Response and outcomes in each group (FLAG IDA/CPX)
| . | FLAG-IDA (n = 82) . | CPX-351 (n = 105) . | P value . |
|---|---|---|---|
| Response after cycle 1 | |||
| CR | 42 (51%) | 42 (40%) | .15 |
| CRi | 11 (13%) | 12 (11%) | |
| ORR (CR + CRi) | 53 (65%) | 54 (51%) | |
| Best response after 2 cycles | |||
| CR | 55 (68%) | 63 (60%) | .06 |
| CRi | 7 (9%) | 4 (4%) | |
| ORR (CR+CRi) | 62 (77%) | 67 (64%) | |
| Early mortality | |||
| Day 30 | 6 (7%) | 5 (5%) | .46 |
| Day 60 | 9 (11%) | 13 (12%) | .77 |
| Count recovery in course 1 | |||
| Recovered neutrophils to >1.0 × 109/L | 71 (88%) | 72 (71%) | .01 |
| Median days to neutrophil recovery (IQR) | 30 (26-35) | 32 (26-39) | .11 |
| Recovered platelets to >100 × 109/L | 58 (72%) | 63 (62%) | .16 |
| Median days to platelet recovery (IQR) | 29 (25-33) | 34 (28-44) | <.01 |
| Count recovery in course 2 | |||
| Recovered neutrophils to >1.0 × 109/L | 41 (71%) | 55 (83%) | .09 |
| Median days to neutrophil recovery (IQR) | 46 (32-52) | 31 (26-41) | <.01 |
| Recovered platelets to >100 × 109/L | 21 (36%) | 39 (59%) | .01 |
| Median days to platelet recovery (IQR) | 36 (35-53) | 31 (24-47) | .20 |
| Allogeneic transplant | |||
| Allogeneic transplant at any time | 36 (44%) | 53 (50%) | .41 |
| Allogeneic transplant in first response∗ | 30 (48%) | 43 (64%) | .10 |
| Outcomes at 3 years | |||
| OS | 25% | 32% | .36 |
| EFS | 24% | 25% | .86 |
| RFS | 29% | 39% | .08 |
| . | FLAG-IDA (n = 82) . | CPX-351 (n = 105) . | P value . |
|---|---|---|---|
| Response after cycle 1 | |||
| CR | 42 (51%) | 42 (40%) | .15 |
| CRi | 11 (13%) | 12 (11%) | |
| ORR (CR + CRi) | 53 (65%) | 54 (51%) | |
| Best response after 2 cycles | |||
| CR | 55 (68%) | 63 (60%) | .06 |
| CRi | 7 (9%) | 4 (4%) | |
| ORR (CR+CRi) | 62 (77%) | 67 (64%) | |
| Early mortality | |||
| Day 30 | 6 (7%) | 5 (5%) | .46 |
| Day 60 | 9 (11%) | 13 (12%) | .77 |
| Count recovery in course 1 | |||
| Recovered neutrophils to >1.0 × 109/L | 71 (88%) | 72 (71%) | .01 |
| Median days to neutrophil recovery (IQR) | 30 (26-35) | 32 (26-39) | .11 |
| Recovered platelets to >100 × 109/L | 58 (72%) | 63 (62%) | .16 |
| Median days to platelet recovery (IQR) | 29 (25-33) | 34 (28-44) | <.01 |
| Count recovery in course 2 | |||
| Recovered neutrophils to >1.0 × 109/L | 41 (71%) | 55 (83%) | .09 |
| Median days to neutrophil recovery (IQR) | 46 (32-52) | 31 (26-41) | <.01 |
| Recovered platelets to >100 × 109/L | 21 (36%) | 39 (59%) | .01 |
| Median days to platelet recovery (IQR) | 36 (35-53) | 31 (24-47) | .20 |
| Allogeneic transplant | |||
| Allogeneic transplant at any time | 36 (44%) | 53 (50%) | .41 |
| Allogeneic transplant in first response∗ | 30 (48%) | 43 (64%) | .10 |
| Outcomes at 3 years | |||
| OS | 25% | 32% | .36 |
| EFS | 24% | 25% | .86 |
| RFS | 29% | 39% | .08 |
IQR, interquartile range.
Percentage of those achieving CR/Cri.