Baseline patient characteristics
| Characteristic . | Laromustine/HDAC, n = 177 . | HDAC/placebo, n = 86 . | All patients, N = 263 . |
|---|---|---|---|
| Age, y | |||
| Median (range) | 59 (22-82) | 60 (25-84) | 59 (22-84) |
| Ethnicity, no. (%) | |||
| White | 151 (85) | 78 (91) | 229 (87) |
| Hispanic | 11 (6) | 4 (5) | 15 (6) |
| Black | 8 (5) | 0 | 8 (3) |
| Asian | 6 (3) | 4 (5) | 10 (4) |
| Other | 1 (1) | 0 | 1 (1) |
| ECOG status, no. (%) | |||
| 0 | 78 (44) | 31 (36) | 109 (41) |
| 1 | 78 (44) | 47 (55) | 125 (48) |
| 2 | 19 (11) | 8 (9) | 27 (10) |
| Missing | 2 (1) | 0 | 2 (1) |
| Duration of first CR/CRp, mo, median (minimum, maximum) | 9.6 (2.6, 23.6) | 9.74 (2.9, 75.1) | 9.7 (2.6, 75.1) |
| Duration of AML, mo,* median (minimum, maximum) | 12.1 (3.9, 30.9) | 11.7 (5.2, 76.7) | 12.0 (3.9, 76.7) |
| Age category, no. (%) | |||
| Younger than 60 y | 92 (52) | 42 (49) | 134 (51) |
| 60 y or older | 85 (48) | 44 (51) | 129 (49) |
| Duration of first CR/CRp, category, no. (%) | |||
| Less than 12 mo | 112 (63) | 52 (61) | 164 (62) |
| 12 mo or longer | 65 (37) | 34 (39) | 99 (37) |
| Stratum/duration of first CR or CRp, no. (%) | |||
| Younger than 60 y/less than 12 mo | 61 (35) | 26 (30) | 87 (33) |
| Younger than 60 y/12 or more mo | 31 (18) | 16 (19) | 47 (18) |
| 60 y or older/less than 12 mo | 51 (28) | 26 (30) | 77 (29) |
| 60 y or older/12 or more mo | 34 (19) | 18 (21) | 52 (20) |
| AML by WHO classification, no. (%) | |||
| AML with recurrent genetic abnormalities | 15 (9) | 4 (5) | 19 (7) |
| AML with multilineage dysplasia | 40 (23) | 21 (24) | 61 (23) |
| AML therapy-related | 1 (1) | 1 (1) | 2 (1) |
| AML, not otherwise categorized | 121 (68) | 60 (70) | 181 (69) |
| Characteristic . | Laromustine/HDAC, n = 177 . | HDAC/placebo, n = 86 . | All patients, N = 263 . |
|---|---|---|---|
| Age, y | |||
| Median (range) | 59 (22-82) | 60 (25-84) | 59 (22-84) |
| Ethnicity, no. (%) | |||
| White | 151 (85) | 78 (91) | 229 (87) |
| Hispanic | 11 (6) | 4 (5) | 15 (6) |
| Black | 8 (5) | 0 | 8 (3) |
| Asian | 6 (3) | 4 (5) | 10 (4) |
| Other | 1 (1) | 0 | 1 (1) |
| ECOG status, no. (%) | |||
| 0 | 78 (44) | 31 (36) | 109 (41) |
| 1 | 78 (44) | 47 (55) | 125 (48) |
| 2 | 19 (11) | 8 (9) | 27 (10) |
| Missing | 2 (1) | 0 | 2 (1) |
| Duration of first CR/CRp, mo, median (minimum, maximum) | 9.6 (2.6, 23.6) | 9.74 (2.9, 75.1) | 9.7 (2.6, 75.1) |
| Duration of AML, mo,* median (minimum, maximum) | 12.1 (3.9, 30.9) | 11.7 (5.2, 76.7) | 12.0 (3.9, 76.7) |
| Age category, no. (%) | |||
| Younger than 60 y | 92 (52) | 42 (49) | 134 (51) |
| 60 y or older | 85 (48) | 44 (51) | 129 (49) |
| Duration of first CR/CRp, category, no. (%) | |||
| Less than 12 mo | 112 (63) | 52 (61) | 164 (62) |
| 12 mo or longer | 65 (37) | 34 (39) | 99 (37) |
| Stratum/duration of first CR or CRp, no. (%) | |||
| Younger than 60 y/less than 12 mo | 61 (35) | 26 (30) | 87 (33) |
| Younger than 60 y/12 or more mo | 31 (18) | 16 (19) | 47 (18) |
| 60 y or older/less than 12 mo | 51 (28) | 26 (30) | 77 (29) |
| 60 y or older/12 or more mo | 34 (19) | 18 (21) | 52 (20) |
| AML by WHO classification, no. (%) | |||
| AML with recurrent genetic abnormalities | 15 (9) | 4 (5) | 19 (7) |
| AML with multilineage dysplasia | 40 (23) | 21 (24) | 61 (23) |
| AML therapy-related | 1 (1) | 1 (1) | 2 (1) |
| AML, not otherwise categorized | 121 (68) | 60 (70) | 181 (69) |
HDAC indicates high-dose cytarabine; ECOG, Eastern Cooperative Oncology Group; CR, complete response; CRp, CR except for a platelet count less than 10×109/L but maintained at 20×109/L or more without platelet transfusions for at least 7 consecutive days; AML, acute myelogenous leukemia; and WHO, World Health Organization.
Duration of AML was the number of days from initial AML diagnosis to date of randomization.