A comparative study of idarubicin 12 mg/m² and 8 mg/m² combined with cytarabine as the first induction regimen for adult acute myeloid leukemia patients

Figures & data

Table 1 Patient characteristics

Characteristics	Overall (n=100)	Treatment arm		P-value
		IDA 12 mg/m^2 (N=45)	IDA 8 mg/m^2 (N=55)
Age (years)		41.87±13.84	42.84±14.50	0.781
<55	79 (79%)	35 (77.8%)	44 (80%)	0.938
≥55	21 (21%)	10 (22.2%)	11 (20%)
WBC at diagnosis (×10^9/L)		34.42±45.78	34.51±65.23	0.195
<10×10^9/L	43 (43%)	20 (44.4%)	23 (41.8%)	0.792
≥10×10^9/L	57 (57%)	25 (55.6%)	32 (58.2%)
Sex, n (%)
Male	57 (57)	25 (55.6)	32 (58.2)	P=1.0
Female	43 (43)	20 (44.4)	23 (41.8)
FAB, n (%)
M0	2 (2)	2 (4.4)	0 (0)	P=0.055
M1	8 (8)	4 (8.8)	4 (7.2)
M2	30 (30)	9 (20)	21 (38.2)
M4	6 (6)	3 (6.7)	3 (5.5)
M5	40 (40)	16 (35.6)	24 (43.6)
M6	4 (4)	3 (6.7)	1 (1.8)
M7	1 (1)	0 (0)	1 (1.8)
Myeloid sarcoma	3 (3)	3 (6.7)	0 (0)
Unclassified AML	6 (6)	5 (11.1)	1 (1.8)
Cytogenetic group, n (%)
Favorable	13 (13)	8 (17.8)	5 (9.1)	P=0.324
Intermediate	62 (62)	28 (62.2)	34 (61.8)
Adverse	25 (25)	9 (20)	16 (29.1)
SCT, n (%)	6 (6)	3 (6.7)	3 (5.5)	P=0.800

Note: Age and WBC are presented as the mean ± standard deviation.

Abbreviations: AML, acute myeloid leukemia; FAB, French–American–British; IDA, idarubicin; WBC, white blood cell; SCT, stem cell transplantation.

Table 2 Adverse events after the start of induction therapy

	IDA 12 mg/m^2 arm (N=45)	IDA 8 mg/m^2 arm (N=55)	P-value
Infection, n (%)	43 (95.6)	51 (92.7)	0.439
Pulmonary infection, n (%)	22 (48.9)	37 (67.2)	0.063
Bloodstream infection, n (%)	4 (8.89)	5 (9.09)	0.502
Fungal infection, n (%)	6 (13.3)	10 (18.2)	0.511
Infusion of RBC (m), mean ± SD	7.53±5.68	6.02±5.11	0.242
Infusion of PLT (m), mean ± SD	5.47±3.07	3.07±2.67	0.047
Duration of neutropenia (days), mean ± SD	16.16±7.72	12.82±7.30	0.330
Duration of PLT <20×10^9 (days), mean ± SD	12.11±7.14	13.15±8.82	0.297
Acute cardiac toxicity, n (%)	1 (2.2)	0 (0)	0.450
Early deatha, n (%)	0 (0)	2 (3.63)	0.300
Economic cost (RMB, Yuan), mean ± SD	79,365.93±30,392.61	76,984.8±97,031.22	0.372

Notes: Duration of neutropenia (days), infusion of RBC, and infusion of PLT are presented as mean ± standard deviation.

a Death within 30 days after the start of induction therapy.

Abbreviations: IDA, idarubicin; PLT, platelet; RBC, red blood cell.

Table 3 Media OS or DFS of patients

Induction treatment	Total (mo)	Deaths (mo)	Censored (mo)	Median OS (mo)	Median DFS (mo)
Media OS or DFS of total patients in 12 mg/m^2 and 8 mg/m^2 arms
IDA 12 mg/m^2 arma	45	4	41	54
IDA 8 mg/m^2 arma	55	16	39	26.7
IDA 12 mg/m^2 arma	45	8	37		54
IDA 8 mg/m^2 arma	55	21	34		18.3
Media OS and DFS of patients with an intermediate cytogenetic profile
IDA 12 mg/m^2 armb	31	1	30	54
IDA 8 mg/m^2 armb	36	11	25	29.5
IDA 12 mg/m^2 armb	31	4	27		54
IDA 8 mg/m^2 armb	36	15	21		15.3

Notes: Kaplan–Meier estimates of overall survival data and disease-free survival data from the intention-to-treat analysis are shown for

a survival of all patients,

b those with an intermediate cytogenetic profile.

Abbreviations: DFS, disease-free survival; IDA, idarubicin; mo, months; OS, overall survival.