Table 2.
Patient Characteristics
| Median (range)/N (%) | ||||
|---|---|---|---|---|
| Parameter | IA+Tipifarnib, N=95 |
IA (Historical Control), N=108 |
P | |
| Age (y) | 50 (17-61) | 52 (17-61) | .517 | |
| PS (1) | 63 (66) | 59 (55) | .089 | |
| WBCs (×109/L) | 5.3 (0.5-161.5) | 10.0 (0.5-390.0) | .047 | |
| Platelets (×109/L) | 62 (9-676) | 58 (5-635) | .159 | |
| AHD (mo) | 2 (1-108) | 0 (0-144) | .807 | |
| 40 (42) | 38 (35) | .312 | ||
| Disease type | AML | 82 (86) | 100 (93) | .144 |
| MDS | 13 (14) | 8 (7) | ||
| CG | Diploid | 41 (43) | 56 (52) | .617 |
| t(8;21)/inversion 16 | 5 (5) | 3 (3) | ||
| Chromosome 5 or 7 abnormalities |
19 (20) | 16 (15) | ||
| Other | 29 (31) | 31 (29) | ||
| Not done | 1 (1) | 2 (2) | ||
| FLT3 (+)a | ITD | 13/83 (16) | 18/57 (32) | .080 |
| Point mutation | 6/83 (7) | 4/57 (7) | ||
IA, idarubicin and cytarabine; ECOG PS, performance status; WBCs, white blood cells; AHD, antecedent of hematologic disorder; AML, acute myeloid leukemia; MDS, myelodysplastic syndrome; CG, cytogenetic; inv, inversion; ITD, internal tandem duplication.
a
Two patients had both mutations on IA+tipifarnib; 1 patient had both mutations on IA.