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Table 3 Comparison of TEAEsa,b and response of WHO MDS and WHO AML patients 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

TEAEsa 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
 TE-thrombocytopeniab G3–4, % 40.5 41.8 0.885 41.8 35.4 0.466 35.4 39.6 0.628
 TE-neutropeniab G3–4, % 35.3 39.2 0.488 39.2 32.3 0.414 32.3 41.5 0.284
 TE-anaemiab G3–4, % 47.8 53.2 0.591 53.2 54.2 0.924 54.2 47.2 0.487
 Febrile neutropenia, % 23.4 12.7 0.075 12.7 8.3 0.337 8.3 10.3 0.643
 Infections G3–4, % 49.5 31.6 0.047 31.6 22.9 0.239 22.9 20.8 0.751
Response   
 ORR (ITT), %
  CR
   CyCR
  CRi
  PR
33.4
13.5
5.4
1.8
18.0
35.4
16.5
10.1
3.8
15.2
0.810
0.584
0.233
0.398
0.627
35.4
16.5
10.1
3.8
15.2
25.0
5.2
5.2
6.3
13.5
0.181
0.015
0.210
0.431
0.751
25.0
5.2
5.2
6.3
13.5
30.2
9.4
1.9
5.7
15.1
0.484
0.272
0.216
0.862
0.764
 HI without marrow responsec, % 22.5 16.5 0.337 16.5 24.0 0.239 24.0 32.1 0.279
 RBC-TIc, % 43.6 42.1 0.872 42.1 28.3 0.100 28.3 58.3 <0.001
 PLT-TIc, % 38.7 47.1 0.365 47.1 43.3 0.689 43.3 58.3 0.137
Outcome   
 30-day mortality, % 8.1 6.3 0.635 6.3 3.1 0.297 3.1 0.0 0.078
 60-day mortality, % 15.3 6.3 0.053 6.3 5.2 0.746 5.2 1.9 0.216
 1-year survival (total cohort), % 49.6 55.7 0.552 55.7 70.8 0.179 70.8 81.1 0.403
 Median overall survival, months 10.9 13.1 0.238 13.1 18.9 0.010 18.9 23.7 0.302
  1. aTEAEs were defined as new or worsening AEs between the time of first dose to the end of the safety follow-up period (28 days after the last dose of azacitidine)
  2. bTE haematological toxicity was calculated from differential blood counts and transfusions status of all cycles for each patient (no missing data)
  3. cHaematological improvement (HI) and achievement of transfusion independence (TI) was assessed according to IWG 2006 criteria. HI and TI are not considered as a form of response in the current AML response criteria but were additionally assessed in AML patients, in order to compare the efficacy of azacitidine across disease entities
  4. TEAE treatment emergent (TE) adverse event (AE), WHO World Health Organization, MDS myelodysplastic syndrome, AML acute myeloid leukaemia, RAEB refractory anaemia with excess blasts, G grade, ORR overall response rate, ITT intent-to-treat, CR complete response, CyCR complete cytogenetic response, CRi CR with incomplete blood count recovery, PR partial response, RBC red blood cell, PLT platelet, IWG International Working Group