Table 5 Characteristics and outcomes of patients enrolled to the QUAZAR study or the ALLG NBCR aged ≥55 years in CR or CRi after intensive chemotherapy#.

From: How comparable are patient outcomes in the “real-world” with populations studied in pivotal AML trials?

Characteristics

CC-486 (EXP) (N = 238)

CC-486 (PBO) (N = 234)

NBCR (no HCT) (N = 185)

NBCR (HCT) (N = 54)

P*

Age, years, median (range)

68 (55–86)

68 (55–82)

65 (55–77)

59 (55–69)

<0.001

 - Age ≥65 years, n (%)

172 (72)

166 (71)

94 (51)

10 (19)

<0.001

Male gender, n (%)

118 (50)

127 (54)

103 (56)

29 (54)

0.9

Cytogenetic risk according to NCCN version 2.2011, n (%)

    

0.04

 - Intermediate

203 (85)

203 (87)

155/181 (86)

39 (72)

 

 - Adverse

35 (15)

31 (13)

26/181 (14)

15 (28)

 

De novo AML, n (%)

213 (89)

216 (92)

174 (94)

49 (91)

0.4

Treatment response, n (%)

    

1

 - CR

187 (79)

197 (84)

155 (84)

46 (85)

 

 - CRi

51 (21)

37 (16)

30 (16)

8 (15)

 

Received consolidation, n (%)

    

0.4

 - No

52 (22)

42 (18)

21 (11)

8 (15)

 

 - 1 cycle

110 (46)

102 (44)

130 (70)

40 (74)

 

 - ≥2 cycles

76 (32)

90 (39)

34 (18)

6 (11)

 

OS, months, median (95% CI)

24.7 (18.7–30.5)

14.8 (11.7–17.6)

32.2 (23.3–48.1)

NR (42.3–NR)

0.04

  1. #N represents the total population; for individual variables, some data were not measured/reported, and the appropriate denominator is specified in these instances. Some percentages do not add up to 100 due to rounding.
  2. *Comparison between HCT or no HCT in first remission in the ALLG NBCR cohort. Student’s t-test for continuous variables, Fisher’s exact test for categorical variables, and log-rank test for overall survival analysis (4-month landmark).
  3. AML acute myeloid leukemia, CR complete remission, CRi CR with incomplete hematologic recovery, EXP experimental, HCT hematopoietic cell transplantation, NCCN National Comprehensive Cancer Network, NR not reached, OS overall survival, PBO placebo.