Table 2.
Efficacy and drug exposure
| Objective response rate; n (%) | 65 (25.2) |
| Median duration of objective response, months | 4.4 (95 %CI: 3.4–4.8) |
| Best overall response | |
| Complete response; n (%) | 1 (0.4) |
| Partial response; n (%) | 64 (24.8) |
| Stable disease (>6 months); n (%) | 28 (10.9) |
| Clinical benefit rate, % (95 %CI) | 36.1 (30.2–42.2) |
| Progressive disease; n (%) | 157 (60.9) |
| Not established; n (%) | 8 (3.1) |
| Median time to progression, months ( 95 %CI) | 4 (3.3–4.3) |
| Overall survival, months (95 %CI) | 11.2 (9.3–12.1) |
| One- year overall survival rate,% (95 %CI) | 45.5 % (38.3–52.4) |
| 18-month overall survival rate, % (95 %CI) | 23.1 % (16.3–30.6) |
| 2-year overall survival rate, % (95 %CI) | 8.5 % (2.2–20.3) |
| Drug exposure | |
| Median EM cycles delivered; n (range) | 5 (1–19) |
| Dose reductions at initiation (%) | 20.9 |
| Relative dose intensity (range) | 0.92 (0.17–1.22) |