Protocols
| . | Protocol 8421: IV azacitidine (n = 48) . | Protocol 8921: SC azacitidine (n = 70) . | Protocol 9221 . | Protocols 8921 and 9221: SC azacitidine (n = 169) . | ||
|---|---|---|---|---|---|---|
| SC azacitidine* (n = 99) . | Observation only† (n = 41) . | SC azacitidine after observation (n = 51) . | ||||
| IWG response, no. of patients (%) | ||||||
| CR | 7 (15) | 12 (17) | 10 (10) | 0 (0) | 3 (6) | 22 (13) |
| PR | 1 (2) | 0 (0) | 1 (1) | 0 (0) | 2 (4) | 1 (1) |
| HI‡ | 13 (27) | 16 (23) | 36 (36) | 7 (17) | 13 (25) | 52 (31) |
| Erythroid response, major | 10 (21) | 11 (16) | 22 (22) | 1 (2) | 8 (16) | 33 (20) |
| Erythroid response, minor | 2 (4) | 3 (4) | 8 (8) | 4 (10) | 4 (8) | 11 (7) |
| Platelet response, major | 9 (19) | 6 (9) | 21 (21) | 2 (5) | 3 (6) | 27 (16) |
| Platelet response, minor | 0 (0) | 2 (3) | 3 (3) | 0 (0) | 1 (2) | 5 (3) |
| Neutrophil response, major | 2 (4) | 0 (0) | 8 (8) | 1 (2) | 2 (4) | 8 (5) |
| Neutrophil response, minor | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Overall: CR + PR + HI | 21 (44) | 28 (40) | 47 (47) | 7 (17) | 18 (35) | 75 (44) |
| . | Protocol 8421: IV azacitidine (n = 48) . | Protocol 8921: SC azacitidine (n = 70) . | Protocol 9221 . | Protocols 8921 and 9221: SC azacitidine (n = 169) . | ||
|---|---|---|---|---|---|---|
| SC azacitidine* (n = 99) . | Observation only† (n = 41) . | SC azacitidine after observation (n = 51) . | ||||
| IWG response, no. of patients (%) | ||||||
| CR | 7 (15) | 12 (17) | 10 (10) | 0 (0) | 3 (6) | 22 (13) |
| PR | 1 (2) | 0 (0) | 1 (1) | 0 (0) | 2 (4) | 1 (1) |
| HI‡ | 13 (27) | 16 (23) | 36 (36) | 7 (17) | 13 (25) | 52 (31) |
| Erythroid response, major | 10 (21) | 11 (16) | 22 (22) | 1 (2) | 8 (16) | 33 (20) |
| Erythroid response, minor | 2 (4) | 3 (4) | 8 (8) | 4 (10) | 4 (8) | 11 (7) |
| Platelet response, major | 9 (19) | 6 (9) | 21 (21) | 2 (5) | 3 (6) | 27 (16) |
| Platelet response, minor | 0 (0) | 2 (3) | 3 (3) | 0 (0) | 1 (2) | 5 (3) |
| Neutrophil response, major | 2 (4) | 0 (0) | 8 (8) | 1 (2) | 2 (4) | 8 (5) |
| Neutrophil response, minor | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Overall: CR + PR + HI | 21 (44) | 28 (40) | 47 (47) | 7 (17) | 18 (35) | 75 (44) |
Reprinted from Silverman et al54 with permission.
IWG indicates International Working Group; MDS, myelodysplastic syndrome; IV, intravenous; SC, subcutaneous; CR, complete remission; PR, partial remission; and HI, hematologic improvement.
Patients randomly assigned to azacitidine.
Patients randomly assigned to observation who did not cross over to azacitidine.
Patients with HI (major or minor) were counted only once in the overall response.