Patient characteristics
| Characteristic . | n (%) . | P* . | ||
|---|---|---|---|---|
| Arm A: decitabine (n = 82) . | Arm B: decitabine + bortezomib (n = 81) . | Total (N = 163) . | ||
| Age stratification, y | 1.0 | |||
| 60-69 | 31 (37.8) | 31 (38.3) | 62 (38.0) | |
| ≥70 | 51 (62.2) | 50 (61.7) | 101 (62.0) | |
| Age, y | .59 | |||
| Median | 72.4 | 72.9 | 72.4 | |
| Range | 60.7-92.3 | 60.5-90.0 | 60.5-92.3 | |
| Sex | .06 | |||
| Male | 51 (62.2) | 62 (76.5) | 113 (69.3) | |
| Female | 31 (37.8) | 19 (23.5) | 50 (30.7) | |
| Race | 1.0 | |||
| Unknown | 3 (3.7) | 2 (2.5) | 5 (3.1) | |
| White | 74 (90.2) | 73 (90.1) | 147 (90.2) | |
| Black/African American | 3 (3.7) | 4 (4.9) | 7 (4.3) | |
| Asian | 0 (0.0) | 1 (1.2) | 1 (0.6) | |
| Native Hawaiian or Pacific Islander | 1 (1.2) | 0 (0.0) | 1 (0.6) | |
| Not reported | 1 (1.2) | 0 (0.0) | 1 (0.6) | |
| Multiple races reported | 0 (0.0) | 1 (1.2) | 1 (0.6) | |
| Ethnicity | .76 | |||
| Non-Hispanic | 77 (93.9) | 77 (95.1) | 154 (94.5) | |
| Not reported | 3 (3.7) | 1 (1.2) | 4 (2.5) | |
| Unknown | 2 (2.4) | 3 (3.7) | 5 (3.1) | |
| ECOG PS | .49 | |||
| 0 | 22 (26.8) | 21 (25.9) | 43 (26.4) | |
| 1 | 41 (50.0) | 48 (59.3) | 89 (54.6) | |
| 2 | 16 (19.5) | 11 (13.6) | 27 (16.6) | |
| 3 | 3 (3.7) | 1 (1.2) | 4 (2.5) | |
| Clinical onset of AML | .58 | |||
| De novo | 57 (69.5) | 53 (65.4) | 110 (67.5) | |
| Therapy related | 10 (12.2) | 8 (9.9) | 18 (11.0) | |
| MDS related/AHD | 15 (18.3) | 20 (24.7) | 35 (21.5) | |
| ELN classification | n = 71 | n = 76 | n = 147 | .37 |
| Normal | 20 (28.2) | 28 (36.8) | 48 (32.7) | |
| Intermediate-II | 19 (26.8) | 22 (28.9) | 41 (27.9) | |
| Adverse | 32 (45.1) | 26 (34.2) | 58 (39.5) | |
| Creatinine, mg/dL | n = 82 | n = 80 | n = 162 | .24 |
| Median | 0.9 | 1.0 | 1.0 | |
| Range | 0.0-7.0 | 0.0-2.2 | 0.0-7.0 | |
| ≥1.5 | 12 (14.6) | 11 (13.8) | 23 (14.2) | 1.0 |
| LVEF, % | n = 79 | n = 76 | n = 155 | .68 |
| Median | 61.0 | 60.0 | 60.0 | |
| Range | 30.0-74.0 | 29.0-81.0 | 29.0-81.0 | |
| <45 | 3 (3.8) | 4 (5.3) | 7 (4.5) | .72 |
| Characteristic . | n (%) . | P* . | ||
|---|---|---|---|---|
| Arm A: decitabine (n = 82) . | Arm B: decitabine + bortezomib (n = 81) . | Total (N = 163) . | ||
| Age stratification, y | 1.0 | |||
| 60-69 | 31 (37.8) | 31 (38.3) | 62 (38.0) | |
| ≥70 | 51 (62.2) | 50 (61.7) | 101 (62.0) | |
| Age, y | .59 | |||
| Median | 72.4 | 72.9 | 72.4 | |
| Range | 60.7-92.3 | 60.5-90.0 | 60.5-92.3 | |
| Sex | .06 | |||
| Male | 51 (62.2) | 62 (76.5) | 113 (69.3) | |
| Female | 31 (37.8) | 19 (23.5) | 50 (30.7) | |
| Race | 1.0 | |||
| Unknown | 3 (3.7) | 2 (2.5) | 5 (3.1) | |
| White | 74 (90.2) | 73 (90.1) | 147 (90.2) | |
| Black/African American | 3 (3.7) | 4 (4.9) | 7 (4.3) | |
| Asian | 0 (0.0) | 1 (1.2) | 1 (0.6) | |
| Native Hawaiian or Pacific Islander | 1 (1.2) | 0 (0.0) | 1 (0.6) | |
| Not reported | 1 (1.2) | 0 (0.0) | 1 (0.6) | |
| Multiple races reported | 0 (0.0) | 1 (1.2) | 1 (0.6) | |
| Ethnicity | .76 | |||
| Non-Hispanic | 77 (93.9) | 77 (95.1) | 154 (94.5) | |
| Not reported | 3 (3.7) | 1 (1.2) | 4 (2.5) | |
| Unknown | 2 (2.4) | 3 (3.7) | 5 (3.1) | |
| ECOG PS | .49 | |||
| 0 | 22 (26.8) | 21 (25.9) | 43 (26.4) | |
| 1 | 41 (50.0) | 48 (59.3) | 89 (54.6) | |
| 2 | 16 (19.5) | 11 (13.6) | 27 (16.6) | |
| 3 | 3 (3.7) | 1 (1.2) | 4 (2.5) | |
| Clinical onset of AML | .58 | |||
| De novo | 57 (69.5) | 53 (65.4) | 110 (67.5) | |
| Therapy related | 10 (12.2) | 8 (9.9) | 18 (11.0) | |
| MDS related/AHD | 15 (18.3) | 20 (24.7) | 35 (21.5) | |
| ELN classification | n = 71 | n = 76 | n = 147 | .37 |
| Normal | 20 (28.2) | 28 (36.8) | 48 (32.7) | |
| Intermediate-II | 19 (26.8) | 22 (28.9) | 41 (27.9) | |
| Adverse | 32 (45.1) | 26 (34.2) | 58 (39.5) | |
| Creatinine, mg/dL | n = 82 | n = 80 | n = 162 | .24 |
| Median | 0.9 | 1.0 | 1.0 | |
| Range | 0.0-7.0 | 0.0-2.2 | 0.0-7.0 | |
| ≥1.5 | 12 (14.6) | 11 (13.8) | 23 (14.2) | 1.0 |
| LVEF, % | n = 79 | n = 76 | n = 155 | .68 |
| Median | 61.0 | 60.0 | 60.0 | |
| Range | 30.0-74.0 | 29.0-81.0 | 29.0-81.0 | |
| <45 | 3 (3.8) | 4 (5.3) | 7 (4.5) | .72 |
AHD, antecedent hematologic disorder; ECOG, Eastern Cooperative Oncology Group; ELN, European LeukemiaNet; LVEF, left ventricular ejection fraction; MDS, myelodysplastic syndrome.
For continuous variables, Kruskal-Wallis test; for discrete variables, Fisher’s exact test.