Table 3.
Efficacy outcomes by tumor HER2 expression below the median and equal to or greater than the median
| |
Median PFS, months |
|
|
|---|---|---|---|
| HER2 expression a | HT | T-DM1 | HR relative to HT (95% CI) |
| All patients |
(n = 70) |
(n = 67) |
0.59 (0.36, 0.97) |
| 9.2 |
14.2 |
||
| < Median |
(n = 32) |
(n = 26) |
0.85 (0.44, 1.67) |
| 9.8 |
10.6 |
||
| ≥ Median |
(n = 29) |
(n = 29) |
0.39 (0.18, 0.85) |
| 8.8 |
Not reached |
||
| |
ORR,% |
|
|
|
HER2 expression
a
|
HT |
T-DM1 |
Odds ratio relative to HT (95% CI) |
| All patients |
(n = 69) |
(n = 67) |
1.26 (0.63, 2.55) |
| 58.0 |
64.2 |
||
| < Median |
(n = 31) |
(n = 26) |
0.84 (0.30, 2.41) |
| 58.1 |
53.8 |
||
| ≥ Median | (n = 29) |
(n = 29) |
1.58 (0.50, 4.98) |
| 65.5 | 72.4 | ||
aHER2 mRNA data were available for 61 of 70 patients in the HT arm and for 55 of 67 patients in the T-DM1 arm. HER2, human epidermal growth factor receptor 2; HT, trastuzumab plus docetaxel; ORR, objective response rate; PFS, progression-free survival; T-DM1, trastuzumab emtansine.