Table 3.
Changes in left ventricular ejection fraction (LVEF) from baseline
| Doxorubicin cumulative dose | Variable | Total | Dexrazoxane |
||
|---|---|---|---|---|---|
| Yes | No | P-value | |||
| Any | N | 401 | 290 | 111 | – |
| LVEFa, n (%): | |||||
| <50% | 48 (12%) | 35 (12.1%) | 13 (11.7%) | – | |
| >10% decrease from baseline | 191 (47.6%) | 149 (51.4%) | 42 (37.8%) | – | |
| <50% and/or >10% decrease from baseline | 194 (48.4%) | 151 (52.1%) | 43 (38.7%) | – | |
| <450 mg/m2 | N | 153 | 68 | 85 | |
| LVEFa, n (%): | |||||
| <50% | 16 (10.5) | 11 (16.2) | 5 (5.9) | 0.060 | |
| >10% decrease from baseline | 59 (38.6) | 32 (47.1) | 27 (31.8) | 0.094 | |
| <50% and/or >10% decrease from baseline | 62 (40.5) | 34 (50.0) | 28 (32.9) | 0.046 | |
| 450 – <600 mg/m2 | N | 159 | 142 | 17 | – |
| LVEFa, n (%): | |||||
| <50% | 18 (11.3) | 14 (9.9) | 4 (23.5) | 0.009b | |
| >10% decrease from baseline | 82 (51.6) | 74 (52.1) | 8 (47.1) | 0.673b | |
| <50% and/or >10% decrease from baseline | 82 (51.6) | 74 (52.1) | 8 (47.1) | 0.682b | |
| ≥600 mg/m2 | N | 89 | 80 | 9 | – |
| LVEFa, n (%): | |||||
| <50% | 14 (15.7) | 10 (12.5) | 4 (44.4) | – | |
| >10% decrease from baseline | 50 (56.2) | 43 (53.8) | 7 (77.8) | – | |
| <50% and/or >10% decrease from baseline | 50 (56.2) | 43 (53.8) | 7 (77.8) | – | |
Results shown for the population with echocardiogram or multigated acquisition scan data at baseline and at least one other time point (N=401).
a
Based on worst postbaseline abnormal LVEF result
b
P-values calculated for all patients who received a doxorubicin cumulative dose ≥450 mg/m2