Table 2 Objective response summary
BICR-assessed | INV-assessed | |||
|---|---|---|---|---|
SG (n = 166) | Chemotherapy (n = 165) | SG (n = 166) | Chemotherapy (n = 165) | |
ORR, n (%) | 34 (20) | 25 (15) | 31 (19) | 26 (16) |
95% CI | (15 to 27) | (10 to 22) | (13 to 25) | (11 to 22) |
Odds ratio (95% CI) | 1.46 (0.82 to 2.61) | 1.24 (0.69 to 2.22) | ||
P value | 0.1994 | 0.4742 | ||
CR | 2 (1) | 0 | 0 | 0 |
PR | 32 (19) | 25 (15) | 31 (19) | 26 (16) |
SD | 93 (56) | 82 (50) | 103 (62) | 89 (54) |
PD | 36 (22) | 45 (27) | 29 (17) | 39 (24) |
Not evaluable | 3 (2) | 13 (8) | 3 (2) | 11 (7) |
CBR, n (%) | 63 (38) | 37 (22) | 77 (46) | 48 (29) |
95% CI | (31 to 46) | (16 to 30) | (39 to 54) | (22 to 37) |
Odds ratio (95% CI) | 2.17 (1.33 to 3.55) | 2.11 (1.34 to 3.33) | ||
P value | 0.0018 | 0.0012 | ||
Median DoR,a months (95% CI) | 5.3 (4.1 to 9.8) | 5.2 (4.2 to 9.7) | 8.2 (5.7 to 9.4) | 4.2 (2.9 to 5.6) |