Table 1.
Patient Characteristics at Baseline and Study Dispositiona
| Characteristic | Cohort A (n=40) | Cohort B (n=31) | Cohort B2 (n=33) | Cohort B3 (n=33) | Cohort C (n=22) | TOTAL (n=159) |
|---|---|---|---|---|---|---|
| Median age, years (range) | 57.0 (22 to 77) | 54.0 (24 to 77) | 57.0 (40 to 74) | 54.0 (23 to 73) | 56.5 (37 to 77) | 56.0 (22 to 77) |
| < 60 years, n (%) | 22 (55.0) | 18 (58.1) | 22 (66.7) | 22 (66.7) | 15 (68.2) | 99 (62.3) |
| ≥ 60 years, n (%) | 18 (45.0) | 13 (41.9) | 11 (33.3) | 11 (33.3) | 7 (31.8) | 60 (37.7) |
| Gender, n (%) | ||||||
| Male | 28 (70.0) | 26 (83.9) | 18 (54.5) | 20 (60.6) | 14 (63.6) | 106 (66.7) |
| Female | 12 (30.0) | 5 (16.1) | 15 (45.5) | 13 (39.4) | 8 (36.4) | 53 (33.3) |
| ECOG Performance status, n (%) | ||||||
| 0 | 24 (60.0) | 16 (51.6) | 9 (27.3) | 10 (30.3) | 6 (27.3) | 65 (40.9) |
| 1 | 16 (40.0) | 15 (48.4) | 24 (72.7) | 23 (69.7) | 16 (72.7) | 94 (59.1) |
| # prior PD (%) | ||||||
| 0 | 40 (100.0) | 0 | 0 | 0 | 0 | 40 (25.2) |
| 1 | 0 | 25 (80.6) | 28 (84.8) | 25 (75.8) | 7 (31.8) | 85 (53.5) |
| 2 | 0 | 6 (19.4) | 5 (15.2 | 8 (24.2) | 15 (68.2) | 34 (21.4) |
| Resection prior to study (%) | ||||||
| Gross total | 8 (20.0) | 5 (16.1) | 3 (9.1) | 4 (12.1) | 1 (4.5) | 21 (13.2) |
| Subtotal | 29 (72.5) | 5 (16.1) | 8 (24.2) | 11 (33.3) | 2 (9.1) | 55 (34.6) |
| Biopsy | 3 (7.5) | 1 (3.2) | 0 | 1 (3.1) | 0 | 5 (3.1) |
| None | 0 | 20 (64.5) | 22 (66.7) | 17 (51.5) | 19 (86.4) | 78 (49.1) |
| Initial glioma diagnosis, n (%) | ||||||
| Grade II | 0 | 1 (3.2) | 0 | 1 (3.0) | 0 | 2 (1.3) |
| Grade III | 0 | 3 (9.7) | 1 (3.0) | 1 (3.0) | 0 | 5 (3.1) |
| Grade IV | 40 (100.0) | 27 (87.1) | 32 (97.0) | 31 (93.9) | 22 (100.0) | 152 (95.6) |
| Dexamethasone use at study entry, n (%) | 14 (35.0) | 11 (35.5) | 17 (51.5) | 17 (51.5) | 7 (31.8) | 66 (41.5) |
| Mean time from initial GBM diagnosis to enrollment, mean weeks (SD) | 4.7 (0.99) | 43.9 (28.31) | 71.0 (65.43) | 75.2 (60.42) | 80.3 (49.93) | 51.2 (54.47) |
| MGMT status, n (%) | ||||||
| Methylated | 0 | 9 (29.0) | 12 (36.4) | 12 (36.4) | 9 (40.9) | 42 (26.4) |
| Unmethylated | 40 (100.0) | 15 (48.4) | 18 (54.5) | 18 (54.5) | 11 (50.0) | 102 (64.2) |
| Unknown | 0 | 7 (22.6) | 3 (9.1) | 3 (9.1) | 2 (9.1) | 15 (9.4) |
| IDH1 Status (%) | ||||||
| Mutant | 5 (12.5) | 4 (12.9) | 4 (12.1) | 2 (6.1) | 1 (4.5) | 16 (10.1) |
| Wild-type | 35 (87.5) | 22 (71.0) | 28 (84.8) | 30 (90.9) | 19 (86.4) | 134 (84.3) |
| Unknown | 0 | 5 (16.1) | 1 (3.0) | 1 (3.0) | 2 (9.1) | 9 (5.7) |
| Tumor source for immunocorrelatives | ||||||
| Original diagnosis | 40 (100) | 22 (71.0) | 25 (75.8) | 26 (78.8) | 19 (86.4) | 132 (83.0) |
| Relapse | 0 | 6 (19.4) | 6 (18.2) | 7 (21.2) | 2 (9.1) | 21 (13.2) |
| Unknown | 0 | 3 (9.7) | 2 (6.1) | 0 | 1 (4.5) | 6 (3.8) |
| # study cycles completed, median (range) | 7.6 (1.2, 16.6) |
3.2 (0.8 to 37.0) |
4.1 (1.5 to 37.4) |
4.0 (2.0 to 17.9) |
2.1 (0.2 to 6.1) |
4.0 (0.2 to 37.4) |
| Reason off study, n (%) | ||||||
| PDb | 27 (67.5) | 26 (83.9) | 28 (84.8) | 24 (72.7) | 20 (90.9) | 125 (78.6) |
| Toxicityc | 4 (10.0) | 2 (6.5) | 2 (6.1) | 5 (15.2) | 1 (4.5) | 14 (8.8) |
| Elective withdrawal | 3 (7.5) | 2 (6.5) | 2 (6.1) | 4 (12.1) | 1 (4.5) | 12 (7.5) |
| Death (unrelated to tumor progression) | 3 (7.5) | 0 | 1 (3.0) | 0 | 0 | 4 (2.5) |
| Status at last contact, n (%) | ||||||
| Dead | 36 (90.0) | 25 (80.6) | 31 (93.9) | 31 (93.9) | 22 (100.0) | 145 (91.2) |
| Alive | 4 (10.0) | 6 (19.4) | 2 (6.1) | 2 (6.1) | 0 | 14 (8.8) |
| On study therapy | 3 (7.5) | 1 (3.2) | 0 | 0 | 0 | 4 (2.5) |
a
Percents are correct for denominators in each cell.
b
PD includes deaths attributed to progressive tumor
c
Includes events that occurred at the time of tumor progression but possible attribution to study therapy could not be excluded
Abbreviations: ECOG, Eastern Cooperative Oncology Group; GBM, glioblastoma; IDH1, isocitrate dehydrogenase 1; MGMT, methylguanine methyltransferase; PD, progressive disease; SD, standard deviation