Table 5.
Dasatinib Exposure and Dose Modifications
| CML in Myeloid Blast Phase | CML in Lymphoid Blast Phase | |||
|---|---|---|---|---|
| Variable | Dasatinib 140 mg QD, n574 |
Dasatinib 70 mg BID, n574 |
Dasatinib 140 mg QD, n533 |
Dasatinib 70 mg BID, n528 |
| Median average daily dasatinib dose [range], mg/d Treatment duration median [range], mo |
140 [49–177] 3.3 [0.0–27.7] |
138 [40–175] 3.1 [0.0–27.7] |
140 [60–170] 3.4 [0.1–10.4] |
123 [83–171] 3.6 [0.2–22.1] |
| Dose interruption, n (%) | 32 (43) | 34 (46) | 11 (33) | 16 (57) |
| Hematologic toxicitya | 10 (14) | 14 (19) | 3 (9) | 6 (21) |
| Nonhematologic toxicitya | 21 (28) | 17 (23) | 8 (24) | 9 (32) |
| Dose reduction, n (%) | 13 (18) | 24 (32) | 9 (27) | 11 (39) |
| Hematologic toxicitya | 3 (4) | 7 (10) | 2 (6) | 3 (11) |
| Nonhematologic toxicitya | 10 (14) | 13 (18) | 7 (21) | 7 (25) |
| Dose escalation, n (%) | 36 (49) | 16 (22) | 10 (30) | 8 (29) |
| Loss or lack of responsea | 17 (23) | 8 (11) | 5 (15) | 4 (14) |
| Rising percentage blastsa,b | 18 (24) | 7 (10) | 5 (15) | 4 (14) |
CML indicates chronic myeloid leukemia; QD, once daily; BID, twice daily.
a
Reasons for dose interruption, reduction, or escalation.
b
Rising percentage blasts on 2 consecutive hematologic assessments at least 2 weeks apart.