Table 2.

Response in the ITT population

Eligible for nonintensive therapyEligible for intensive therapy
Magro/Aza (n = 101)Ven/Aza (n = 104)Magro/Aza (n = 27)7+3 chemotherapy (n = 25)
BOR, n (%)     
CR 8 (7.9) 32 (30.8) 4 (14.8) 7 (28.0) 
CRMRD− 1 (1.0) 12 (11.5) 2 (8.0) 
CRi and CRh 2 (1.9) 
CRi only 4 (4.0) 9 (8.7) 2 (7.4) 3 (12.0) 
CRh only 1 (1.0) 2 (1.9) 1 (4.0) 
MLFS 5 (5.0) 5 (4.8) 1 (4.0) 
PR 6 (5.9) 3 (2.9) 1 (4.0) 
SD 49 (48.5) 27 (26.0) 17 (63.0) 6 (24.0) 
PD 5 (5.0) 4 (3.8) 1 (3.7) 2 (8.0) 
No assessment 23 (22.8) 20 (19.2) 3 (11.1) 4 (16.0) 
ORR (95% CI), % 23.8 (15.9-33.3) 51.0 (41.0-60.9) 22.2 (8.6-42.3) 52.0 (31.3-72.2) 
CRc rate, % 12.9 43.3 22.2 44.0 
Eligible for nonintensive therapyEligible for intensive therapy
Magro/Aza (n = 101)Ven/Aza (n = 104)Magro/Aza (n = 27)7+3 chemotherapy (n = 25)
BOR, n (%)     
CR 8 (7.9) 32 (30.8) 4 (14.8) 7 (28.0) 
CRMRD− 1 (1.0) 12 (11.5) 2 (8.0) 
CRi and CRh 2 (1.9) 
CRi only 4 (4.0) 9 (8.7) 2 (7.4) 3 (12.0) 
CRh only 1 (1.0) 2 (1.9) 1 (4.0) 
MLFS 5 (5.0) 5 (4.8) 1 (4.0) 
PR 6 (5.9) 3 (2.9) 1 (4.0) 
SD 49 (48.5) 27 (26.0) 17 (63.0) 6 (24.0) 
PD 5 (5.0) 4 (3.8) 1 (3.7) 2 (8.0) 
No assessment 23 (22.8) 20 (19.2) 3 (11.1) 4 (16.0) 
ORR (95% CI), % 23.8 (15.9-33.3) 51.0 (41.0-60.9) 22.2 (8.6-42.3) 52.0 (31.3-72.2) 
CRc rate, % 12.9 43.3 22.2 44.0 

BOR, best overall response; CRMRD−, CR without measurable residual disease; MLFS, morphologic leukemia-free state; SD, stable disease.

Seven days of continuous IV cytarabine (100 or 200 mg/m2 daily) and 3 days of IV daunorubicin (60 mg/m2 daily) or idarubicin (12 mg/m2 daily) on days 1 through 3.

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