Baseline characteristics of the study cohort (N = 105)
| Characteristic . | No. . | % . | Median (range) . |
|---|---|---|---|
| Age at diagnosis, y | 64 (60-75) | ||
| 60-64 | 54 | 51.4 | |
| 65-70 | 37 | 35.3 | |
| 71-75 | 14 | 13.3 | |
| Sex | |||
| Male | 65 | 61.9 | |
| Female | 40 | 38.1 | |
| AML disease type | |||
| De novo | 73 | 69.5 | |
| Secondary | 32 | 30.5 | |
| ELN 2017 criteria | |||
| Favorable | 24 | 22.9 | |
| Intermediate | 49 | 46.7 | |
| Poor | 32 | 30.5 | |
| Genetic mutation | |||
| Biallelic CEBPA | 6 | 5.7 | |
| NPM1 without FLT3- ITD or with FLT3-ITD (low) | 13 | 12.4 | |
| NPM1 with FLT3-ITD (high) | 10 | 9.5 | |
| FLT3-ITD (high) without NPM1 | 9 | 8.6 | |
| RUNX1 | 10 | 9.5 | |
| ASXL1 | 9 | 8.6 | |
| TP53 | 2 | 1.9 | |
| Laboratory findings at baseline | |||
| WBC × 109/L | 3.8 (0.3-345.7) | ||
| Hemoglobin | 9.1 (5.2-13.0) | ||
| Platelet count × 109/L | 68.0 (9.0-827.0) | ||
| Creatinine, mg/dL | 0.9 (0.5-1.7) | ||
| Albumin, g/dL | 3.8 (2.8-5.0) | ||
| Fibrinogen, mg/dL | 344.0 (57.0-500.0) | ||
| Lactate dehydrogenase, U/L | 471.0 (184.0-13 200.0) | ||
| Basic assessment | |||
| Cardiac function, LVEF (%) | 64.0 (52.0-74.2) | ||
| Pulmonary function | |||
| FEV-1 (%) | 88.0 (57.0-115.0) | ||
| Adjusted DLCO (%) | 77.0 (42.0-119.0) | ||
| ECOG PS | |||
| 0-1 | 98 | 93.3 | |
| 2 | 7 | 6.7 | |
| HCT-CI | |||
| ≥3 | 24 | 22.9 | |
| ≥4 | 15 | 14.3 | |
| ≥5 | 9 | 8.6 | |
| Wheatley index* | |||
| Score | 7 (4-14) | ||
| Good risk (4-6) | 52 | 49.5 | |
| Standard risk (7-8) | 30 | 28.6 | |
| Poor risk (≥9) | 23 | 21.9 | |
| AML scores† | |||
| ED score, % | 18.9 (6.1-52.4) | ||
| 1st quartile | 26 | 24.8 | |
| 2nd quartile | 26 | 24.8 | |
| 3rd quartile | 24 | 22.9 | |
| 4th quartile | 29 | 27.6 | |
| CR score, % | 61.3 (14.5-90.6) | ||
| 1st quartile | 27 | 25.7 | |
| 2nd quartile | 26 | 24.8 | |
| 3rd quartile | 28 | 26.7 | |
| 4th quartile | 24 | 22.8 | |
| Ferrara criteria† | |||
| Age 75 years or older | 1 | ||
| ECOG PS ≥3 | 0 | ||
| Heart (LVEF ≤50%) | 0 | ||
| Lungs (DLCO ≤65% or FEV-1 ≤65%) | 21 | ||
| Kidney (on dialysis) | 3 | ||
| Liver (LFT >3× normal values) | 4 | ||
| Infection (resistant to anti-infective therapy) | 0 | ||
| Mental illness or uncontrolled cognitive status | 0 | ||
| Any other comorbidity that the physician judged to be incompatible with chemotherapy | 0 | ||
| Unfit‡ | 28 | 26.7 |
| Characteristic . | No. . | % . | Median (range) . |
|---|---|---|---|
| Age at diagnosis, y | 64 (60-75) | ||
| 60-64 | 54 | 51.4 | |
| 65-70 | 37 | 35.3 | |
| 71-75 | 14 | 13.3 | |
| Sex | |||
| Male | 65 | 61.9 | |
| Female | 40 | 38.1 | |
| AML disease type | |||
| De novo | 73 | 69.5 | |
| Secondary | 32 | 30.5 | |
| ELN 2017 criteria | |||
| Favorable | 24 | 22.9 | |
| Intermediate | 49 | 46.7 | |
| Poor | 32 | 30.5 | |
| Genetic mutation | |||
| Biallelic CEBPA | 6 | 5.7 | |
| NPM1 without FLT3- ITD or with FLT3-ITD (low) | 13 | 12.4 | |
| NPM1 with FLT3-ITD (high) | 10 | 9.5 | |
| FLT3-ITD (high) without NPM1 | 9 | 8.6 | |
| RUNX1 | 10 | 9.5 | |
| ASXL1 | 9 | 8.6 | |
| TP53 | 2 | 1.9 | |
| Laboratory findings at baseline | |||
| WBC × 109/L | 3.8 (0.3-345.7) | ||
| Hemoglobin | 9.1 (5.2-13.0) | ||
| Platelet count × 109/L | 68.0 (9.0-827.0) | ||
| Creatinine, mg/dL | 0.9 (0.5-1.7) | ||
| Albumin, g/dL | 3.8 (2.8-5.0) | ||
| Fibrinogen, mg/dL | 344.0 (57.0-500.0) | ||
| Lactate dehydrogenase, U/L | 471.0 (184.0-13 200.0) | ||
| Basic assessment | |||
| Cardiac function, LVEF (%) | 64.0 (52.0-74.2) | ||
| Pulmonary function | |||
| FEV-1 (%) | 88.0 (57.0-115.0) | ||
| Adjusted DLCO (%) | 77.0 (42.0-119.0) | ||
| ECOG PS | |||
| 0-1 | 98 | 93.3 | |
| 2 | 7 | 6.7 | |
| HCT-CI | |||
| ≥3 | 24 | 22.9 | |
| ≥4 | 15 | 14.3 | |
| ≥5 | 9 | 8.6 | |
| Wheatley index* | |||
| Score | 7 (4-14) | ||
| Good risk (4-6) | 52 | 49.5 | |
| Standard risk (7-8) | 30 | 28.6 | |
| Poor risk (≥9) | 23 | 21.9 | |
| AML scores† | |||
| ED score, % | 18.9 (6.1-52.4) | ||
| 1st quartile | 26 | 24.8 | |
| 2nd quartile | 26 | 24.8 | |
| 3rd quartile | 24 | 22.9 | |
| 4th quartile | 29 | 27.6 | |
| CR score, % | 61.3 (14.5-90.6) | ||
| 1st quartile | 27 | 25.7 | |
| 2nd quartile | 26 | 24.8 | |
| 3rd quartile | 28 | 26.7 | |
| 4th quartile | 24 | 22.8 | |
| Ferrara criteria† | |||
| Age 75 years or older | 1 | ||
| ECOG PS ≥3 | 0 | ||
| Heart (LVEF ≤50%) | 0 | ||
| Lungs (DLCO ≤65% or FEV-1 ≤65%) | 21 | ||
| Kidney (on dialysis) | 3 | ||
| Liver (LFT >3× normal values) | 4 | ||
| Infection (resistant to anti-infective therapy) | 0 | ||
| Mental illness or uncontrolled cognitive status | 0 | ||
| Any other comorbidity that the physician judged to be incompatible with chemotherapy | 0 | ||
| Unfit‡ | 28 | 26.7 |
DLCO, diffusing capacity of lungs for carbon monoxide; FEV-1, forced expiratory volume at 1 second; ITD, internal tandem duplication; LFT, liver function test; LVEF, left ventricular ejection fraction; WBC, white blood cell count.
Wheatley risk score comprises cytogenetic risk group, WBC group, ECOG PS, age group, and AML type.16
AML scores calculate the probability of CR or ED (%) with appropriate formula, including initial body temperature, hemoglobin, platelet count, fibrinogen level, lactate dehydrogenase level, age, cytogenetic/molecular risk classification, and AML type.14
Ferrara operation criteria define unfitness for intensive chemotherapy in AML. The definition of unfitness for intensive chemotherapy should require the fulfillment of ≥1 of 9 criteria.44