Table 1.
Patient Demographics and Baseline Characteristics
| Nivolumab plus radiotherapy (n = 280) | Temozolomide plus radiotherapy (n = 280) | |
|---|---|---|
| Age, years | ||
| Median | 59.5 | 56.0 |
| Range | 18–83 | 23–81 |
| Age, no. (%) | ||
| < 65 years | 190 (67.9) | 207 (73.9) |
| ≥ 65 to < 75 years | 76 (27.1) | 61 (21.8) |
| ≥ 75 years | 14 (5.0) | 12 (4.3) |
| Sex, no. (%) | ||
| Male | 190 (67.9) | 175 (62.5) |
| Female | 90 (32.1) | 105 (37.5) |
| Histopathologic diagnosis, no. (%) | ||
| Glioblastoma | 272 (97.1) | 270 (96.4) |
| Gliosarcoma | 8 (2.9) | 10 (3.6) |
| RPA class, no. (%)a | ||
| III | 20 (7.1) | 42 (15.0) |
| IV | 219 (78.2) | 202 (72.1) |
| V | 41 (14.6) | 36 (12.9) |
| Other | 0 | 0 |
| Extent of surgery, no. (%)b | ||
| Complete resection | 151 (53.9) | 144 (51.4) |
| Partial resection | 129 (46.1) | 136 (48.6) |
| KPS, no. (%) | ||
| 100 | 76 (27.1) | 91 (32.5) |
| 90 | 122 (43.6) | 118 (42.1) |
| 80 | 54 (19.3) | 47 (16.8) |
| 70 | 28 (10.0) | 20 (7.1) |
| Not reported | 0 | 4 (1.4) |
| Time from diagnosis to randomization, weeks | ||
| Median | 4.93 | 5.14 |
| Range | (4.1–5.6) | (4.3–5.9) |
| Patients with evaluable PD-L1 expression, no. (%) | ||
| PD-L1 expression level, no. (%)c | 275 (99.6) | 280 (100.0) |
| < 1% | 171 (62.2) | 155 (55.4) |
| ≥ 1% | 104 (37.8) | 125 (44.6) |
| Not quantifiable | 1 (0.4) | 0 |
| Corticosteroid use, no. (%)d | ||
| Yes | 78 (27.9) | 95 (33.9) |
| ≤ 3 mg/day | 62 (22.1) | 73 (26.1) |
| > 3 mg/day | 16 (5.7) | 22 (7.9) |
| No | 202 (72.1) | 185 (66.1) |
KPS, Karnofsky Performance Scale; PD-L1, programmed cell death ligand 1; RPA, recursive-partitioning analysis.
aThe RPA classes were as follows: class III, age < 50 years and KPS ≥ 90 (on a scale of 0–100, with higher scores indicating better function); class IV, < 50 years and KPS < 90 (or ≥ 50 years, KPS ≥ 70, complete or partial tumor resection, and ability to work); class V, ≥ 50 years, KPS ≥ 70, complete or partial tumor resection, and inability to work (or ≥ 50 years, KPS ≥ 70, and tumor-biopsy specimen only; or ≥ 50 years and KPS < 70).35
bThis characteristic was used as a stratification factor as recorded in the interactive voice response system at time of randomization. Information presented as collected in the case report form.
cPercentages were based on the number of patients with evaluable PD-L1 expression.
dBased on average corticosteroid use 5 days before start of dosing or randomization date for patients not treated (in dexamethasone equivalent). Patients enrolled at doses > 3 mg/day were tapered off; treatment did not commence until the dose was ≤ 3 mg/day.