Table 4.
Best Objective Response for Measurable Tumors by HER2 Status by Arm
| Response | HER2 Negative |
HER2 Positive |
||||||
|---|---|---|---|---|---|---|---|---|
| Lapatinib (n = 32) |
Placebo (n = 32) |
Lapatinib (n = 8) |
Placebo (n = 13) |
|||||
| No. | % | No. | % | No. | % | No. | % | |
| No. assessable for response | 31 | 100 | 30 | 100 | 8 | 100 | 12 | 100 |
| CR | 0 | 0 | 1 | 3 | 1 | 13 | 1 | 8 |
| PR | 4 | 13 | 6 | 20 | 2 | 25 | 1 | 8 |
| SD | 17 | 55 | 8 | 27 | 3 | 38 | 3 | 25 |
| PD | 10 | 32 | 15 | 50 | 2 | 25 | 7 | 58 |
| Objective response (CR plus PR) | 4 | 13 | 7 | 23 | 3 | 38 | 2 | 17 |
| 95% CI for objective response, % | 5 to 29 | 12 to 41 | 14 to 70 | 5 to 45 | ||||
| Interaction P | .53 | |||||||
Abbreviations: CR, complete response; HER2, human epidermal growth factor receptor 2; PD, progressive disease; PR, partial response; SD, stable disease.