Table 4.
Trial 8421 Phase I | Trial 8921 Phase II | Trial 9221 RCT | ||
---|---|---|---|---|
Intravenous | Subcutaneous | Supportive care | Azacytidine | |
Patient evaluated | 43 | 68 | 92 | 99 |
CR | 5 (12%) | 8 (12%) | 0 (0%) | 7(7%)* |
PR | 11 (25%) | 10 (15%) | 0 (0%) | 16 (16%)+ |
Improved | 5 (12%) | 18 (27%) | 5 (5%) | 37 (37%)+ |
Total response | 21 (49%) | 36 (53%) | 5 (5%) | 60 (60%)+ |
Note: p=0.01,
p<0.0001
Abbreviations: CALGB, Cancer And Leukemia Group B; CR, complete response; PR, partial response, RCT, randomized controlled trial.