Table 1.
Metastatic sites at screening
| Patients with adenocarcinoma histology NSCLC
|
Patients with squamous cell histology NSCLC
|
|||||||
|---|---|---|---|---|---|---|---|---|
| All
|
TSFLT <9
|
PD-FLT
|
||||||
| Nintedanib (n=322) |
Placebo (n=336) |
Nintedanib (n=206) |
Placebo (n=199) |
Nintedanib (n=53) |
Placebo (n=64) |
Nintedanib (n=276) |
Placebo (n=279) |
|
| Patients with metastases at screening, n (%) | 300 (93.2) | 320 (95.2) | 197 (95.6) | 195 (98.0) | 50 (94.3) | 62 (96.9) | 235 (85.1) | 244 (87.5) |
| Metastatic sites at screening, n (%) | ||||||||
| 0 | 22 (6.8) | 16 (4.8) | 9 (4.4) | 4 (2.0) | 3 (5.7) | 2 (3.1) | 41 (14.9) | 35 (12.5) |
| 1–2 | 187 (58.1) | 196 (58.3) | 116 (56.3) | 113 (56.8) | 27 (50.9) | 34 (53.1) | 164 (59.4) | 176 (63.1) |
| >2 | 113 (35.1) | 124 (36.9) | 81 (39.3) | 82 (41.2) | 23 (43.4) | 28 (43.8) | 71 (25.7) | 68 (24.4) |
| Location of metastatic sites at screening, n (%) | ||||||||
| Lung ipsilateral | 163 (50.6) | 175 (52.1) | 109 (52.9) | 103 (51.8) | 30 (56.6) | 34 (53.1) | 105 (38.0) | 115 (41.2) |
| Lung contralateral | 140 (43.5) | 144 (42.9) | 87 (42.2) | 83 (41.7) | 25 (47.2) | 29 (45.3) | 98 (35.5) | 90 (32.3) |
| Bone | 92 (28.6) | 100 (29.8) | 66 (32.0) | 73 (36.7) | 18 (34.0) | 22 (34.4) | 43 (15.6) | 48 (17.2) |
| Liver | 63 (19.6) | 53 (15.8) | 45 (21.8) | 35 (17.6) | 14 (26.4) | 13 (20.3) | 64 (23.2) | 45 (16.1) |
| Adrenal glands | 42 (13.0) | 56 (16.7) | 29 (14.1) | 40 (20.1) | 8 (15.1) | 15 (23.4) | 36 (13.0) | 45 (16.1) |
| Brain | 26 (8.1) | 23 (6.8) | 14 (6.8) | 10 (5.0) | 5 (9.4) | 2 (3.1) | 6 (2.2) | 11 (3.9) |
| Other | 138 (42.9) | 156 (46.4) | 94 (45.6) | 104 (52.3) | 26 (49.1) | 34 (53.1) | 124 (44.9) | 129 (46.2) |
Abbreviations: NSCLC, non-small-cell lung cancer; PD-FLT, progressive disease as the best response to first-line therapy; TSFLT, time from start of first-line therapy, 9 months.