Table 1. Patient Demographics and Baseline Characteristics.
| Characteristic | No. (%) | |
|---|---|---|
| Nivolumab (n = 184) | Bevacizumab (n = 185) | |
| Age, median (range), y | 55.5 (22-77) | 55.0 (22-76) |
| <65 y | 142 (77.2) | 156 (84.3) |
| Male | 116 (63.0) | 119 (64.3) |
| Histopathologic diagnosis | ||
| Glioblastoma | 183 (99.5) | 184 (99.5) |
| Gliosarcoma | 1 (0.5) | 1 (0.5) |
| Radiotherapy completed | 184 (100.0) | 185 (100.0) |
| Temozolomide received | 183 (99.5) | 185 (100.0) |
| Median No. of prior temozolomide cycles (range) | 6.0 (0-42) | 5.0 (1-26) |
| Time from last RT dose to first dose of study drug | ||
| No. of patients | 182 | 163 |
| Median (range), mo | 8.8 (1.8-47.5) | 6.9 (1.1-36.9) |
| Time from initial diagnosis to recurrence | ||
| Median (range), mo | 10.1 (3.4-49.6) | 8.5 (0-38.2) |
| <1 y | 108 (58.6) | 139 (75.1) |
| ≥1 y | 76 (41.3) | 46 (24.9) |
| Karnofsky performance status at study entry | ||
| 100 | 42 (22.8) | 25 (13.5) |
| 90 | 71 (38.6) | 78 (42.2) |
| 80 | 50 (27.2) | 57 (30.8) |
| 70 | 19 (10.3) | 24 (13.0) |
| <70 | 2 (1.1) | 0 |
| Not reported | 0 | 1 (0.5) |
| Measurable target lesion(s) | 153 (83.2) | 156 (84.3) |
| Target lesion size, median (range), mm2 | 859.0 (100-5278) | 854.0 (110-4030) |
| Site of target lesion(s) | ||
| Temporal lobe | 64 (34.8) | 54 (29.2) |
| Frontal lobe | 49 (26.6) | 53 (28.6) |
| Parietal lobe | 23 (12.5) | 27 (14.6) |
| Occipital lobe | 12 (6.5) | 11 (5.9) |
| Cerebellum | 0 | 2 (1.1) |
| Brain stem | 1 (0.5) | 0 |
| Insula | 0 | 1 (0.5) |
| Other | 20 (10.9) | 28 (15.1) |
| MGMT promoter methylation status | ||
| Methylated | 43 (23.4) | 42 (22.7) |
| Unmethylated | 59 (32.1) | 67 (36.2) |
| Not reported | 82 (44.6) | 76 (41.1) |
| PD-L1 expression level | ||
| <1% | 107 (58.2) | 114 (61.6) |
| ≥1% | 48 (26.1) | 35 (18.9) |
| Not quantifiable | 29 (15.8) | 36 (19.5) |
| Corticosteroid usea | ||
| Yes | 73 (39.7) | 79 (42.7) |
| <2 mg/d | 20 (10.9) | 25 (13.5) |
| ≥2 to <4 mg/d | 27 (14.7) | 26 (14.1) |
| ≥4 mg/d | 26 (14.1) | 28 (15.1) |
| No | 111 (60.3) | 106 (57.3) |
Abbreviations: PD-L1, programmed death ligand 1; RT, radiotherapy.
a
Dexamethasone equivalents.