Table 1.
Baseline Patient Characteristics
| CML in Myeloid Blast Phase | CML in Lymphoid Blast Phase | |||
|---|---|---|---|---|
| Characteristic | Dasatinib 140 mg QD, n575 |
Dasatinib 70 mg BID, n574 |
Dasatinib 140 mg QD, n533 |
Dasatinib 70 mg BID, n528 |
| Median age [range], y | 48 [16–78] | 52 [18–76] | 49 (21–76) | 56 (21–78) |
| Median CML duration [range], mo | 41 [1–461] | 40 [1–212] | 31 [5–172] | 23 [4–137] |
| Median blast phase duration [range], mo | 5.2 [0.03–103.5] | 4.7 [0.1–85.8] | 3.6 [0.2–41.0] | 7.1 [0.3–61.7] |
| Highest previous imatinib dose, n (%)a | ||||
| 400–600 mg | 42 (56) | 40 (54) | 18 (55) | 17 (61) |
| >600 mg | 33 (44) | 34 (46) | 15 (45) | 10 (36) |
| Previous imatinib therapy duration, n (%) | ||||
| <1 y | 28 (37) | 23 (31) | 17 (52) | 13 (46) |
| 1–3 y | 25 (33) | 26 (35) | 9 (27) | 12 (43) |
| >3 y | 22 (29) | 25 (34) | 7 (21) | 3 (11) |
| Imatinib resistance, n (%) | 60 (80) | 64 (86) | 27 (82) | 26 (93) |
| Imatinib intolerance, n (%) | 15 (20) | 10 (14) | 6 (18) | 2 (7) |
| Other previous treatment, n (%) | ||||
| Interferon-a | 28 (37) | 28 (38) | 13 (39) | 7 (25) |
| Chemotherapy | 46 (61) | 37 (50) | 22 (67) | 21 (75) |
| Stem cell transplantation | 12 (16) | 9 (12) | 6 (18) | 6 (21) |
| Radiotherapy | 7 (9) | 6 (8) | 5 (15) | 4 (14) |
| Median platelet count/nL [range] | 46 [2–1495] | 49 [7–3993] | 47 [2–331] | 41 [6–611] |
| Platelets <100/nL | 48 (64) | 48 (65) | 25 (76) | 19 (68) |
| Median WBC count/nL [range] | 22 (0.4–223) | 21 [0.1–258] | 12 [1–300] | 7 [1–127] |
| WBC count ‡20/nL | 42 (56) | 38 (51) | 15 (45) | 9 (32) |
| Median bone marrow blasts [range], % | 42 [0–99] | 41 [0–94] | 70 [0–98] | 81 [1–100] |
CML indicates chronic myeloid leukemia; QD, once daily; BID, twice daily; WBC, white blood cell.
a
No data were available for 1 patient with CML in lymphoid blast phase who was randomized to receive dasatinib 70 mg twice daily.