Patient and disease characteristics of the AMLSG 16-10 study and the historical control according to age
| . | AMLSG 16-10 . | Historical controls . | ||||
|---|---|---|---|---|---|---|
| . | All patients (n = 284) . | Younger, 18 to 60 yr (n = 198) . | Older, 61 to 70 yr (n = 86) . | All patients (n = 415)* . | Younger, 18 to 60 yr (n = 353) . | Older, 61 to 70 yr (n = 62) . |
| Age, years | ||||||
| Median (range) | 54.1 (18-70) | 50.3 (18-60) | 65.2 (61-70) | 50.5 (18-70) | 47.2 (18-60) | 66.4 (61-70) |
| ECOG performance status | ||||||
| 0, n (%) | 106 (38.7) | 77 (40.5) | 29 (34.5) | 92 (22.2) | 82 (23.2) | 10 (16.1) |
| >0, n (%) | 168 (61.3) | 113 (59.5) | 55 (65.5) | 323 (77.8) | 271 (76.8) | 52 (83.9) |
| Missing | 10 | 8 | 2 | 0 | 0 | 0 |
| Male sex, No. (%) | 120 (42) | 77 (39) | 43 (50) | 193 (46.5) | 157 (44.5) | 36 (58.1) |
| WBC, 109/L | ||||||
| Median (range) | 43.3 (1.0-879) | 45.4 (1.1-879) | 40.4 (1.0-854) | 44.8 (0.2-439) | 41.4 (0.2-427) | 66.7 (1.2-439) |
| Missing | 6 | 3 | 3 | 3 | 2 | 1 |
| Hemoglobin, g/dL | ||||||
| Median (range) | 8.9 (4.1-18.1) | 8.9 (4.1-18.1) | 8.9 (5.4-15.0) | 9.0 (3.1-14.6) | 9.0 (3.1-14.6) | 9.4 (7.0-13.9) |
| Missing | 6 | 3 | 3 | 3 | 2 | 1 |
| Platelets, 109/L | ||||||
| Median (range) | 58.5 (5-333) | 59 (8-328) | 58 (5-333) | 58 (6-734) | 58 (8-734) | 65 (6-358) |
| Missing | 6 | 3 | 3 | 2 | 2 | 0 |
| Bone marrow blasts, %† | ||||||
| Median (range) | 85 (0-100) | 85 (0-100) | 85 (7-100) | 85 (2-100) | 85 (2-100) | 89 (10-100) |
| Missing | 36 | 21 | 15 | 25 | 20 | 5 |
| Peripheral blood blasts, %† | ||||||
| Median (range) | 52 (0-99) | 53 (0-99) | 48 (0-98) | 62 (0-100) | 61 (1-100) | 73 (0-100) |
| Missing | 24 | 14 | 10 | 33 | 30 | 3 |
| 2010 ELN risk classification, n (%)20 | ||||||
| Favorable | 2 (1) | 2 (2.6) | 6 (1.4) | 5 (1.4) | 1 (1.6) | |
| Intermediate-1 | 187 (71.7) | 141 (77) | 46 (59) | 315 (75.9) | 271 (76.8) | 44 (71) |
| Intermediate-2 | 57 (21.8) | 35 (19.1) | 22 (28.2) | 72 (17.4) | 56 (15.9) | 16 (25.8) |
| Adverse | 15 (5.3) | 7 (3.8) | 8 (10.3) | 22 (5.3) | 21 (6.0) | 1 (1.6) |
| AML type | ||||||
| De novo AML, n (%) | 245 (88) | 178 (92) | 67 (79) | 396 (95.5) | 339 (96) | 57 (93) |
| s-AML, n (%) | 21 (8) | 8 (4) | 13 (15) | 6 (1.5) | 4 (1) | 2 (3) |
| t-AML, n (%) | 13 (5) | 8 (4) | 5 (6) | 12 (3) | 10 (3) | 2 (3) |
| Missing | 5 | 4 | 1 | 1 | 0 | 1 |
| Mutated NPM1 | ||||||
| n (%) | 165 (58) | 119 (60) | 46 (53) | 230 (56.5) | 197 (57.1) | 33 (53.2) |
| Missing | 0 | 0 | 0 | 8 | 8 | 0 |
| FLT3-ITD allelic ratio | ||||||
| <0.5 | 134 (47) | 91 (46) | 43 (50) | 131 (43.0) | 125 (43.4) | 6 (35.3) |
| ≥0.5 | 149 (53) | 106 (54) | 43 (50) | 174 (57.0) | 163 (56.6) | 11 (64.7) |
| Missing | 1 | 1 | 0 | 110 | 65 | 45 |
| FLT3 TKD mutation | ||||||
| n (%) | 10 (4) | 8 (4) | 2 (2) | 16 (4.1) | 15 (4.5) | 1 (1.5) |
| Missing | 0 | 0 | 0 | 2 | 1 | 1 |
| . | AMLSG 16-10 . | Historical controls . | ||||
|---|---|---|---|---|---|---|
| . | All patients (n = 284) . | Younger, 18 to 60 yr (n = 198) . | Older, 61 to 70 yr (n = 86) . | All patients (n = 415)* . | Younger, 18 to 60 yr (n = 353) . | Older, 61 to 70 yr (n = 62) . |
| Age, years | ||||||
| Median (range) | 54.1 (18-70) | 50.3 (18-60) | 65.2 (61-70) | 50.5 (18-70) | 47.2 (18-60) | 66.4 (61-70) |
| ECOG performance status | ||||||
| 0, n (%) | 106 (38.7) | 77 (40.5) | 29 (34.5) | 92 (22.2) | 82 (23.2) | 10 (16.1) |
| >0, n (%) | 168 (61.3) | 113 (59.5) | 55 (65.5) | 323 (77.8) | 271 (76.8) | 52 (83.9) |
| Missing | 10 | 8 | 2 | 0 | 0 | 0 |
| Male sex, No. (%) | 120 (42) | 77 (39) | 43 (50) | 193 (46.5) | 157 (44.5) | 36 (58.1) |
| WBC, 109/L | ||||||
| Median (range) | 43.3 (1.0-879) | 45.4 (1.1-879) | 40.4 (1.0-854) | 44.8 (0.2-439) | 41.4 (0.2-427) | 66.7 (1.2-439) |
| Missing | 6 | 3 | 3 | 3 | 2 | 1 |
| Hemoglobin, g/dL | ||||||
| Median (range) | 8.9 (4.1-18.1) | 8.9 (4.1-18.1) | 8.9 (5.4-15.0) | 9.0 (3.1-14.6) | 9.0 (3.1-14.6) | 9.4 (7.0-13.9) |
| Missing | 6 | 3 | 3 | 3 | 2 | 1 |
| Platelets, 109/L | ||||||
| Median (range) | 58.5 (5-333) | 59 (8-328) | 58 (5-333) | 58 (6-734) | 58 (8-734) | 65 (6-358) |
| Missing | 6 | 3 | 3 | 2 | 2 | 0 |
| Bone marrow blasts, %† | ||||||
| Median (range) | 85 (0-100) | 85 (0-100) | 85 (7-100) | 85 (2-100) | 85 (2-100) | 89 (10-100) |
| Missing | 36 | 21 | 15 | 25 | 20 | 5 |
| Peripheral blood blasts, %† | ||||||
| Median (range) | 52 (0-99) | 53 (0-99) | 48 (0-98) | 62 (0-100) | 61 (1-100) | 73 (0-100) |
| Missing | 24 | 14 | 10 | 33 | 30 | 3 |
| 2010 ELN risk classification, n (%)20 | ||||||
| Favorable | 2 (1) | 2 (2.6) | 6 (1.4) | 5 (1.4) | 1 (1.6) | |
| Intermediate-1 | 187 (71.7) | 141 (77) | 46 (59) | 315 (75.9) | 271 (76.8) | 44 (71) |
| Intermediate-2 | 57 (21.8) | 35 (19.1) | 22 (28.2) | 72 (17.4) | 56 (15.9) | 16 (25.8) |
| Adverse | 15 (5.3) | 7 (3.8) | 8 (10.3) | 22 (5.3) | 21 (6.0) | 1 (1.6) |
| AML type | ||||||
| De novo AML, n (%) | 245 (88) | 178 (92) | 67 (79) | 396 (95.5) | 339 (96) | 57 (93) |
| s-AML, n (%) | 21 (8) | 8 (4) | 13 (15) | 6 (1.5) | 4 (1) | 2 (3) |
| t-AML, n (%) | 13 (5) | 8 (4) | 5 (6) | 12 (3) | 10 (3) | 2 (3) |
| Missing | 5 | 4 | 1 | 1 | 0 | 1 |
| Mutated NPM1 | ||||||
| n (%) | 165 (58) | 119 (60) | 46 (53) | 230 (56.5) | 197 (57.1) | 33 (53.2) |
| Missing | 0 | 0 | 0 | 8 | 8 | 0 |
| FLT3-ITD allelic ratio | ||||||
| <0.5 | 134 (47) | 91 (46) | 43 (50) | 131 (43.0) | 125 (43.4) | 6 (35.3) |
| ≥0.5 | 149 (53) | 106 (54) | 43 (50) | 174 (57.0) | 163 (56.6) | 11 (64.7) |
| Missing | 1 | 1 | 0 | 110 | 65 | 45 |
| FLT3 TKD mutation | ||||||
| n (%) | 10 (4) | 8 (4) | 2 (2) | 16 (4.1) | 15 (4.5) | 1 (1.5) |
| Missing | 0 | 0 | 0 | 2 | 1 | 1 |
ECOG, Eastern Cooperative Oncology Group; ELN, European LeukemiaNet; ITD, internal tandem duplication; NPM1, nucleophosmin-1; s-AML, AML after previous myelodysplastic syndrome or myeloproliferative neoplasm; t-AML, therapy-related AML.
Clinical trials distribution; AMLHD9316 (n = 29), AMLHD98-A17 (n = 121); AMLHD98B13 (n = 23), AMLSG 06-0414 (n = 39), and AMLSG 07-0415 (n = 203).
In case of bone marrow blasts <20%, diagnosis of AML was established on the basis of extramedullary disease or peripheral blood blasts >20%