Table 2.
3 months | 6 months | 9 months | 12 months | 18 months | |
---|---|---|---|---|---|
Cytogenetic response
| |||||
CCyR (%) | 45/50 (90%) | 43/46 (94%) | 37/40 (93%) | 26/27 (96%) | 21/20 (96%) |
PCyR (%) | 3/50 (6%) | 1/46 (2%) | 3/40 (7%) | 1/27 (4%) | 1/22 (5%) |
No CG (%) | 2/50 (4%) | 2/46 (4%) | 0 | 0 | 0 |
Not evaluable | 1* (1) | 5* (3) | 11* (5) | 24* (16) | 29* (20) |
| |||||
Molecular response
| |||||
MMR (%) | 26/50 (52%) | 38/46 (83%) | 33/40 (83%) | 22/27 (82%) | 20/22 (91%) |
MR4.5 (%) | 2/50 (4%) | 23/46 (50%) | 51/40 (53%) | 15/27 (56%) | 16/22 (73%) |
No MMR (%) | 24/50 (48%) | 8/46 (17%) | 7/40 (17%) | 5/27 (19%) | 2/22 (9%) |
Not evaluable | 1* (1) | 5* (3) | 11* (5) | 24* (16) | 29* (20) |
| |||||
Responses according to European Leukemia Net (ELN) categories23
| |||||
Optimal | 48/50 (96%) | 43/46 (96%) | .. | 22/27 (82%) | .. |
Warning | 48/50 (4%) | 1/46 (2%) | .. | 4/27 (15%) | .. |
Failure | .. | 1/46 (2%) | .. | 1/27 (3%) | .. |
CCyR=complete cytogenetic response. PCyR=partial cytogenetic response. CG=cytogenetic response. MMR=major molecular response. MR4.5=deep molecular response.
All patients who were not evaluable came off study due to US Food and Drug Administration warning (indicated in parentheses) or adverse events.