Table 2 Comparison of treatment characteristics of patients with WHO-MDS or WHO-AML receiving azacitidine front-line
|  | AML30+ (n = 111) | AML20–30 (n = 79) | p value | AML20–30 (n = 79) | RAEB-II (n = 96) | p value | RAEB-II (n = 96) | RAEB-I (n = 53) | p value |
|---|---|---|---|---|---|---|---|---|---|
Median AZA cycles, n (range)  Responders  Non-responders | 5 (1–51) 10 (2–51) 2 (1–13) | 6 (1–49) 9 (1–49) 3.5 (1–28) | 0.763 0.818 0.522 | 6 (1–49) 9 (1–49) 3.5 (1–28) | 5 (1–96) 9 (3–81) 3 (1–31) | 0.763 1 0.845 | 5 (1–96) 9 (3–81) 3 (1–31) | 7 (1–66) 9 (4–66) 5 (1–12) | 0.564 1 0.480 |
Average AZA cyclesa, n  <3 cycles, %  ≥6 cycles, %  ≥12 cycles, % | 8.5 28.8 49.5 25.2 | 9.1 16.5 55.7 25.3 | 0.888 0.069 0.546 1 | 9.1 16.5 55.7 25.3 | 9.3 20.8 49.0 22.9 | 0.964 0.481 0.512 0.729 | 9.3 20.8 49.0 22.9 | 8.6 13.2 58.5 26.4 | 0.869 0.192 0.360 0.618 |
AZA 7 daysa, % | 75.4 | 78.9 | 0.779 | 78.9 | 69.2 | 0.426 | 69.2 | 71.1 | 0.872 |
EMA target dosea, b, % | 63.5 | 62.8 | 0.950 | 62.8 | 59.0 | 0.730 | 59.0 | 43.4 | 0.123 |
Median AZA dose/cyclea, mg  Dose/d, mg | 882 130 | 910 135 | 0.508 0.759 | 910 135 | 905 136 | 0.906 0.950 | 905 136 | 882 130 | 0.586 0.713 |
Reason for AZA discont., %  Adverse event  Death  Progressive disease/relapse  No response  Allo-SCT  Patient wish/others  Still on AZA at study closure | 11.7 32.4 23.4 8.1 1.8 14.4 9.4 | 3.8 25.3 27.8 10.1 2.5 21.5 6.3 | 0.045 0.350 0.539 0.639 0.736 0.236 0.434 | 3.8 25.3 27.8 10.1 2.5 21.5 6.3 | 3.1 17.7 19.8 12.5 3.1 17.7 24.0 | 0.790 0.247 0.250 0.614 0.800 0.544 0.001 | 3.1 17.7 19.8 12.5 3.1 17.7 24.0 | 1.9 11.3 30.2 7.5 13.2 18.9 17.0 | 0.592 0.235 0.141 0.264 0.012 0.843 0.274 |
Patient status, %  Dead at data cut-off  Alive at data cut-off  Unknown | 87.5 12.5 0.0 | 83.5 16.4 0.0 | 0.700 0.468 1 | 83.5 16.4 0.0 | 49.0 51.1 0.0 | 0.003 <0.001 1 | 49.0 51.1 0.0 | 52.8 47.2 0.0 | 0.706 0.694 1 |