Table 1. Summary of patient characteristics, treatment delivery and outcome.
| CENTRIC All Patients N=545 |
CENTRIC Biomarker Cohort n=274 |
CORE All Patients N=265 |
CORE Biomarker Cohort n=224 |
|
|---|---|---|---|---|
| Age at baseline | ||||
| Median (years) | 57.9 | 58.8 | 56.2 | 56.6 |
| Range (years) | 21.7 - 81.0 | 21.7-81.0 | 20.8 - 77.5 | 20.8 - 76.5 |
| Gender | ||||
| Male | 291 (53.4) | 148 (54.0%) | 155 (58.5) | 131 (58.5) |
| Female | 254 (46.6) | 126(46.0%) | 110 (41.5) | 93 (41.5) |
| Histological subtype | ||||
| Glioblastoma | 496 (91.0) | 248 (90.5) | 251 (94.7) | 211 (94.2) |
| Gliosarcoma | 21 (3.9) | 10 (3.6) | 10 (3.8) | 9 (4.0) |
| Giant cell | 17 (3.1) | 12 (4.4) | 3 (1.1) | 3 (1.3) |
| Other | 11 (2.0) | 4 (1.5) | 1 (0.4) | 1 (0.4) |
| ECOG Performance Status at baseline | ||||
| PS 0 | 309 (56.7) | 163 (59.5) | 131 (49.4) | 111 (49.6) |
| PS 1 | 236 (43.3) | 111 (40.5) | 132 (49.8) | 111 (49.6) |
| No data | 0 (0.0) | 0 (0.0) | 2 (0.8) | 2 (0.9) |
| Surgery | ||||
| Subtotal resection (partial/biopsy) | 274 (50.3) | 128 (46.7) | 128 (48.3) | 102 (45.5) |
| Gross total resection | 269 (49.4) | 144 (52.6) | 136 (51.3) | 121 (54.0) |
| No data | 2 (0.4) | 2 (0.7) | 1 (0.4) | 1 (0.4) |
| Treatment received | ||||
| TMZ (n=273) | TMZ (n=137) | TMZ (n=89) | TMZ (n=71) | |
| Received study intervention | 258 (94.5) | 130 (94.9) | 85(95.5) | 68 (95.8) |
| Started RTX | 256 (93.8) | 129 (94.2) | 85(95.5) | 68 (95.8) |
| Started maintenance TMZ | 211 (77.3) | 106 (77.4) | 71(80.0) | 58 (81.7) |
| Number of TMZ maintenance cycles | ||||
| Median | 6 | 6 | 6 | 6 |
| Range | 1-32 | 1-21 | 1-11 | 1-8 |
| Cilengitide (n=272) | Cilengitide (n=137) | Cilengitide (n=176) | Cilengitide (n=153) | |
| Received study intervention | 263 (96.7) | 133 (97.0) | 170(96.6) | 147(96.1) |
| Started Pre-RTX phase | 259 (95.2) | 131 (95.6) | 168(95.5) | 146(95.4) |
| Started RTX phase | 260 (95.6) | 131 (95.6) | 168(95.5) | 146(95.4) |
| Started maintenance TMZ | 221 (81.3) | 111 (81.0) | 144(81.8) | 125(81.7) |
| Number of TMZ maintenance cycles | ||||
| Median | 6 | 6 | 6 | 6 |
| Range | 1-21 | 1-21 | 1-19 | 1-19 |
| Started cilengitide monotherapy phase | 168 (61.8) | 77 (56.2) | 85(48.3) | 74(48.4) |
| Total number of cilengitide infusions | ||||
| Median | 90 | 72 | 69 | 69 |
| Range | 1-388 | 1-317 | 2-224 | 2-224 |
| Outcome | ||||
| Median PFS (months, 95% CI) | 12.3 (10.6, 13.6) | 12.1 (10.4,13.6) | 6.2 (5.9, 7.7) | 6.3 (5.9, 7.7) |
| Median OS (months, 95% CI) | 26.3 (24.4, 29.3) | 25.4 (23.3,30.9) | 14.4 (13.4, 15.6) | 14.1 (12.9, 15.5) |