Characteristic Treatment of choice (TC) Decitabine All patients
Supportive care Cytarabine Total TC (n=242) (N=485)
(n=28) (n=215) (n=243)    
No. of Patients % No. of Patients % No. of Patients % No. of Patients % No. of Patients %
Age, years
                     
Median 75   73   73   73   73  
                     
Range 66–86   64–91   64–91   64–89   64–91  
65–69 5 17.9 64 29.8 69 28.4* 68 28.1† 137 28.2
                     
≥ 70 23 82.1 150 69.8 173 71.2 171 70.7 344 70.9
Sex                    
Female 8 28.6 84 39.1 92 37.9 105 43.4 197 40.6
Male 20 71.4 131 60.9 151 62.1 137 56.6 288 59.4
BSA, m2
Median 1.75   1.8   1.8   1.82   1.81  
Range 1.3–2.4   1.4–2.7   1.3–2.7   1.4–2.6   1.3–2.7  
Time since AML diagnosis, days
Median 27   15   15   14   15  
Range 0.0–363.0   0.0–398.0   0.0–398.0   3.0–346.0   0.0–398.0  
Type of AML
De novo 17 60.7 140 65.1 157 64.6 155 64 312 64.3
Secondary 11 39.3 73 34 84 34.6 87 36 171 35.3
Bone marrow blasts‡                    
20%–30% 5 17.9 53 24.9 58 24.1 65 27 123 25.5
>30%–50% 10 35.7 64 30 74 30.7 67 27.8 141 29.3
>50% 11 39.3 90 42.3 101 41.9 105 43.69 206 42.7
Cytogenetics
Intermediate risk 20 71.4 134 62.6 154 63.6 152 63.1 306 63.4
Poor risk 8 28.6 79 36.9 87 36 87 36.1 174 36
ECOG PS                    
0 or 1 19 67.9 164 76.3 183 75.3 184 76 367 75.7
2 9   51   60   58   118  
Hemoglobin, g/dL
Median 9.3   9.4   9.4   9.3   9.3  
Range 6.6–10.7   5.0–12.6   5.0–12.6   5.2–15.0   5.0–15.0  
Median white blood cells, 109/L (range)
Median 2.73   3.71   3.69   3.1   3.43  
Range 0.7–26.5   0.5–80.9   0.5–80.9   0.3–127.0   0.3–127.0  
Table 1: Patient demographics and baseline clinical characteristics [8]. *One patient (not included) was aged <65 years. †Three patients (not included) were aged 65 years. ‡Twelve patients with <20% blasts in the safety population included 1 patient with M6 AML (defined by marrow erythroblasts), 3 patients with a misdiagnosis of AML, 5 patients with unknown blast counts at screening, and 3 protocol deviations. AML indicates acute myeloid leukemia; ECOG PS, Eastern Cooperative Oncology Group performance status. Reprinted with permission from Kantarjian et al. [8].