Table 3 Responses to treatment with valproic acid+all-trans retinoic acid (ATRA)+low-dose cytarabine according to the myelodysplastic syndrome (MDS) criteria for hematological improvement (increased cell counts for at least eight weeks); a summary of the observations for nine acute myeloid leukemia (AML) patients fulfilling these criteria (referred to as stable disease, SD)
Patient characteristics and treatment responses | Detailed description of disease characteristics and the clinical course |
|---|---|
SD1 - stable disease | Risk factor: previous primary MDS. |
Male, 83 years | Status at diagnosis: performance status 0 to 2, 45% blasts in bone marrow; circulating blasts < 0.5 × 109/L. |
Duration of treatment: 3 months | Valproic acid level: 340 μmol/L. |
Response duration: 2.5 months | Peripheral blood cell counts: (i) platelet counts > 15 × 109/L for 2.5 months; (ii) neutrophils > 0.1 × 109/L for 3 months; and (iii) erythrocyte level > 8.5 × 109 for 2.5 months without transfusions. |
Survival: 102 days | |
SD2 - stable diseasea | Risk factor: previous primary MDS. |
Female, 77 years | Status at diagnosis: performance status 0 to 2, 25% blasts in bone marrow; circulating blasts < 0.5 × 109/L. |
Duration of treatment: 10 months | Valproic acid level: 324 μmol/L. |
Response duration: 3.5 months | Peripheral blood cell counts: (i) platelet counts > 25 for 7 months; (ii) neutrophils > 0.2 × 109 for 5 months; and (iii) erythrocyte level > 8.5 × 109 for 3.5 months without transfusions. |
Survival: 419 days | |
SD3- stable disease | Risk factor: previous primary MDS. |
Female, 85 years | Status at diagnosis: performance status 0 to 2, 70% blasts in bone marrow; circulating blasts < 0.5 × 109/L |
Duration of treatment: 5.5 months | Valproic acid level: 442 μmol/L. |
Response duration: 2 months | Peripheral blood cell counts: (i) platelet counts > 18 × 109 for 2 months; (ii) neutrophils could mostly not be reported; and (iii) erythrocyte level > 8.5 × 109 for 3 months with stable transfusion level |
Survival: 171 days | |
SD4 – stable disease | Risk factor: none |
Male, 74 years | Status at diagnosis: performance status 3 to 5, > 20% blasts in bone marrow; circulating blasts > 15 × 109/L |
Duration of treatment: 2 months | Valproic acid level: 70 μmol/L. |
Response duration: 3 months | Peripheral blood cell counts: (i) platelet counts > 50 × 109 for 3 months, > 100 for 1 month; (ii) neutrophils could mostly not be reported; and (iii) erythrocyte level > 8.5 × 109 for 4 months with stable transfusion level. |
Survival: 151 days | |
SD5 – stable diseasea | Risk factor: previous primary MDS, incomplete response to 5-azacitidine for AML. |
Male, 66 years | |
Duration of treatment: 7.5 months | Status at diagnosis: performance status 0 to 2, > 15% blasts in bone marrow when included in the study; circulating blasts < 0,5 × 109/L. |
Response duration: 2 months | Valproic acid level: 419 μmol/L. |
Survival: 239 days | Peripheral blood cell counts: (i) platelet counts > 10 × 109 for 2 months; (ii) neutrophils stable 0.1 × 109/L for 3 months; and (iii) erythrocyte level > 8.5 × 109 for 2 months without transfusions. |
SD6 - stable disease | Risk factor: none |
Female, 78 years | Status at diagnosis: performance status 0 to 2, > 20% blasts in bone marrow; circulating blasts < 0,5 × 109/L. |
Duration of treatment: 4.5 months | Valproic acid level: 476 μmol/L |
Response duration: 2 months | Peripheral blood cell counts: (i) platelet counts > 30 × 109/L for 2 months; (ii) neutrophils stable around 0.1 × 109/L; and (iii) erythrocyte level > 8.5 × 109/L for 3 months with stable transfusion frequency. |
Survival: 147 days | |
SD7 - stable diseasea | Risk factor: previous primary MDS |
Female, 72 years Duration of treatment: 1 month | |
Status at diagnosis: performance status 0 to 2, > 30% blasts in bone marrow; circulating blasts > 30 × 109/L | |
Valproic acid level: 478 μmol/L. | |
Response duration: 3 months | Peripheral blood cell counts: (i) platelet counts > 15 × 109 for 3 months with stable transfusion frequency; (ii) neutrophils could not be reported; and (iii) erythrocyte level > 8.5 × 109 for 3 months with stable transfusion frequency. |
Survival: 132 days | |
SD8- stable diseasea | Risk factor: previous polycythemia vera, AML with del(5) |
Male, 81 years | Status at diagnosis: performance status 0 to 2, 25% blasts in bone marrow; circulating blasts > 20 × 109/L. |
Duration of treatment: 4 months | Valproic acid level: 404 μmol/L |
Response duration: 2 months | Peripheral blood cell counts: (i) Platelet counts > 30 × 109 for 3 months; (ii) neutrophils > 0.2 × 109 for 2 months; and (iii) erythrocyte level > 8.5 × 109 for 2 months with stable transfusion frequency. |
Survival: > 574 days | |
SD9 – stable diseasea | Risk factor: previous primary MDS. |
Female, 77 years | Status at diagnosis: performance status 0 to 2, 30 % blasts in bone marrow; circulating blasts > 25 × 109/L. |
Duration of treatment: 3.5 months | Valproic acid level: 467 μmol/L |
Response duration: > 2 months | Peripheral blood cell counts: (i) platelet counts > 25 × 109 for > 2 months; (ii) neutrophils could not be reported; and (iii) erythrocyte level > 8.5 for 4 months with stable transfusion frequency. |
Survival: > 141 days |