Table 1.
Characteristic | Enzastaurin (n = 174) |
Lomustine (n = 92) |
||
---|---|---|---|---|
No. | % | No. | % | |
Sex | ||||
Male | 116 | 66.7 | 56 | 60.9 |
Female | 58 | 33.3 | 36 | 39.1 |
Age, years | ||||
< 50 | 44 | 25.3 | 28 | 30.4 |
≥ 50 | 130 | 74.7 | 64 | 69.6 |
Karnofsky performance status* | ||||
Low, 70 or 80 | 83 | 47.7 | 46 | 50.0 |
High, 90 or 100 | 90 | 51.7 | 45 | 48.9 |
Pathologic diagnosis* | ||||
Glioblastoma | 171 | 98.8 | 89 | 97.8 |
Gliosarcoma | 2 | 1.2 | 2 | 2.2 |
Time from diagnosis to random assignment, months | ||||
Median | 10.1 | 12.1 | ||
Range | 0.9-51.5 | 4.4-92.0 | ||
Disease recurrence† | ||||
First | 129 | 74.1 | 70 | 76.9 |
Second | 45 | 25.9 | 21 | 23.1 |
History of seizures | ||||
Yes | 84 | 48.3 | 45 | 48.9 |
No | 90 | 51.7 | 47 | 51.1 |
Prior therapies | ||||
Surgery | 174 | 100 | 91 | 98.9 |
Radiotherapy | 174 | 100 | 91 | 98.9 |
Systemic therapy | 173 | 99.4 | 90 | 97.8 |
Corticosteroid | 92 | 52.9 | 48 | 52.2 |
EIAED therapy | 54 | 31.0 | 25 | 27.2 |
Abbreviation: EIAED, enzyme-inducing antiepileptic drugs.
The status of two patients was unknown.
Disease recurrence was reported in 91 patients in lomustine arm.