Table 1.

Patient characteristics

Characteristicn (%)P*
Arm A: decitabine (n = 82)Arm B: decitabine + bortezomib (n = 81)Total (N = 163)
Age stratification, y1.0
 60-6931 (37.8)31 (38.3)62 (38.0)
 ≥7051 (62.2)50 (61.7)101 (62.0)
Age, y.59
 Median72.472.972.4
 Range60.7-92.360.5-90.060.5-92.3
Sex.06
 Male51 (62.2)62 (76.5)113 (69.3)
 Female31 (37.8)19 (23.5)50 (30.7)
Race1.0
 Unknown3 (3.7)2 (2.5)5 (3.1)
 White74 (90.2)73 (90.1)147 (90.2)
 Black/African American3 (3.7)4 (4.9)7 (4.3)
 Asian0 (0.0)1 (1.2)1 (0.6)
 Native Hawaiian or Pacific Islander1 (1.2)0 (0.0)1 (0.6)
 Not reported1 (1.2)0 (0.0)1 (0.6)
 Multiple races reported0 (0.0)1 (1.2)1 (0.6)
Ethnicity.76
 Non-Hispanic77 (93.9)77 (95.1)154 (94.5)
 Not reported3 (3.7)1 (1.2)4 (2.5)
 Unknown2 (2.4)3 (3.7)5 (3.1)
ECOG PS.49
 022 (26.8)21 (25.9)43 (26.4)
 141 (50.0)48 (59.3)89 (54.6)
 216 (19.5)11 (13.6)27 (16.6)
 33 (3.7)1 (1.2)4 (2.5)
Clinical onset of AML.58
 De novo57 (69.5)53 (65.4)110 (67.5)
 Therapy related10 (12.2)8 (9.9)18 (11.0)
 MDS related/AHD15 (18.3)20 (24.7)35 (21.5)
ELN classificationn = 71n = 76n = 147.37
 Normal20 (28.2)28 (36.8)48 (32.7)
 Intermediate-II19 (26.8)22 (28.9)41 (27.9)
 Adverse32 (45.1)26 (34.2)58 (39.5)
Creatinine, mg/dLn = 82n = 80n = 162.24
 Median0.91.01.0
 Range0.0-7.00.0-2.20.0-7.0
 ≥1.512 (14.6)11 (13.8)23 (14.2)1.0
LVEF, %n = 79n = 76n = 155.68
 Median61.060.060.0
 Range30.0-74.029.0-81.029.0-81.0
 <453 (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.