Table 2.
CML in Myeloid Blast Phase |
CML in Lymphoid Blast Phase |
|||
---|---|---|---|---|
Response | Dasatinib 140 mg QD |
Dasatinib 70 mg BID |
Dasatinib 140 mg QD |
Dasatinib 70 mg BID |
Hematologic response | ||||
No. of patients | n¼75 | n¼74 | n¼33 | n¼28 |
MHR, n (%) | 21 (28) | 21 (28) | 14 (42) | 9 (32) |
95% CI | 18–40 | 19–40 | 26–61 | 16–52 |
Median time to MHR [95%CI], moa | 2 [1.8–2.8] | 3 [1.5–2.8] | 2 [1.0–1.8] | 2 [1.2–3.0] |
Median duration of MHR [95% CI], moa | 8 [5.6–20.7] | 9 [7.1-NA] | 5 [4.0–8.1] | 8 [7.1–9.9] |
Any BCR-ABL mutation, n/total (%) | 9/32 (28) | 9/28 (32) | 7/20 (35) | 4/14 (29) |
No mutation, n/total (%) | 10/33 (30) | 10/36 (28) | 3/9 (33) | 2/7 (29) |
Complete hematologic response, n (%) | 13 (17) | 13 (18) | 7 (21) | 4 (14) |
No evidence of leukemia, n (%) | 8 (11) | 8 (11) | 7 (21) | 5 (18) |
Cytogenetic responseb | ||||
No. of patients | n¼72 | n¼71 | n¼32 | n¼25 |
MCyR, n (%) | 18 (25) | 20 (28) | 16 (50) | 10 (40) |
95% CI | 16–37 | 18–40 | 32–68 | 21–61 |
Median time to MCyR [95%CI], moa | 1.9 [1.4–2.8] | 1.6 [1.0–2.8] | 1.4 [1.0–1.9] | 1.4 [1.1–1.9] |
Median duration of MCyR [95%CI], moa | 7.7 [4.7–13.1] | 10.1 [7.3-NA] | 4.0 [3.0–6.3] | 7.0 [2.0–10.5] |
CCyR, n (%) | 10 (14) | 15 (21) | 12 (38) | 9 (36) |
Median time to CCyR [95% CI], moa | 2.1 [1.8–2.8] | 2.8 [1.7–3.6] | 1.8 [1.0–1.9] | 1.4 [1.1–1.9] |
Median duration of CCyR [95% CI], moa | NR [3.7-NA] | 7.4 [7.1-NA] | 4.9 [3.9–6.3] | 7.9 [3.7–10.5] |
CML indicates chronic myeloid leukemia; QD, once daily; BID, twice daily; MHR, major hematologic response; CI, confidence interval; BCR-ABL, breakpoint cluster region-Abelson murine leukemia viral oncogene fusion protein; NA, not available; MCyR, major cytogenetic response; CCyR, complete cytogenetic response; NR, not reached.
Computed from Kaplan-Meier analysis in patients who achieved this response.
The analysis excluded 10 Philadelphia chromosome-negative patients. Cytogenetic response could not be determined among patients with CML in myeloid blast phase for 22 patients in the QD arm and 23 patients in the BID arm or among patients with CML in lymphoid blast phase for 8 patients in the QD arm and 9 patients in the BID arm.