Dexrazoxane. A review of its use as a cardioprotective agent in patients receiving anthracycline-based chemotherapy

Drugs

Volumn 56, Issue 3, 1998, Pages 385-403

  Wiseman, Lynda R ^a   Spencer, Caroline M ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ANTHRACYCLINE; DOXORUBICIN; IRON; PIPERAZINE DERIVATIVE; RAZOXANE; REACTIVE OXYGEN METABOLITE;

ANEMIA; BIOPSY; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER SURVIVAL; CARDIOTOXICITY; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; COST EFFECTIVENESS ANALYSIS; DIARRHEA; DRUG BINDING; DRUG EFFICACY; FATIGUE; FEVER; HEART LEFT VENTRICLE EJECTION FRACTION; HEART PROTECTION; HUMAN; LEUKOPENIA; META ANALYSIS; NAUSEA; PHLEBITIS; REVIEW; STOMATITIS; THROMBOCYTOPENIA; VOMITING;

ANIMALS; ANTIBIOTICS, ANTINEOPLASTIC; ANTINEOPLASTIC AGENTS; CARDIOVASCULAR AGENTS; CHELATING AGENTS; HEART DISEASES; HUMANS; NEOPLASMS; RAZOXANE;

EID: 0031693006     PISSN: 00126667     EISSN: None     Source Type: Journal    
DOI: 10.2165/00003495-199856030-00009     Document Type: Review

References (75)

1. Von Hoff DD, Rozencweig M, Piccart M. The cardiotoxicity of anticancer agents. Semin Oncol 1982; 9: 23-33
2. Praga C, Beretta O, Vigo PL, et al. Adriamycin cardiotoxicity: a survey of 1273 patients. Cancer Treat Rep 1979; 63: 827-34
3. Von Hoff DD, Rozencweig M, Layard M, et al. Daunomycin-induced cardiotoxicity in children and adults: a review of 110 cases. Am J Med 1977; 62: 200-8
4. Dearth J, Osborn R, Wilson E, et al. Anthracycline-induced cardiomyopathy in children: a report of six cases. Med Pediatr Oncol 1984; 12: 54-8
5. Unverferth DV, Magorien RD, Leier CV, et al. Doxorubicin cardioloxicity. Cancer Treat Res 1983; 9: 149-64
6. Von Hoff DD, Layard MW, Basa P, et al. Risk factors for doxorubicin-induced congestive heart failure. Ann Intern Med 1979; 91:710-7
7. Swain SM, Whaley FS, Gerber MC, et al. Cardioprotection with dexrazoxane for doxoruhicin-containing therapy in advanced breast cancer. J Clin Oncol 1997 Apr; 15: 1318-32
8. Blum RH. Clinical status and optimal use of the cardioprtectant dexrazoxane. Oncology 1997; 11: 1669-78
9. Lipschultz SE, Colan SD, Gelber RD, et al. Late cardiac effects of doxoruhicin therapy for acute lymphoblastic leukemia in childhood. N Engl J Med 1991; 324: 808-15
10. Lipschultz SE. Dexrazoxane for protection against cardiotoxic effects of anthracyclines in children. J Clin Oncol 1996; 14: 326-31
11. Chiron BV, Cardioxane product monograph. Amsterdam, The Netherlands, 1995
12. Handa K, Sato S. Generation of free radicals of quinone group containing anti-cancer chemicals in NADPH-microsome system as evidenced by initiation of sulfite oxidation. Jpn J Cancer Res 1975; 66:43-75
13. Pigram WJ, Fuller W, Hamilton LDH. Stereochemistry of intercalation: interaction of daunomycin with DNA. Nature 1972; 235: 17-9
14. Myers CE, Gianni L, Zweier J, et al. The role of iron in adriamycin biochemistry. Fed Proc 1986; 1986: 2792-7
15. Myers CE, McGuire WP, Liss RH, et al. Adriamycin: the role of lipid peroxidation in cardiac toxicity and tumor response. Science 1977; 197: 165-7
16. Weijl NI, Cleton FJ, Osanto S. Free radicals and antioxidants in chemotherapy-induced toxicity. Cancer Treat Rev 1997 Jul; 23: 209-40
17. Hasinoff BB, Hellmann K, Herman EH, et al. Chemical, biological and clinical aspects of dexrazoxane and other bisdioxopiperazines. Curr Med Chem 1998; 5: 1-28
18. Doroshow JH, Locker GY, Baldinger J, et al. The effect of doxorubicin on hepatic and cardiac glutathione. Res Commun Chem Pathol Pharmacol 1979; 26: 285-95
19. Doroshow JH, Locker GY, Myers CE. Enzymatic defenses of the mouse heart against reactive oxygen metabolites: alterations produced by doxorubicin. J Clin Invest 1980; 65: 128-35
20. 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
21. Legha S, Wang Y-M, Mackay B, et al. Clinical and pharmacological investigation of the effects of α-tocopherol on adriamycin cardiotoxicity. Ann N Y Acad Sci 1982; 393: 411-8
22. Myers CE, Bonow R, Palmeri S, et al. A randomized controlled trial assessing the prevention of doxorubicin cardiomyopathy by N-acetylcysteine. Semin Oncol 1983; 10 Suppl. 1: 53-5
23. Hasinoff BB, Kala SV. The removal of metal ions from transferrin, ferritin and ceruloplasmin by the cardioprotective agent ICRF-187 [(+)-1,2-bis(3,5-dioxopiperazinyl-1-yl)propane] and its hydrolysis product ADR-925. Agents Actions 1993 May; 39: 72-81
24. Hasinoff BB. The interaction of the cardioprotective agent ICRF-187 ((+)-1,2-bis(3,5-dioxopiperazinyl-1-yl)propane): its hydrolysis product (ICRF-198); and other chelating agents with the Fe(III) and Cu(II) complexes of adriamycin. Agents Actions 1989 Mar; 26 (3-4): 378-85
25. Buss JL, Hasinoff BB. The one-ring open hydrolysis product intermediates of the cardioprotective agent ICRF-187 (dexrazoxane) displace iron from iron-anthracycline complexes. Agents Actions 1993 Sep; 40: 86-95
26. Hüsken BC, de Jong J, Beekman B, et al. Modulation of the in vitro cardiotoxicity of doxorubicin by flavonoids. Cancer Chemother Pharmacol 1995; 37: 55-62
27. Yeung TK, Jaenke RS, Wilding D, et al. The protective effect of ICRF-187 against doxorubicin-induced cardiotoxicity in the rat. Cancer Chemother Pharmacol 1992 May; 30: 58-64
28. Alderton PM, Gross J, Green MD. Comparative study of doxorubicin, mitoxantrone, and epirubicin in combination with ICRF-187 (ADR-529) in a chronic cardiotoxicity animal model. Cancer Res 1992 Jan 1; 52: 194-201
29. Herman EH, Zhang J, Ferrans VJ. Comparison of the protective effects of desferrioxamine and ICRF-187 against doxorubicin-induced toxicity in spontaneously hypertensive rats. Cancer Chemother Pharmacol 1994 Dec; 35: 93-100
30. Herman EH, Zhang J, Hasinoff BB, et al. Comparison of the protective effects against chronic doxorubicin cardiotoxicity and the rates of iron (III) displacement reactions of ICRF-187 and other bisdiketopiperazines. Cancer Chemother Pharmacol 1997 Sep; 40: 400-8
31. Imondi AR, Della Torre P, Mazué G, et al. Dose-response relationship of dexrazoxane for prevention of doxorubicin-induced cardiotoxicity in mice, rats, and dogs. Cancer Res 1996 Sep 15; 56: 4200-4
32. van-Acker SA, Kramer K, Voest EE, et al. Doxorubicin-induced cardiotoxicity monitored hy ECG in freely moving mice: a new model to test potential protectors. Cancer Chemother Pharmacol 1996; 38: 45-101
33. Villani F, Galimberti M, Monti E, et al. Effect of ICRF-187 pretreatment against doxorubicin-induced delayed cardiotoxicity in the rat. Toxicol Appl Pharmacol 1990 Feb; 102: 292-9
34. Agen C, Bernardini N, Danesi R, et al. Reducing doxorubicin cardiotoxicity in the rat using deferred treatment with ADR-529. Cancer Chemother Pharmacol 1992 Jun; 30: 95-9
35. Herman EH, Ferrans VJ, Pretreatment with ICRF-187 provides long-lasting protection against chronic daunorubicin cardioloxicity in rabbits. Cancer Chemother Pharmacol 1986; 16: 102-6
36. Pouna P, Bonoron-Adèle S, Gouverneur G, et al. Development of the model of rat isolated perfused heart for the evaluation of anthracycline cardiotoxicity and its circumvention. Br J Pharmacol 1996 Apr; 117: 1593-9
37. Herman EH, Ferrans VJ. Timing of treatment with ICRF-187 and its effect on chronic doxorubicin cardiotoxicity. Cancer Chemother Pharmacol 1993; 32:445-9
38. Holcenberg JS, Tutsch KD, Earhart 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: 703-9
39. 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
40. Earhart RH, Tutsch KD, Koeller JM, et al. Pharmacokinctics of (+)-1,2-Di(3.5-dioxopiperazin-1-yl)propane intravenous infusions in adult cancer patients. Cancer Res 1982; 42: 5255-61
41. 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 Nov 18; 84: 1725-30
42. Pharmacia and Upjohn Company. Zinecard (dexrazoxane for injection) prescribing information. Kalamazoo, MI, USA, 1996
43. Hasinotf BB. Enzymatic ring-opening reactions of the chiral cardioprotective agent (+) (S)-ICRF-187 and its (-) (R)-enantiomer ICRF-186 by dihydropyrimidine amidohydrolase. Drug Metab Dispos 1993 Sep-Oct; 21: 883-8
44. Hasinoff BB, Stereoselective hydrolysis of ICRF-187 (dexrazoxane) and ICRF-186 by dihydropyrimidine amidohydrolase. Chirality 1994; 6: 213-5
45. Hasinoff BB. Pharmacodynamics of the hydrolysis-activation of the cardioprotective agenl (+)-1,2-bis(3,5-dioxopiperazinyl-1-yl)propane. J Pharm Sci 1994 Jan; 83: 64-7
46. Robert J, Bellott R, Debled M, et al. Lack of interference of dexrazoxane on the pharmacokinetics of doxorubicin in cancer patients [abstract no. 960]. Proceedings of the American Society of Oncology 1998; 17: 250a
47. 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: 1659-66
48. Jakobsen P, Sorensen B, Bastholt L, et al. The pharmacokinetics of high-dose epirubicin and of the cardioprotector ADR-529 given together with cyclophosphamide, 5-fluorouracil, and lamoxifen in metastatic breast-cancer patients. Cancer Chemother Pharmacol 1994; 35: 45-52
49. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982; 5: 649-55
50. Miller AB, Hoogstraten B, Staquet M, et al. Reporting results of cancer treatment. Cancer 1981; 47: 207-14
51. Riga A, Francini G, Pein F, et al. Cardioprotection by Cardioxane® (dexrazoxane) in breast cancer patients at increased risk for anthracycline-induced cardioloxicity [abstract]. 84th Annual Meeting of the American Association of Cancer Reseaarch 1993 Mar: 34: 228
52. Neijens V, ten Hoeve R, Valdes Olmos R, et al. Feasibility study of the combination of high dose epirubicin and cyclophosphamide and G-CSF every two weeks together with ICRF 187 [abstract]. Ann Oncol 1994; 5 Suppl. 5: 182
53. Kussianenko I, Pivnjuk V, Tarutinov V, et al. The role of cardiotoxicity protector cardioxane combined with chemotherapy with doxorubicin in advanced breast cancer [abstract]. 2nd European Congress of the Senologic International Society 1994: 52
54. Maral J, Vinke J, Oskam R, et al. Cardioxane still induces effective cardioprotection in anthracycline pretreated breast cancer patients [abstract]. Eur J Cancer A 1996; 32A Suppl. 2:48
55. Orditura M, De Rimini ML, Ciaramella F, et al. Is ICRF-187 effective against doxorubicin induced cardiotoxicity? (abstract]. Med Microbiol Lett 1996 May; 5 Suppl. 1 : S107
56. Kolaric K, Bradamante V, Cervek J, et al. A phase II trial of cardioprotection with cardioxane (ICRF-187) in patients with advanced breast cancer receiving 5-fluorouracil, doxorubicin and cyclophosphamide. Oncology 1995 May-Jun; 52: 251-5
57. Lopez M, Vici P, Di Lauro L, et al. Randomized prospective clinical trial ol high-dose epirubicin and dexrazoxane in patients with advanced breast cancer and soft tissue sarcomas. J Clin Oncol 1998 Jan; 16:86-92
58. Speyer JL, Green MD, Kramer E, et al. Protective effect of the bispiperazinedione ICRF-187 against doxoruhicin-induced cardiac toxicity in women with advanced breast cancer. N Engl J Med 1988 Sep 22; 319: 745-52
59. 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: 1333-40
60. 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: 3112-20
61. 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: 117-27
62. Jelić S, Radulović S, Neskovic-Konstanlinovic 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 May; 3: 176-82
63. Steinherz LJ, Steinherz PG, Tan CTC, et al. Cardiac toxicity 4 to 20 years after completing anthracycline therapy. JAMA 1991; 266: 1672-7
64. Lemez P, Maresová J. Protective effects of cardioxane against anthracycline-induced cardioloxicity in relapsed acute myeloid lcukemias. Neoplasma 1996; 43 (6): 417-9
65. Schuler D, Horváth E, Koós R, et al. Safely of dexrazoxane in children with ALL undergoing anthracycline therapy: preliminary results of a prospective pilot study. Pediatr Hematol Oncol 1997 Jan-Feb; 14: 93-4
66. 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 May-Jun; 14: 213-22
67. 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: 362-72
68. Rubio ME, Wiegman A, Naeff MSJ, et al. ICRF-187 protection against doxorubicin induced cardiomyopathy in paediatric osteosarcoma patients [abstract]. Med Pediatr Oncol 1995 Oct: 25: 292
69. 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 Aug; 70: 185-8
70. 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 IIIB or IV metastatic breast cancer. Clin Ther 1997 Jan-Feb; 19: 167-84
71. Bates M, Tasch R, Williamson T, et al. Cost effectiveness of dexrazoxane cardioprotection in patients receiving FAC chemotherapy: a comparison between the US and Canada [abstruct]. 13th Annual International Meeting of the International Society of Technology Assessment in Health Care 1997 May 25: 137
72. Picci P, Ferrari S, Bacci G, et al. Treatment recommendations for osteosarcoma and adult soft tissue sarcomas. Drugs 1994; 47: 82-92
73. Dombernowski P, Gehl J, Boesgaard M, et al. Doxorubicin and paclitaxel, a highly active combination in the treatment of metastatic breast cancer. Semin Oncol 1996; 11 Suppl. 11: 23-7
74. Dombernowski P, Boesgard M, Andersen E, et al. Doxorubicin plus paclitaxel in advanced breast cancer. Semin Oncol 1997; 24 Suppl. 17: 15-8
75. Gianni L, Munzone E, Capri G, et al. Paclitaxel by 3-hour infusion in combination with bolus doxorubicin in women with untreated metastatic breast cancer: high antitumour efficacy and cardiac effects in a dose-finding and sequence-finding study. J Clin Oncol 1995; 1995: 2688-99