Table 2.
Patient Characteristics by HER-2 Status and Treatment Arm
| Characteristic | HER-2 Positive
|
HER-2 Negative
|
||||||
|---|---|---|---|---|---|---|---|---|
| P + L (n = 49)
|
P + P (n = 37)
|
P + L (n = 202)
|
P + P (n = 204)
|
|||||
| No. of Patients | % | No. of Patients | % | No. of Patients | % | No. of Patients | % | |
| Age, years | ||||||||
| Mean | 51 | 51 | 52 | 52 | ||||
| Range | 34-75 | 28-78 | 23-74 | 26-78 | ||||
| ECOG PS* | ||||||||
| 0 | 29 | 59 | 21 | 54 | 115 | 57 | 114 | 57 |
| 1 | 20 | 41 | 16 | 46 | 85 | 42 | 85 | 42 |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | < 1 |
| Unknown | 0 | 0 | 0 | 0 | 4 | 1 | 2 | < 1 |
| Prior adjuvant taxane | 1 | 2 | 0 | 0 | 15 | 7 | 17 | 8 |
| Prior adjuvant anthracycline | 22 | 45 | 16 | 43 | 85 | 42 | 99 | 48 |
| Stage of disease | ||||||||
| III | 6 | 12 | 8 | 22 | 26 | 13 | 21 | 10 |
| IV | 43 | 88 | 29 | 78 | 176 | 87 | 183 | 90 |
| Visceral disease | 34 | 69 | 19 | 51 | 125 | 62 | 138 | 68 |
Abbreviations: HER-2, human epidermal growth factor receptor 2; P + L, paclitaxel plus lapatinib; P + P, paclitaxel plus placebo; ITT, intent to treat; ECOG PS, Eastern Cooperative Oncology Group performance status; ER, estrogen receptor; PR, progesterone receptor.
*
Based on the safety population (ITT: 293 patients in the P + L arm and 286 patients in the P + P arm; HER-2 negative: 204 patients in the P + L arm and 202 patients in the P + P arm).