Real-world data confirming the efficacy and safety of decitabine in acute myeloid leukaemia – results from a retrospective Belgian registry study

Figures & data

Table 1. Baseline characteristics study population (n = 45)

	Mean (SD)	Median (min-max)
Age (years)	76.5 (5.9)	76.0 (68.0–91.0)
Height (cm)	168.5 (8.9)	170.0 (147.0–185.0)
Weight (kg)	72.7 (13.8)	72.9 (46.5–99.6)
Body Surface Area (m^2)	1.8 (0.2)	1.9 (1.4–2.2)
Baseline peripheral blast count (%)	27.7 (27.7)	21.0 (0.0–95.0)
Baseline bone marrow blast count (%)	48.0 (26.9)	42.0 (6.0–95.0)
Baseline Haemoglobin (g/dL)	9.3 (1.6)	9.0 (6.5–13.5)
Baseline platelet count (x 10^9/L)	63.3 (55.1)	45.0 (2.0–296.0)
Baseline white blood cell count (x 10^9/L)	15.0 (18.9)	6.5 (0.7–71.5)
Baseline absolute neutrophil count (x 10^9/L)	2.8 (3.8)	1.2 (0.0–15.3)

Table 2. Reasons for discontinuing decitabine treatment

	N (%)
Reason	Cycle 1	Cycle 2	Cycle 3	Cycle 4	Cycles 5 – 26	Total
Death	8	1	1	0	3	13 (29%)
Progressive disease	2	4	0	2	7	15 (33%)
Non-response	0	0	0	1	0	1 (2%)
Patient decision	2	1	0	0	0	3 (7%)
Decitabine-related adverse event	0	0	0	0	1	1 (2%)
Other medical event (not decitabine-related)	3	0	1	0	1	5 (11%)
Physician’s decision	0	1	0	0	2	3 (7%)
Unknown	N/A	N/A	N/A	N/A	N/A	4 (9%)

Figure 1. OS in patients treated with at least 4 cycles of decitabine vs. total population (Kaplan–Meier curves)

Figure 2. PFS in patients treated with at least 4 cycles of decitabine vs. full population (Kaplan–Meier curves)

Table 3. Evolution of transfusion dependency (RBC/PLT) in the study population (N = 45)

	Number of patients	%	Average duration of transfusion independence (SD, median)
RBC dependent at start of decitabine treatment	20	44%	-
RBC transfusion independent during ≥ 8 consecutive weeks	5	25%	37.9 weeks (27.1, 24)
PLT transfusion dependent at start of decitabine treatment	12	27%	-
PLT transfusion independent during ≥ 8 consecutive weeks	7	58%	23.1 weeks (25.8, 14)

Table 4. All non-haematological decitabine-related adverse events (AEs) in the study population (MedDRA standardized classification; NCI-CTC grading)

Adverse Event	Number of patients	%	Maximum observed NCI-CTC grade
Diarrhea	2	4.4	1
Bacteremia	1	2.2	2
Bronchial infection	1	2.2	3
Pneumonia	1	2.2	3
Stomatitis	1	2.2	2
Nausea	1	2.2	1
Rash	1	2.2	1