Characteristics at study start and early treatment exposure according to BCR-ABL transcript level at 3 months
| . | Nilotinib 300 mg twice daily . | Nilotinib 400 mg twice daily . | Imatinib 400 mg once daily . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Characteristics at study start . | . | BCR-ABLIS at 3 months . | . | BCR-ABLIS at 3 months . | . | BCR-ABLIS at 3 months . | |||
| n . | ≤10% . | >10% . | n . | ≤10% . | >10% . | n . | ≤10% . | >10% . | |
| Patients, n (%)* | 258 | 234 (91) | 24 (9) | 260 | 232 (89) | 28 (11) | 264 | 176 (67) | 88 (33) |
| Median spleen size below costal margin (range), cm | 5.0 (1-27) | 8.0 (2-19) | 6.0 (1-25) | 8.0 (1-20) | 3.5 (1-15) | 10.5 (1-25) | |||
| Median platelet count (range), ×109/L | 431 (90-3880) | 355 (101-1385) | 368 (103-1817) | 490 (126-1819) | 370 (66-1400) | 362 (84-2232) | |||
| Median white cell count (range), ×109/L | 24 (2-247) | 40 (3-167) | 23 (2-435) | 28 (4-254) | 23 (3-181) | 34 (3-482) | |||
| Median blasts in peripheral blood (range), % | 0 (0-10) | 0 (0-15) | 0 (0-12) | 0 (0-6) | 0 (0-14) | 0 (0-12) | |||
| Splenomegaly, n (%) | 109 | 91 (83) | 18 (17) | 103 | 89 (86) | 14 (14) | 99 | 47 (47) | 52 (53) |
| Chromosomal abnormalities in addition to the Philadelphia chromosome, n (%) | 26 | 22 (85) | 4 (15) | 39 | 33 (85) | 6 (15) | 30 | 17 (57) | 13 (43) |
| Clonal evolution (major route aberrations), n (%)† | 5 | 3 (60) | 2 (40) | 3 | 3 (100) | 0 | 4 | 1 (25) | 3 (75) |
| Treatment exposure in the first 3 months | |||||||||
| Patients, n (%)* | 258 | 234 (91) | 24 (9) | 260 | 232 (89) | 28 (11) | 264 | 176 (67) | 88 (33) |
| Median dose intensity (range; % of planned dose), mg/day‡ | 600 (210-604; 100) | 474 (270-600; 79) | 800 (222-800; 100) | 492 (270-800; 62) | 400 (255-405; 100) | 400 (215-400; 100) | |||
| Dose interruption for ≥5 consecutive days, n (%) | 85 | 71 (84) | 14 (16) | 94 | 72 (77) | 22 (23) | 49 | 30 (61) | 19 (39) |
| No dose interruption or dose interruption for <5 consecutive days, n (%) | 173 | 163 (94) | 10 (6) | 166 | 160 (96) | 6 (4) | 215 | 146 (68) | 69 (32) |
| . | Nilotinib 300 mg twice daily . | Nilotinib 400 mg twice daily . | Imatinib 400 mg once daily . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Characteristics at study start . | . | BCR-ABLIS at 3 months . | . | BCR-ABLIS at 3 months . | . | BCR-ABLIS at 3 months . | |||
| n . | ≤10% . | >10% . | n . | ≤10% . | >10% . | n . | ≤10% . | >10% . | |
| Patients, n (%)* | 258 | 234 (91) | 24 (9) | 260 | 232 (89) | 28 (11) | 264 | 176 (67) | 88 (33) |
| Median spleen size below costal margin (range), cm | 5.0 (1-27) | 8.0 (2-19) | 6.0 (1-25) | 8.0 (1-20) | 3.5 (1-15) | 10.5 (1-25) | |||
| Median platelet count (range), ×109/L | 431 (90-3880) | 355 (101-1385) | 368 (103-1817) | 490 (126-1819) | 370 (66-1400) | 362 (84-2232) | |||
| Median white cell count (range), ×109/L | 24 (2-247) | 40 (3-167) | 23 (2-435) | 28 (4-254) | 23 (3-181) | 34 (3-482) | |||
| Median blasts in peripheral blood (range), % | 0 (0-10) | 0 (0-15) | 0 (0-12) | 0 (0-6) | 0 (0-14) | 0 (0-12) | |||
| Splenomegaly, n (%) | 109 | 91 (83) | 18 (17) | 103 | 89 (86) | 14 (14) | 99 | 47 (47) | 52 (53) |
| Chromosomal abnormalities in addition to the Philadelphia chromosome, n (%) | 26 | 22 (85) | 4 (15) | 39 | 33 (85) | 6 (15) | 30 | 17 (57) | 13 (43) |
| Clonal evolution (major route aberrations), n (%)† | 5 | 3 (60) | 2 (40) | 3 | 3 (100) | 0 | 4 | 1 (25) | 3 (75) |
| Treatment exposure in the first 3 months | |||||||||
| Patients, n (%)* | 258 | 234 (91) | 24 (9) | 260 | 232 (89) | 28 (11) | 264 | 176 (67) | 88 (33) |
| Median dose intensity (range; % of planned dose), mg/day‡ | 600 (210-604; 100) | 474 (270-600; 79) | 800 (222-800; 100) | 492 (270-800; 62) | 400 (255-405; 100) | 400 (215-400; 100) | |||
| Dose interruption for ≥5 consecutive days, n (%) | 85 | 71 (84) | 14 (16) | 94 | 72 (77) | 22 (23) | 49 | 30 (61) | 19 (39) |
| No dose interruption or dose interruption for <5 consecutive days, n (%) | 173 | 163 (94) | 10 (6) | 166 | 160 (96) | 6 (4) | 215 | 146 (68) | 69 (32) |