Hematologic response, cytogenetic response, discontinuation for AE, and failure
| . | 3 mo,n (%) . | 6 mo, n (%) . | 12 mo, n (%) . |
|---|---|---|---|
| No. of patients | 73 | 73 | 73 |
| HR | |||
| Complete | 73 (100) | 72 (98) | 71 (97) |
| Less than complete or lost | 0 | 1† (1) | 1† (1) |
| Nonevaluable | 0 | 0 | 1‡ (1) |
| CgR | |||
| Complete* | 57 (78) | 70 (96) | 70 (96) |
| Partial (Ph+ 1%-35%) | 5 (7) | 2 (3) | 1 (1) |
| Minor (Ph+ 36%-65%) | 5 (7) | 0 | 0 |
| Minimal (Ph+ 66%-95%) | 3 (4) | 0 | 0 |
| None or lost | 0 | 1† (1) | 1† (1) |
| Nonevaluable | 3 (4) | 0 | 1‡ (1) |
| Discontinued for AEs | 0 | 0 | 1‡ (1) |
| Failure | 0 | 1† (1) | 1† (1) |
| . | 3 mo,n (%) . | 6 mo, n (%) . | 12 mo, n (%) . |
|---|---|---|---|
| No. of patients | 73 | 73 | 73 |
| HR | |||
| Complete | 73 (100) | 72 (98) | 71 (97) |
| Less than complete or lost | 0 | 1† (1) | 1† (1) |
| Nonevaluable | 0 | 0 | 1‡ (1) |
| CgR | |||
| Complete* | 57 (78) | 70 (96) | 70 (96) |
| Partial (Ph+ 1%-35%) | 5 (7) | 2 (3) | 1 (1) |
| Minor (Ph+ 36%-65%) | 5 (7) | 0 | 0 |
| Minimal (Ph+ 66%-95%) | 3 (4) | 0 | 0 |
| None or lost | 0 | 1† (1) | 1† (1) |
| Nonevaluable | 3 (4) | 0 | 1‡ (1) |
| Discontinued for AEs | 0 | 0 | 1‡ (1) |
| Failure | 0 | 1† (1) | 1† (1) |
All rates are calculated on all 73 patients, according to the intention-to-treat principle.
HR indicates hematologic response; and CgR, cytogenetic response.
The assessment of CCgR was based on CBA of marrow cell metaphases in 90%, 85% and 80% of patients. It was based on I-FISH in 10%, 15%, and 20% of patients.
This patient was in CHR and CCgR at 3 months, but developed sudden BC (lymphoid, with the T315I mutation) and died at 9 months.
This patient discontinued nilotinib after 9 months, for persistent lipase increase, grade 3/4 (no pancreatitis).