Table 3.
Summary of tumor response
| Response | Local assessment | Central assessment | ||
|---|---|---|---|---|
| EVE+EXE (n = 485) | PBO+EXE (n = 239) | EVE+EXE (n = 485) | PBO+EXE (n = 239) | |
| Best overall response (%) | ||||
| Complete response (CR) | 0.6 | 0 | 0 | 0 |
| Partial response (PR) | 12.0 | 1.7 | 12.6 | 2.1 |
| Stable disease (SD) | 71.3 | 59.0 | 73.4 | 62.8 |
| Progressive disease | 10.1 | 32.6 | 5.8 | 23.4 |
| Unknown | 6.0 | 6.7 | 8.2 | 11.7 |
| ORR (CR or PR), % | 12.6* | 1.7 | 12.6 | 2.1 |
| 95% CI for ORR | 9.8–15.9 | 0.5–4.2 | 9.8–15.9 | 0.7–4.8 |
| CBR (CR+PR+SD ≥ 24 weeks), % | 51.3* | 26.4 | 49.9 | 22.2 |
| 95% CI for CBR | 46.8–55.9 | 20.9–32.4 | 45.4–54.4 | 17.1–28.0 |
CI confidence interval, CBR clinical benefit rate, EVE everolimus, EXE exemestane, ORR objective response rate, PBO placebo
* Statistically significant difference, P < 0.0001