Patient demographics and baseline characteristics
| . | MBC-CML . | LBC-CML . | ||||
|---|---|---|---|---|---|---|
| Intolerant . | Resistant . | Total . | Intolerant . | Resistant . | Total . | |
| No. patients | 6 | 68 | 74 | 5 | 37 | 42 |
| Median age, y (range) | 60.5 (40-69) | 54.5 (21-71) | 55.0 (21-71) | 58.0 (26-72) | 47.0 (19-72) | 47.0 (19-72) |
| Male sex, % | 33 | 57 | 55 | 80 | 49 | 52 |
| Median duration of CML, mo (range) | 73 (39-130) | 47 (3-216) | 49 (3-216) | 60 (8-88) | 20 (2-186) | 28 (2-186) |
| Imatinib therapy duration, %; | ||||||
| Less than 1 y | 17 | 15 | 15 | 20 | 51 | 48 |
| 1 to 3 y | 17 | 40 | 38 | 40 | 27 | 29 |
| More than 3 y | 67 | 46 | 47 | 40 | 22 | 24 |
| Highest imatinib dose, %; | ||||||
| Less than 400 mg | 0 | 0 | 0 | 20 | 0 | 2 |
| 400 to 600 mg | 100 | 47 | 51 | 40 | 46 | 45 |
| More than 600 mg | 0 | 53 | 49 | 40 | 54 | 52 |
| Prior chemotherapy, % | 33 | 69 | 66 | 60 | 81 | 79 |
| Prior interferon-α, % | 100 | 51 | 55 | 80 | 43 | 48 |
| Prior SCT, % | 17 | 12 | 12 | 40 | 32 | 33 |
| Median bone marrow blasts, % (range) | 50 (12-67) | 40 (0-95) | 40 (0-95) | 80 (30-100) | 82 (0-100) | 82 (0-100) |
| Median peripheral blasts, % (range) | 3 (3-16) | 40 (0-99) | 39 (0-99) | 20 (1-48) | 31 (0-82) | 31 (0-82) |
| Peripheral blasts 30% or more, % | 0 | 44 | 39 | 40 | 35 | 36 |
| Median WBC count, ×109/L (range) | 5 (1.0-24.8) | 18 (0.4-191.6) | 17 (0.4-191.6) | 1.7 (0.8-7.8) | 7.9 (0.6-443.1) | 7.7 (0.6-443.1) |
| WBC count 20 × 109/L or more, % | 17 | 49 | 47 | 0 | 41 | 33 |
| Median platelet count, ×109/L (range) | 61 (18-1191) | 51 (10-2121) | 51 (10-2121) | 29 (17-230) | 33 (6-423) | 33 (6-423) |
| Platelet count below 100 × 109/L, % | 67 | 72 | 72 | 80 | 78 | 79 |
| . | MBC-CML . | LBC-CML . | ||||
|---|---|---|---|---|---|---|
| Intolerant . | Resistant . | Total . | Intolerant . | Resistant . | Total . | |
| No. patients | 6 | 68 | 74 | 5 | 37 | 42 |
| Median age, y (range) | 60.5 (40-69) | 54.5 (21-71) | 55.0 (21-71) | 58.0 (26-72) | 47.0 (19-72) | 47.0 (19-72) |
| Male sex, % | 33 | 57 | 55 | 80 | 49 | 52 |
| Median duration of CML, mo (range) | 73 (39-130) | 47 (3-216) | 49 (3-216) | 60 (8-88) | 20 (2-186) | 28 (2-186) |
| Imatinib therapy duration, %; | ||||||
| Less than 1 y | 17 | 15 | 15 | 20 | 51 | 48 |
| 1 to 3 y | 17 | 40 | 38 | 40 | 27 | 29 |
| More than 3 y | 67 | 46 | 47 | 40 | 22 | 24 |
| Highest imatinib dose, %; | ||||||
| Less than 400 mg | 0 | 0 | 0 | 20 | 0 | 2 |
| 400 to 600 mg | 100 | 47 | 51 | 40 | 46 | 45 |
| More than 600 mg | 0 | 53 | 49 | 40 | 54 | 52 |
| Prior chemotherapy, % | 33 | 69 | 66 | 60 | 81 | 79 |
| Prior interferon-α, % | 100 | 51 | 55 | 80 | 43 | 48 |
| Prior SCT, % | 17 | 12 | 12 | 40 | 32 | 33 |
| Median bone marrow blasts, % (range) | 50 (12-67) | 40 (0-95) | 40 (0-95) | 80 (30-100) | 82 (0-100) | 82 (0-100) |
| Median peripheral blasts, % (range) | 3 (3-16) | 40 (0-99) | 39 (0-99) | 20 (1-48) | 31 (0-82) | 31 (0-82) |
| Peripheral blasts 30% or more, % | 0 | 44 | 39 | 40 | 35 | 36 |
| Median WBC count, ×109/L (range) | 5 (1.0-24.8) | 18 (0.4-191.6) | 17 (0.4-191.6) | 1.7 (0.8-7.8) | 7.9 (0.6-443.1) | 7.7 (0.6-443.1) |
| WBC count 20 × 109/L or more, % | 17 | 49 | 47 | 0 | 41 | 33 |
| Median platelet count, ×109/L (range) | 61 (18-1191) | 51 (10-2121) | 51 (10-2121) | 29 (17-230) | 33 (6-423) | 33 (6-423) |
| Platelet count below 100 × 109/L, % | 67 | 72 | 72 | 80 | 78 | 79 |