Skip to main content

Table 2 Comparison of treatment characteristics of patients with WHO-MDS or WHO-AML receiving azacitidine front-line

From: Azacitidine front-line in 339 patients with myelodysplastic syndromes and acute myeloid leukaemia: comparison of French-American-British and World Health Organization classifications

  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
  1. aRegards total azacitidine (AZA) cycles applied to the whole cohort (n = 508 [RAEB-I], n = 893 [RAEB-II], n = 715 [AML20–30], n = 111 [AML30+])
  2. b75 mg/m2 d1–7
  3. WHO World Health Organization, MDS myelodysplastic syndrome, AML acute myeloid leukaemia, RAEB refractory anaemia with excess blasts, EMA European Medicines Agency, allo-SCT allogeneic stem cell transplant, d day