Table 1.
Baseline characteristics of the study population
| Overall population (n=54) |
Cohort-1 (n=27) |
Cohort-2 (n=27) |
|
| Sex, n(%) | |||
| Male | 34 (63) | 14 (52) | 20 (74) |
| Female | 20 (37) | 13 (48) | 7 (26) |
| Median age at treatment initiation, years | 55 (range 19–75) | 57 (range 20–70) | 47 (range 19–75) |
| ECOG performance status, n(%) | |||
| 0 | 27 (50) | 20 (74) | 7 (26) |
| 1 | 22 (41) | 6 (22) | 16 (59) |
| 2 | 5 (9) | 1 (4) | 4 (15) |
| Diagnosis, n(%) | |||
| Primary diagnosis of grade IV glioma | 37 (69) | 18 (67) | 19 (70) |
| Primary diagnosis of lower-grade glioma with evolution to high-grade glioma | 17 (31) | 9 (33) | 8 (30) |
| Molecular profile, n(%) | |||
| IDH1/2 mutation | |||
| Mutant | 10 (19) | 5 (19) | 5 (19) |
| Wild-type | 34 (63) | 20 (74) | 14 (52) |
| Unknown | 10 (19) | 2 (7) | 8 (30) |
| MGMT promotor | |||
| Methylated | 6 (11) | 3 (11) | 3 (11) |
| Unmethylated | 14 (26) | 8 (30) | 6 (22) |
| Unknown | 34 (63) | 16 (59) | 18 (67) |
| 1 p/19q codeletion | |||
| Yes | 4 (7) | 1 (4) | 3 (11) |
| No | 19 (35) | 11 (41) | 8 (30) |
| Unknown | 31 (57) | 15 (56) | 16 (59) |
| Use of oral corticosteroid therapy at treatment initiation, n(%) | 31 (57) | 4 (15) | 27 (100) |
| Median daily dose of methylprednisolone at baseline | 8 mg | 32 mg | |
| Prior therapy for primary diagnosis of glioma, n(%) | |||
| Primary surgery for diagnosis | |||
| Resection | 47 (87) | 24 (89) | 23 (85) |
| Biopsy | 7 (13) | 3 (11) | 4 (15) |
| Primary therapeutic strategy | |||
| Resection/biopsy only | 7 (13) | 3 (11) | 4 (15) |
| Radiation therapy only | 1 (2) | 0 (0) | 1 (4) |
| Chemotherapy only | 1 (2) | 0 (0) | 1 (4) |
| Surgery+chemotherapy only | 1 (2) | 1 (4) | 0 (0) |
| Surgery+radiation therapy only | 3 (6) | 2 (7) | 1 (4) |
| Surgery+radiation therapy +chemotherapy (sequential) | 1 (2) | 0 (0) | 1 (4) |
| Surgery+concomitant radiation therapy/TMZ+adjuvant TMZ | 40 (74) | 21 (78) | 19 (70) |
| Prior therapy for recurrent GB, n(%) | 39 (72) | 20 (74) | 19 (70) |
| Surgery | 33 (61) | 18 (33) | 15 (56) |
| Median no of surgeries | 1 (range 1–4) | 1 (range 1–2) | 1 (range 1–4) |
| Radiation therapy | 11 (20) | 6 (22) | 5 (19) |
| Systemic therapy | 33 (61) | 16 (59) | 17 (63) |
| Median no of lines of systemic therapy | 1 (range 1–4) | 1 (range 1–4) | 1 (range 1–3) |
1 p/19q codeletion: deletion of short arm of chromosome one and long arm of chromosome 19.
ECOG, Eastern Cooperative Oncology Group; GB, glioblastoma; IDH, isocitrate dehydrogenase; MGMT, O-6-methylguanine-DNA methyltransferase; TMZ, temozolomide.