Table 1.
Patient characteristics among randomized patients, n (%)
| Baseline Characteristics: randomized patients (n = 639) | Placebo (n = 316) | Depatux-m (n = 323) |
|---|---|---|
| Age, years | ||
| Median | 60 | 59 |
| Range | 29–82 | 22–84 |
| Gender, n (%) | ||
| Male | 188 (59) | 206 (64) |
| Female | 128 (41) | 117 (36) |
| Histology, (central review) n (%) | ||
| Glioblastoma | 311 (98) | 319 (99) |
| Gliosarcoma | 1 (<1) | 3 (1) |
| Other | 1 (<1) | 1 (<1) |
| Missing | 3 (1) | 0 (0) |
| Karnofsky Performance Status (KPS), n (%) | ||
| 70 | 38 (12) | 44 (14) |
| 80 | 80 (25) | 76 (23) |
| 90–100 | 198 (63) | 203 (63) |
| Extent of resection (EOR), n (%) | ||
| Gross total resection | 181 (57) | 185 (57) |
| Partial/subtotal resection | 122 (39) | 128 (40) |
| Biopsy | 10 (3) | 10 (3) |
| Missing | 3 (1) | 0 (0) |
| Impairment of Neurologic Function (INF), n (%) | ||
| > minor | 25 (8) | 27 (8) |
| ≤ minor | 288 (91) | 296 (92) |
| Missing | 3 (1) | 0 (0) |
| a Radiation Therapy Oncology Group—Recursive Partitioning Analysis (RTOG-RPA) Prognostic Class, n (%) | ||
| III | 46 (14) | 51 (16) |
| IV | 233 (74) | 236 (73) |
| V | 37 (12) | 36 (11) |
| HVLT-R | ||
| Total Recall, mean (Standard Deviation) | −1.5 (2.2) | −1.4 (1.9) |
| a Region of World, n (%) | ||
| Other | 214 (68) | 216 (67) |
| USA/Canada | 102 (32) | 107 (33) |
| a MGMT, n (%) | ||
| Methylated | 117 (37) | 118 (37) |
| Unmethylated | 199 (63) | 205 (63) |
| a EGFRvIII, n (%) | ||
| Mutated | 168 (53) | 164 (51) |
| Other | 148 (47) | 159 (49) |
aStratification factor.
RTOG-RPA Class definitions
•III: Age < 50, KPS ≥ 90
•IV: Age < 50, KPS < 90; OR Age ≥ 50, KPS ≥ 70, EOR > biopsy, INF ≤ minor
•V: Age ≥ 50, KPS ≥ 70, EOR > biopsy, INF > minor; OR Age ≥ 50, KPS ≥ 70, EOR = Biopsy