Randomized studies of anthracycline dose and type for AML induction therapy
| Study . | Age (y) . | Patients (N) . | Experimental arm . | Control arm . | Key conclusions . |
|---|---|---|---|---|---|
| ECOG2,3 | 17-60 | 657 | D, 90 mg/m2 d1-3 | D, 45 mg/m2 d1-3 | Higher response rate |
| A, 100 mg/m2 CIV d1-7 | A, 100 mg/m2 CIV d1-7 | Similar toxicity | |||
| cycle 1* | cycle 1* | Longer OS | |||
| HOVON-SAKK-AMLSG4 | >60 | 813 | D, 90 mg/m2 d1-3 | D, 45 mg/m2 d1-3 | Higher response rate |
| A, 200 mg/m2 CIV d1-7 | A, 200 mg/m2 CIV d1-7 | Similar toxicity | |||
| cycle 1 | cycle 1 | Similar OS† | |||
| Korean Group5 | 15-60 | 383 | D, 90 mg/m2 d1-3 | D, 45 mg/m2 d1-3 | Higher response rate |
| A, 200 mg/m2 CIV d1-7 | A, 200 mg/m2 CIV d1-7 | Similar toxicity | |||
| cycle 1‡ | cycle 1‡ | Longer EFS and OS | |||
| NCRI AML176 | 16-72 | 1206 | D, 90 mg/m2 d1/3/5 | D, 60 mg/m2 d1/3/5 | Similar response rate |
| A, 100 mg/m2/12 h d1-10 | A, 100 mg/m2/12 h d1-10 | Higher early death rate with 90 mg/m2 | |||
| cycle 1§ | cycle 1§ | Similar EFS and OS | |||
| ALFA-98017 | 50-70 | 468 | I, 12 mg/m2 d1-3 or d1-4 | D, 80 mg/m2 d1-3 | Higher response rate in one course |
| A, 200 mg/m2 CIV d1-7 | A, 200 mg/m2 CIV d1-7 | Similar early death rates | |||
| cycle 1 | cycle 1 | Similar EFS and OS | |||
| JALSG AML2018 | 15-64 | 1057 | D, 50 mg/m2 d1-5 | I, 12 mg/m2 d1-3 | Similar response rate |
| A, 100 mg/m2 CIV d1-7 | A, 100 mg/m2 CIV d1-7 | Higher early death rate with control arm | |||
| cycle 1∥ | cycle 1∥ | Similar RFS and OS |
| Study . | Age (y) . | Patients (N) . | Experimental arm . | Control arm . | Key conclusions . |
|---|---|---|---|---|---|
| ECOG2,3 | 17-60 | 657 | D, 90 mg/m2 d1-3 | D, 45 mg/m2 d1-3 | Higher response rate |
| A, 100 mg/m2 CIV d1-7 | A, 100 mg/m2 CIV d1-7 | Similar toxicity | |||
| cycle 1* | cycle 1* | Longer OS | |||
| HOVON-SAKK-AMLSG4 | >60 | 813 | D, 90 mg/m2 d1-3 | D, 45 mg/m2 d1-3 | Higher response rate |
| A, 200 mg/m2 CIV d1-7 | A, 200 mg/m2 CIV d1-7 | Similar toxicity | |||
| cycle 1 | cycle 1 | Similar OS† | |||
| Korean Group5 | 15-60 | 383 | D, 90 mg/m2 d1-3 | D, 45 mg/m2 d1-3 | Higher response rate |
| A, 200 mg/m2 CIV d1-7 | A, 200 mg/m2 CIV d1-7 | Similar toxicity | |||
| cycle 1‡ | cycle 1‡ | Longer EFS and OS | |||
| NCRI AML176 | 16-72 | 1206 | D, 90 mg/m2 d1/3/5 | D, 60 mg/m2 d1/3/5 | Similar response rate |
| A, 100 mg/m2/12 h d1-10 | A, 100 mg/m2/12 h d1-10 | Higher early death rate with 90 mg/m2 | |||
| cycle 1§ | cycle 1§ | Similar EFS and OS | |||
| ALFA-98017 | 50-70 | 468 | I, 12 mg/m2 d1-3 or d1-4 | D, 80 mg/m2 d1-3 | Higher response rate in one course |
| A, 200 mg/m2 CIV d1-7 | A, 200 mg/m2 CIV d1-7 | Similar early death rates | |||
| cycle 1 | cycle 1 | Similar EFS and OS | |||
| JALSG AML2018 | 15-64 | 1057 | D, 50 mg/m2 d1-5 | I, 12 mg/m2 d1-3 | Similar response rate |
| A, 100 mg/m2 CIV d1-7 | A, 100 mg/m2 CIV d1-7 | Higher early death rate with control arm | |||
| cycle 1∥ | cycle 1∥ | Similar RFS and OS |
A, cytarabine; CIV, continuous IV infusion; D, daunorubicin; EFS, event-free survival; I, idarubicin; OS, overall survival.
A second 7+3 DA cycle with 45 mg/m2 per day daunorubicin was given to patients with residual marrow blasts on d12/14 of cycle 1.
A significant EFS and OS benefit was observed in the subgroup of patients aged 60 to 65 years.
A second 5+2 DA cycle with 45 mg/m2 per day daunorubicin was given to patients with persistent leukemia after cycle 1.
In this study, all patients but poor-risk received a second DA course with 50 mg/m2 per day daunorubicin.
A second cycle, identical to the first one, was given to patients with persistent leukemia after cycle 1.