Clinical experience with 5-azactidine in myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) in both untreated and relapsed/refractory patients.
| . | CALGB 922113 . | Updated CALGB 922123 . | 5-azacitidine and phenylbutyrate*41 . | 5-azacitidine and valproic acid*34 . | 5-azacitidine and valproic acid in untreated patients34 . |
|---|---|---|---|---|---|
| * Includes patients with AML and relapsed and refractory disease. | |||||
| Abbreviations: N, number; CR, complete remission; PR, partial remission; HI, hematologic improvement; OR, overall response. HI may include complete marrow responses. | |||||
| Phase | 3 | 3 | 1/2 | 1/2 | 1/2 |
| N | 99 | 99 | 29 | 53 | 33 |
| CR, no. (%) | 7 (7) | 10 (10) | 4 (14) | 12 (22) | 11 (33) |
| PR, no. (%) | 16 (16) | 1 (1) | 1 (3) | 3 (6) | 3 (9) |
| HI, no. (%) | 37 (37) | 36 (36) | 6 (21) | 7 (13) | 3 (9) |
| OR, no. (%) | 60 (60) | 47 (47) | 11 (38) | 22 (41) | 17 (51) |
| . | CALGB 922113 . | Updated CALGB 922123 . | 5-azacitidine and phenylbutyrate*41 . | 5-azacitidine and valproic acid*34 . | 5-azacitidine and valproic acid in untreated patients34 . |
|---|---|---|---|---|---|
| * Includes patients with AML and relapsed and refractory disease. | |||||
| Abbreviations: N, number; CR, complete remission; PR, partial remission; HI, hematologic improvement; OR, overall response. HI may include complete marrow responses. | |||||
| Phase | 3 | 3 | 1/2 | 1/2 | 1/2 |
| N | 99 | 99 | 29 | 53 | 33 |
| CR, no. (%) | 7 (7) | 10 (10) | 4 (14) | 12 (22) | 11 (33) |
| PR, no. (%) | 16 (16) | 1 (1) | 1 (3) | 3 (6) | 3 (9) |
| HI, no. (%) | 37 (37) | 36 (36) | 6 (21) | 7 (13) | 3 (9) |
| OR, no. (%) | 60 (60) | 47 (47) | 11 (38) | 22 (41) | 17 (51) |