HHE Sponsored handbook: Cardioprotection in clinical | Page 4

4 HHE 2019 FIGURE 1B Dexrazoxane protects against FAC-induced cardiac failure in advanced breast cancer 1 1.0 Dexrazoxane 0.8 HR for Cardiac failure: 13.05 95% Cl: 3.72-46.0 p<0.001 0.6 0.4 Placebo 0.2 0.0 Dexrazoxane 102 Placebo 99 92 92 300 59 57 500 42 19 31 7 20 6 700 11 1 900 7 1 7 1 1100 3 1 2 1 2 1 1300 1 1 1500 Cumulative dose of doxorubicin mg/m 2 Cardioprotection in patients with advanced and/or metastatic breast cancer Cardioxane ® protects against anthracycline- induced cardiotoxicity in patients with advanced breast cancer. 1,15,16 Cardioxane ® preserves left ventricular ejection fraction (LVEF) in patients with advanced breast cancer treated with doxorubicin-based chemotherapy. 15 Cardioxane ® treatment enables patients to receive more cycles of doxorubicin-containing chemotherapy and higher cumulative doses of doxorubicin compared with patients receiving chemotherapy alone. 15 The risk of cardiac events and risk of heart failure following doxorubicin-based chemotherapy in patients with advanced breast cancer treated with fluorouracil, doxorubicin, and cyclophosphamide are significantly reduced by Cardioxane ® compared with placebo (p<0.001). 1 (See Figures 1A and B). Cardioxane ® administration protected against epirubicin-associated reductions in LVEF, and increases in brain natriuretic peptide and cardiac troponin in patients receiving adjuvant chemotherapy (Table 1). 2 TABLE 1 Cardioprotective effects of dexrazoxane in patients receiving epirubicin for treatment of advanced breast cancer 2 Parameter n (%) Epirubicin alone (n=61) Before treatment After treatment P-value BNP (pg/ml) 107 ± 4.5 187 ± 8.7 <0.05 cTNT (ng/ml) 12.6 ± 2.7 31.1 ± 7.1 <0.05 HR (bpm) 75.3 ± 7.1 89.6 ± 9.2 <0.05 LVEF 65.2 ± 7.8 55.2 ± 7.2 <0.05 Neutrophil count (x10 9 /l) 4.0 ± 1.4 3.5 ± 1.5 NS Study design: 122 breast cancer patients were randomised to dexrazoxane (n=61) or contral (n=61) in addition to an epirubicin-based adjuvant cemotherapy regimen. Dexrazoxane was administered at a ratio of 10:1 to epirubicin. All patients received four cycles of adjuvant chemotherapy and changes in speciific cardiac functional status and haematology status before and after chemotherapy, as well as non-cardiac toxicity, were observed and analysed.