Table 1.
Participant Baseline Characteristics
| Experimental Arm (N = 84) | Standard Arm (N = 41) | All Participants (N = 125) | |||||
|---|---|---|---|---|---|---|---|
| Age in years | Median (range) | 60 | (22-78) | 62 | (24-73) | 61 | (22-78) |
| Sex | Female | 25 | (30%) | 13 | (32%) | 38 | (30%) |
| Male | 59 | (70%) | 28 | (68%) | 87 | (70%) | |
| ECOG performance status | 0 | 50 | (60%) | 24 | (59%) | 74 | (59%) |
| 1 | 31 | (37%) | 16 | (39%) | 47 | (38%) | |
| 2 | 3 | (4%) | 1 | (2%) | 4 | (3%) | |
| Karnofsky performance status | 100 | 28 | (33%) | 17 | (41%) | 45 | (36%) |
| 90 | 38 | (45%) | 17 | (41%) | 55 | (44%) | |
| 80 | 11 | (13%) | 5 | (12%) | 16 | (13%) | |
| 70 | 4 | (5%) | 1 | (2%) | 5 | (4%) | |
| 60 | 2 | (2%) | 0 | (0%) | 2 | (2%) | |
| Unknown | 1 | (1%) | 1 | (2%) | 2 | (2%) | |
| Surgery type | Macroscopic | 72 | (86%) | 37 | (90%) | 109 | (87%) |
| Subtotal or biopsy | 12 | (14%) | 4 | (10%) | 16 | (13%) | |
| On dexamethasone at baseline | Yes | 45 | (54%) | 22 | (54%) | 67 | (54%) |
| No | 39 | (46%) | 19 | (46%) | 58 | (46%) | |
| Dexamethasone dose at baseline | Mean (range) | 2.9 mg | (1-8) | 3.2 mg | (2-6) | 3.0 mg | (1-8) |
| IDH R132H status by immunohistochemistry | Mutant | 1 | (1%) | 0 | (0%) | 1 | (1%) |
| Non-mutant | 78 | (93%) | 39 | (95%) | 117 | (94%) | |
| Unknown | 5 | (6%) | 2 | (5%) | 7 | (6%) |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; IDH, isocitrate dehydrogenase.