Treatment outcomes of 246 patients with chronic-phase CML, by treatment arm
| . | Imatinib 400 mg/d . | Dasatinib 100 mg/d* . | P† . | ||
|---|---|---|---|---|---|
| No. of patients (%) . | 95% CI . | No. of patients (%) . | 95% CI . | ||
| n = 123 | n = 123 | ||||
| Complete hematologic response (confirmed) | 101 (82) | 74-88 | 100 (81) | 73-88 | 1.00 |
| Complete hematologic response (any) | 113 (92) | 86-96 | 107 (87) | 80-92 | .30 |
| Resistant disease | 7 (6) | 2-11 | 6 (5) | 2-10 | 1.00 |
| n = 61 | n = 70 | ||||
| Complete cytogenetic response | 42 (69) | 56-80 | 59 (84) | 74-92 | .040 |
| n = 91 | n = 99 | ||||
| Molecular response at 1 year‡ | |||||
| 3-log decrease | 40 (44) | 34-55 | 58 (59) | 48-68 | .059 |
| 4-log decrease | 19 (21) | 13-31 | 27 (27) | 19-37 | .32 |
| 4.5-log decrease | 14 (15) | 9-24 | 21 (21) | 14-31 | .35 |
| . | Imatinib 400 mg/d . | Dasatinib 100 mg/d* . | P† . | ||
|---|---|---|---|---|---|
| No. of patients (%) . | 95% CI . | No. of patients (%) . | 95% CI . | ||
| n = 123 | n = 123 | ||||
| Complete hematologic response (confirmed) | 101 (82) | 74-88 | 100 (81) | 73-88 | 1.00 |
| Complete hematologic response (any) | 113 (92) | 86-96 | 107 (87) | 80-92 | .30 |
| Resistant disease | 7 (6) | 2-11 | 6 (5) | 2-10 | 1.00 |
| n = 61 | n = 70 | ||||
| Complete cytogenetic response | 42 (69) | 56-80 | 59 (84) | 74-92 | .040 |
| n = 91 | n = 99 | ||||
| Molecular response at 1 year‡ | |||||
| 3-log decrease | 40 (44) | 34-55 | 58 (59) | 48-68 | .059 |
| 4-log decrease | 19 (21) | 13-31 | 27 (27) | 19-37 | .32 |
| 4.5-log decrease | 14 (15) | 9-24 | 21 (21) | 14-31 | .35 |
CML indicates chronic myeloid leukemia; CI, confidence interval; DAS, dasatinib; IM, imatinib mesylate; CHR, complete hematologic response; and CCyR, complete cytogenetic response.
One patient randomized to DAS received IM 400; this patient achieved CHR (confirmed), was in CCyR at 12 months, and remains alive without report of CHR at 35 months; but did not achieve 3-log molecular response in 12 months (1.34-log at 90 days, 1.73 log at 174 days, 2.05 log at 266 days, 2.39 log at 363 days).
Two-sided P value from the Fisher exact test.
Based on blood specimens collected 295-406 days after randomization.