Table 1.
Patient Characteristics
| All Patients n=53 |
ARM 1 (DD) n=25 |
ARM 2 (MN) n=28 |
|
|---|---|---|---|
| Median Age, years (range) | 52.3 (20.9–76.4) | 50.8 (21.3–75.9) | 55.5 (20.9–76.4) |
| Female/male | 13/40 | 6/19 | 7/21 |
| Median KPS (range) | 90 (70–100) | 90 (70–100) | 90 (70–100) |
| Tumor type at screening* | |||
| Glioblastoma, IDH-wildtype | 35 | 16 | 19 |
| Glioblastoma, IDH-mutant | 4 | 0 | 4 |
| Glioblastoma, NOS | 1 | 1 | 0 |
| Anaplastic astrocytoma, IDH-mutant | 9 | 6 | 3 |
| Anaplastic astrocytoma, IDH-wildtype | 2 | 2 | 0 |
| Diffuse midline glioma, H3K27M-mutant | 2 | 0 | 2 |
| 1st/2nd recurrence | |||
| 1st relapse | 38 | 18 | 20 |
| 2nd relapse | 15 | 7 | 8 |
| IDH mutation status** | |||
| IDH-mutant | 13 | 6 | 7 |
| IDH-wildtype | 39 | 18 | 21 |
| MGMT promoter status*** | |||
| methylated | 24 | 10 | 14 |
| unmethylated | 28 | 14 | 14 |
| Prior brain tumor therapies | |||
| Concurrent XRT/TMZ Followed by adjuvant TMZ | 50 | 23 | 27 |
| XRT and TMZ in sequential | 3 | 2 | 1 |
| Others**** | 18 | 10 | 8 |
Note:
Tumor type at screening is based on “The 2016 World Health Organization Classification of the Tumor of the Central Nervous System”.
IDH mutation status is not available in one patient due to lack of enough tumor material.
MGMT promoter methylation status is not available due to lack of enough tumor material in one case.
Other therapies include clinical trial therapies, re-irradiation, TTF (Tumor Treating Field). All 18 patients who received these therapies also received concurrent XRT/TMZ followed by adjuvant TMZ as well.
Abbreviations: DD, dose-dense; MN, metronomic; KPS, Karnofsky performance status; GBM, glioblastoma; AA, anaplastic astrocytoma; IDH, isocitrate dehydrogenase; TMZ, temozolomide; XRT, radiation therapy.