Table 3.
Time to occurrence of new lesions
| 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) | |
| Sensitivity analysis 1a | ||||||||
| Patients with event, n (%) | 142 (44.1) | 154 (45.8) | 89 (43.2) | 93 (46.7) | 19 (35.8) | 28 (43.8) | 106 (38.4) | 111 (39.8) |
| Time to occurrence of new lesions (months) | ||||||||
| Median (months) | 11.7 | 10.9 | 11.3 | 9.9 | NR | 7.3 | 26.3 | 18.2 |
| HR (95% CI); P-value | 0.88 (0.70–1.11); P=0.2748 | 0.79 (0.59–1.06); P=0.1181 | 0.58 (0.31–1.09); P=0.0848 | 0.88 (0.67–1.14); P=0.3334 | ||||
| Sensitivity analysis 2b | ||||||||
| Patients with event, n (%) | 285 (88.5) | 295 (87.8) | 187 (90.8) | 182 (91.5) | 49 (92.5) | 60 (93.8) | 259 (93.8) | 253 (90.7) |
| New lesions | 142 (44.1) | 154 (45.8) | 89 (43.2) | 93 (46.7) | 19 (35.8) | 28 (43.8) | 106 (38.4) | 111 (39.8) |
| Death | 143 (44.4) | 141 (42.0) | 98 (47.6) | 89 (44.7) | 30 (56.6) | 32 (50.0) | 153 (55.4) | 142 (50.9) |
| Time to occurrence of new lesions (months) | ||||||||
| Median (months) | 6.9 | 5.6 | 6.4 | 4.7 | 6.0 | 4.5 | 5.6 | 4.6 |
| HR (95% CI); P-value | 0.90 (0.76–1.06); P=0.1970 | 0.77 (0.63–0.95); P=0.0161 | 0.62 (0.41–0.94); P=0.0232 | 0.93 (0.78–1.11); P=0.4295 | ||||
Notes:
a
In sensitivity analysis 1, patients were recorded as being censored using the OS results (time to new lesion).
b
In sensitivity analysis 2, death was counted as an event and patients could have either an event or be censored using the OS results (new lesion-free survival).
Abbreviations: HR, hazard ratio; NR, not reached; NSCLC, non-small-cell lung cancer; OS, overall survival; PD-FLT, progressive disease as the best response to first-line therapy; TSFLT <9, time from start of first-line therapy <9 months.