Response assessment
| . | Overall (n = 42) . | AML with primitive phenotype (n = 33) . | AML with monocytic phenotype (n = 9) . |
|---|---|---|---|
| CRc rate | 39/42 (93% [81-99]) | 32/33 (97% [80-100]) | 7/9 (78% [40-97]) |
| CR | 34/42 (81% [66-91]) | 27/33 (82% [65-93]) | 7/9 (78% [40-97]) |
| CRi | 1/42 (2% [0-13]) | 1/33 (3% [0-16]) | 0 |
| MLFS | 4/42 (10% [3-23]) | 4/33 (12% [3-28]) | 0 |
| Partial remission | 1/42 (2% [0-13]) | 1/33 (3% [0-16]) | 0 |
| No response | 2/42 (5% [1-16]) | 0 | 2/9 (22% [3-60]) |
| MRD negativity after induction | 31/39 (79% [64-91]) | 25/32 (78% [60-91]) | 6/7 (86% [42-100]) |
| MRD negativity from all enrolled patients | 31/42 (74% [58-86]) | 25/33 (76% [58-89]) | 6/9 (67% [30-93]) |
| CRc after cycle 1 | 33/42 (79% [63-90]) | 28/33 (85% [68-95]) | 5/9 (56% [21-86]) |
| CR | 29/42 (69% [53-82]) | 24/33 (73% [54-87]) | 5/9 (56% [21-86]) |
| CRi | 2/42 (5% [1-16]) | 2/33 (6% [1-20]) | 0 |
| MLFS | 2/42 (5% [1-16]) | 2/33 (6% [1-20]) | 0 |
| Partial remission after cycle 1 | 8/42 (19% [9-34]) | 5/33 (15% [5-32]) | 3/9 (33% [7-70]) |
| No response after cycle 1 | 1/42 (2% [0-13]) | 0 | 1/9 (11% [0-48]) |
| MRD negativity after cycle 1 | 25/33 (76% [58-89]) | 21/28 (75% [55-89]) | 4/5 (80% [28-99]) |
| MRD negativity from all enrolled patients after cycle 1 | 25/42 (60% [43-74]) | 21/33 (64% [45-80]) | 4/9 (44% [14-79]) |
| Mortality at 30 days | 0 | 0 | 0 |
| Patients who received antifungal therapy | 24/42 (57% [41-72]) | 21/33 (64% [45-80]) | 3/9 (33% [7-70]) |
| High-dose Ara-C given after CRc | 30/42 (71% [55-84]) | 24/33 (73% [54-87]) | 6/9 (67% [30-93]) |
| 1-2 cycles | 26/42 (62% [46-76]) | 22/33 (67% [48-82]) | 4/9 (44% [14-79]) |
| 3 or more cycles | 4/42 (10% [3-23]) | 2/33 (6% [1-20]) | 2/9 (22% [3-60]) |
| Patients who received allogeneic HSCT | 36/42 (86% [71-95]) | 29/33 (88% [72-97]) | 7/9 (78% [40-97]) |
| Time to blood cell count recovery∗ after induction, days | 34.0 (26.0-42.0) | 34.0 (26.0-42.0) | 30 (28.0-41.5) |
| Time to absolute neutrophil count recovery to ≥1000 cells per μL, days | 31.0 (26.0-41.5) | 32.5 (26.0-41.3) | 30 (28.0-41.5) |
| Time to platelet count recovery to 50 000 platelets per μL, days | 20.0 (17.0-28.0) | 20.0 (17-33.25) | 19.0 (9.5-22.0) |
| . | Overall (n = 42) . | AML with primitive phenotype (n = 33) . | AML with monocytic phenotype (n = 9) . |
|---|---|---|---|
| CRc rate | 39/42 (93% [81-99]) | 32/33 (97% [80-100]) | 7/9 (78% [40-97]) |
| CR | 34/42 (81% [66-91]) | 27/33 (82% [65-93]) | 7/9 (78% [40-97]) |
| CRi | 1/42 (2% [0-13]) | 1/33 (3% [0-16]) | 0 |
| MLFS | 4/42 (10% [3-23]) | 4/33 (12% [3-28]) | 0 |
| Partial remission | 1/42 (2% [0-13]) | 1/33 (3% [0-16]) | 0 |
| No response | 2/42 (5% [1-16]) | 0 | 2/9 (22% [3-60]) |
| MRD negativity after induction | 31/39 (79% [64-91]) | 25/32 (78% [60-91]) | 6/7 (86% [42-100]) |
| MRD negativity from all enrolled patients | 31/42 (74% [58-86]) | 25/33 (76% [58-89]) | 6/9 (67% [30-93]) |
| CRc after cycle 1 | 33/42 (79% [63-90]) | 28/33 (85% [68-95]) | 5/9 (56% [21-86]) |
| CR | 29/42 (69% [53-82]) | 24/33 (73% [54-87]) | 5/9 (56% [21-86]) |
| CRi | 2/42 (5% [1-16]) | 2/33 (6% [1-20]) | 0 |
| MLFS | 2/42 (5% [1-16]) | 2/33 (6% [1-20]) | 0 |
| Partial remission after cycle 1 | 8/42 (19% [9-34]) | 5/33 (15% [5-32]) | 3/9 (33% [7-70]) |
| No response after cycle 1 | 1/42 (2% [0-13]) | 0 | 1/9 (11% [0-48]) |
| MRD negativity after cycle 1 | 25/33 (76% [58-89]) | 21/28 (75% [55-89]) | 4/5 (80% [28-99]) |
| MRD negativity from all enrolled patients after cycle 1 | 25/42 (60% [43-74]) | 21/33 (64% [45-80]) | 4/9 (44% [14-79]) |
| Mortality at 30 days | 0 | 0 | 0 |
| Patients who received antifungal therapy | 24/42 (57% [41-72]) | 21/33 (64% [45-80]) | 3/9 (33% [7-70]) |
| High-dose Ara-C given after CRc | 30/42 (71% [55-84]) | 24/33 (73% [54-87]) | 6/9 (67% [30-93]) |
| 1-2 cycles | 26/42 (62% [46-76]) | 22/33 (67% [48-82]) | 4/9 (44% [14-79]) |
| 3 or more cycles | 4/42 (10% [3-23]) | 2/33 (6% [1-20]) | 2/9 (22% [3-60]) |
| Patients who received allogeneic HSCT | 36/42 (86% [71-95]) | 29/33 (88% [72-97]) | 7/9 (78% [40-97]) |
| Time to blood cell count recovery∗ after induction, days | 34.0 (26.0-42.0) | 34.0 (26.0-42.0) | 30 (28.0-41.5) |
| Time to absolute neutrophil count recovery to ≥1000 cells per μL, days | 31.0 (26.0-41.5) | 32.5 (26.0-41.3) | 30 (28.0-41.5) |
| Time to platelet count recovery to 50 000 platelets per μL, days | 20.0 (17.0-28.0) | 20.0 (17-33.25) | 19.0 (9.5-22.0) |
Data are presented as n/N (% [95% confidence interval]) or median (interquartile range).
Blood cell count recovery was defined as an absolute neutrophil count ≥ 1000 cells/μL and a platelet count ≥ 50 000 platelets/μL.