Table 1.
CR and CR+CRi rates and postremission consolidation cycles by patient subgroup
| Characteristic, n (%) | CPX-351 | 7+3* | OR (95% CI) |
|---|---|---|---|
| Total study population | 153 | 156 | |
| CR+CRi | 73 (48) | 52 (33) | 1.77 (1.11, 2.81) |
| CR | 57 (37) | 40 (26) | 1.69 (1.03, 2.78) |
| Number of consolidation cycles | 73 | 52 | |
| 0 | 25 (34) | 20 (38) | |
| 1 | 25 (34) | 20 (38) | |
| 2 | 23 (32) | 12 (23) | |
| t-AML | 30 | 33 | |
| CR+CRi | 14 (47) | 12 (36) | 1.53 (0.56, 4.20) |
| CR | 11 (37) | 10 (30) | 1.33 (0.47, 3.81) |
| Number of consolidation cycles | 14 | 12 | |
| 0 | 4 (29) | 5 (42) | |
| 1 | 4 (29) | 5 (42) | |
| 2 | 6 (43) | 2 (17) | |
| AML-MRC | 123 | 123 | |
| CR+CRi | 59 (48) | 40 (33) | 1.83 (1.09, 3.09) |
| CR | 46 (37) | 30 (24) | 1.80 (1.02, 3.17) |
| Number of consolidation cycles | 59 | 40 | |
| 0 | 21 (36) | 15 (38) | |
| 1 | 21 (36) | 15 (38) | |
| 2 | 17 (29) | 10 (25) | |
| Prior HMA exposure† | 62 | 71 | |
| CR+CRi | 23 (37) | 20 (28) | 1.50 (0.73, 3.12) |
| CR | 16 (26) | 11 (15) | 1.90 (0.80, 4.48) |
| Number of consolidation cycles | 23 | 20 | |
| 0 | 11 (48) | 9 (45) | |
| 1 | 6 (26) | 6 (30) | |
| 2 | 6 (26) | 5 (25) | |
| Ages 60 to 69 y | 96 | 102 | |
| CR+CRi | 48 (50) | 37 (36) | 1.76 (1.00, 3.10) |
| CR | 38 (40) | 27 (26) | 1.82 (1.00, 3.32) |
| Number of consolidation cycles | 48 | 37 | |
| 0 | 18 (38) | 17 (46) | |
| 1 | 16 (33) | 14 (38) | |
| 2 | 14 (29) | 6 (16) | |
| Ages 70 to 75 y | 57 | 54 | |
| CR+CRi | 25 (44) | 15 (28) | 2.03 (0.92, 4.49) |
| CR | 19 (33) | 13 (24) | 1.58 (0.69, 3.62) |
| Number of consolidation cycles | 25 | 15 | |
| 0 | 7 (28) | 3 (20) | |
| 1 | 9 (36) | 6 (40) | |
| 2 | 9 (36) | 6 (40) |
*
Patients in the 7+3 arm received consolidation with cytarabine and daunorubicin on a 5+2 schedule.
†
Includes patients in the prespecified randomization strata of antecedent MDS with prior HMA exposure, as well as patients in other strata (eg, t- AML, antecedent CMML) who had previously received HMAs.