Table 2.
Baseline characteristics of patients who achieved CR or CRi
| Achieved CR or CRi | Achieved CR | Achieved CRi | ||||
|---|---|---|---|---|---|---|
| CPX-351 | 7+3 | CPX-351 | 7+3 | CPX-351 | 7+3 | |
| Characteristic, n (%) | (n = 73) | (n = 52) | (n = 57) | (n = 40) | (n = 16) | (n = 12) |
| Age | ||||||
| 60 to 69 y | 48 (66) | 37 (71) | 38 (67) | 27 (68) | 10 (63) | 10 (83) |
| 70 to 75 y | 25 (34) | 15 (29) | 19 (33) | 13 (33) | 6 (38) | 2 (17) |
| Male | 45 (62) | 25 (48) | 34 (60) | 19 (48) | 11 (69) | 6 (50) |
| ECOG PS | ||||||
| 0 | 20 (27) | 20 (38) | 17 (30) | 17 (43) | 3 (19) | 3 (25) |
| 1 | 48 (66) | 26 (50) | 35 (61) | 19 (48) | 13 (81) | 7 (58) |
| 2 | 5 (7) | 6 (12) | 5 (9) | 4 (10) | 0 | 2 (17) |
| AML subtype | ||||||
| t-AML | 14 (19) | 12 (23) | 11 (19) | 10 (25) | 3 (19) | 2 (17) |
| Antecedent MDS with prior HMA* | 18 (25) | 18 (35) | 13 (23) | 10 (25) | 5 (31) | 8 (67) |
| Antecedent MDS without prior HMA* | 14 (19) | 7 (13) | 12 (21) | 7 (18) | 2 (13) | 0 |
| Antecedent CMML* | 4 (5) | 3 (6) | 2 (4) | 3 (8) | 2 (13) | 0 |
| De novo AML with MDS karyotype* | 23 (32) | 12 (23) | 19 (33) | 10 (25) | 4 (25) | 2 (17) |
| Prior HMA therapy† | 23 | 20 | 16 | 11 | 7 | 9 |
| Azacitidine only | 18 (78) | 13 (65) | 13 (81) | 8 (73) | 5 (71) | 5 (56) |
| Decitabine only | 4 (17) | 5 (25) | 3 (19) | 3 (27) | 1 (14) | 2 (22) |
| Azacitidine and decitabine | 1 (4) | 2 (10) | 0 | 0 | 1 (14) | 2 (22) |
| Median duration of prior HMA therapy (range), d | 120 (22, 1644) | 126 (6, 761) | 130.5 (22, 1644) | 95 (6, 761) | 113 (28, 307) | 185 (53, 320) |
| Bone marrow blast (aspirate) percentage‡ | 68 | 48 | 53 | 37 | 15 | 11 |
| Median (range) | 33 (5, 80) | 30.5 (6, 77) | 35 (5, 80) | 32 (6, 77) | 27 (8, 75) | 29 (12, 60) |
| Cytogenetic risk by NCCN | ||||||
| Favorable/intermediate | 39/70 (56) | 30/48 (63) | 30/55 (55) | 21/36 (58) | 9/15 (60) | 9/12 (75) |
| Unfavorable | 31/70 (44) | 18/48 (38) | 25/55 (45) | 15/36 (42) | 6/15 (40) | 3/12 (25) |
| FLT3 mutation | 15/68 (22) | 5/44 (11) | 12/53 (23) | 4/34 (12) | 3/15 (20) | 1/10 (10) |
| WBC count | ||||||
| <20 × 103/µL | 68/73 (93) | 47/51 (92) | 52/57 (91) | 36/39 (92) | 16/16 (100) | 11/12 (92) |
| ≥20 × 103/µL | 5/73 (7) | 4/51 (8) | 5/57 (9) | 3/39 (8) | 0/16 (0) | 1/12 (8) |
| Platelet count | ||||||
| ≤50 × 103/µL | 43/73 (59) | 25/51 (49) | 34/57 (60) | 17/39 (44) | 9/16 (56) | 8/12 (67) |
| >50 × 103/µL | 30/73 (41) | 26/51 (51) | 23/57 (40) | 22/39 (56) | 7/16 (44) | 4/12 (33) |
ECOG PS, Eastern Cooperative Oncology Group performance status; FLT3, fms-like tyrosine kinase 3; NCCN, National Comprehensive Cancer Network; WBC, white blood cell.
*
Subgroup of patients with AML-MRC.
†
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.
‡
Pathological diagnosis of AML was according to 2008 World Health Organization criteria (ie, ≥20% blasts in the peripheral blood or bone marrow) and confirmed by an independent pathologist.