Patient characteristics
| . | All patients . | sAML-like mutations* . | |||
|---|---|---|---|---|---|
| Present† . | Absent† . | P† . | Not tested . | ||
| Patients | 509 | 226 | 245 | — | 38 |
| Sex, male/female | 289/220 | 156/70 | 111/134 | <.001 | 22/16 |
| Median age (range), y | 68 (60-85) | 69 (60-85) | 67 (60-80) | <.001 | 69 (61-83) |
| ECOG-PS 0/1/2+/na | 219/219/66/5 | 99/91/34/2 | 106/109/27/3 | .22 | 14/19/5/0 |
| HCT-CI 0/1/2/3+/na | 226/92/66/115/10 | 90/41/35/55/5 | 115/44/29/53/4 | .51 | 21/7/2/7/1 |
| Median WBC (range), ×109/L | 4.9 (0.25-547) | 4.8 (0.25-547) | 5.9 (0.48-358) | .43 | 2.9 (0.5-122) |
| WBC ≥50 × 109/L | 80 | 31 (41) | 45 (59) | .21 | 4 |
| sAML‡ | 74 | 56 (82) | 12 (18) | <.001 | 6 |
| Cytogenetics (N = 472 evaluable) | |||||
| CBF abnormalities | 15 | 2 (15) | 11 (85) | .022 | 2 |
| Normal karyotype | 238 | 100 (45) | 120 (55) | .29 | 18 |
| MRC abnormalities§ | 90 | 41 (49) | 43 (51) | .90 | 6 |
| AML type (N = 472 classifiable) | |||||
| WHO AML-MRC‖ | 133 | 75 (56) | 47 (35) | .001 | 11 |
| Therapy-related AML | 14 | 5 (38) | 8 (62) | .58 | 1 |
| De novo AML¶ | 325 | 129 (43) | 172 (57) | .002 | 24 |
| Gene mutations, n/N tested | |||||
| Biallelic CEBPA mutation | 8/471 | 2 (25) | 6 (75) | .29 | 0 |
| NPM1 mutation | 132/496 | 31 (24) | 96 (76) | <.001 | 5 |
| FLT3-ITD mutation | 90/497 | 23 (26) | 65 (74) | <.001 | 2 |
| FLT3-ITD high ratio# | 21/495 | 6 (29) | 15 (71) | .077 | 0 |
| ASXL1 mutation | 89/471 | 89 (100) | NA | NA | 0 |
| RUNX1 mutation | 82/471 | 69 (84) | 13 (16) | <.001 | 0 |
| TP53 mutation | 34/471 | 12 (35) | 22 (65) | .15 | 0 |
| ELN-2017 subgroups | <.001 | ||||
| Favorable | 136 | 33 (25) | 100 (75) | — | 3 |
| Intermediate | 157 | 49 (38) | 80 (62) | — | 28 |
| Adverse | 200 | 141 (72) | 54 (28) | — | 5 |
| Not classified | 16 | 3 (21) | 11 (79) | — | 2 |
| . | All patients . | sAML-like mutations* . | |||
|---|---|---|---|---|---|
| Present† . | Absent† . | P† . | Not tested . | ||
| Patients | 509 | 226 | 245 | — | 38 |
| Sex, male/female | 289/220 | 156/70 | 111/134 | <.001 | 22/16 |
| Median age (range), y | 68 (60-85) | 69 (60-85) | 67 (60-80) | <.001 | 69 (61-83) |
| ECOG-PS 0/1/2+/na | 219/219/66/5 | 99/91/34/2 | 106/109/27/3 | .22 | 14/19/5/0 |
| HCT-CI 0/1/2/3+/na | 226/92/66/115/10 | 90/41/35/55/5 | 115/44/29/53/4 | .51 | 21/7/2/7/1 |
| Median WBC (range), ×109/L | 4.9 (0.25-547) | 4.8 (0.25-547) | 5.9 (0.48-358) | .43 | 2.9 (0.5-122) |
| WBC ≥50 × 109/L | 80 | 31 (41) | 45 (59) | .21 | 4 |
| sAML‡ | 74 | 56 (82) | 12 (18) | <.001 | 6 |
| Cytogenetics (N = 472 evaluable) | |||||
| CBF abnormalities | 15 | 2 (15) | 11 (85) | .022 | 2 |
| Normal karyotype | 238 | 100 (45) | 120 (55) | .29 | 18 |
| MRC abnormalities§ | 90 | 41 (49) | 43 (51) | .90 | 6 |
| AML type (N = 472 classifiable) | |||||
| WHO AML-MRC‖ | 133 | 75 (56) | 47 (35) | .001 | 11 |
| Therapy-related AML | 14 | 5 (38) | 8 (62) | .58 | 1 |
| De novo AML¶ | 325 | 129 (43) | 172 (57) | .002 | 24 |
| Gene mutations, n/N tested | |||||
| Biallelic CEBPA mutation | 8/471 | 2 (25) | 6 (75) | .29 | 0 |
| NPM1 mutation | 132/496 | 31 (24) | 96 (76) | <.001 | 5 |
| FLT3-ITD mutation | 90/497 | 23 (26) | 65 (74) | <.001 | 2 |
| FLT3-ITD high ratio# | 21/495 | 6 (29) | 15 (71) | .077 | 0 |
| ASXL1 mutation | 89/471 | 89 (100) | NA | NA | 0 |
| RUNX1 mutation | 82/471 | 69 (84) | 13 (16) | <.001 | 0 |
| TP53 mutation | 34/471 | 12 (35) | 22 (65) | .15 | 0 |
| ELN-2017 subgroups | <.001 | ||||
| Favorable | 136 | 33 (25) | 100 (75) | — | 3 |
| Intermediate | 157 | 49 (38) | 80 (62) | — | 28 |
| Adverse | 200 | 141 (72) | 54 (28) | — | 5 |
| Not classified | 16 | 3 (21) | 11 (79) | — | 2 |
Values are n or n (%), except as noted.
CBF, core binding factor; ECOG-PS, Eastern Cooperative Oncology Group performance status; HCT-CI, hematopoietic cell transplantation comorbidity index; na, not available; NA, not applicable; WBC, white blood cell count.
Defined by the presence of at least 1 gene mutation in the ASXL1, SRSF2, STAG2, BCOR, U2AF1, EZH2, SF3B1, or ZRSR2 genes.
Percentages and P values refer to distribution within sAML-like positive vs negative subsets for each characteristic.
sAML, clinically defined as patients with prior MDS or chronic myelomonocytic leukemia.
MRC cytogenetic abnormalities, according to the WHO AML-MRC definition.9
Includes sAML and/or AML with MRC cytogenetic abnormalities (the multilineage dysplasia criteria were not taken into account here).
Defined as AML classifiable in the WHO 2016 classification but not in the AML-MRC (as defined earlier) or therapy-related AML subgroups.
Defined as FLT3 mutated/wild-type allelic ratio >0.5.