Demographic and baseline characteristics of the study population (de novo vs sAML, n = 8521)
| Characteristic . | Overall . | De novo . | Secondary AML . | P value . | |||
|---|---|---|---|---|---|---|---|
| Median (range) . | n (%) . | Median (range) . | n (%) . | Median (range) . | n (%) . | ||
| Total | 8521 (100) | 6211 (100) | 2310 (100) | ||||
| Age, y | 66 (18-104) | 8507 (100) | 64 (18-99) | 6201 (100) | 69 (18-104) | 2306 (100) | <.001* |
| 18-29 | 389 (5) | 359 (6) | 30 (1) | <.001 | |||
| 30-39 | 549 (6) | 480 (8) | 69 (3) | ||||
| 40-49 | 823 (10) | 706 (11) | 117 (5) | ||||
| 50-59 | 1285 (15) | 998 (16) | 287 (12) | ||||
| 60-69 | 2087 (25) | 1421 (23) | 666 (29) | ||||
| 70-79 | 2333 (27) | 1535 (25) | 798 (35) | ||||
| 80-89 | 967 (11) | 649 (10) | 318 (14) | ||||
| ≥90 | 74 (1) | 53 (1) | 21 (1) | ||||
| Gender | 8432 (100) | 6127 (100) | 2304 (100) | ||||
| Male | 4643 (55) | 3266 (53) | 1377 (60) | <.001 | |||
| Female | 3788 (45) | 2861 (47) | 927 (40) | ||||
| ECOG | 1 (0-4) | 6640 (100) | 1 (0-4) | 4819 (100) | 1 (0-4) | 1821 (100) | <.001* |
| 0 | 1949 (29) | 1481 (31) | 468 (26) | <.001 | |||
| 1 | 2740 (41) | 2028 (42) | 712 (39) | ||||
| 2 | 1239 (19) | 852 (18) | 387 (21) | ||||
| 3 | 538 (8) | 336 (7) | 202 (11) | ||||
| 4 | 174 (3) | 122 (3) | 52 (3) | ||||
| FAB subtype | 8521 (100) | 6211 (100) | 2310 (100) | ||||
| M0/M6/M7 | 872 (10) | 638 (10) | 234 (10) | <.001 | |||
| M1/M2 | 2301 (27) | 1814 (29) | 487 (21) | ||||
| M4/M5 | 2156 (37) | 1764 (28) | 392 (17) | ||||
| Not available | 3192 (37) | 1995 (32) | 1197 (52) | ||||
| Hepatosplenomegaly | 4380 (100) | 3263 (100) | 1117 (100) | .63 | |||
| Yes | 962 (22) | 723 (22) | 239 (21) | ||||
| No | 3418 (78) | 2540 (78) | 878 (79) | ||||
| WBC, ×109/L | 9.2 (0-669) | 7801 (100) | 10.4 (0-669) | 5762 (100) | 6.6 (0.1-312) | 2039 (100) | <.001* |
| ≤5 | 3135 (40) | 2199 (38) | 936 (46) | <.001 | |||
| 5-10 | 883 (11) | 651 (11) | 232 (11) | ||||
| 10-50 | 2137 (27) | 1574 (27) | 563 (28) | ||||
| >50 | 1646 (21) | 1338 (23) | 308 (15) | ||||
| Hemoglobin, g/dL | 9 (1.3-18.7) | 7204 (100) | 9 (1.3-18.7) | 5353 (100) | 9 (3.3-17.2) | 1851 (100) | .71* |
| Platelet count, ×109/L | 56 (0-1645) | 7225 (100) | 57 (0-1419) | 5368 (100) | 51 (1-1645) | 1857 (100) | <.001* |
| BM blasts, % | 60 (0-100) | 6612 (100) | 64 (0-100) | 4937 (100) | 42 (0-100) | 1675 (100) | <.001* |
| Creatinine, mg/dL | 0.9 (0.1-10) | 4439 (100) | 0.88 (0.1-10) | 3022 (100) | 0.94 (0.1-9.2) | 1417 (100) | <.001* |
| Urea, mg/dL | 34 (2-267) | 3931 (100) | 33 (4-241) | 2650 (100) | 38 (2-267) | 1281 (100) | <.001* |
| Uric acid, mg/dL | 4.9 (0-45) | 3649 (100) | 4.8 (0-45) | 2443 (100) | 5.3 (0-21) | 1206 (100) | <.001* |
| Bilirubin, mg/dL | 0.6 (0.07-21) | 4011 (100) | 0.6 (0.1-21) | 2692 (100) | 0.67 (0.07-9.94) | 1319 (100) | <.001* |
| AST, U/L | 22 (2-1085) | 3869 (100) | 22 (2-1085) | 2599 (100) | 22 (5-496) | 1270 (100) | .61* |
| ALT, U/L | 20 (1-743) | 3987 (100) | 20 (1-743) | 2682 (100) | 19 (2-623) | 1305 (100) | .004* |
| AP, U/L | 73 (2-3571) | 3570 (100) | 71 (4-1474) | 2385 (100) | 78 (2-3571) | 1185 (100) | <.001 |
| Albumin, g/dL | 3.6 (0.5-8.5) | 3520 (100) | 3.6 (0.5-8.5) | 2388 (100) | 3.7 (1.7-7) | 1132 (100) | .03* |
| LDH, U/L | 480 (12-42 630) | 4827 (100) | 486 (16-42 630) | 3342 (100) | 460 (12-13 420) | 1485 (100) | .38* |
| Fibrinogen, mg/dL | 426 (1-1500) | 3686 (100) | 423 (1-1150) | 2610 (100) | 430 (1-1500) | 1076 (100) | .22* |
| Cytogenetics | 8521 (100) | 6211 (100) | 2310 (100) | ||||
| Normal | 2892 (34) | 2299 (37) | 593 (26) | <.001 | |||
| Abnormal | 3192 (37) | 2201 (35) | 991 (43) | ||||
| No metaphases | 592 (7) | 436 (7) | 156 (7) | ||||
| Not available | 1845 (22) | 1275 (21) | 570 (22) | ||||
| MRC cytogenetic risk | 6099 (100) | 4501 (100) | 1598 (100) | ||||
| Favorable | 474 (8) | 420 (9) | 54 (3) | <.001 | |||
| Intermediate | 3919 (64) | 3014 (67) | 905 (57) | ||||
| Adverse | 1706 (28) | 1067 (24) | 639 (40) | ||||
| FLT3-ITD | 4291 (100) | 3301 (100) | 990 (100) | ||||
| Positive | 789 (18) | 677 (21) | 112 (11) | <.001 | |||
| Negative | 3502 (82) | 2624 (79) | 878 (89) | ||||
| NPM1 | 4024 (100) | 3097 (100) | 927 (100) | ||||
| Positive | 1173 (29) | 1023 (33) | 150 (16) | <.001 | |||
| Negative | 2851 (71) | 2074 (67) | 777 (84) | ||||
| Therapeutic approach | 8520 (100) | 6210 (100) | 2310 (100) | ||||
| Intensive | 4620 (54) | 3744 (60) | 876 (38) | <.001 | |||
| Nonintensive | 974 (11) | 649 (10) | 325 (14) | ||||
| HMA | 780 (9) | 452 (7) | 328 (14) | ||||
| Clinical trial | 192 (2) | 113 (2) | 79 (3) | ||||
| BSC | 1467 (17) | 923 (15) | 544 (24) | ||||
| Unknown | 487 (6) | 329 (5) | 158 (7) | ||||
| Characteristic . | Overall . | De novo . | Secondary AML . | P value . | |||
|---|---|---|---|---|---|---|---|
| Median (range) . | n (%) . | Median (range) . | n (%) . | Median (range) . | n (%) . | ||
| Total | 8521 (100) | 6211 (100) | 2310 (100) | ||||
| Age, y | 66 (18-104) | 8507 (100) | 64 (18-99) | 6201 (100) | 69 (18-104) | 2306 (100) | <.001* |
| 18-29 | 389 (5) | 359 (6) | 30 (1) | <.001 | |||
| 30-39 | 549 (6) | 480 (8) | 69 (3) | ||||
| 40-49 | 823 (10) | 706 (11) | 117 (5) | ||||
| 50-59 | 1285 (15) | 998 (16) | 287 (12) | ||||
| 60-69 | 2087 (25) | 1421 (23) | 666 (29) | ||||
| 70-79 | 2333 (27) | 1535 (25) | 798 (35) | ||||
| 80-89 | 967 (11) | 649 (10) | 318 (14) | ||||
| ≥90 | 74 (1) | 53 (1) | 21 (1) | ||||
| Gender | 8432 (100) | 6127 (100) | 2304 (100) | ||||
| Male | 4643 (55) | 3266 (53) | 1377 (60) | <.001 | |||
| Female | 3788 (45) | 2861 (47) | 927 (40) | ||||
| ECOG | 1 (0-4) | 6640 (100) | 1 (0-4) | 4819 (100) | 1 (0-4) | 1821 (100) | <.001* |
| 0 | 1949 (29) | 1481 (31) | 468 (26) | <.001 | |||
| 1 | 2740 (41) | 2028 (42) | 712 (39) | ||||
| 2 | 1239 (19) | 852 (18) | 387 (21) | ||||
| 3 | 538 (8) | 336 (7) | 202 (11) | ||||
| 4 | 174 (3) | 122 (3) | 52 (3) | ||||
| FAB subtype | 8521 (100) | 6211 (100) | 2310 (100) | ||||
| M0/M6/M7 | 872 (10) | 638 (10) | 234 (10) | <.001 | |||
| M1/M2 | 2301 (27) | 1814 (29) | 487 (21) | ||||
| M4/M5 | 2156 (37) | 1764 (28) | 392 (17) | ||||
| Not available | 3192 (37) | 1995 (32) | 1197 (52) | ||||
| Hepatosplenomegaly | 4380 (100) | 3263 (100) | 1117 (100) | .63 | |||
| Yes | 962 (22) | 723 (22) | 239 (21) | ||||
| No | 3418 (78) | 2540 (78) | 878 (79) | ||||
| WBC, ×109/L | 9.2 (0-669) | 7801 (100) | 10.4 (0-669) | 5762 (100) | 6.6 (0.1-312) | 2039 (100) | <.001* |
| ≤5 | 3135 (40) | 2199 (38) | 936 (46) | <.001 | |||
| 5-10 | 883 (11) | 651 (11) | 232 (11) | ||||
| 10-50 | 2137 (27) | 1574 (27) | 563 (28) | ||||
| >50 | 1646 (21) | 1338 (23) | 308 (15) | ||||
| Hemoglobin, g/dL | 9 (1.3-18.7) | 7204 (100) | 9 (1.3-18.7) | 5353 (100) | 9 (3.3-17.2) | 1851 (100) | .71* |
| Platelet count, ×109/L | 56 (0-1645) | 7225 (100) | 57 (0-1419) | 5368 (100) | 51 (1-1645) | 1857 (100) | <.001* |
| BM blasts, % | 60 (0-100) | 6612 (100) | 64 (0-100) | 4937 (100) | 42 (0-100) | 1675 (100) | <.001* |
| Creatinine, mg/dL | 0.9 (0.1-10) | 4439 (100) | 0.88 (0.1-10) | 3022 (100) | 0.94 (0.1-9.2) | 1417 (100) | <.001* |
| Urea, mg/dL | 34 (2-267) | 3931 (100) | 33 (4-241) | 2650 (100) | 38 (2-267) | 1281 (100) | <.001* |
| Uric acid, mg/dL | 4.9 (0-45) | 3649 (100) | 4.8 (0-45) | 2443 (100) | 5.3 (0-21) | 1206 (100) | <.001* |
| Bilirubin, mg/dL | 0.6 (0.07-21) | 4011 (100) | 0.6 (0.1-21) | 2692 (100) | 0.67 (0.07-9.94) | 1319 (100) | <.001* |
| AST, U/L | 22 (2-1085) | 3869 (100) | 22 (2-1085) | 2599 (100) | 22 (5-496) | 1270 (100) | .61* |
| ALT, U/L | 20 (1-743) | 3987 (100) | 20 (1-743) | 2682 (100) | 19 (2-623) | 1305 (100) | .004* |
| AP, U/L | 73 (2-3571) | 3570 (100) | 71 (4-1474) | 2385 (100) | 78 (2-3571) | 1185 (100) | <.001 |
| Albumin, g/dL | 3.6 (0.5-8.5) | 3520 (100) | 3.6 (0.5-8.5) | 2388 (100) | 3.7 (1.7-7) | 1132 (100) | .03* |
| LDH, U/L | 480 (12-42 630) | 4827 (100) | 486 (16-42 630) | 3342 (100) | 460 (12-13 420) | 1485 (100) | .38* |
| Fibrinogen, mg/dL | 426 (1-1500) | 3686 (100) | 423 (1-1150) | 2610 (100) | 430 (1-1500) | 1076 (100) | .22* |
| Cytogenetics | 8521 (100) | 6211 (100) | 2310 (100) | ||||
| Normal | 2892 (34) | 2299 (37) | 593 (26) | <.001 | |||
| Abnormal | 3192 (37) | 2201 (35) | 991 (43) | ||||
| No metaphases | 592 (7) | 436 (7) | 156 (7) | ||||
| Not available | 1845 (22) | 1275 (21) | 570 (22) | ||||
| MRC cytogenetic risk | 6099 (100) | 4501 (100) | 1598 (100) | ||||
| Favorable | 474 (8) | 420 (9) | 54 (3) | <.001 | |||
| Intermediate | 3919 (64) | 3014 (67) | 905 (57) | ||||
| Adverse | 1706 (28) | 1067 (24) | 639 (40) | ||||
| FLT3-ITD | 4291 (100) | 3301 (100) | 990 (100) | ||||
| Positive | 789 (18) | 677 (21) | 112 (11) | <.001 | |||
| Negative | 3502 (82) | 2624 (79) | 878 (89) | ||||
| NPM1 | 4024 (100) | 3097 (100) | 927 (100) | ||||
| Positive | 1173 (29) | 1023 (33) | 150 (16) | <.001 | |||
| Negative | 2851 (71) | 2074 (67) | 777 (84) | ||||
| Therapeutic approach | 8520 (100) | 6210 (100) | 2310 (100) | ||||
| Intensive | 4620 (54) | 3744 (60) | 876 (38) | <.001 | |||
| Nonintensive | 974 (11) | 649 (10) | 325 (14) | ||||
| HMA | 780 (9) | 452 (7) | 328 (14) | ||||
| Clinical trial | 192 (2) | 113 (2) | 79 (3) | ||||
| BSC | 1467 (17) | 923 (15) | 544 (24) | ||||
| Unknown | 487 (6) | 329 (5) | 158 (7) | ||||
ALT, alanine transaminase; AP, alkaline phosphatase; AST, aspartate transaminase; FAB, French–American–British.
P compare continuous variables.