Patient disposition
| . | R/I to imatinib or dasatinib (n = 33) . | Newly diagnosed (n = 25) . |
|---|---|---|
| Treatment ongoing | 23 (69.7) | 15 (60.0) |
| End of treatment | 10 (30.3) | 10 (40.0) |
| Primary reason for end of treatment | ||
| Adverse events | 5 (15.2) | 6 (24.0) |
| Lack of efficacy* | 1 (3.0) | 3 (12.0) |
| Patient withdrew consent | 0 | 1 (4.0) |
| Bone marrow transplant | 1 (3.0) | 0 |
| Disease progression | 1 (3.0) | 0 |
| Protocol deviation† | 2 (6.1) | 0 |
| . | R/I to imatinib or dasatinib (n = 33) . | Newly diagnosed (n = 25) . |
|---|---|---|
| Treatment ongoing | 23 (69.7) | 15 (60.0) |
| End of treatment | 10 (30.3) | 10 (40.0) |
| Primary reason for end of treatment | ||
| Adverse events | 5 (15.2) | 6 (24.0) |
| Lack of efficacy* | 1 (3.0) | 3 (12.0) |
| Patient withdrew consent | 0 | 1 (4.0) |
| Bone marrow transplant | 1 (3.0) | 0 |
| Disease progression | 1 (3.0) | 0 |
| Protocol deviation† | 2 (6.1) | 0 |
Data are presented as number (%).
A patient in the R/I cohort who was not in MMR at cycle 15 discontinued after 14.8 months of study drug exposure. Three patients in the newly diagnosed cohort discontinued because of lack of efficacy: 1 with BCR-ABL1IS >10% discontinued after 6.3 months of study drug exposure, 1 with disease progression according to the investigator (but not meeting protocol criteria for progression) discontinued after 19.6 months of study drug exposure, and 1 with loss of MMR discontinued after 13.5 months of study drug exposure.
Protocol deviations were 2 cases of noncompliance.