Dexrazoxane: A review of its use for cardioprotection during anthracycline chemotherapy

Drugs

Volumn 65, Issue 7, 2005, Pages 1005-1024

  Cvetković, Risto S ^a   Scott, Lesley J ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ANTHRACYCLINE DERIVATIVE; CYCLOPHOSPHAMIDE; DAUNORUBICIN; DIHYDROOROTASE; DIHYDROPYRIMIDINASE; DOXORUBICIN; EDETIC ACID DERIVATIVE; EPIRUBICIN; ETOPOSIDE; FLUOROURACIL; IDARUBICIN; PIRARUBICIN; PLACEBO; RAZOXANE; TROPONIN T; VINCRISTINE;

ACUTE LYMPHOBLASTIC LEUKEMIA; ADVANCED CANCER; ALOPECIA; ANEMIA; ANIMAL EXPERIMENT; ANIMAL MODEL; AREA UNDER THE CURVE; BRAIN METASTASIS; BREAST CANCER; CANCER; CANCER SURVIVAL; CARDIOTOXICITY; CHELATION; CHILDHOOD CANCER; CLINICAL TRIAL; COMPARTMENT MODEL; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DEATH; DIARRHEA; DOG; DOSE CALCULATION; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG COST; DRUG CROSS REACTIVITY; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG HYDROLYSIS; DRUG MECHANISM; DRUG MEGADOSE; DRUG METABOLISM; DRUG PROTEIN BINDING; DRUG TOLERABILITY; ECG ABNORMALITY; EXERCISE TOLERANCE; FATIGUE; FEVER; GRANULOCYTOPENIA; HAMSTER; HEART ARRHYTHMIA; HEART DILATATION; HEART LEFT VENTRICLE EJECTION FRACTION; HEART MUSCLE BIOPSY; HEART MUSCLE CONDUCTION DISTURBANCE; HEART PROTECTION; HUMAN; INJECTION PAIN; LEUKOPENIA; LUNG CONGESTION; LUNG SMALL CELL CANCER; META ANALYSIS; MINIPIG; MOUSE; NAUSEA; NONHUMAN; OXIDATIVE STRESS; PERICARDITIS; PHARMACODYNAMICS; PHASE 3 CLINICAL TRIAL; PHLEBITIS; PLEURA EFFUSION; PROPHYLAXIS; QT PROLONGATION; RABBIT; RANDOMIZED CONTROLLED TRIAL; RAT; REVIEW; SINGLE BLIND PROCEDURE; SOFT TISSUE SARCOMA; STOMATITIS; SYSTEMATIC REVIEW; TACHYCARDIA; TACHYPNEA; THROMBOCYTOPENIA; VOMITING;

ANTHRACYCLINES; ANTINEOPLASTIC AGENTS; CARDIOVASCULAR AGENTS; CARDIOVASCULAR DISEASES; HUMANS; NEOPLASMS; RANDOMIZED CONTROLLED TRIALS; RAZOXANE;

ANIMALIA;

EID: 18744377282     PISSN: 00126667     EISSN: None     Source Type: Journal    
DOI: 10.2165/00003495-200565070-00008     Document Type: Review

References (85)

1. Links M, Lewis C. Chemoprotectants: a review of their clinical pharmacology and therapeutic efficacy. Drugs 1999 Mar; 57 (3): 293-308
2. Pai VB, Nahata MC. Cardiotoxicity of chemotherapeutic agents: incidence, treatment and prevention. Drug Saf 2000 Apr; 22 (4): 263-302
3. Picci P, Ferrari S, Bacci G, et al. Treatment recommendations for osteosarcoma and adult soft tissue sarcomas. Drugs 1994; 47 (1): 82-92
4. Wiseman LR, Spencer CM. Dexrazoxane: a review of its use as a cardioprotective agent in patients receiving anthracycline-based chemotherapy. Drugs 1998 Sep; 56 (3): 385-403
5. Swain SM, Whaley FS, Ewer MS. Congestive heart failure in patients treated with doxorubicin: a retrospective analysis of three trials. Cancer 2003 Jun 1; 97 (11): 2869-79
6. Speyer J, Wasserheit C. Strategies for reduction of anthracycline cardiac toxicity. Semin Oncol 1998 Oct; 25 (5): 525-37
7. Blum RH. Clinical status and optimal use of the cardioprotectant dexrazoxane. Oncology 1997 Nov; 11 (11): 1669-78
8. Hoekman K, van der Vijgh WJF, Vermorken JB. Clinical and preclinical modulation of chemotherapy-induced toxicity in patients with cancer. Drugs 1999 Feb; 57 (2): 133-55
9. Ryberg M, Nielsen D, Skovsgaard T, et al. Epirubicin cardiotoxicity: an analysis of 469 patients with metastatic breast cancer. J Clin Oncol 1998 Nov; 16(11): 3502-8
10. Lipschultz SE, Colan SD, Gelber RD, et al. Late cardiac effects of doxorubicin therapy for acute lymphoblastic leukemia in childhood. N Engl J Med 1991 Mar 21; 324 (12): 808-15
11. Lipschultz SE. Dexrazoxane for protection against cardiotoxic effects of anthracyclines in children. J Clin Oncol 1996; 14: 326-31
12. Steinherz LJ, Steinherz PG, Tan CTC, et al. Cardiac toxicity 4 to 20 years after completing anthracycline therapy. JAMA 1991 Sep 25; 266 (12): 1672-7
13. Sugioka KA, Nakano M. Mechanisms of phospholipid peroxidation induced by ferric iron-ADP adriamycin co-ordination complex. Biochem Biophys Res Commun 1982; 713: 333-43
14. Hasinoff BB, Schnabl KL, Vlarusak RA, et al. Dexrazoxane (ICRF-187) protects cardiac myocytes against doxorubicin by preventing damage to mitochondria. Cardiovasc Toxicol 2003; 3 (2): 89-99
15. Seifert CF, Nesser ME, Thompson DF. Dexrazoxane in the prevention of doxorubicin-induced cardiotoxicity. Ann Pharmacother 1994 Sep; 28: 1063-72
16. Myers C. The role of iron in doxorubicin-induced cardiomyopathy. Semin Oncol 1998 Aug; 25 (4 Suppl. 10): 10-4
17. Lewis C. A review of the use of chemoprotectants in cancer chemotherapy. Drug Saf 1994 Sep; 11 (3): 153-62
18. Hasinoff BB, Hellmann K, Herman EH, et al. Chemical, biological and clinical aspects of dexrazoxane and other bisdioxopiperazines. Curr Med Chem 1998; 5 (1): 1-28
19. Hasinoff BB, Schroeder PE Patel D. The metabolites of the cardioprotective drug dexrizoxane do not protect myocytes from doxorubicin-induced cytotoxicity. Mol Pharmacol 2003 Sep; 64 (3): 670-8
20. Vogel CL, Gorowski E, Davila E, et al. Phase I clinical trial and pharmacokinetics of weekly ICRF-187 (NSC 169780) infusion in patients with solid tumors. Invest New Drugs 1987; 5: 187-98
21. Zinecard® (dexrazoxane for injection) US prescribing information. Kalamazoo (MI): Pharmacia and Upjohn Company, 2003
22. Earhart RH, Tutsch KD, Koeller JM, et al. Pharmacokinetics of (+)-1,2-Di(3,5-dioxopiperaxin-1-yl)propane intravenous infusions in adult cancer patients. Cancer Res 1982 Dec; 42: 5255-61
23. Rosing H, Ten Bokkel Huinink WW, Van Gijn R, et al. Comparative open, randomized, cross-over bioequivalence study of two intravenous dexrazoxane formulations (Cardioxane® and ICRF-187) in patients with advanced breast cancer, treated with 5-fluoruracil-doxorubicin-cyclophosphamide (FDC). Eur J Drug Metab Pharmacokinet Jan-Mar 1999; 24 (1): 69-77
24. Holcenberg JS, Tutsch KD, Sarhart RH, et al. Phase I study of ICRF-187 in pediatric cancer patients and comparison of its pharmacokinetics in children and adults. Cancer Treat Rep 1986 Jun; 70 (6): 703-9
25. Schroeder PE, Davidson JN, Hasinoff BB. Dihydroorotase catalyzes the ring opening of the hydrolysis intermediates of the cardioprotective drug dexrizoxane (ICRF-187). Drug Metab Dispos 2002 Dec; 30 (12): 1431-5
26. Hochster H, Liebes L, Wadler S, et al. Pharmacokinetics of the cardioprotector ADR-529 (ICRF-187) in escalating doses combined with fixed-dose doxorubicin. J Natl Cancer Inst 1992; 84: 1725-30
27. Basser RL, Sobol MM, Duggan G, et al. Comparative study of the pharmacokinetics and toxicity of high-dose epirubicin with or without dexrazoxane in patients with advanced malignancy. J Clin Oncol 1994 Aug; 12 (8): 1659-66
28. Jakobsen P, Sorensen B, Bastholt L, et al. The pharmacokinetics of high-dose epirubicin an 1 of the cardioprotector ADR-529 given together with cyclophosphamide, 5-fluorouracil, and tamoxifen in metastatic breast-cancer patients. Cancer Chemother Pharmacol 1994; 35: 45-52
29. Schroeder PE, Jensen PB, Sehested M, et al. Metabolism of dexrazoxane (ICRF-187) used as a rescue agent in cancer patients treated with high-dose etoposide. Cancer Chemother Pharmacol 2003 Aug; 52 (2): 167-74
30. Schroeder PE, Hofland KF, Jensen PB, et al. Pharmacokinetics of etoposide in cancer patients treated with high-dose etoposide and with dexrazoxane (ICRF-187) as a rescue agent. Cancer Chemother Pharmacol 2004 Jan; 53 (1): 91-3
31. Swain SM, Whaley FS, Gerber MC, et al. Cardioprotection with dexrazoxane for doxorubicin-containing therapy in advanced breast cancer. J Clin Oncol 1997 Apr; 15 (4): 1318-32
32. Marty M, Espie M, Llombart A, et al. A phase III study to investigate the cardioprotective potential of dexrazoxane (Cardioxane®) in advanced/metastatic breast cancer patients undergoing anthracycline-based chemotherapy [abstract and poster no. 5052]. 27th Breast Cancer Symposium; 2004 Dec 8-11; San Antonio
33. Speyer JL, Green MD, Zeleniuch-Jacquotte A, et al. ICRF-187 permits longer treatment with doxorubicin in women with breast cancer. J Clin Oncol 1992 Jan; 10 (1): 117-27
34. Venturini M, Michelotti A, Del Mastro L, et al. Multicenter randomized controlled clinical trial to evaluate cardioprotection of dexrazoxane versus no cardioprotection in women receiving epirubicin chemotherapy for advanced breast cancer. J Clin Oncol 1996 Dec; 14 (12): 3112-20
35. Vici P, Ferraironi A, Di Lauro L, et al. Dexrazoxane cardioprotection in advanced breast cancer patients undergoing high-dose epirubicin treatment. Clin Ter Jan-Feb 1998; 149: 15-20
36. Feldmann JE, Jones SE, Weisberg SR, et al. Advanced small cell lung cancer treated with CAV (cyclophosphamide + Adriamycin® + vincristine) chemotherapy and the cardioprotective agent dexrazoxane (ADR-529, ICRF-187, Zinecard®) [abstract no. 993]. Proc Am Soc Clin Oncol 1992 Mar; 11: 296
37. Lopez M, Vici P, Di Lauro L, et al. Randomized prospective clinical trial of high-dose epirubicin and dexrazoxane in patients with advanced breast cancer and soft tissue sarcomas. J Clin Oncol 1998 Jan; 16 (1): 86-92
38. Wexler LH, Andrich MP, Venzon D, et al. Randomized trial of the cardioprotective agent ICRF-187 in pediatric sarcoma patients treated with doxorubicin. J Clin Oncol 1996 Feb; 14 (2): 362-72
39. Lipshultz SE, Rifai N, Daltaon VM, et al. The effect of dexrazoxane on myocardial injury in doxorubicin-treated children with acute lymphoblastic leukemia. N Engl J Med 2004 Jul 8; 351 (2): 145-53
40. Jelić S, Radulović S, Nešković- Konstantinović Z, et al. Cardioprotection with ICRF-187 (Cardioxane) in patients with advanced breast cancer having cardiac risk factors for doxorubicin cardiotoxicity, treated with the FDC regimen. Support Care Cancer 1995; 3 (3): 176-82
41. Chiron Corporation. Dexrazoxane: CS-CX-002 clinical study report. 2004 Jun 16. (Data on file)
42. Chiron Corporation Ltd. Dexrazoxane: 2.7.6 synopses of individual studies. 2003 May. (Data on file)
43. Chiron Corporation Ltd. Dexrazoxane: 2.7.6 synopses of individual studies. 2004 Jun 1. (Data on file)
44. Swain SM, Whaley FS, Gerber MC, et al. Delayed administration of dexrazoxane provides cardioprotection for patients with advanced breast cancer treated with doxorubicin-containing therapy. J Clin Oncol 1997 Apr; 15 (4): 1333-40
45. The Criteria Committee of the New York Heart Association. Functional capacity and objective assessment. In: Dolgin M, editor. Nomenclature and criteria for diagnosis of diseases of the heart and great vessels. 9th ed. Boston (MA): Little, Brown and Company, 1994: 253-5
46. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982 Dec; 5: 649-55
47. Miller AB, Hoogstraten B, Staquet M, et al. Reporting results of cancer treatment. Cancer 1981 Jan 1; 47 (1): 207-14
48. Lemež P, Marešová J. Protective effects of cardioxane against anthracycline-induced cardiotoxicity in relapsed acute myeloid leukemias. Neoplasma 1996; 43 (6): 417-9
49. Leměz P, Marešová J. Efficacy of dexrazoxane as a cardioprotective agent in patients receiving mitoxantrone- and daunorubicin-based chemotherapy. Semin Oncol 1998 Aug; 25 (4 Suppl. 10): 61-5
50. Woodlock TJ, Lifton R, Disalle M. Coincident acute myelogenous leukemia and ischemic heart disease: use of the cardioprotectant dexrazoxane during induction chemotherapy. Am J Hematol 1998 Nov; 59: 246-8
51. Orditura M, De Rimini ML, Ciaramella F, et al. Is ICRF-187 effective against doxorubicin induced cardiotoxicity? Med Microbiol Lett 1996 May; 5 Suppl. 1: 107
52. Mladosievicová B, Foltinová A, Petráš ová̂ H, et al. Signal-averaged electrocardiography in survivors of Hodgkin's disease treated with and without dexrazoxane. Neoplasma 2001; 48 (1): 61-5
53. Schiavetti A, Castello MA, Versacci P, et al. Use of ICRF-187 for prevention of anthracycline cardiotoxicity in children: preliminary results. Pediatr Hematol Oncol 1997; 14: 213-22
54. Bu'Lock FA, Gabriel HM, Oakhill A, et al. Cardioprotection by ICRF187 against high dose anthracycline toxicity in children with malignant disease. Br Heart J 1993; 70: 185-8
55. Silverman LB, Levy DE, Dalton VK, et al. Outcome of Dana-Farber Cancer Institute (DFCI) Consortium Protocol 95-01 for children with newly diagnosed acute lymphoblastic leukemia (ALL) [abstract no. 679]. Blood 2004 Nov 16; 104 (11 Pt 1): 195
56. van Dalen E, Caron H, Dickinson H, et al. Cardioprotective interventions for cancer patients receiving anthracyclines. Cochrane Database Syst Rev 2005 Jan 24; (1): CD003917
57. Seymour L, Bramwell V, Moran LA. Use of dexrazoxane as a cardioprotectant in patients receiving doxorubicin or epirubicin chemotherapy for the treatment of cancer: the Provincial Systemic Treatment Disease Site Group. Cancer Prev Control 1999 Apr; 3 (2): 145-59
58. Bates M, Lieu D, Zagari M, et al. A pharmacoeconomic evaluation of the use of dexrazoxane in preventing anthracycline-induced cardiotoxicity in patients with stage HIB or IV metastatic breast cancer. Clin Ther 1997; 19 (1): 167-84
59. Tonkin K, Bates M, Lieu D, et al. Dexrazoxane cardioprotection for patients receiving FAC chemotherapy: a pharmacoeconomic evaluation. Can J Oncol 1996 Nov; 6 (2): 458-73
60. Bristow MR, Lopez MB, Mason JW, et al. Cancer 1982; 50: 32-41
61. Baker MS, Kessler LG, Urban N, et al. Estimating the treatment costs of breast and lung cancer. Med Care 1991; 29: 40-9
62. Grover TS, Martin C, Gao S, et al. A cost-effectiveness analysis of the use of bolus, continuous and dexrazoxane-associated infusion of doxorubicin in breast cancer in the reduction of cardiomyopathy related morbidity and mortality [abstract no. 962]. Proc Am Soc Clin Oncol 2001 May 12; 20 (Pt 1): 241
63. Schuchter LM, Hensley ML, Meropol NJ, et al. 2002 update of recommendations for the use of chemotherapy and radiotherapy protectants: clinical practice guidelines of the American Society of Clinical Oncology. J Clin Oncol 2002 Jun 15; 20 (12): 2895-903
64. Chiron France. Cardioxane®: summary of product characteristics. Sureness: Chiron France, 2000 Oct 9
65. Chiron B.V. Cardioxane® Ireland: summary of product characteristics. Amsterdam: Chiron B.V., 2003 Jun
66. Chiron B.V. Summary of product characteristics for Cardioxane®, powder for solution for infusion. Amsterdam: Chiron B.V., 2004 Jan 9
67. Chiron B.V. Cardioxane® (dexrazoxane) summary of product characteristics/data sheet. Vienna: Chiron B.V., 2000 Jan
68. Chiron Italia Srl. Cardioxane® (dexrazoxane, 500mg): summary of product characteristics. Milan: Chiron Italia Srl, 2001 Feb
69. Pouillait P. Evaluating the role of dexrazoxane as a cardioprotectant in cancer patients receiving anthracyclines. Cancer Treat Rev 2004 Nov; 30 (7): 643-50
70. Simpson C, Herr H, Courville KA. Concurrent therapies that protect against doxorubicin-induced cardiomyopathy. Clin J Oncol Nurs 2004 Oct; 8 (5): 497-501
71. Schmid P, Possinger K. Liposomal anthracyclines for improved cardiac tolerability. Breast 2001; 10 Suppl. 2: 22-7
72. Dando TM, Keating GM. Liposomal doxorubicin: a review of its use in metastatic breast cancer. Am J Cancer. In Press
73. Dorr RT. Cytoprotective agents for anthracyclines. Semin Oncol 1996 Aug; 23 (4 Suppl. 8): 23-34
74. Myers CE, Bonow R, Palmeri S, et al. A randomised controlled trial assessing the prevention of doxorubicin cardiomyopathy by N-acetylcysteine. Semin Oncol 1983 Mar; 10 (1 Suppl. 1): 53-5
75. Legha S, Wang YM, Mackay B, et al. Clinical and pharmacological investigation of the effects of alpha-tocopherol on adriamycin cardiotoxicity. Ann N Y Acad Sci 1982; 393: 411-8
76. Von Hoff DD. Phase I trials of dexrazoxane and other potential applications for the agent. Semin Oncol 1998 Aug; 25 (4 Suppl. 10): 31-6
77. Elihu N, Anandasbapathy S, Frishman WH. Chelation therapy in cardiovascular disease: ethylenediaminetetraacetic acid, deferoxamine, and dexrazoxane. J Clin Pharmacol 1998 Feb; 38: 101-5
78. Langer SW, Sehested M, Jensen PB. Treatment of anthracycline extravasation with dexrazoxane. Clin Cancer Res 2000 Sep; 6: 3680-6
79. Langer SW, Sehested M, Jensen PB. Dexrazoxane is a potent and specific inhibitor of anthracycline induced subcutaneous lesions in mice. Ann Oncol 2001; 12: 405-10
80. Langer SW, Sehested M, Jensen PB, et al. Dexrazoxane in anthracycline extravasation [letter]. J Clin Oncol 2000 Aug; 18 (16): 3064
81. Bos AM, van der Graaf WT, Willemse PH. A new conservative approach to extravasation of anthracyclines with dimethyl-sulfoxide and dexrazoxane. Acta Oncol 2001; 40 (4): 541-2
82. Jensen JN, Lock-Andersen J, Langer SW, et al. Dexrazoxane: a promising antidote in the treatment of accidental extravasation of anthracyclines. Scand J Plast Reconstr Surg Hand Surg 2003; 37 (3): 174-5
83. El-Saghir N, Otrock Z, Mufarrij A, et al. Dexrazoxane for anthracycline extravasation and GM-CSF for skin ulceration and wound healing. Lancet Oncol 2004 May; 5 (5): 320-1
84. Holm B, Jensen PB, Sehested M. ICRF-187 rescue in etoposide treatment in vivo: a model targeting high-dose topoisomerase II poisons to CNS tumors. Cancer Chemother Pharmacol 1996 Jul; 38: 203-9
85. Holm B, Sehested M, Jensen PB, et al. Improved targeting of brain tumors using dexrazoxane rescue of topoisomerase II combined with supralethal doses of etoposide and teniposide. Clin Cancer Res 1998 Jun; 4: 1367-73