Table 1.
Main baseline characteristics of whole study population, and according to nivolumab (NIV) timing groups.
| Characteristics | All Patients (N = 95) |
‘Morning’ Group (n = 48) |
‘Afternoon’ Group (n = 47) |
p-Value |
|---|---|---|---|---|
| Timing of >50% of infusions | 09:27 to 12:54 | 12:55 to 17:14 | ||
| Actual NIV a timing | ||||
| Median time, hh:min | 12:54 | 11:55 | 13:34 | <0.001 |
| (range) | (9:27–17:14) | (9:27–16:52) | (10:10–17:14) | |
| (IQR) | (11:55–13:34) | (11:11–12:26) | (13:10–14:44) | |
| Median intra-patient CV b | 10% | 11% | 8% | |
| (range) | (2%–21%) | (2%–21%) | (2%–19%) | |
| Age, years | ||||
| Median (range) | 66.9 (41.2–82.5) | 66.2 (41.2–80.8) | 69.2 (48.8–82.5) | 0.012 |
| Sex | ||||
| Female | 16 (16.8%) | 4 (8.3%) | 12 (25.5%) | 0.025 |
| Male | 79 (83.2%) | 44 (91.7%) | 35 (74.5%) | |
| Tobacco-induced COPD c | 74 (77.9%) | 37 (77.1%) | 37 (78.7%) | 0.847 |
| Histological type | ||||
| Adenocarcinoma | 55 (57.9%) | 26 (54.2%) | 29 (61.7%) | 0.696 |
| Squamous cell carcinoma | 37 (38.9%) | 20 (41.7%) | 17 (36.2%) | |
| NSCLC unspecified | 3 (3.2%) | 2 (4.2%) | 1 (2.1%) | |
| Tumor PD-L1 expression | 0.098 | |||
| ≥1% | 39 (41.1%) | 23 (47.9%) | 16 (34.0%) | |
| <1% | 33 (34.7%) | 13 (27.1%) | 20 (42.6%) | |
| Not assessed | 23 (24.2%) | 12 (25.0%) | 11 (23.4%) | |
| Primary resected | 15 (15.8%) | 9 (18.8%) | 6 (12.8%) | 0.424 |
| Prior adjuvant chemo. | 11 (11.6%) | 7 (14.6%) | 4 (8.5%) | 0.355 |
| Prior radiotherapy | 57 (60.0%) | 27 (56.3%) | 30 (63.8%) | 0.451 |
| N of prior chemo. lines | ||||
| 0 | 1 (1.1%) | 1 (2.1%) | 0 (0.0%) | 0.955 |
| 1 | 72 (75.8%) | 36 (75.0%) | 36 (76.6%) | |
| 2–5 | 22 (23.2%) | 11 (22.9%) | 11 (23.4%) | |
| Number of sites involved | ||||
| Median (range) | 4 (1–8) | 4 (1–7) | 3 (2–8) | 0.854 |
| Site of metastases | ||||
| Brain | 23 (24.2%) | 12 (25.0%) | 11 (23.4%) | 0.856 |
| Pleura | 39 (41.1%) | 16 (33.3%) | 23 (48.9%) | 0.122 |
| Bone | 49 (51.6%) | 21 (43.8%) | 28 (59.6%) | 0.123 |
| Liver | 24 (25.3%) | 15 (31.3%) | 9 (19.1%) | 0.175 |
| Adrenal gland | 19 (20.0%) | 10 (20.8%) | 9 (19.1%) | 0.837 |
| Pericardium | 7 (7.4%) | 4 (8.3%) | 3 (6.4%) | 1 |
| WHO performance status | ||||
| 0 | 35 (36.8%) | 23 (47.9%) | 12 (25.5%) | 0.061 |
| 1 | 56 (58.9%) | 23 (47.9%) | 33 (70.2%) | |
| 2 | 4 (4.2%) | 2 (4.2%) | 2 (4.3%) |
a Nivolumab; b coefficient of variation; c chronic obstructive pulmonary disease.