Table 2:
Investigator-assessed efficacy outcomes (intention-to-treat population)
| Ramucirumab plus docetaxel (n=263) | Placebo plus docetaxel (n=267) | HR (95% CI)* | p value* | |
|---|---|---|---|---|
| Overall survival | ||||
| Deaths | 185 (70%) | 200 (75%) | .. | .. |
| Median overall survival, months | 9·4 (7·9–11·4) | 7·9 (7·0–9·3) | 0·887 (0·724–1·086) | 0·25 |
| 6-month overall survival | 67·7% (61·5–73·2) | 62·6% (56·4–68·3) | .. | 0·23 |
| 9-month overall survival | 51·5% (45·0–57·6) | 44·4% (38·1–50·5) | .. | 0·12 |
| 12-month overall survival | 40·0% (33·7–46·2) | 35–2% (29·2–41·2) | .. | 0·27 |
| 24-month overall survival | 17·1% (11·8–23·2) | 12·3% (7·6–18·1) | .. | 0·23 |
| Progression-free survival | ||||
| Deaths or disease progressions | 212 (81%) | 236 (88%) | .. | .. |
| Median progression-free survival, months | 4·1 (3·3–4·8) | 2·8 (2·6–2·9) | 0·696 (0·573–0·845) | 0·0002 |
| 3-month progression-free survival | 59·3% (52·8–65·2) | 42·2% (36·1–48·3) | .. | 0·0001 |
| 6-month progression-free survival | 29·1% (23·2–35·2) | 17·6% (13·1–22·6) | .. | 0·0035 |
| 9-month progression-free survival | 15·7% (11·1–21·1) | 8·9% (5·7–13·1) | .. | 0·031 |
| 12-month progression-free survival | 11·0% (7·1–15·8) | 4·5% (2·2–8·0) | .. | 0·014 |
| Best overall response | .. | .. | .. | .. |
| Complete response | 10 (4%) | 2 (<1%) | .. | .. |
| Partial response | 58 (22%) | 35 (13%) | .. | .. |
| Stable disease | 104 (40%) | 110 (41%) | .. | .. |
| Progressive disease | 56 (21%) | 92 (34%) | .. | .. |
| Not evaluable | 35 (13%) | 28 (10%) | .. | .. |
| Objective response | 25·9% (20·6–31·1) | 13·9% (9·7–18·0) | .. | .. |
| Disease control | 65·4% (59·7–71·1) | 55·1% (49·1–61·0) | .. | .. |
Data are n (%), median (95% CI), or % (95% CI), unless otherwise specified. Confidence intervals are based on normal approximation.
*
Stratified by interactive web response system factors.