Glucarpidase following high-dose methotrexate: Update on development

Expert Opinion on Biological Therapy

Volumn 10, Issue 1, 2010, Pages 105-111

  Patterson, Daniel M ^a   Lee, Siow Ming ^a  

^a UNIVERSITY COLLEGE HOSPITAL   (United Kingdom)

Author keywords

Carboxypeptidase; Folinic acid; Glucarpidase; Methotrexate; Renal failure; Voraxaze

Indexed keywords

CARBOXYPEPTIDASE G2; FOLINIC ACID; GLUCARPIDASE; METHOTREXATE; PLACEBO; UNCLASSIFIED DRUG;

ABSENCE OF SIDE EFFECTS; ANAPHYLAXIS; AREA UNDER THE CURVE; BONE MARROW SUPPRESSION; CENTRAL NERVOUS SYSTEM TUMOR; CLINICAL TRIAL; CONTINUOUS INFUSION; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ELIMINATION; DRUG FATALITY; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG MARKETING; DRUG MECHANISM; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG TOXICITY; HUMAN; INFECTION; LOADING DRUG DOSE; LYMPHOMA; MUCOSA INFLAMMATION; NEPHROTOXICITY; NEUTROPENIA; NONHUMAN; OSTEOSARCOMA; PARESTHESIA; REVIEW; STOMATITIS; UNSPECIFIED SIDE EFFECT;

ANIMALS; ANTIMETABOLITES, ANTINEOPLASTIC; GAMMA-GLUTAMYL HYDROLASE; HUMANS; KIDNEY FAILURE; KIDNEY NEOPLASMS; METHOTREXATE;

EID: 72449203127     PISSN: 14712598     EISSN: None     Source Type: Journal    
DOI: 10.1517/14712590903468677     Document Type: Review

References (47)

1. Demirdjian S, Laghouati S, Vassal G. Glucarpidase: a method of rescue from high dose methotrexate. Eur J Oncol Pharm 2008;2(1):20-21
2. Jolivet J, Cowan KH, Curt GA, et al. The pharmacology and clinical use of methotrexate. N Engl J Med 1983;309(18):1094-1104
3. Frei E III, Blum RH, Pitman SW, et al. High dose methotrexate with leucovorin rescue. Rationale and spectrum of antitumor activity. Am J Med 1980;68(3):370-376
4. Stoller RG, Hande KR, Jacobs SA, et al. Use of plasma pharmacokinetics to predict and prevent methotrexate toxicity. N Engl J Med 1977;297(12):630-634
5. Bleyer WA. Methotrexate: clinical pharmacology, current status and therapeutic guidelines. Cancer Treat Rev 1977;4(2):87-101
6. Widemann BC, Balis FM, Murphy RF, et al. Carboxypeptidase-G2, thymidine, and leucovorin rescue in cancer patients with methotrexate-induced renal dysfunction. J Clin Oncol 1997;15(5):2125-2134
7. Widemann BC, Adamson PC. Understanding and managing methotrexate nephrotoxicity. Oncologist 2006;11(6):694-703
8. Ackland SP, Schilsky RL. High-dose methotrexate: a critical reappraisal. J Clin Oncol 1987;5(12):2017-2031
9. Jacobs SA, Stoller RG, Chabner BA, Johns DG. 7-Hydroxymethotrexate as a urinary metabolite in human subjects and rhesus monkeys receiving high dose methotrexate. J Clin Invest 1976;57(2):534-538
10. Lankelma J, Van Der Klein E, Ramaekers F. The role of 7-hydroxymethotrexate during methotrexate anti-cancer therapy. Cancer Lett 1980;9(2):133-142
11. Widemann BC, Balis FM, Kempf-Bielack B, et al. High-dose methotrexate-induced nephrotoxicity in patients with osteosarcoma. Cancer 2004;100(10):2222-2232
12. Green MR, Chamberlain MC. Renal dysfunction during and after high-dose methotrexate. Cancer Chemother Pharmacol 2009;63(4):599-604
13. Wall SM, Johansen MJ, Molony DA, et al. Effective clearance of methotrexate using high-flex hemodialysis membranes. Am J Kidney Dis 1996;28(6):846-854
14. Flombaum CD, Meyers PA. High-dose leucovorin as sole therapy for methotrexate toxicity. J Clin Oncol 1999;17(5):1589-1594
15. Skarby TV, Anderson H, Heldrup J, et al. High leucovorin doses during high-dose methotrexate treatment may reduce the cure rate in childhood acute lymphoblastic leukaemia. Leukemia 2006;20(11):1955-1962
16. Cohen IJ. Progression of osteosarcoma after high-dose methotrexate: over-rescue by folinic acid. Pediatr Hematol Oncol 2003;20(8):579-581
17. Goldman P, Levy CC. The enzymatic hydrolysis of folate analogues. Biochem Pharmacol 1968;17(11):2265-2270
18. Levy CC, Goldman P. The enzymatic hydrolysis of methotrexate and folic acid. J Biol Chem 1967;242(12):2933-2938
19. Widemann BC, Sung E, Anderson L, et al. Pharmacokinetics and metabolism of the methotrexate metabolite 2, 4-diamino-N10-methylpteroic acid. J Pharmacol Exp Ther 2000;294(3):894-901
20. Chabner BA, Johns DG, Bertino JR. Enzymatic cleavage of methotrexate provides a method for prevention of drug toxicity. Nature 1972;239(5372):395-397
21. Abelson HT, Ensminger W, Rosowsky A, Uren J. Comparative effects of citrovorum factor and carboxypeptidase G1 on cerebrospinal fluid-methotrexate pharmacokinetics. Cancer Treat Rep 1978;62(10):1549-1552
22. Abelson HT, Kufe DW, Skarin AT, et al. Treatment of central nervous system tumors with methotrexate. Cancer Treat Rep 1981;65:(Suppl 1):137-140
23. Adamson PC, Balis FM, McCully CL, et al. Methotrexate pharmacokinetics following administration of recombinant carboxypeptidase-G2 in rhesus monkeys. J Clin Oncol 1992;10(8):1359-1364
24. Minton NP, Atkinson T, Sherwood RF. Molecular cloning of the Pseudomonas carboxypeptidase G2 gene and its expression in Escherichia coli and Pseudomonas putida. J Bacteriol 1983;156(3):1222-1227
25. Sherwood RF, Melton RG, Alwan SM, Hughes P. Purification and properties of carboxypeptidase G2 from Pseudomonas sp. strain RS-16. Use of a novel triazine dye affinity method. Eur J Biochem 1985;148(3):447-453
26. Hempel G, Lingg R, Boos J. Interactions of carboxypeptidase G2 with 6S-leucovorin and 6R-leucovorin in vitro: implications for the application in case of methotrexate intoxications. Cancer Chemother Pharmacol 2005;55(4):347-353
27. DeAngelis LM, Tong WP, Lin S, et al. Carboxypeptidase G2 rescue after high-dose methotrexate. J Clin Oncol 1996;14(7):2145-2149
28. Adamson PC, Balis FM, McCully CL, et al. Rescue of experimental intrathecal methotrexate overdose with carboxypeptidase-G2. J Clin Oncol 1991;9(4):670-674
29. Headley D, Ogilvie L, Springer CJ. Carboxypeptidase G2-based gene-directed enzyme-prodrug therapy: a new weapon in the GDEPT armoury. Nat Rev Cancer 2007;7:870-879
30. Marais R, Spooner RA, Light Y, et al. Gene-directed enzyme prodrug therapy with a mustard prodrug/carboxypeptidase G2 combination. Cancer Res 1996;56:4735-4742
31. Phillips M, Smith W, Balan G, Ward S. Pharmacokinetics of glucarpidase in subjects with normal and impaired renal function. J Clin Pharmacol 2008;48(3):279-284
32. Grill J, Amigo-Ferreiro ME, Schoepfer C, et al. Carboxypeptidase-G2 rescue of methotrexate intoxication. Bull Cancer 1998;85(12):1066. Erratum in: Bull Cancer 1999 86(2):232
33. Hum M, Kamen BA. Successful carboxypeptidase G2 rescue in delayed MTX-elimination due to renal failure. Pediatr Hematol Oncol 1995;12(6):521-524
34. Krause AS, Weihrauch MR, Bode U, et al. Carboxypeptidase-G2 rescue in cancer patients with delayed methotrexate elimination after high-dose methotrexate therapy. Leuk Lymphoma 2002;43(11):2139-2143
35. Mantadakis E, Rogers ZR, Smith AK, et al. Delayed methotrexate clearance in a patient with sickle cell anemia andosteosarcoma. J Pediatr Hematol Oncol 1999;21(2):165-169
36. Mohty M, Peyriere H, Guinet C, et al. Carboxypeptidase G2 rescue in delayed methotrexate elimination in renal failure. Leuk Lymphoma 2000;37(3-4):441-443
37. Nowicki TS, Bjornard K, Kudlowitz D, et al. Early recognition of renal toxicity of high-dose methotrexate therapy: a case report. J Pediatr Hematol Oncol 2008;30(12):950-952
38. Peyriere H, Cociglio M, Margueritte G, et al. Optimal management of methotrexate intoxication in a child with osteosarcoma. Ann Pharmacother 2004;38(3):422-427
39. Sieniawski M, Rimpler M, Herrmann R, Josting A. Successful carboxypeptidase G2 rescue of a high-risk elderly Hodgkin lymphoma patient with methotrexate intoxication and renal failure. Leuk Lymphoma 2007;48(8):1641-1643
40. Snyder RL. Resumption of high-dose methotrexate after methotrexate-induced nephrotoxicity and carboxypeptidase G2 use. Am J Health Syst Pharm 2007;64(11):1163-1169
41. Widemann BC, Hetherington ML, Murphy RF, et al. Carboxypeptidase-G2 rescue in a patient with high dose methotrexate-induced nephrotoxicity. Cancer 1995;76(3):521-526
42. Zoubek A, Zaunschirm HA, Lion T, et al. Successful carboxypeptidase G2 rescue in delayed methotrexate elimination due to renal failure. Pediatr Hematol Oncol 1995;12(5):471-477
43. Buchen S, Ngampolo D, Melton RG, et al. Carboxypeptidase G2 rescue in patients with methotrexate intoxication and renal failure. Br J Cancer 2005;92(3):480-487
44. Schwartz S, Borner K, Muller K, et al. Glucarpidase (carboxypeptidase G2) intervention in adult and elderly cancer patients with renal dysfunction and delayed methotrexate elimination after high-dose methotrexate therapy. Oncologist 2007;12(11):1299-1308
45. Widemann BC, Balis FM, Shalabi A, et al. Treatment of accidental intrathecal methotrexate overdose with intrathecal carboxypeptidase G2. J Natl Cancer Inst 2004;96(20):1557-1559
46. Withdrawal assessment report for Voraxaze. International nonproprietary name: glucarpidase. EMEA/H/C/681, London, UK: EMEA, 2008. Available from: http://www.emea.europa.eu/humandocs/PDFs/EPAR/voraxaze/H-681-WAR-en.pdf [Last accessed 10 November 2009]
47. Voraxaze BTG, London UK. Available from: http://www.btgplc.com/ BTGPipeline/273/Voraxaze.html [Last accessed 10 November 2009]