Baseline demographics and disease characteristics of all randomized patients
| Characteristic . | 140 mg once daily (n = 158) . | 70 mg twice daily (n = 159) . |
|---|---|---|
| Median age, y (range) | 56.0 (17.0-81.0) | 56.0 (19.0-84.0) |
| Male, n (%) | 88 (56) | 94 (59) |
| Median disease duration, mo (range) | 74.3 (5.1-326.8) | 70.1 (2.5-199.7) |
| Prior imatinib > 600 mg/day, n (%) | 68 (43) | 73 (46) |
| Prior imatinib duration | ||
| Less than 1 year, n (%) | 23 (15) | 24 (15) |
| 1-3 years, n (%) | 51 (32) | 54 (34) |
| More than 3 years, n (%) | 84 (53) | 80 (50) |
| Best response before imatinib failure, n (%) | ||
| CHR | 121 (77) | 119 (75) |
| MCyR | 48 (30) | 44 (28) |
| Imatinib status, n (%) | ||
| Resistant | 117 (74) | 116 (73) |
| Intolerant | 41 (26) | 43 (27) |
| BCR-ABL mutation detected, no. (%) | 66/141 (47) | 70/151 (46) |
| T315I mutation detected, n (%) | 11/141 (8) | 9/151 (6) |
| Other prior therapy, n (%) | ||
| Interferon-α | 85 (54) | 87 (55) |
| Chemotherapy | 70 (44) | 70 (44) |
| Stem cell transplantation | 19 (12) | 9 (6) |
| Response status, n (%) | ||
| Patients in CHR at entry | 16 (10) | 31 (19) |
| Patients in MCyR at entry | 15 (9) | 12 (8) |
| Patients in CCyR at entry | 1 (1) | 3 (2) |
| ECOG performance status 0 or 1 | 148 (94) | 143 (90) |
| Characteristic . | 140 mg once daily (n = 158) . | 70 mg twice daily (n = 159) . |
|---|---|---|
| Median age, y (range) | 56.0 (17.0-81.0) | 56.0 (19.0-84.0) |
| Male, n (%) | 88 (56) | 94 (59) |
| Median disease duration, mo (range) | 74.3 (5.1-326.8) | 70.1 (2.5-199.7) |
| Prior imatinib > 600 mg/day, n (%) | 68 (43) | 73 (46) |
| Prior imatinib duration | ||
| Less than 1 year, n (%) | 23 (15) | 24 (15) |
| 1-3 years, n (%) | 51 (32) | 54 (34) |
| More than 3 years, n (%) | 84 (53) | 80 (50) |
| Best response before imatinib failure, n (%) | ||
| CHR | 121 (77) | 119 (75) |
| MCyR | 48 (30) | 44 (28) |
| Imatinib status, n (%) | ||
| Resistant | 117 (74) | 116 (73) |
| Intolerant | 41 (26) | 43 (27) |
| BCR-ABL mutation detected, no. (%) | 66/141 (47) | 70/151 (46) |
| T315I mutation detected, n (%) | 11/141 (8) | 9/151 (6) |
| Other prior therapy, n (%) | ||
| Interferon-α | 85 (54) | 87 (55) |
| Chemotherapy | 70 (44) | 70 (44) |
| Stem cell transplantation | 19 (12) | 9 (6) |
| Response status, n (%) | ||
| Patients in CHR at entry | 16 (10) | 31 (19) |
| Patients in MCyR at entry | 15 (9) | 12 (8) |
| Patients in CCyR at entry | 1 (1) | 3 (2) |
| ECOG performance status 0 or 1 | 148 (94) | 143 (90) |
CHR indicates complete hematologic response; MCyR, major cytogenetic response; CcyR, complete cytogenetic response; and ECOG, Eastern Cooperative Oncology Group.