Response in the ITT population
. | Eligible for nonintensive therapy . | Eligible 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) | 0 | 2 (8.0) |
CRi and CRh | 0 | 2 (1.9) | 0 | 0 |
CRi only | 4 (4.0) | 9 (8.7) | 2 (7.4) | 3 (12.0) |
CRh only | 1 (1.0) | 2 (1.9) | 0 | 1 (4.0) |
MLFS | 5 (5.0) | 5 (4.8) | 0 | 1 (4.0) |
PR | 6 (5.9) | 3 (2.9) | 0 | 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 therapy . | Eligible 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) | 0 | 2 (8.0) |
CRi and CRh | 0 | 2 (1.9) | 0 | 0 |
CRi only | 4 (4.0) | 9 (8.7) | 2 (7.4) | 3 (12.0) |
CRh only | 1 (1.0) | 2 (1.9) | 0 | 1 (4.0) |
MLFS | 5 (5.0) | 5 (4.8) | 0 | 1 (4.0) |
PR | 6 (5.9) | 3 (2.9) | 0 | 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.