Table 1.
Demographic and Baseline Characteristics
| Characteristic | 5‐d Regimens | 10‐d Regimen at 60 mg/m2 (n = 53) | Total (n = 103) | ||
|---|---|---|---|---|---|
| 60 mg/m2 (n = 24) | 90 mg/m2 (n = 26) | Total (n = 50) | |||
| Age, median (range), y | 58 (22‐77) | 65 (30‐81) | 62 (22‐81) | 57 (29‐82) | 60 (22‐82) |
| Sex, No. (%) | |||||
| Male | 15 (63) | 20 (77) | 35 (70) | 27 (51) | 62 (60) |
| Female | 9 (38) | 6 (23) | 15 (30) | 26 (49) | 41 (40) |
| Race, No. (%) | |||||
| White | 18 (75) | 21 (81) | 39 (78) | 44 (83) | 83 (81) |
| Black or African American | 4 (17) | 0 | 4 (8) | 5 (9) | 9 (9) |
| Asian | 2 (8) | 4 (15) | 6 (12) | 2 (4) | 8 (8) |
| Pacific Islander | 0 | 0 | 0 | 1 (2) | 1 (<1) |
| Other/unknown | 0 | 1 (4) | 1 (2) | 1 (2) | 2 (2) |
| ECOG, No. (%) | |||||
| 0 | 2 (8) | 3 (12) | 5 (10) | 9 (17) | 14 (14) |
| 1 | 20 (83) | 20 (77) | 40 (80) | 35 (66) | 75 (73) |
| 2 | 2 (8) | 3 (12) | 5 (10) | 9 (17) | 14 (14) |
| No. of prior induction regimens, No. (%) | |||||
| Unknowna | 0 | 1 (2) | 0 | 2 (4) | 3 (3) |
| 1 | 3 (12) | 7 (27) | 10 (20) | 17 (32) | 27 (26) |
| 2 | 8 (33) | 6 (23) | 14 (28) | 17 (32) | 31 (30) |
| 3‐5 | 13 (54) | 9 (35) | 22 (44) | 17 (32) | 39 (38) |
| >5 | 0 | 2 (8) | 2 (4) | 0 | 2 (2) |
| No. of prior induction regimens | |||||
| Mean (SD) | 2.7 (1.1) | 2.9 (2.1) | 2.8 (1.7) | 2.3 (1.5) | 2.5 (1.6) |
| Median (range) | 2.5 (1‐5) | 2.0 (1‐10) | 2.0 (1‐10) | 2.0 (1‐7) | 2.0 (1‐10) |
| >1 cycle of prior HMA therapy, No. (%) | 0 | 1 (4) | 1 (2) | 3 (6) | 4 (4) |
| Disease status, No. (%) | |||||
| Primary refractory | 8 (33) | 12 (46) | 20 (40) | 28 (53) | 48 (47) |
| Relapse | 16 (66) | 14 (54) | 30 (60) | 25 (47) | 55 (53) |
| First relapse | 3 (13) | 2 (8) | 5 (10) | 9 (17) | 14 (14) |
| Later relapseb | 13 (54) | 12 (46) | 25 (50) | 16 (30) | 41 (40) |
| Length of 1st remission, No. (%) | |||||
| >1 y | 6 (25) | 7 (27) | 13 (26) | 9 (17) | 22 (21) |
| ≤1 y | 10 (42) | 7 (27) | 17 (34) | 16 (30) | 33 (32) |
| Prior HCT, No. (%) | 5 (21) | 5 (19) | 10 (20) | 9 (17) | 19 (18) |
| Cytogenetic risk, No. (%) | |||||
| Favorable | 0 | 0 | 0 | 0 | 0 |
| Intermediate | 12 (50) | 14 (54) | 26 (52) | 26 (49) | 52 (50) |
| Poor | 9 (38) | 11 (42) | 20 (40) | 22 (42) | 42 (42) |
| Unknown | 3 (13) | 1 (4) | 4 (8) | 5 (9) | 9 (9) |
| BM blast, % | |||||
| Mean (SD) | 40.3 (27.3) | 38.6 (29.0) | 39.4 (27.9) | 38.7 (25.1) | 39.1 (26.4) |
| Median (range) | 34.0 (9‐93) | 35.5 (2‐94) | 35.0 (2‐94) | 32.0 (4‐95) | 33.0 (2‐95) |
| PB blast, % | |||||
| Mean (SD) | 22.8 (30.9) | 25.1 (26.6) | 24.0 (28.5) | 23.0 (30.7) | 23.5 (29.5) |
| Median (range) | 5 (0‐95) | 14 (0‐81) | 10.0 (0‐95) | 2.5 (0‐99) | 6.0 (0‐99) |
| WBC, × 109/L | |||||
| Mean (SD) | 3 (3.9) | 3.9 (4.5) | 3.5 (4.2) | 5.8 (11.8) | 4.7 (9.0) |
| Median (range) | 1.7 (0.3‐18.7) | 2.1 (0.3‐18.6) | 1.7 (0.3‐18.7) | 2.1 (0.2‐75.5) | 1.8 (0.2‐75.5) |
Abbreviations: BM, bone marrow; d, day; ECOG, Eastern Cooperative Oncology Group; HCT, hematopoietic cell transplantation; HMA, hypomethylating agent; PB, peripheral blood; SD, standard deviation; WBC, white blood cell.
a
One patient in the 10‐day group with proliferative secondary acute myeloid leukemia received only a single dose of low‐dose cytosine arabinoside before enrollment.
b
This category includes patients refractory to 1 or more regimens during the first relapse before guadecitabine treatment.