Table 1.
Baseline Demographics
| Demographics Characteristics | N (%) |
|---|---|
| All patients | 202 (100) |
| Median age—years (range) | (20–80) |
| Sex | |
| Male | 124 (59) |
| Female | 78 (37) |
| Karnofsky Performance | |
| 70 | 22 (11) |
| 80 | 60 (29) |
| 90 | 79 (38) |
| 100 | 41 (20) |
| EGFR amplification status | |
| Amplified | 148 (71) |
| Not amplified | 45 (21) |
| Unknown | 9 (4) |
| EGFRvIII mutation status | |
| Positive | 110 (52) |
| Negative | 82 (39) |
| Unknown | 10 (5) |
| MGMT methylation status | |
| Methylated | 28 (13) |
| Unmethylated | 59 (28) |
| Unknown | 115 (55) |
| Treatment arm A—Adjuvant | |
| (Depatux-M in combination with radiation and temozolomide) | 45 (22) |
| Arm A: Dose escalation | 24 (11) |
| Arm A: Dose expansion | 21 (10) |
| Treatment arm B—Recurrent | |
| (Depatux-M in combination with temozolomide) | 68 (34) |
| Arm B: Dose escalation | 15 (7) |
| Arm B: Dose expansion | 53 (25) |
| Treatment arm B—Adjuvant | 14 (7) |
| Arm B: Adjuvant, Dose escalation | 14 (7) |
| Treatment arm C—Recurrent | |
| (Depatux-M monotherapy) | 75(36) |
| Arm C: Monotherapy | 75 (36) |
EGFR, Epidermal growth factor receptor; MGMT, O6-methylguanine-DNA methyltransferase.