Table 1. Demographic and Baseline Characteristics by Treatment Group.
| LY2181308 (Monotherapy Cohort) N=8 |
LY2181308 + idarubicin + cytarabine (Combination Cohort) N=16 |
Total N=24 |
|
|---|---|---|---|
| Sex: female/male, n | 5/3 | 6/10 | 11/13 |
| Age: mean ± SD, years | 60.3 (15.9) | 48.2 (14.7) | 52.2 (15.9) |
| Race: n (%) | |||
| African | 0 | 2 (12.5) | 2 (8.3) |
| Caucasian | 7 (87.5) | 11 (68.8) | 18 (75.0) |
| East Asian | 1 (12.5) | 0 | 1 (4.2) |
| Hispanic | 0 | 1 (6.3) | 1 (4.2) |
| West Asian | 0 | 2 (12.5) | 2 (8.3) |
| ECOG PS: n (%) | |||
| 0 | 1 (12.5) | 1 (6.3) | 2 (8.3) |
| 1 | 7 (87.5) | 11 (68.8) | 18 (75.0) |
| 2 | 0 | 4 (25.0) | 4 (16.7) |
| AML WHO Criteria: n (%) | 7 (87.5) | 15 (93.8) | 22 (91.7) |
| De novo: n (%) | 6 (75.0) | 14 (87.5) | 20 (83.3) |
| Not specified | 0 | 1 (6.3) | 1 (4.2) |
| Genetic abberations | 0 | 2 (12.5) | 2 (8.3) |
| Erythroblastic | 0 | 2 (12.5) | 2 (8.3) |
| Myeloblastic | |||
| Minimal differentiation | 3 (37.5) | 3 (18.8) | 6 (25.0) |
| Differentiated | 1 (12.5) | 3 (18.8) | 4 (16.7) |
| Monocytic | 1 (12.5) | 0 | 1 (4.2) |
| Myelomonocytic | 1 (12.5) | 3 (18.8) | 4 (16.7) |
| Secondary AML: n (%) | |||
| Not specified | 1 (12.5) | 2 | 3 (12.5) |
| Multi-lineage | 0 | 0 | 0 |
| Myeloblastic with minimal differentiation | 1 (12.5) | 0 | 1 (4.2) |
| With FLT3 mutation: n (%) | 0 | 2 (12.5) | 2 (8.3) |
| Prior history | |||
| Prior remissions: n (%) | |||
| 1 | 1 (25.0) | 4 (25.0) | 5 (20.8) |
| 2 | 3 (37.5) | 4 (25.0) | 7 (29.2) |
| 3 | 1 (12.5) | 1 (6.3) | 2 (8.3) |
| ≥4 | 1 (12.5) | 2 (25.0) | 3 (12.5) |
| Primary refractory disease: n (%) | 2 (25.0) | 5 (31.3) | 7 (29.2) |
| WBCs at first visit actual, ×109/L: n (%) | |||
| <4.5 | 3 (37.5) | 8 (50.0) | 11 (45.8) |
| ≥4.5 and ≤11 | 2 (25.0) | 3 (18.8) | 5 (20.8) |
| >11 | 3 (37.5) | 5 (31.3) | 8 (33.3) |
Abbreviations: AML = acute myeloid leukemia; ECOG = Eastern Cooperative Oncology Group; n = number of patients in each category; N = number of enrolled patients; PS = performance status; SD = standard deviation; WBC = white blood cell; WHO = World Health Organization.