Table 4 Characteristics and outcomes of patients enrolled to the CPX-351 study or the ALLG NBCR aged 60–75 years with secondary or therapy-related AML receiving induction chemotherapy#.

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

Characteristics

CPX-351 (N = 153)

7 + 3 (N = 156)

NBCR (N = 85)

Age, years, mean (SD)

67.8 (4.2)

67.7 (4.1)

65.7 (3.8)

 - Age 60–69, n (%)

96 (62.7)

102 (65.4)

69 (81.2)

 - Age 70–75, n (%)

57 (37.3)

54 (34.6)

16 (18.8)

Male gender, n (%)

94 (61.4)

96 (61.5)

49 (57.6)

White blood cell, n (%)

 - <20 × 109/L

131 (85.6)

131/155 (84.5)

59 (69.4)

 - ≥20 × 109/L

22 (14.4)

24/155 (15.5)

26 (30.6)

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

 - Favorable

7/143 (4.9)

5/146 (3.4)

1/81 (1.2)

 - Intermediate

64/143 (44.8)

58/146 (39.7)

24/81 (29.6)

 - Adverse

72/143 (50.3)

83/146 (56.8)

56/81 (69.1)

FLT3 mutation, n (%)†

22/138 (15.9)

21/141 (14.9)

10/64 (15.6)

AML subtype, n (%)

 - Therapy-related AML

30 (19.6)

33 (21.2)

13 (15.3)

 - AML with antecedent MDS

71 (46.4)

74 (47.4)

18 (21.2)

 - AML with antecedent CMML

11 (7.2)

12 (7.7)

4 (4.7)

 - De novo with MDS karyotype

41 (26.8)

37 (23.7)

50 (58.8)

Treatment response, n (%)

 - CR/CRi

47.7%

33.3%

42/79 (53.2)

 - CR

37.3%

25.6%

28/79 (35.4)

 - TRM at 30 days

5.9%

10.6%

11/83 (13.3)

 - TRM at 60 days

13.7%

21.2%

20/83 (24.1)

Allogeneic HCT in CR1, n (%)

52 (34.0)

39 (25.0)

6 (7.1)

EFS, months, median (95% CI)

2.53 (2.07–4.99)

1.31 (1.08–1.64)

4.01 (2.43–7.06)

OS, months, median (95% CI)

9.56 (6.60–11.86)

5.95 (4.99–7.75)

9.46 (4.3–13.8)

OS landmarked from HCT, months, median (95% CI)

NR

10.25 (6.21–16.69)

11.07 (9.89–NR)

  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. *NCCN version was not specified in the original publication. As the patient enrollment commenced in 2012 in the CPX-351 study, we have classified the patients in the NBCR cohort using NCCN version 2.2011.
  3. †FLT3 ITD versus TKD status was not specified in the original publication. The NBCR cohort included 8 patients with FLT3-ITD and 2 patients with FLT3-TKD.
  4. AML acute myeloid leukemia, CMML chronic myelomonocytic leukemia, CR1 first remission, CR complete remission, CRi CR with incomplete hematologic recovery, EFS event-free survival, HMA hypomethylating agent, HCT hematopoietic cell transplantation, MDS myelodysplastic syndrome, NCCN National Comprehensive Cancer Network, NR not reached, NR not reached, OS overall survival, SD standard deviation, TRM treatment-related mortality.
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