Table 3.
Best Overall Response Per Investigator According to RECIST
| Response | Everolimus 70 mg/week | Everolimus 10 mg/day |
|---|---|---|
| Per protocol set | N = 71 | N = 71 |
| CR | 0 | 0 |
| PR | 0 | 0 |
| SD | 22 (31.0) | 23 (32.4) |
| PD | 49 (69.0) | 48 (67.6) |
| Unknown | 0 | 0 |
| DCR, a % (95% CI) | 31.0 (20.5–43.1) | 32.4 (21.8–44.5) |
| Full analysis set | n = 99 | n = 100 |
| CR | 0 | 0 |
| PR | 0 | 0 |
| SD | 25 (25.3) | 26 (26.0) |
| PD | 58 (58.6) | 55 (55.0) |
| Unknown | 16 (16.2) | 19 (19.0) |
| DCR, % (95% CI) | 25.3 (17.1–35.0) | 26.0 (17.7–35.7) |
Unless otherwise noted, all data are presented as n (%).
a
Primary study endpoint.
CI, confidence interval; CR, complete response; DCR, disease control rate (CR+PR+SD); PD, progressive disease; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease.