Patient | This study | Soriano et al. | Voso et al. | Raffoux et al. | Craddock et al. |
---|---|---|---|---|---|
Drugs | VPA, 5-Aza | VPA, Aza, ATRA | VPA, Aza, ATRAa | VPA, Aza, ATRA | VPA, Aza, ATRA, theophylline |
Dosage VPA | Median dosage 25 mg/kg continuously | 50–75 mg/kg 7 days | 600–1,500 mg continuously | 35–50 mg/kg 7 days | ng |
Dosage AZA | 100 mg/m2 5 days | 75 mg/m2 7 days | 75 mg/m2 7 days | 75 mg/m2 7 days | 75 mg/m2 5 days |
No. of pts. | n = 25, evaluable 24 | n = 53 | n = 62, 26 evaluableb | n = 65 | n = 45 |
Median age | 73 years | 69 years | 70 years | 72 years | 66 years |
No. AML/MDS | 75%/25%c | 92%/8% | 31%/69%d | 85%/15% | 80%/20% |
Pretreatment | n = 10 (42%) | n = 20 (38%) | ng | n = 13 (20%) | n = 30 (67%) |
ORR | 37% | 27%e | 31% | 26% | 33% |
CR/PR/HI/marrow response | 7/2/0/4 | 27/0/0/7 | 3/5/4/ng | 14/3/ngf/ng | 7/8/ng/ng |
Median cycles to response | 2 (1–9) | 2 (1–3) | 5 (2–10) monthsg | ng | 2 (1–6) |
OS | 9 months (23 in responders) | 6.5 months (14+ in responders) | 14.4 months | 12.4 months (19.5 in responders) | ng |