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Table 1 Baseline characteristics

From: Venetoclax Combined with Azacitidine and Homoharringtonine in Relapsed/Refractory AML: A Multicenter, Phase 2 Trial

Characteristics

All patients (n = 96)

Refractory AML (n = 37)

Relapsed AML after chemotherapy (n = 16)

Relapsed AML after allo-HSCT (n = 43)

P

Age, median (IQR), y

45 (33–55)

48 (38–57)

45.5 (33–64)

41 (32–52)

 

Gender, No (%)

0.47

 Male

51 (53.1)

21 (56.8)

10 (62.5)

20 (46.5)

 

 Female

45 (46.9)

16 (43.2)

6 (37.5)

23 (53.5)

 

Prior hypomethylating agent†, No (%)

0.06

 Yes

36 (37.5)

9 (24.3)

9 (56.3)

18 (41.9)

 

 No

60 (62.5)

28 (75.7)

7 (43.8)

25 (58.1)

 

Cytogenetics‡, No (%)

0.55

 Favorable

6 (6.3)

4 (10.8)

0 (0)

2 (4.7)

 

 Intermediate

53 (55.2)

18 (48.7)

10 (62.5)

25 (58.1)

 

 Poor

27 (28.1)

12 (32.4)

3 (18.8)

12 (27.9)

 

 Unknown

10 (10.4)

3 (8.1)

3 (18.8)

4 (9.3)

 

ELN classification, No (%)

0.68

 Favorable

17 (17.7)

7 (18.9)

2 (12.5)

8 (18.6)

 

 Intermediate

22 (22.9)

10 (27.0)

5 (31.3)

7 (16.3)

 

 Adverse

57 (59.4)

20 (54.1)

9 (56.3)

28 (65.1)

 

Number of VEN cycles, No (%)

0.01

 One

45 (46.9)

25 (67.6)

6 (37.5)

14 (32.6)

 

 Two

42 (43.7)

12 (32.4)

8 (50.0)

22 (51.2)

 

 Three

9 (9.4)

0 (0)

2 (12.5)

7 (16.3)

 

 Patients bridge to Allo-HSCT, No (%)

40 (41.7)

26 (70.3)

7 (43.8)

7 (16.3)

 < 0.01

Molecular abnormalities, No (%)

 NPM1

11 (11.5)

3 (8.1)

2 (12.5)

6 (14.0)

0.71

 AML1-ETO

6 (6.3)

4 (10.8)

0 (0)

2 (4.7)

0.28

 CEBPA

10 (10.4)

3 (8.1)

2 (12.5)

5 (11.6)

0.84

 TET2

41 (42.7)

13 (35.1)

7 (43.8)

21 (48.8)

0.46

 DNMT3A

18 (18.8)

9 (24.3)

2 (12.5)

7 (16.3)

0.51

 IDH1/2

14 (14.6)

8 (21.6)

3 (18.8)

3 (7.0)

0.16

 FLT3

19 (19.8)

7 (18.9)

2 (12.5)

10 (23.3)

0.64

 ASXL1

22 (22.9)

7 (18.9)

4 (25.0)

11 (25.6)

0.76

 RUNX1

22 (22.9)

6 (16.2)

3 (18.8)

13 (30.2)

0.30

 TP53

7 (7.3)

4 (10.8)

0 (0)

3 (7.0)

0.38

 MLL

7 (7.3)

2 (5.4)

3 (18.8)

2 (4.7)

0.15

 EZH2

6 (6.3)

1 (2.7)

1 (6.3)

4 (9.3)

0.48

 BCL6

7 (7.3)

1 (2.7)

1 (6.3)

5 (11.6)

0.31

 BCOR

7 (7.3)

6 (16.2)

0 (0)

1 (2.3)

0.03

 GATA2

5 (5.2)

1 (2.7)

0 (0)

4 (9.3)

0.25

 RAS

9 (9.4)

6 (16.2)

1 (6.3)

2 (4.7)

0.19

 CD101

8 (8.3)

2 (5.4)

1 (6.3)

5 (11.6)

0.57

  1. Data are number of patients (%) or median (IQR)
  2. AML acute myeloid leukemia, Allo-HSCT allogeneic hematopoietic stem cell transplantation, ELN European Leukemia Net, VEN venetoclax
  3. †Prior hypomethylating agent included azacitidine in 21 patients and decitabine in 15 patients
  4. ‡Cytogenetic risks were based on 2017 European Leukemia Net risk stratification