Table 3 Characteristics and outcomes of patients enrolled to the ALFA-0701 study or the ALLG NBCR aged 50–70 years with de novo AML receiving induction chemotherapy#.

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

Characteristics

ALFA – EXP (N = 139)

ALFA – PBO (N = 139)

NBCR (N = 418)

Age, years, median (IQR)

62.8 (59.3, 66.8)

61.7 (57.4, 65.6)

61.0 (56.0, 66.0)

 - Age ≥60, n (%)

100 (72)

86 (62)

246 (59)

Male gender, n (%)

77 (55)

61 (44)

235 (56)

White blood cell (x109/L), median (IQR)

6.9 (2.3, 30.4)

5.0 (1.9, 26.7)

5.2 (2.1, 21.4)

Platelet count (x109/L), median (IQR)

66.0 (36.5, 118.5)

67.5 (36.3, 125.5)

65.0 (38.0, 127.5)

Cytogenetic risk according to study definition, n (%)

 - Favorable

3/122 (2.5)

6/127 (4.7)

36/397 (9.1)

 - Intermediate

91/122 (74.6)

91/127 (71.7)

274/397 (69.0)

 - Adverse

28/122 (23.0)

30/127 (23.6)

87/397 (21.9)

FLT3-ITD, n (%)

22/137 (16.1)

27/138 (19.6)

76/366 (20.8)

NPM1 mutation, n (%)

45/136 (33.1)

48/138 (34.8)

113/307 (36.8)

Favorable ELN 2010, n (%)

24/119 (20.2)

24/125 (19.2)

61/359 (17.0)

Induction courses >1

25 (18.0)

35 (25.2)

42 (10.0)

Treatment response, n (%)*

 - CR

102 (73.4)

100 (71.9)

259/396 (65.4)

 - CRp

11 (7.9)

4 (2.9)

57/396 (14.4)

 - No CR/CRp

17 (12)

29 (21)

67/396 (16.9)

 - Death

9 (6.4)

6 (4.3)

13/396 (3.3)

Allogeneic HCT, n (%)

 - All patients

32 (23.7)

53 (39.0)

109 (26.1)

 - In first remission

17/135 (12.6)

22 (16.2)

87/417 (20.9)

EFS, months, median (95% CI)

15.6 (11.7–22.4)

9.7 (8.0–11.9)

15.9 (12.3–21.4)

EFS at 2 years, % (95% CI)

40.8 (32.8–50.8)

17.1 (10.8–27.1)

42.7 (37.8–48.2)

OS, months, median (95% CI)†

27.5 (21.4–45.6)

21.8 (15.5–27.4)

28.1 (22.7–40.6)

OS at 2 years, % (95% CI)

53.2 (44.6–63.5)

41.9 (33.1–53.1)

53.5 (48.4–59.1)

  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. *CRp rates are not available for the NBCR; CRi rates are reported instead.
  3. †Median OS for the ALFA-0701 cohort was based on the study update analysis (Lambert, Haematologica 2019).
  4. CR complete remission, CRp CR with incomplete platelet recovery, EFS event-free survival, ELN European LeukemiaNet, EXP experimental, HCT hematopoietic cell transplantation, IQR interquartile range, NCCN National Comprehensive Cancer Network, OS overall survival, PBO placebo.
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