Table 4 Cross-tabulation of baseline characteristics and LVSD/asymptomatic LVEF decline on and off treatment.
LVEF reduction from baseline | Total number of patients | No cardiac toxicity | Symptomatic congestive heart failure or asymptomatic LVEF decline | RR (95%) | P |
|---|---|---|---|---|---|
TH arm | 114 | 106 | 8 | ||
Age at study entry (years) | |||||
<50 | 41 (36%) | 37 (35%) | 4 (50%) | Reference | 0.42 |
≥50 | 73 (64%) | 69 (65%) | 4 (50%) | 0.56 (0.15-2.13) | |
Baseline LVEF (%) | |||||
≤55 | 14 (12%) | 13 (12%) | 1 (12%) | 1.02 (0.14–7.69) | 0.92 |
>55 | 100 (88%) | 93 (88%) | 7 (88%) | Reference | |
BMI | |||||
≤25 | 42 (37%) | 39 (37%) | 3 (38%) | Reference | 0.95 |
>25 | 72 (63%) | 67 (63%) | 5 (62%) | 0.97 (0.24–3.86) | |
T-DM1 arm | 383 | 377 | 6 | ||
Age at study entry (years) | |||||
<50 | 110 (29%) | 109 (29%) | 1 (17%) | Reference | 0.58 |
≥50 | 273 (71%) | 268 (71%) | 5 (83%) | 2.01 (0.24–17.05) | |
Baseline LVEF (%) | |||||
≤55 | 59 (15%) | 57 (15%) | 2 (33%) | 2.74 (0.51–14.65) | 0.28 |
>55 | 324 (85%) | 320 (85%) | 4 (67%) | Reference | |
BMI | |||||
≤25 | 161 (42%) | 158 (42%) | 3 (50%) | Reference | 0.70 |
>25 | 222 (58%) | 219 (58%) | 3 (50%) | 0.73 (0.15–3.55) | |