Table 2.
Safety outcomes by age subgroups from the KAMILLA study of TDM-1 in patients with HER2-positive advanced breast cancer [21].
| Age |
Overall safety population |
||
|---|---|---|---|
| <65 years |
≥65 years |
||
| T-DM1 (n = 1628) | T-DM1 (n = 373) | T-DM1 (n = 2002) | |
| Any TEAE, n (%) | / | / | 1862 (93) |
| Grade ≥3 (%) | 540 (33.2) | 160 (42.9) | 816 (40.8) |
| Leading to dose reduction (%) | / | / | / |
| Leading to drug interruption (%) | / | / | / |
| Leading to drug discontinuation (%) | 112 (9.5) | 41 (14.3) | 237 (11.8) |
| Leading to death (%) | 17 (1) | 10 (2.7) | 45 (2.24) |
TEAE treatment emergent adverse event, SAE serious adverse event, T-DM1 trastuzumab emtansine.