Table 2.
Selected patient demographic and baseline characteristics by HER2 mRNA expression and treatment arm
|
Characteristic |
HER2 mRNA < median (n = 58) |
HER2 mRNA ≥ median (n = 58) |
||||
|---|---|---|---|---|---|---|
|
HT |
T-DM1 |
Total |
HT |
T-DM1 |
Total |
|
| (n = 32) | (n = 26) | (n = 58) | (n = 29) | (n = 29) | (n = 58) | |
|
Median age, years (range) |
52.5 |
54.5 |
53.5 |
51.0 |
54.0 |
53.0 |
| (36 to 72) |
(32 to 74) |
32 to 74 |
(33 to 75) |
(27 to 82) |
(27 to 82) |
|
|
World region, % |
|
|
|
|
|
|
| US |
34.4 |
38.5 |
36.2 |
24.1 |
27.6 |
25.9 |
| Non-US |
65.6 |
61.5 |
63.8 |
75.9 |
72.4 |
74.1 |
|
Race, %
a
|
|
|
|
|
|
|
| White |
81.3 |
80.8 |
81.0 |
86.2 |
72.4 |
79.3 |
| American Indian or Alaskan native |
9.4 |
7.7 |
8.6 |
6.9 |
6.9 |
6.9 |
| Black |
6.3 |
0.0 |
3.4 |
3.4 |
6.9 |
5.2 |
| Other or not available |
3.1 |
11.5 |
6.9 |
3.4 |
13.8 |
8.6 |
|
ECOG PS, % |
|
|
|
|
|
|
| 0 |
62.5 |
80.8 |
70.7 |
57.1 |
69.0 |
63.2 |
| 1 |
37.5 |
19.2 |
29.3 |
42.9 |
31.0 |
36.8 |
|
HER2 status by central laboratory, % |
|
|
|
|
|
|
| HER2-positive |
71.9 |
73.1 |
72.4 |
100.0 |
100.0 |
100.0 |
| Normal |
28.1 |
26.9 |
27.6 |
0.0 |
0.0 |
0.0 |
|
ER/PR status, %
a
|
|
|
|
|
|
|
| ER-positive and/or PR-positive |
65.6 |
57.7 |
62.1 |
48.3 |
44.8 |
46.6 |
| ER-negative and PR-negative |
28.1 |
42.3 |
34.5 |
48.3 |
51.7 |
50.0 |
| ER and PR unknown |
6.3 |
0 |
3.4 |
3.4 |
3.4 |
3.4 |
|
Number of distinct sites involved
a
|
|
|
|
|
|
|
| 1 to 2 |
43.8 |
30.8 |
37.9 |
50.0 |
44.8 |
47.4 |
| >2 | 56.3 | 69.2 | 62.1 | 50.0 | 55.2 | 52.6 |
aPercentages may not add to 100% due to rounding. ECOG PS, Eastern Cooperative Oncology Group performance status; ER, estrogen receptor; HER2, human epidermal growth factor receptor 2; HT, trastuzumab plus docetaxel; mRNA, messenger RNA; PR, progesterone receptor; T-DM1, trastuzumab emtansine.