of discontinued L-asparaginase in children with standard-risk acute lymphoblastic leukemia: Tokyo Children's Cancer Study Group (TCCSG) Study L99-15 [abstract]. Blood. 2005; 106:258a.
23. Graham ML. Pegasparaginase: a review of clinical studies. Adv Drug Del Rev. 2003;55:1293-1302.
24. Schorin MA, Blattner S, Gelber RD, et al. Treatment of childhood acute lymphoblastic leukemia: results of Dana-Farber Cancer Institute/Children's Hospital Acute Lymphoblastic Leukemia Consortium Protocol 85-01. J Clin Oncol. 1994;12:740-747.
25. Killander D, Dohlwitz A, Engstedt L, et al Hypersensitive reactions and antibody formation during L-asparaginase treatment of children and adults with acute leukemia. Cancer 1976;37:220-228.
26. Larson RA, Fretzin MH, Dodge RK, Schiffer CA. Hypersensitivity reactions to L-asparaginase do not impact on the remission duration of adults with acute lymphoblastic leukemia. Leukemia. 1998;12:660-665.
27. Oettgen HF, Stephenson PA, Schwartz MK, et al. Toxicity of E. coli asparaginase in man. Cancer. 1970;25:253-278.
28. Billett A, Carls A, Gelber RD, Sallan SE. Allergic reactions to Erwinia asparaginase in children with acute lymphoblastic leukemia who had previous allergic reactions to Escherichia coli asparaginase. Cancer. 1992;70:201-206.
29. Kurtzberg J, Asselin B, Poplack D, et al. Antibodies to asparaginase alter pharmacokinetics and decrease enzyme activity in patients on asparaginase therapy [abstract]. Proc Am Assoc Cancer Res. 1993;34:304. Abstract no. 1807.
30. Cheung NK, Chau IY, Coccia PF. Antibody response to Escherichia coli L-asparaginase: prognostic significance and clinical utility of antibody measurement. Amer J Ped Hematol Oncol 1986;8:99-104.
31. 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.
32. Asselin BL, Whitin JC, Coppola DJ, Rupp IP, Sallan SE, Cohen HJ. Comparative pharmacokinetic studies of three asparaginase preparations. J Clin Oncol. 1993;11:1780-1786.
33. Ohnuma T, Holland JF, Freeman A, Sinks LF. Biochemical and pharmacological studies with asparaginase in man. Cancer Res. 1970;30:2297-2305.
34. Panosyan, EH, Seibel, NL, Gaynon PS, et al. Asparaginase antibody and asparaginase activity in children with higher risk acute lymphoblastic leukemia: Children's Cancer Group Study CCG-1961. J Ped Hema Oncol. 2004;26:217-226.
35. 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.
36. Keating MJ, Holmes R, Lerner S, Ho DH. L-asparaginase and PEG asparaginase: past, present, and future. Leuk Lymph. 1993;10:153-157.
37. Ho DH, Brown NS, Yen A, et al. Clinical pharmacology of polyethylene glycol L-asparaginase. Drug Metab Dispos. 1986;14:349-352.
38. Holle LM. Pegaspargase: an alternative? Ann Pharmacother. 1997;31:616-624.
39. Ettinger LJ, Kurtzberg J, Voute PA, Jurgens H, Halpern SL. An open-label, multicenter study of polyethylene glycol-asparaginase for the treatment of acute lymphoblastic leukemia. Cancer. 1995;75:1176-1181.
40. Kurtzberg J, Friedman H, Asselin B, et al. The use of polyethylene glycol-conjugated L-asparaginase (PEG-ASP) in pediatric patients with prior hypersensitivity to native L-asparaginase [abstract]. Proc Am Soc Clin Oncol. 1990;9:219. Abstract no. 848.
41. Oncaspar (pegaspargase) [package insert]. Collegeville, PA: Rhone-Poulenc Rorer; 1994.
42. Kurtzberg J, Asselin B, Pollack B, Bernstein M, Buchanan G. Peg-asparaginase (PEGasp) vs native E. coli asparaginase for reinduction of relapsed acute lymphoblastic leukemia: POG no. 8866 phase II trial [abstract]. Proc Am Soc Clin Oncol. 1993;12:325. Abstract no. 1079.
43. Abshire T, Pollock B, Billett A, et al. Weekly polyethylene glycol conjugated asparaginase compared with biweekly doses produces superior induction remission rates in childhood relapsed acute lymphoblastic leukemia: a Pediatric Oncology Group study. Blood. 2000;96:1709-1715.
44. Hawkins DS, Park JR, Thomson BG, et al. Asparaginase pharmacokinetics following intensive polyethylene glycol conjugated L-asparaginase (PEG-asparaginase) therapy for children with relapsed acute lymphoblastic leukemia. Clin Cancer Res. 2004;10:5335-5341.
45. Wetzler M, Sanford BL, Owzar K, et al. Effective asparagine depletion with pegylated asparaginase results in improved outcomes in adult acute lymphoblastic leukemia (ALL)-CALGB 9511 [abstract]. Blood. 2005;106;519a. Abstract no. 1825.
46. Periclou AP, Avramis VI. NONMEM Population pharmacokinetic (PPK) studies of cytosine arabinoside (ara-C) after high does (HDara-C) and after loading bolus (LB) followed by continuous infusion (CI) of the drug in pediatric patients with leukemias. Cancer Chemother Pharmacol. 1996;39:42-50.
47. Pui C-H, Evans WE. Treatment of acute lymphoblastic leukemia. New Engl J Med. 2006;354:166-178.
48. Larson R. Acute lymphoblastic leukemia: older patients and newer drugs. ASH Educational Program Book. 2005:131-136.
49. Kantarjian HM, O'Brien S, Smith T, et al. Results of treatment with hyper-CVAD, a dose-intensive regimen, in adult acute lymphoblastic leukemia. J Clin Oncol. 2000;18:547-651.
50. Panosyan EH, Grigorian RS, Avramis IA, et al. Deamination of glutamine is a prerequisite for optimal asparagine deamination by asparaginases in vivo (CCG-1961). Anticancer Res. 2004;24:1121-1126.
51. Kurtzberg J, Asselin B, Poplack D, et al. PEG-L-asparaginase (PEG-ASP) pharmacology in pediatric patients with acute lymphoblastic leukemia (ALL) [abstract]. Proc Am Soc Clin Oncol. 1994;13:144. Abstract no. 370.
52. Gaynon PS, Harris RE, Stram DO J, et al. Asparagine (asn) depletion and treatment response in childhood acute lymphoblastic leukemia (ALL) after an early marrow relapse: a Children's Cancer Group trial (CCG-1941) [abstract]. Blood.1999;94:628a. Abstract no. 2789.
53. AvramisVI, Panosyan EH. Pharmacokinetic-pharmacodynamic relationships of asparaginase formulations: the past, the present and recommendations for the future. J Clin Pharmacokin. 2005;44:367-393.
54. Woo MH, Hak LJ, Storm MC, et al. Hypersensitivity or development of antibodies to asparaginase does not impact treatment outcome of childhood acute lymphoblastic leukemia. J Clin Oncol. 2000:18:1525-1532.
55. Nesbit M, Chard R, Evans A, Karon M, Hammond GD. Evaluation of intramuscular versus intravenous administration of L-asparaginase in childhood leukemia. American J Ped Hemat Oncol. 1979;1:9-13.
56. 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.
57. Reiter A, Schrappe M, Ludwig WD, et al. Chemotherapy in 998 unselected childhood acute lymphoblastic leukemia patients: results and conclusions of the multicenter trial ALL-BFM 86. Blood. 1994;84:3122-3133.
58. Hans-Joachim M, Lutz L, Alexander H, et al. Pegylated asparaginase (Oncaspar™) in children with ALL: drug monitoring in reinduction according to the ALL/NHL-BFM 95 protocols. Br J Hematol. 2000;110:370-384.
59. Aguayo A, Cortes J, Thomas D, Pierce S, Keating M, Kantarjian H. Combination therapy with methotrexate, vincristine, polyethylene-glycol conjugated-asparaginase, and prednisone in the treatment of patients with refractory or recurrent acute lymphoblastic leukemia. Cancer. 1999;86:1203-1209.