Table 1.
Phase I hematologic and cytogenetic responses to nilotinib in patients with CML
|
No. (%) Hematologic response |
No. (%) Cytogenetic response |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Results in CML transformation | Total/activea | CHR | MR | RTC | Overall | CR | PR | Minor | Minimal | Major | Overall |
| Accelerated phase | |||||||||||
| – Hematologic disease | 46 | 21 | 3 | 9 | 33 (72) | 6 | 3 | 4 | 9 | 9 (20) | 22 (48) |
| – Clonal evolution onlyb | 10/5 | 5 | – | – | 5 (100) | 2 | 4 | 1 | 2 | 6 (60) | 9 (90) |
| Total | 56/51 | 26 | 3 | 9 | 38 (74) | 8 | 7 | 5 | 11 | 15 (27) | 31 (55) |
| Blastic phase | |||||||||||
| – Myeloid | 24 | 2 | 2 | 6 | 10 (42) | 1 | 4 | 2 | – | (21) | (29) |
| – Lymphoid | 9 | – | 1 | 2 | 3 (33) | 1 | – | – | 1 | (11) | (22) |
| Total | 33 | 2 | 3 | 8 | 13 (39) | 2 | 4 | 2 | 1 | 6 (18) | 9 (27) |
Notes:
a
Patients with hematologic manifestation of disease (ie, not CHR);
b
Patients whose only criteria for accelerated phase was clonal evolution.
Abbreviations: CHR, complete hematologic response; CR, cytogenetic response; MR molecular response; RTC, return to chronic phase.