Phase 3 studies concerned with the therapeutic value of dose-escalated cytarabine (HDAC, 2000-3000 mg/m2) regimens in AML in adults up to 60 years of age
| . | Reference . | Study size, n . | Improved outcome for HDAC . | |
|---|---|---|---|---|
| DFS . | OS . | |||
| Remission induction chemotherapy | ||||
| HDAC (3000) vs Ara-C 100* | 6 | 301 | Yes | No |
| HDAC (2000) vs Ara-C 200* | 7 | 665 | Yes | No |
| HDAC 1000/2000 vs Ara-C 200/1000* | 8 | 840 | No | No |
| Consolidation of complete remission | ||||
| HDAC (3000) vs Ara-C 100/400† | 5 | 596 | Yes | Yes |
| HDAC (3000) vs Ara-C 1000* | 9 | 933 | No | No |
| HDAC (2000) vs Ara-C 200* | 10 | 781 | No | No |
| . | Reference . | Study size, n . | Improved outcome for HDAC . | |
|---|---|---|---|---|
| DFS . | OS . | |||
| Remission induction chemotherapy | ||||
| HDAC (3000) vs Ara-C 100* | 6 | 301 | Yes | No |
| HDAC (2000) vs Ara-C 200* | 7 | 665 | Yes | No |
| HDAC 1000/2000 vs Ara-C 200/1000* | 8 | 840 | No | No |
| Consolidation of complete remission | ||||
| HDAC (3000) vs Ara-C 100/400† | 5 | 596 | Yes | Yes |
| HDAC (3000) vs Ara-C 1000* | 9 | 933 | No | No |
| HDAC (2000) vs Ara-C 200* | 10 | 781 | No | No |
HDAC indicates high-dose cytarabine at 2000 mg/m2 or 3000 mg/m2 per intravenous infusion given twice daily; and Ara-C, cytarabine at conventional dose (100, 200, 400 mg/m2 per 24-hour continuous infusion) or intermediate dose (1000 mg/m2 twice daily).
In adults younger than 60-65 years.
In adults 15-86 years of age.