Table 1.
Baseline characteristics and demographics (FAS).
| Parameters | Buparlisib daily dose (+imatinib 400 mg) | All patients | ||||
|---|---|---|---|---|---|---|
| 40 mg n = 4 |
50 mg n = 4 |
70 mg n = 3 |
80 mg n = 43 |
100 mg n = 6 |
n = 60 | |
| Age (years) | ||||||
| Median (range) | 40.5 (30–72) | 52.0 (44–63) | 63.0 (56–78) | 57.0 (28–78) | 63.5 (42–72) | 56.5 (28–78) |
| Age category (years), n (%) | ||||||
| <65 | 3 (75.0) | 4 (100) | 2 (66.7) | 31 (72.1) | 3 (50.0) | 43 (71.7) |
| ≥65 | 1 (25.0) | 0 | 1 (33.3) | 12 (27.9) | 3 (50.0) | 17 (28.3) |
| Sex, n (%) | ||||||
| Male | 2 (50.0) | 2 (50.0) | 3 (100) | 27 (62.8) | 5 (83.3) | 39 (65.0) |
| Female | 2 (50.0) | 2 (50.0) | 0 | 16 (37.2) | 1 (16.7) | 21 (35.0) |
| Race, n (%) | ||||||
| Caucasian | 4 (100) | 4 (100) | 3 (100) | 39 (90.7) | 6 (100) | 56 (93.3) |
| Asian | 0 | 0 | 0 | 3 (7.0) | 0 | 3 (5.0) |
| Black | 0 | 0 | 0 | 1 (2.3) | 0 | 1 (1.7) |
| ECOG performance status, n (%) | ||||||
| 0 | 0 | 2 (50.0) | 3 (100) | 24 (55.8) | 4 (66.7) | 33 (55.0) |
| 1 | 4 (100) | 2 (50.0) | 0 | 18 (41.9) | 2 (33.3) | 26 (43.3) |
| 2 | 0 | 0 | 0 | 1 (2.3) | 0 | 1 (1.7) |
| Mitotic index (per 50 HPFs)a | ||||||
| ≤5 | 0 | 1 (25.0) | 0 | 9 (20.9) | 1 (16.7) | 11 (18.3) |
| >5 to ≤10 | 0 | 0 | 0 | 5 (11.6) | 1 (16.7) | 6 (10.0) |
| >10 | 0 | 3 (75.0) | 1 (33.3) | 8 (18.6) | 2 (33.3) | 14 (23.3) |
| Missing | 2 (50.0) | 0 | 2 (66.7) | 13 (30.2) | 2 (33.3) | 19 (31.7) |
| Complete gross resection (primary tumour) | ||||||
| No | 2 (50.0) | 0 | 0 | 10 (23.3) | 0 | 12 (20.0) |
| Yes | 2 (50.0) | 4 (100) | 3 (100) | 33 (76.7) | 6 (100) | 48 (80.0) |
| Number of prior regimens | ||||||
| 2 | 2 (50.0) | 3 (75.0) | 0 | 12 (27.9) | 3 (50.0) | 20 (33.3) |
| 3 | 1 (25.0) | 0 | 1 (33.3) | 24 (55.8) | 0 | 26 (43.3) |
| 4 | 0 | 0 | 1 (33.3) | 6 (14.0) | 1 (16.7) | 8 (13.3) |
| ≥5 | 1 (25.0) | 1 (25.0) | 1 (33.3) | 1 (2.3) | 2 (33.3) | 6 (10.0) |
| Time since initial diagnosis (primary site) to the first dose of study treatment, median (range), months |
68.0 (42.6–305.1) |
68.3 (56.5–79.3) |
85.9 (74.7–128.9) |
67.6 (6.2–181.6) |
65.8 (40.6–124.9) |
70.4 (6.2–305.1) |
ECOG Eastern Cooperative Oncology Group, FAS full-analysis set, HPF high-power field.
aIf the mitotic count was provided for HPFs other than 50, the count was scaled by multiplying it by 50/number of HPF used.