Table 2 Efficacy and survival in the intention-to-treat and per-protocol cohorts
|  | Intention-to-treat population (n = 64) | Per-protocol population (n = 61) | ||
|---|---|---|---|---|
No. (%) or % | 95% CI | No. (%) or % | 95% CI | |
Response | ||||
 CR | 1 (1.6) | - | 1 (1.6) | - |
 PR | 24 (37.5) | - | 24 (39.3) | - |
 SD | 30 (46.9) | - | 27 (44.3) | - |
 PD | 9 (14.1) | - | 9 (14.8) | - |
ORR | 39.1 | 27.1–52.1 | 41.0 | 28.6–54.3 |
DCR | 85.9 | 75.0–93.4 | 85.2 | 73.8–93.0 |
Progression-free survival | ||||
 Median, months | 7.5 | 5.0–10.0 | 7.5 | 5.1–9.9 |
 6-month rate | 57.8 | 45.6–70.0 | 57.4 | 45.1–69.7 |
 12-month rate | 37.5 | 25.3–49.7 | 36.1 | 23.8–48.4 |
Overall survival | ||||
 Median, months | 15.7 | 11.3–20.1 | 13.4 | 9.0–17.8 |
 6-month rate | 81.3 | 71.6–90.9 | 82.0 | 72.4–91.6 |
 12-month rate | 65.6 | 53.6–77.6 | 65.6 | 53.3–77.9 |