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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