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) |