Multicenter randomized phase III study of the cardioprotective effect of dexrazoxane (Cardioxane®) in advanced/metastatic breast cancer patients treated with anthracycline-based chemotherapy

Annals of Oncology

Volumn 17, Issue 4, 2006, Pages 614-622

  Marty, M ^a   Espie M ^a   Llombart, A ^b   Monnier, A ^c   Rapoport, B L ^d   Stahalova, V ^e  

^a SAINT LOUIS HOSPITAL   (France)

^b INSTITUTO VALENCIANO DE ONCOLOGÍA   (Spain)

^c Centre Hospitalier André Boulloche   (France)

^d Medical Oncology Centre of Rosebank   (South Africa)

^e UNIVERSITY HOSPITAL BULOVKA   (Czech Republic)

Author keywords

Anthracycline; Breast cancer; Cardioprotection; Clinical trial; Dexrazoxane

Indexed keywords

ANTHRACYCLINE DERIVATIVE; DOXORUBICIN; EPIRUBICIN; RAZOXANE;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ARTICLE; ASTHENIA; BLOOD TOXICITY; BONE MARROW APLASIA; BONE PAIN; BREAST CANCER; BREAST SURGERY; CANCER ADJUVANT THERAPY; CARDIOTOXICITY; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DIARRHEA; DISEASE SEVERITY; DOSE CALCULATION; DRUG EFFICACY; DRUG FATALITY; DRUG FEVER; DRUG RESPONSE; DRUG USE; DRUG WITHDRAWAL; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HEART DISEASE; HEART PROTECTION; HIGH RISK PATIENT; HUMAN; INCIDENCE; LEUKOPENIA; LUNG EMBOLISM; MAJOR CLINICAL STUDY; METASTASIS; MUCOSA INFLAMMATION; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY FAILURE; SEPTICEMIA; STATISTICAL SIGNIFICANCE; STOMATITIS; THROMBOCYTOPENIA; VOMITING;

ADULT; AGED; ANTHRACYCLINES; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; CARDIOTONIC AGENTS; FEMALE; HUMANS; MIDDLE AGED; NEOPLASM METASTASIS; RAZOXANE;

EID: 33645294906     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdj134     Document Type: Article

References (31)

1. Lipshultz SE, Rifai N, Sallan SE et al. Predictive value of cardiac troponin T in pediatric patients at risk for myocardial injury. Circulation 1997; 96: 2641-2648.
2. Ewer MS, Ali MK, Mackay B et al. A comparison of cardiac biopsy grades and ejection fraction estimations in patients receiving adriamycin. J Clin Oncol 1984; 2: 112-117.
3. Speyer JL, Green MD, Kramer E et al. Protective effect of the bispiperazinedione ICRF-187 against doxorubicin-induced cardiac toxicity in women with advanced breast cancer. N Engl J Med 1988; 319: 745-752.
4. 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; 10: 117-127.
5. Von Hoff DD, Layard MW, Basa P et al. Risk factors for doxorubicin-induced congestive heart failure. Ann Intern Med 1979; 91: 710-717.
6. Swain SM, Whaley FS, Ewer MS et al. Congestive heart failure in patients treated with doxorubicin: A retrospective analysis of three trials. Cancer 2003; 97: 2869-2879.
7. Swain SM, Vici P. The current and future role of dexrazoxane as a cardioprotectant in anthracycline treatment: Expert panel review. J Cancer Res Clin Oncol 2004; 130: 1-7.
8. Lopez M, Vici P, Di Lauro K 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; 16: 86-92.
9. 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; 15: 1333-1340.
10. Swain SM, Whaley FS, Gerber MC et al. Cardioprotection with dexrazoxane for doxorubicin-containing therapy in advanced breast cancer. J Clin Oncol 1997; 15: 1318-1332.
11. 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; 14: 3112-3120.
12. Lipshultz SE, Rifai N, Dalton VM et al. The effect of dexrazoxane on myocardial injury in doxorubicin-treated children with acute lymphoblastic leukemia. N Engl J Med 2004; 351: 145-153.
13. 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; 14: 362-372.
14. 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®). Proc Ann Meet Am Soc Clin Oncol 1992; 11: AA93.
15. Herman EH, Ferrans VJ. Amelioration of chronic anthracycline cardiotoxicity by icrf-187 and other compounds. Cancer Treat Rev 1987; 14: 225-229.
16. Green MD, Alderton P, Gross J et al. Evidence of the selective alteration of anthracycline activity due to modulation by ICRF-187 (ADR-529). Pharmacol Ther 1990; 48: 61-69.
17. 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; 26: 378-385.
18. Criteria Committee of New York Heart Association. Nomenclature and criteria for diagnosis of diseases of the heart and great vessels (8th edn). Boston, MA: Little Brown 1979.
19. Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer 1981; 47: 207-214.
20. 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; 3: 145-159.
21. Juenger J, Schellberg D, Kraemer S et al. Health related quality of life in patients with congestive heart failure: Comparison with other chronic diseases and relation to functional variables. Heart 2002; 87: 235-241.
22. Hobbs FD, Kenkre JE, Roalfe AK et al. Impact of heart failure and left ventricular systolic dysfunction on quality of life: A cross-sectional study comparing common chronic cardiac and medical disorders and a representative adult population. Eur Heart J 2002; 23: 1867-1876.
23. 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; 19: 167-184.
24. Tengs TO, Adams ME, Pliskin JS et al. Five-hundred life-saving interventions and their cost-effectiveness. Risk Anal 1995; 15: 369-390.
25. Stockler M, Wilcken N, Coates A. Chemotherapy for metastatic breast cancer-when is enough enough? Eur J Cancer 1997; 33: 2147-2148.
26. Fumoleau P, Kerbrat P, Romestaing P et al. Randomized trial comparing six versus three cycles of epirubicin-based adjuvant chemotherapy in premenopausal, node-positive breast cancer patients: 10-year follow-up results of the french adjuvant study group 01 trial. J Clin Oncol 2003; 21: 298-305.
27. Ejlertsen B, Pfeiffer P, Pedersen D et al. Decreased efficacy of cyclophosphamide, epirubicin and 5-fluorouracil in metastatic breast cancer when reducing treatment duration from 18 to 6 months. Eur J Cancer 1993; 29A: 527-531.
28. Biganzoli L, Piccart MJ. The bigger the better? Or what we know and what we still need to learn about anthracycline dose per course, dose density and cumulative dose in the treatment of breast cancer. Ann Oncol 1997; 8: 1177-1182.
29. 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 antitumor efficacy and cardiac effects in a dose-finding and sequence-finding study. J Clin Oncol 1995; 13: 2688-2699.
30. Pearlman M, Jendiroba D, Pagliaro L et al. Dexrazoxane in combination with anthracyclines lead to a synergistic cytotoxic response in acute myelogenous leukemia cell lines. Leuk Res 2003; 27: 617-626.
31. Imondi AR. Preclinical models of cardiac protection and testing for effects of dexrazoxane on doxorubicin antitumor effects. Semin Oncol 1998; 25 (4 Suppl 10): 22-30.