Table 1 Response to treatment.

From: “Randomized phase II study of azacitidine ± lenalidomide in higher-risk myelodysplastic syndromes and acute myeloid leukemia with a karyotype including Del(5q)”

Variable, No. (%)

Total

AZA

AZA + LEN

AZA vsAZA + LEN

n = 72

n = 36

n = 36

P

ORR

30 (42)

14 (39)

16 (44)

0.63

CR

6 (8)

4 (11)

2 (6)

0.67

Marrow CR

16 (22)

6 (17)

10 (28)

0.086

PR

0

0

0

1.0

HI

8 (11)

4 (11)

4 (11)

1.0

No response

42 (58)

22 (61)

20 (56)

0.63

Stable disease

8 (11)

5 (14)

3 (8)

0.71

Failure or treatment interrupted due to AE or subject request

34 (47)

17 (47)

17 (47)

1.0

Cytogenetic CR, final assessment

11 (15)

4 (11)

7 (19)

0.18

Cytogenetic PR, final assessment

2 (3)

2 (6)

0

0.49

Cytogenetic response, CR or PR, 3 cycles (FISH)

30 (42)

13 (36)

17 (47)

0.063

No cytogenetic response

28 (39)

16 (44)

12 (33)

0.51

Allogeneic transplantation

11 (15)

6 (17)

5 (14)

0.74

  1. AE  adverse events, AZA azacitidine, CR complete remission, FISH fluorescence in situ hybridization HI, hematologic improvement, LEN lenalidomide, ORR overall response rate, PR partial remission.
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