The current and future role of dexrazoxane as a cardioprotectant in anthracycline treatment: Expert panel review

Journal of Cancer Research and Clinical Oncology

Volumn 130, Issue 1, 2004, Pages 1-7

  Swain, S M ^a   Vici, P ^b  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

^b REGINA ELENA NATIONAL CANCER INSTITUTE   (Italy)

Author keywords

Anthracycline; Cancer; Cardiotoxicity; Dexrazoxane; Doxorubicin

Indexed keywords

ANTHRACYCLINE DERIVATIVE; CYCLOPHOSPHAMIDE; DOXORUBICIN; EPIRUBICIN; FLUOROURACIL; LIPOSOME; PACLITAXEL; RAZOXANE; TAXANE DERIVATIVE; TRASTUZUMAB;

ACUTE LYMPHOBLASTIC LEUKEMIA; BONE MARROW SUPPRESSION; BREAST CANCER; CANCER CHEMOTHERAPY; CARDIOMEGALY; CARDIOTOXICITY; CARDIOVASCULAR RISK; CHILDHOOD CANCER; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; DOSE RESPONSE; DRUG DOSE REGIMEN; DRUG HALF LIFE; DRUG MECHANISM; DRUG MEGADOSE; DYSPNEA; EWING SARCOMA; EXPERT SYSTEM; GOOD CLINICAL PRACTICE; HEART LEFT VENTRICLE EJECTION FRACTION; HEART PROTECTION; HIGH RISK PATIENT; HODGKIN DISEASE; HUMAN; LUNG SMALL CELL CANCER; META ANALYSIS; NEUTROPENIA; ORTHOPNEA; OSTEOSARCOMA; PAROXYSMAL DYSPNEA; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; SOFT TISSUE SARCOMA; THROMBOCYTOPENIA; TREATMENT OUTCOME;

ANTHRACYCLINES; ANTIBIOTICS, ANTINEOPLASTIC; CARDIOTONIC AGENTS; HEART; HUMANS; RAZOXANE;

EID: 0742269397     PISSN: 01715216     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00432-003-0498-7     Document Type: Review

References (45)

1. Agence Française de Sécurité des Produits de Santé. Besoins en Médicaments Pédiatriques (March 2002) Working report
2. Bates M, Lieu D, Zagari M, Spiers A, Williamson T (1997) 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 19:167-184
3. Brennan MF, Alektiar KM, Maki RG (2001) Sarcomas of the soft tissue and bone. Section 1: Soft tissue sarcoma. In: DeVita VT, Hellman S, Rosenberg SA (eds) Cancer: principles and practice of oncology, 6th edn. Lippincott, Williams & Wilkins:1841-1891
4. Bu'Lock FA, Gabriel HM, Oakhill A, Mott MG, Martin RP (1993) Cardioprotection by ICRF187 against high-dose anthracycline toxicity in children with malignant disease. Br Heart J 70:185-188
5. Dardir M, Herman EH, Ferrans VJ (1989) Effects of ICRF-187 on the cardiac and renal toxicity of epirubicin in spontaneously hypertensive rats. Cancer Chemother Pharmacol 34:269-275
6. Dombernowsky P, Gehl J, Boesgaard M, Paaske T, Jensen BV (1996) Doxorubicin and paclitaxel, a highly active combination in the treatment of metastatic breast cancer. Semin Oncol 23:23-27
7. Earhart RH, Tutsch KD, Koeller JM, Rodriguez R, Robins HI, Vogel CL, Davis HL, Tormey DC (1982) Pharmacokinetics of (+)-1,2-di(3,5-dioxopiperazin-1- yl)propane intravenous infusions in adult cancer patients. Cancer Res 42:5255-5261
8. European Commission, Enterprise Directorate-General (2002) Better medicines for children. Proposed regulatory actions on paediatric medicinal products. Brussels
9. Feldmann JE, Jones SE, Weisberg SR, Gandara DR, Lyman GH, York RM, Mailliard JA, Hayes DM, Tranum B, Spaulding MB, Shaikh BS, Khojasteh A, Wajima T, Rivera RR, Abramson N, Horvath WL, Pendergrass KB, Reynolds RD, Gerber M, Winston J, Squillace K, Kline A, Swearengin B, Hess D, Scott D, Banks P, Jones G, Jones D, Gams RA (1992) Advanced small-cell lung cancer treated with CAV (cyclophosphamide + adriamycin + vincristine) chemotherapy and the cardioprotective agent dexrazoxane (ADR-529, ICRF-187, Zinecard). Proc Ann Meet Am Soc Clin Oncol 11:296
10. Food and Drug Administration (1999) Center for Drug Evaluation and Research. Oncologic Drug Advisory Committee 62nd Meeting
11. Gianni L, Munzone E, Capri G, Fulfaro F, Tarenzi E, Villani F, Spreafico C, Laffranchi A, Caraceni A, Martini C (1995) Paclitaxel by 3-hour infusion in combination with bolus doxorubicin in women with untreated metastatic breast cancer. High antitumor activity and cardiac effects in a dose-finding and sequence-finding study. J Clin Oncol 13:2688-2699
12. Gilladoga AC, Manuel C, Tann CC, et al. (1975) Cardiotoxicity of adriamycin (NSC-123127) in children. Cancer Chemother Rep 6:209-214
13. Hasinoff BB (1989) 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 26:378-385
14. Hellmann K (2000) Dexrazoxane and the ASCO guidelines for the use of chemotherapy and radiotherapy products: a critique. J Clin Oncol 18:2004-2006
15. Hensley ML, Schuchter LM, Lindley C, Meropol NJ, Cohen GI, Broder G, Gradishar WJ, Green DM, Langdon RJ Jr, Mitchell RB, Negrin R, Szatrowski TP, Thigpen JT, Von Hoff D, Wasserman TH, Winer EP, Pfister DG (1999) American Society of Clinical Oncology clinical practice guidelines for the use of chemotherapy and radiotherapy protectants. J Clin Oncol 17:3333-3355
16. Herman EH, el-Hage A, Ferrans VJ (1988) Protective effect of ICRF-187 on doxorubicin-induced cardiac and renal toxicity in spontaneously hypertensive (SHR) and normotensive (WKY) rats. Toxicol Appl Pharmacol 92:42-53
17. Herman EH, Zhang J, Chadwick DP, Ferrans VJ (2000) Comparison of the protective effects of amifostine and dexrazoxane against the toxicity of doxorubicin in spontaneously hypertensive rats. Cancer Chemother Pharmacol 45:329-334
18. Hershko C, Link G, Tzahor M, Pinson A (1993) The role of iron and iron chelators in anthracycline cardiotoxicity. Leuk Lymphoma 11:207-214
19. Krischer JP, Epstein S, Cuthbertson DD, Goorin AM, Epstein ML, Lipshultz SE (1997) Clinical cardiotoxicity following anthracycline treatment for childhood cancer: the pediatric oncology group experience. J Clin Oncol 15:1544-1552
20. Lipshultz SE, Colan SD, Silverman LB, Levy DE, Dalton VK, Rifai N, Lipsitz SR, Gelber RD, Sallan SE (2002) Dexrazoxane reduces incidence of doxorubicin-associated acute myocardiocyte injury in children with acute lymphoblastic leukemia (ALL). Proc Am Soc Clin Oncol 21:390
21. Lopez M, Vici P (1998) European trials with dexrazoxane in amelioration of doxorubicin and epirubicin-induced cardiotoxicity. Semin Oncol 25 [Suppl 10]: 55-60
22. Lopez M, Vici P, Di Lauro L, Conti F, Paoletti G, Ferraironi A, Sciuto R, Giannarelli D, Maini CL (1998) Randomized prospective clinical trial to evaluate cardio-protection of dexrazoxane in patients with advanced breast cancer and soft tissue sarcomas. J Clin Oncol 16:86-92
23. O'Shaughnessy JA, Wittes RE, Burke G, Friedman MA, Johnson JR, Niederhuber JE, Rothenberg ML, Woodcock J, Chabner BA, Temple R (1991) Commentary concerning demonstration of safety and efficacy of investigational anticancer agents in clinical trials. J Clin Oncol 9:2225-2232
24. Pratt CB, Ransom JL, Evans WE (1978) Age-related adriamycin cardiotoxicity in children. Cancer Treat Rep 62:1381-1385
25. Rubio ME, Wiegman A, Naeff MSJ, Voogd PJ, Nooy MA, Cyrus PAH, Voute PA (1995) ICRF 187 (Cardioxane) protection against doxorubicin induced cardiomyopathy in paediatric osteosarcoma patients. Proc Am Soc Clin Oncol 14:440
26. Sargent JM, Williamson CJ, Yardley C, Taylor CG, Hellmann K (2001) Dexrazoxane significantly impairs the induction of doxorubicin resistance in the human leukaemia line, K562. Br J Cancer 84:959-964
27. Schiavetti A, Castello MA, Versacci P, Varrasso G, Padula A, Ventriglia F, Werner B, Colloridi V (1997) Use of ICRF-187 for prevention of anthracycline cardiotoxicity in children: preliminary results. Pediatr Hematol Oncol 14:213-222
28. Schuchter LM, Hensley ML, Meropol NJ, Winer EP (2002) 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 20:2895-2903
29. Sehested M, Jensen PB (1996). Mapping of DNA topoisomerase II poisons (etoposide, clerocidin) and catalytic inhibitors (aclarubicin, ICRF187) to four distinct steps in the topoisomerase II catalytic cycle. Biochem Pharmacol 51:879-886
30. Seymour L, Bramwell V, Moran LA (1999) Use of dexrazoxane as a cardioprotectant in patients receiving doxorubicin or epirubicin chemotherapy for the treatment of cancer. Cancer Prev Control 3:145-159 (2002 update available: http://www.cco-pebc.ca/guidelines/sys/full12_5.pdf)
31. Simbre II VC, Adams MJ, Deshpande SS, Duffy SA, Miller TL, Lipshultz SE (2001) Cardiomyopathy caused by antineoplastic therapies. Curr Treat Opt Cardiovasc Med 3:493-505
32. Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L (2001) Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 344:783-792
33. Soudon J (1995) Study of the in vitro cytotoxicity of doxorubicin combined with Cardioxane® to 9 breast cancer cell lines. French Authorisation Application File for Cardioxane®
34. Sparano JA, Speyer J, Gradishar WJ, Liebes L, Sridhara R, Mendoza S, Fry D, Egorin MJ (1999) Phase I trial of escalating doses of paclitaxel plus doxorubicin and dexrazoxane in patients with advanced breast cancer. J Clin Oncol 17:880-886
35. Speyer JL, Green MD, Kramer E, Rey M, Sanger J, Ward C, Dubin N, Ferrans V, Stecy P, Zeleniuch-Jacquotte A, et al (1988) Protective effect of the bispiperazinedione ICRF-187 against doxorubicin-induced cardiac toxicity in women with advanced breast cancer. New Engl J Med 319:745-752
36. Speyer JL, Green MD, Zeleniuch-Jacotte A, Wernz JC, Rey M, Sanger J, Kramer E, Ferrans V, Hochster H, Meyers M, Blum RH, Feit F, Attubato M, Burrows W, Muggia FM (1992) ICRF-187 permits longer treatment with doxorubicin in women with breast cancer. J Clin Oncol 10:117-127
37. Steinherz LJ, Steinherz PG, Tan CTC, Heller G, Murphy ML (1991) Cardiac toxicity 4 to 20 years after completing anthracycline therapy. JAMA 266:1672-1677
38. Swain SM, Whaley FS, Gerber MC, Weisberg S, York M, Spicer D, Jones SE, Wadler S, Desai A, Vogel C, Speyer J, Mittelman A, Reddy S, Pendergrass K, Velez-Garcia E, Ewer MS, Bianchine JR, Gams RA (1997a) Cardioprotection with dexrazoxane for doxorubicin-containing therapy in advanced breast cancer. J Clin Oncol 15:1318-1322
39. Swain SM, Whaley, FS, Gerber MC, Ewer MS, Bianchine JR, Garns RA (1997b) Delayed administration of dexrazoxane provides cardioprotection for patients with advanced breast cancer treated with doxorubicin-containing therapy. J Clin Oncol 15:1333-1340
40. Ten Bokkel Huinink WW, Schreuder JE, Dubbelman R, Bierhorst F, van Tinteren H, Dalesio O, Valdés Olmos RA, McVie JG (1992) ICRF 187 protects against doxorubicin induced cardiomyopathy. Ann Oncol 3:114
41. Tetef ML, Synold TW, Chow W, Leong L, Margolin K, Morgan R, Raschko J, Shibata S, Somlo G, Yen Y, Groshen S, Johnson K, Lenz HJ, Gandara D, Doroshow JH (2001) Phase I trial of 96-hour continuous infusion of dexrazoxane in patients with advanced malignancies. Clin Cancer Res 7:1569-1576
42. Vats T, Kamen B, Krischer JP (1991) Phase II trial of ICRF-187 in children with solid tumors and acute leukemia. Invest New Drugs 9:333-337
43. Venturini M, Michelotti A, Del Mastro L, Gallo L, Carnino F, Garrone O, Tibaldi C, Molea N, Bellina RC, Pronzato P, Cyrus P, Vinke J, Testore F, Guelfi M, Lionetto R, Bruzzi P, Conte PF, Rosso R (1996) Multicenter randomized controlled clinical trial to evaluate cardio-protection of dexrazoxane versus no cardio-protection in women receiving epirubicin chemotherapy for advanced breast cancer. J Clin Oncol 14:3112-3120
44. Von Hoff DD, Layard MW, Basa P, Davis HL Jr, Von Hoff AL, Rozencweig M, Muggia FM (1979) Risk factors for doxorubicin induced congestive heart failure. Ann Intern Med 91:710-717
45. Wexler LH, Andrich MP, Venzon D, Berg SL, Weaver-McClure L, Chen CC, Dilsizian V, Avila N, Jarosinski P, Balis FM, Poplack DG, Horowitz ME (1996) Randomized trial of the cardioprotective agent ICRF-187 in pediatric sarcoma patients treated with doxorubicin. J Clin Oncol 14:362-372