Table 3.
Hematologic responses, times to response, and durations of response
| Patients with newly diagnosed AML N = 39 | |
|---|---|
|
| |
| Overall response rate (ORR),a n(%) | 30.8% (12/39) |
| 95% CI | 17.0, 47.6 |
| Best response, n(%) | |
| Complete remission (CR) | 7 (18) |
| CR with incomplete count recovery (CRi/CRp) | 1 (3) |
| Partial remission | 2 (5) |
| Morphologic leukemia-free state | 2 (5) |
| Stable disease,b n(%) | 19 (49) |
| Disease progression, n(%) | 1 (3) |
| Not evaluable,c n(%) | 7 (18) |
| Time to first response, months, median (range) | 1.9 (1.0–3.8) |
| Time to best response, months, median (range) | 3.7 (1.0–12.9) |
| Duration of any response, months, median [95% CI] | NR [7.4, NR] |
| Time to CR, months, median (range) | 5.6 (3.4–12.9) |
| Duration of CR, months, median [95% CI] | NR [3.7, NR] |
a
Overall response included complete remission (CR), CR with incomplete count recovery, partial remission, and morphologic leukemia-free state, per modified IWG 2003 response criteria for AML
b
Failure to achieve a response but not meeting criteria for disease progression, sustained for a period of ≥8 weeks
c
Patients discontinued before undergoing a clinical response assessment
95% CI, 95% confidence interval; NR not reached