Patient demographics and baseline characteristics
| Characteristics . | All patients (N = 301) . |
|---|---|
| Age, median (range), y | 59.0 (19-85) |
| ≤60 y, n (%) | 159 (52.8) |
| >60 y, n (%) | 142 (47.2) |
| Time (d) since initial diagnosis to start of CT, median (range) | 5.0 (0.0-76.0) |
| Male, n (%) | 141 (46.8) |
| Female, n (%) | 160 (53.2) |
| White, n (%) | 225 (74.8) |
| BMI, median (range), kg/m2 | 25.7 (17.0-53.4) |
| Creatinine, median (range), μmol/L∗ | 61.9 (0.6-187)† |
| Lactate dehydrogenase, median (range), U/L∗ | 330.0 (0.8-7745)‡ |
| Bilirubin, median (range), μmol/L∗ | 13.7 (0.7-66.2)§ |
| ECOG PS, n (%) | |
| 0 | 97 (32.2) |
| 1 | 155 (51.5) |
| 2 | 44 (14.6) |
| Missing | 5 (1.7) |
| AML mutational status, n (%) | |
| FLT3 mutation (ITD and/or TKD)‖ | 300 (99.7) |
| FLT3-ITD | 249 (82.7) |
| FLT3-TKD | 53 (17.6) |
| NPM1 | 126 (41.9) |
| Other | 43 (14.3) |
| Peripheral blood and bone marrow at baseline¶, median (range) | |
| Hemoglobin, g/L | 83.0 (58.0-126.0) |
| Platelet count, 109/L | 23.0 (3.0-225.0) |
| Bone marrow blasts, % | 76.0 (1.0-99.0) |
| Absolute neutrophil count, 109/L | 0.2 (0.0-33.0) |
| WBC count (109/L) | 0.6 (0.01-198.4) |
| Induction chemotherapy group, n (%) | |
| 7+3 | 242 (80.4) |
| 5+2 | 59 (19.6) |
| Induction chemotherapy group by age, n (%) | |
| 7+3 | |
| ≤60 y, n (%) | 145 (48.2) |
| >60 y, n (%) | 97 (32.2) |
| 5+2 | |
| ≤60 y, n (%) | 14 (4.7) |
| >60 y, n (%) | 45 (15.0) |
| Induction chemotherapy group by drug, n (%) | |
| 7+3 | |
| Daunorubicin | 110 (36.5) |
| Idarubicin | 132 (43.9) |
| 5+2 | |
| Daunorubicin | 25 (8.3) |
| Idarubicin | 34 (11.3) |
| Characteristics . | All patients (N = 301) . |
|---|---|
| Age, median (range), y | 59.0 (19-85) |
| ≤60 y, n (%) | 159 (52.8) |
| >60 y, n (%) | 142 (47.2) |
| Time (d) since initial diagnosis to start of CT, median (range) | 5.0 (0.0-76.0) |
| Male, n (%) | 141 (46.8) |
| Female, n (%) | 160 (53.2) |
| White, n (%) | 225 (74.8) |
| BMI, median (range), kg/m2 | 25.7 (17.0-53.4) |
| Creatinine, median (range), μmol/L∗ | 61.9 (0.6-187)† |
| Lactate dehydrogenase, median (range), U/L∗ | 330.0 (0.8-7745)‡ |
| Bilirubin, median (range), μmol/L∗ | 13.7 (0.7-66.2)§ |
| ECOG PS, n (%) | |
| 0 | 97 (32.2) |
| 1 | 155 (51.5) |
| 2 | 44 (14.6) |
| Missing | 5 (1.7) |
| AML mutational status, n (%) | |
| FLT3 mutation (ITD and/or TKD)‖ | 300 (99.7) |
| FLT3-ITD | 249 (82.7) |
| FLT3-TKD | 53 (17.6) |
| NPM1 | 126 (41.9) |
| Other | 43 (14.3) |
| Peripheral blood and bone marrow at baseline¶, median (range) | |
| Hemoglobin, g/L | 83.0 (58.0-126.0) |
| Platelet count, 109/L | 23.0 (3.0-225.0) |
| Bone marrow blasts, % | 76.0 (1.0-99.0) |
| Absolute neutrophil count, 109/L | 0.2 (0.0-33.0) |
| WBC count (109/L) | 0.6 (0.01-198.4) |
| Induction chemotherapy group, n (%) | |
| 7+3 | 242 (80.4) |
| 5+2 | 59 (19.6) |
| Induction chemotherapy group by age, n (%) | |
| 7+3 | |
| ≤60 y, n (%) | 145 (48.2) |
| >60 y, n (%) | 97 (32.2) |
| 5+2 | |
| ≤60 y, n (%) | 14 (4.7) |
| >60 y, n (%) | 45 (15.0) |
| Induction chemotherapy group by drug, n (%) | |
| 7+3 | |
| Daunorubicin | 110 (36.5) |
| Idarubicin | 132 (43.9) |
| 5+2 | |
| Daunorubicin | 25 (8.3) |
| Idarubicin | 34 (11.3) |
AML, acute myeloid leukemia; BMI, body mass index; ECOG PS, Eastern Cooperative Oncology Group performance status; HSCT, hematopoietic stem cell transplant; ITD, internal tandem duplication.
Baseline was defined as the latest assessment before the start of midostaurin (including assessment during chemotherapy treatment period).
n = 300.
n = 274.
n = 297.
ITD and TKD categories are not mutually exclusive. Two patients had both FLT3-ITD and TKD mutations. One patient did not have a FLT3 mutation and was excluded from the efficacy analysis.
Baseline was defined as the latest assessment prior to start of midostaurin