Patient demographics and baseline disease characteristics
| Characteristic . | Cohort . | ||
|---|---|---|---|
| 45 mg (n = 94) . | 30 mg (n = 94) . | 15 mg (n = 94) . | |
| Age | |||
| Median y (range) | 46 (19-81) | 51 (21-77) | 49 (18-81) |
| Sex | |||
| Male | 50 (53) | 38 (40) | 53 (56) |
| ECOG PS score 0 or 1 | 93 (99) | 93 (99) | 94 (100) |
| Time since diagnosis | |||
| Median y (range) | 5.5 (1-21) | 5.1 (1-29) | 5.7 (1-22) |
| Patients with CV risk factors | |||
| Hypertension | 26 (28) | 25 (27) | 22 (23) |
| Diabetes mellitus | 5 (5) | 3 (3) | 7 (7) |
| Hyperlipidemia | 19 (20) | 14 (15) | 16 (17) |
| Patients with ≥1 CV risk factor | 32 (34) | 30 (32) | 32 (34) |
| Patients with >1 CV risk factor | 5 (5) | 4 (4) | 4 (4) |
| Current or former smokers | 29 (31) | 37 (39) | 33 (35) |
| Body mass index | |||
| Median, kg/m2 (range) | 27 (17-45) | 26 (17-49) | 26 (18-49) |
| Prior TKIs | |||
| 1 | 1 (1) | 1 (1) | 4 (4) |
| 2 | 43 (46) | 37 (39) | 42 (45) |
| ≥3 | 50 (53) | 56 (60) | 48 (51) |
| BCR-ABL1 mutations | |||
| No mutation | 51 (54) | 58 (62) | 54 (57) |
| Any mutation | 41 (44) | 35 (37) | 39 (42) |
| T315I | 25 (27) | 21 (22) | 21 (22) |
| Mutation other than T315I* | |||
| G250E | 7 (7) | 2 (2) | 4 (4) |
| F317L | 2 (2) | 4 (4) | 2 (2) |
| F359V | 1 (1) | 1 (1) | 5 (5) |
| E255K | 1 (1) | 2 (2) | 3 (3) |
| V299L | 3 (3) | 1 (1) | 2 (2) |
| M244V | 1 (1) | 2 (2) | 2 (2) |
| ≥2 mutations | 10 (11) | 6 (6) | 5 (5) |
| Reason prior therapy stopped | |||
| Resistant | 92 (98) | 94 (100) | 94 (100) |
| Best response to last prior therapy | |||
| CHR or worse | 61 (65) | 55 (59) | 57 (61) |
| ≤1% BCR-ABL1IS or better | 2 (2) | 7 (7) | 7 (7) |
| Characteristic . | Cohort . | ||
|---|---|---|---|
| 45 mg (n = 94) . | 30 mg (n = 94) . | 15 mg (n = 94) . | |
| Age | |||
| Median y (range) | 46 (19-81) | 51 (21-77) | 49 (18-81) |
| Sex | |||
| Male | 50 (53) | 38 (40) | 53 (56) |
| ECOG PS score 0 or 1 | 93 (99) | 93 (99) | 94 (100) |
| Time since diagnosis | |||
| Median y (range) | 5.5 (1-21) | 5.1 (1-29) | 5.7 (1-22) |
| Patients with CV risk factors | |||
| Hypertension | 26 (28) | 25 (27) | 22 (23) |
| Diabetes mellitus | 5 (5) | 3 (3) | 7 (7) |
| Hyperlipidemia | 19 (20) | 14 (15) | 16 (17) |
| Patients with ≥1 CV risk factor | 32 (34) | 30 (32) | 32 (34) |
| Patients with >1 CV risk factor | 5 (5) | 4 (4) | 4 (4) |
| Current or former smokers | 29 (31) | 37 (39) | 33 (35) |
| Body mass index | |||
| Median, kg/m2 (range) | 27 (17-45) | 26 (17-49) | 26 (18-49) |
| Prior TKIs | |||
| 1 | 1 (1) | 1 (1) | 4 (4) |
| 2 | 43 (46) | 37 (39) | 42 (45) |
| ≥3 | 50 (53) | 56 (60) | 48 (51) |
| BCR-ABL1 mutations | |||
| No mutation | 51 (54) | 58 (62) | 54 (57) |
| Any mutation | 41 (44) | 35 (37) | 39 (42) |
| T315I | 25 (27) | 21 (22) | 21 (22) |
| Mutation other than T315I* | |||
| G250E | 7 (7) | 2 (2) | 4 (4) |
| F317L | 2 (2) | 4 (4) | 2 (2) |
| F359V | 1 (1) | 1 (1) | 5 (5) |
| E255K | 1 (1) | 2 (2) | 3 (3) |
| V299L | 3 (3) | 1 (1) | 2 (2) |
| M244V | 1 (1) | 2 (2) | 2 (2) |
| ≥2 mutations | 10 (11) | 6 (6) | 5 (5) |
| Reason prior therapy stopped | |||
| Resistant | 92 (98) | 94 (100) | 94 (100) |
| Best response to last prior therapy | |||
| CHR or worse | 61 (65) | 55 (59) | 57 (61) |
| ≤1% BCR-ABL1IS or better | 2 (2) | 7 (7) | 7 (7) |
Data are expressed as the number of patients (percentage of study group), unless otherwise stated.
ECOG PS, Eastern Cooperative Oncology Group performance status.
Mutations identified in at least 5 patients (combined for the 3 cohorts) are presented.