Clinical and laboratory features
| . | All (N = 806) . | Brazil (n = 362) . | Chile (n = 234) . | Paraguay (n = 39) . | Peru (n = 163) . | Uruguay (n = 8) . | P value∗ . | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n . | % . | n . | % . | n . | % . | n . | % . | n . | % . | n . | % . | ||
| Median age, y (range) | 35 (15-74) | 36 (15-73) | 34 (15-74) | 38 (18-72) | 35 (15-70) | 25 (15-34) | .88 | ||||||
| Patient sex | .14 | ||||||||||||
| Female | 415 | 51.6 | 193 | 53.5 | 124 | 53 | 21 | 53.8 | 75 | 46 | 2 | 25 | |
| Male | 390 | 48.4 | 168 | 46.5 | 110 | 47 | 18 | 46.2 | 88 | 54 | 6 | 75 | |
| UNK | 1 | 1 | |||||||||||
| ECOG PS score | <.0001 | ||||||||||||
| 0 | 201 | 24.9 | 134 | 37 | 19 | 8.1 | 23 | 59 | 17 | 10.4 | 8 | 100 | |
| 1 | 343 | 42.6 | 119 | 32.9 | 126 | 53.8 | 15 | 38.5 | 83 | 50.9 | |||
| 2 | 184 | 22.8 | 72 | 19.9 | 70 | 29.9 | 1 | 2.6 | 41 | 25.2 | |||
| 3 | 78 | 9.7 | 37 | 10.2 | 19 | 8.1 | 22 | 13.5 | |||||
| Relapse risk | .027 | ||||||||||||
| Low | 87 | 10.8 | 38 | 10.6 | 24 | 10.3 | 11 | 28.2 | 13 | 8 | 1 | 12.5 | |
| Intermediate | 422 | 52.6 | 192 | 53.5 | 126 | 53.8 | 16 | 41 | 85 | 52.1 | 3 | 37.5 | |
| High | 294 | 36.6 | 129 | 35.9 | 84 | 35.9 | 12 | 30.8 | 65 | 39.9 | 4 | 50 | |
| UNK | 3 | 3 | |||||||||||
| Morphology | .009 | ||||||||||||
| Classical | 710 | 89.5 | 318 | 91.1 | 198 | 84.6 | 39 | 100 | 147 | 90.2 | 8 | 100 | |
| Variant | 83 | 10.5 | 31 | 8.9 | 36 | 15.4 | 16 | 9.8 | |||||
| UNK | 13 | 13 | |||||||||||
| PML/RARA breakpoint | .53 | ||||||||||||
| bcr1 | 453 | 59 | 188 | 57.5 | 129 | 55.4 | 28 | 71.8 | 102 | 63.4 | 6 | 75 | |
| bcr1/2 | 1 | 0.1 | 1 | 0.3 | |||||||||
| bcr2 | 34 | 4.4 | 18 | 5.5 | 9 | 3.9 | 1 | 2.6 | 6 | 3.7 | |||
| bcr3 | 280 | 36.5 | 120 | 36.7 | 95 | 40.8 | 10 | 25.6 | 53 | 32.9 | 2 | 25 | |
| UNK | 38 | 35 | 1 | 2 | |||||||||
| Blasts in BM, % | |||||||||||||
| Median (Q1-Q3) | 87 (78-92) | 87 (79-92) | 88.5 (83-93) | 90 (80-96) | 80 (70-88) | 86 (70-90) | <.001 | ||||||
| WBCs, ×109/L | .35 | ||||||||||||
| <5 | 418 | 52.1 | 188 | 52.5 | 131 | 56 | 23 | 59 | 73 | 44.8 | 3 | 37.5 | |
| 5 to <10 | 90 | 11.2 | 41 | 11.5 | 19 | 8.1 | 4 | 10.3 | 25 | 15.3 | 1 | 12.5 | |
| ≥10 | 294 | 36.7 | 129 | 36 | 84 | 35.9 | 12 | 30.8 | 65 | 39.9 | 4 | 50 | |
| UNK | 4 | 4 | |||||||||||
| Median (Q1-Q3) | 4.1 (1.5, 20.4) | 4 (1.4, 19) | 3.5 (1.3, 21.4) | 1.9 (0.9, 10.7) | 6 (1.9, 21.4) | 9.5 (2, 17.5) | |||||||
| Platelets, ×109/L | .08 | ||||||||||||
| ≤40 | 664 | 82.7 | 299 | 83.3 | 191 | 81.6 | 27 | 69.2 | 141 | 86.5 | 6 | 75 | |
| >40 | 139 | 17.3 | 60 | 16.7 | 43 | 18.4 | 12 | 30.8 | 22 | 13.5 | 2 | 25 | |
| UNK | 3 | 3 | |||||||||||
| Median (Q1-Q3) | 20.4 (12-34) | 22 (13-34) | 19 (12-32) | 30 (14.2-55) | 18 (11-33) | 11.5 (18-41) | |||||||
| Hemoglobin, g/dL | .52 | ||||||||||||
| ≤10 | 644 | 80.5 | 279 | 78.4 | 195 | 83.3 | 32 | 82.1 | 131 | 80.4 | 7 | 87.5 | |
| >10 | 156 | 19.5 | 77 | 21.6 | 39 | 16.7 | 7 | 17.9 | 32 | 19.6 | 1 | 12.5 | |
| UNK | 6 | 6 | |||||||||||
| Median (Q1-Q3) | 8.3 (7-9.5) | 8.4 (7.1-9.8) | 8.2 (6.9-9.3) | 8.1 (7.2-9.5) | 8.3 (7-9.3) | 8.5 (7-9) | |||||||
| Creatinine, mg/dL | NA | ||||||||||||
| ≤1.4 | 554 | 97.5 | 337 | 96.6 | 12 | 85.7 | 37 | 100 | 161 | 100 | 7 | 100 | |
| >1.4 | 14 | 2.5 | 12 | 3.4 | 2 | 14.3 | |||||||
| UNK | 238 | 13 | 220 | 2 | 2 | 1 | |||||||
| Median (Q1-Q3) | 8.3 (7-9.5) | 8.4 (7.1-9.8) | 8.2 (6.9-9.3) | 8.1 (7.2-9.5) | 8.3 (6.9-9.3) | 8.5 (7-9) | |||||||
| Uric acid, mg/dL | NA | ||||||||||||
| ≤7 | 512 | 95.9 | 322 | 96.7 | 8 | 80 | 33 | 94.3 | 143 | 96 | 6 | 85.7 | |
| >7 | 22 | 4.1 | 11 | 3.3 | 2 | 20 | 2 | 5.7 | 6 | 4 | 1 | 14.3 | |
| UNK | 272 | 29 | 224 | 4 | 14 | 1 | |||||||
| Median (Q1-Q3) | 3.9 (3-5) | 3.9 (3-5.1) | 2.8 (2-4.2) | 3.9 (3.2-4.8) | |||||||||
| Fibrinogen, mg/dL | NA | ||||||||||||
| ≤170 | 343 | 56.3 | 205 | 60.3 | 41 | 67.2 | 11 | 28.9 | 82 | 50.3 | 4 | 57.1 | |
| >170 | 266 | 43.7 | 135 | 39.7 | 20 | 32.8 | 27 | 71.1 | 81 | 49.7 | 3 | 42.9 | |
| UNK | 197 | 22 | 173 | 1 | 1 | ||||||||
| Median (Q1-Q3) | 154 (100-229) | 149 (93-208) | 134 (82-195) | 228 (161-283) | 170 (110-245) | 150 (124-300) | |||||||
| Albumin, g/dL | NA | ||||||||||||
| ≤3.5 | 114 | 22.7 | 64 | 21.9 | 2 | 15.4 | 9 | 27.3 | 39 | 24.7 | |||
| >3.5 | 388 | 77.3 | 228 | 78.1 | 11 | 84.6 | 24 | 72.7 | 119 | 75.3 | 6 | 100 | |
| UNK | 304 | 70 | 221 | 6 | 5 | 2 | |||||||
| Median (Q1-Q3) | 4 (3.6-4.4) | 4 (3.6-4.4) | 4.2 (3.7-4.5) | 4 (3.5-4.2) | 4 (3.6-4.5) | 4 (3.9-4) | |||||||
| Median aPTT, s (Q1-Q3) | 29 (26-34) | 28.4 (25.3-32) | 27 (24.2-32) | 29 (27-31) | 32 (29-37.5) | 34.5 (29-41) | NA | ||||||
| Median prothrombin time, INR (Q1-Q3) | 1.3 (1.2-1.5) | 1.3 (1.2-1.5) | 1.4 (1.2-1.5) | 1.3 (1.2-1.5) | 1.4 (1.3-1.6) | 1.5 (1.2-1.8) | |||||||
| Fever | NA | ||||||||||||
| No | 373 | 54 | 188 | 53.1 | 48 | 37.8 | 21 | 53.8 | 115 | 70.6 | 1 | 12.5 | |
| Yes | 318 | 46 | 166 | 46.9 | 79 | 62.2 | 18 | 46.2 | 48 | 29.4 | 7 | 87.5 | |
| UNK | 115 | 14.3 | 8 | 107 | |||||||||
| GI bleeding | <.001 | ||||||||||||
| Yes | 52 | 6.5 | 23 | 6.4 | 2 | 0.9 | 6 | 15.4 | 21 | 12.9 | |||
| No | 754 | 93.5 | 339 | 93.6 | 232 | 99.1 | 33 | 84.6 | 142 | 87.1 | 8 | 100 | |
| CNS bleeding | .32 | ||||||||||||
| Yes | 65 | 8.1 | 21 | 5.8 | 22 | 9.4 | 2 | 5.1 | 19 | 11.7 | 1 | 12.5 | |
| No | 741 | 91.9 | 341 | 94.2 | 212 | 90.6 | 37 | 94.9 | 144 | 88.3 | 7 | 87.5 | |
| GU bleeding | <.001 | ||||||||||||
| Yes | 99 | 12.3 | 62 | 17.1 | 9 | 3.8 | 7 | 17.9 | 21 | 12.9 | |||
| No | 707 | 87.7 | 300 | 82.9 | 225 | 96.2 | 32 | 82.1 | 142 | 87.1 | 8 | 100 | |
| Pulmonary bleeding | .017 | ||||||||||||
| Yes | 27 | 3.3 | 17 | 4.7 | 1 | 0.4 | 1 | 2.6 | 8 | 4.9 | |||
| No | 779 | 96.7 | 345 | 95.3 | 233 | 99.6 | 38 | 97.4 | 155 | 95.1 | 8 | 100 | |
| Thrombosis | <.001 | ||||||||||||
| No | 770 | 95.5 | 330 | 91.2 | 232 | 99.1 | 39 | 100 | 161 | 98.8 | 8 | 100 | |
| Yes | 36 | 4.5 | 32 | 8.8 | 2 | 0.9 | 2 | 1.2 | |||||
| UNK | 6 | 6 | |||||||||||
| Time from SX to DX | <.001 | ||||||||||||
| <24 h | 59 | 8.1 | 29 | 8.8 | 30 | 14.5 | |||||||
| 24-48 h | 110 | 15 | 23 | 7 | 82 | 39.6 | 5 | 3.2 | |||||
| 48-72 h | 76 | 10.4 | 10 | 3 | 62 | 30 | 4 | 2.6 | |||||
| 4-7 d | 105 | 14.3 | 48 | 14.5 | 24 | 11.6 | 12 | 36.4 | 20 | 12.8 | 1 | 16.7 | |
| 8-10 d | 55 | 7.5 | 35 | 10.6 | 3 | 1.4 | 4 | 12.1 | 11 | 7.1 | 2 | 33.3 | |
| >10 d | 327 | 44.7 | 185 | 56.1 | 6 | 2.9 | 17 | 51.5 | 116 | 74.4 | 3 | 50 | |
| UNK | 74 | 32 | 27 | 6 | 7 | 2 | |||||||
| . | All (N = 806) . | Brazil (n = 362) . | Chile (n = 234) . | Paraguay (n = 39) . | Peru (n = 163) . | Uruguay (n = 8) . | P value∗ . | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n . | % . | n . | % . | n . | % . | n . | % . | n . | % . | n . | % . | ||
| Median age, y (range) | 35 (15-74) | 36 (15-73) | 34 (15-74) | 38 (18-72) | 35 (15-70) | 25 (15-34) | .88 | ||||||
| Patient sex | .14 | ||||||||||||
| Female | 415 | 51.6 | 193 | 53.5 | 124 | 53 | 21 | 53.8 | 75 | 46 | 2 | 25 | |
| Male | 390 | 48.4 | 168 | 46.5 | 110 | 47 | 18 | 46.2 | 88 | 54 | 6 | 75 | |
| UNK | 1 | 1 | |||||||||||
| ECOG PS score | <.0001 | ||||||||||||
| 0 | 201 | 24.9 | 134 | 37 | 19 | 8.1 | 23 | 59 | 17 | 10.4 | 8 | 100 | |
| 1 | 343 | 42.6 | 119 | 32.9 | 126 | 53.8 | 15 | 38.5 | 83 | 50.9 | |||
| 2 | 184 | 22.8 | 72 | 19.9 | 70 | 29.9 | 1 | 2.6 | 41 | 25.2 | |||
| 3 | 78 | 9.7 | 37 | 10.2 | 19 | 8.1 | 22 | 13.5 | |||||
| Relapse risk | .027 | ||||||||||||
| Low | 87 | 10.8 | 38 | 10.6 | 24 | 10.3 | 11 | 28.2 | 13 | 8 | 1 | 12.5 | |
| Intermediate | 422 | 52.6 | 192 | 53.5 | 126 | 53.8 | 16 | 41 | 85 | 52.1 | 3 | 37.5 | |
| High | 294 | 36.6 | 129 | 35.9 | 84 | 35.9 | 12 | 30.8 | 65 | 39.9 | 4 | 50 | |
| UNK | 3 | 3 | |||||||||||
| Morphology | .009 | ||||||||||||
| Classical | 710 | 89.5 | 318 | 91.1 | 198 | 84.6 | 39 | 100 | 147 | 90.2 | 8 | 100 | |
| Variant | 83 | 10.5 | 31 | 8.9 | 36 | 15.4 | 16 | 9.8 | |||||
| UNK | 13 | 13 | |||||||||||
| PML/RARA breakpoint | .53 | ||||||||||||
| bcr1 | 453 | 59 | 188 | 57.5 | 129 | 55.4 | 28 | 71.8 | 102 | 63.4 | 6 | 75 | |
| bcr1/2 | 1 | 0.1 | 1 | 0.3 | |||||||||
| bcr2 | 34 | 4.4 | 18 | 5.5 | 9 | 3.9 | 1 | 2.6 | 6 | 3.7 | |||
| bcr3 | 280 | 36.5 | 120 | 36.7 | 95 | 40.8 | 10 | 25.6 | 53 | 32.9 | 2 | 25 | |
| UNK | 38 | 35 | 1 | 2 | |||||||||
| Blasts in BM, % | |||||||||||||
| Median (Q1-Q3) | 87 (78-92) | 87 (79-92) | 88.5 (83-93) | 90 (80-96) | 80 (70-88) | 86 (70-90) | <.001 | ||||||
| WBCs, ×109/L | .35 | ||||||||||||
| <5 | 418 | 52.1 | 188 | 52.5 | 131 | 56 | 23 | 59 | 73 | 44.8 | 3 | 37.5 | |
| 5 to <10 | 90 | 11.2 | 41 | 11.5 | 19 | 8.1 | 4 | 10.3 | 25 | 15.3 | 1 | 12.5 | |
| ≥10 | 294 | 36.7 | 129 | 36 | 84 | 35.9 | 12 | 30.8 | 65 | 39.9 | 4 | 50 | |
| UNK | 4 | 4 | |||||||||||
| Median (Q1-Q3) | 4.1 (1.5, 20.4) | 4 (1.4, 19) | 3.5 (1.3, 21.4) | 1.9 (0.9, 10.7) | 6 (1.9, 21.4) | 9.5 (2, 17.5) | |||||||
| Platelets, ×109/L | .08 | ||||||||||||
| ≤40 | 664 | 82.7 | 299 | 83.3 | 191 | 81.6 | 27 | 69.2 | 141 | 86.5 | 6 | 75 | |
| >40 | 139 | 17.3 | 60 | 16.7 | 43 | 18.4 | 12 | 30.8 | 22 | 13.5 | 2 | 25 | |
| UNK | 3 | 3 | |||||||||||
| Median (Q1-Q3) | 20.4 (12-34) | 22 (13-34) | 19 (12-32) | 30 (14.2-55) | 18 (11-33) | 11.5 (18-41) | |||||||
| Hemoglobin, g/dL | .52 | ||||||||||||
| ≤10 | 644 | 80.5 | 279 | 78.4 | 195 | 83.3 | 32 | 82.1 | 131 | 80.4 | 7 | 87.5 | |
| >10 | 156 | 19.5 | 77 | 21.6 | 39 | 16.7 | 7 | 17.9 | 32 | 19.6 | 1 | 12.5 | |
| UNK | 6 | 6 | |||||||||||
| Median (Q1-Q3) | 8.3 (7-9.5) | 8.4 (7.1-9.8) | 8.2 (6.9-9.3) | 8.1 (7.2-9.5) | 8.3 (7-9.3) | 8.5 (7-9) | |||||||
| Creatinine, mg/dL | NA | ||||||||||||
| ≤1.4 | 554 | 97.5 | 337 | 96.6 | 12 | 85.7 | 37 | 100 | 161 | 100 | 7 | 100 | |
| >1.4 | 14 | 2.5 | 12 | 3.4 | 2 | 14.3 | |||||||
| UNK | 238 | 13 | 220 | 2 | 2 | 1 | |||||||
| Median (Q1-Q3) | 8.3 (7-9.5) | 8.4 (7.1-9.8) | 8.2 (6.9-9.3) | 8.1 (7.2-9.5) | 8.3 (6.9-9.3) | 8.5 (7-9) | |||||||
| Uric acid, mg/dL | NA | ||||||||||||
| ≤7 | 512 | 95.9 | 322 | 96.7 | 8 | 80 | 33 | 94.3 | 143 | 96 | 6 | 85.7 | |
| >7 | 22 | 4.1 | 11 | 3.3 | 2 | 20 | 2 | 5.7 | 6 | 4 | 1 | 14.3 | |
| UNK | 272 | 29 | 224 | 4 | 14 | 1 | |||||||
| Median (Q1-Q3) | 3.9 (3-5) | 3.9 (3-5.1) | 2.8 (2-4.2) | 3.9 (3.2-4.8) | |||||||||
| Fibrinogen, mg/dL | NA | ||||||||||||
| ≤170 | 343 | 56.3 | 205 | 60.3 | 41 | 67.2 | 11 | 28.9 | 82 | 50.3 | 4 | 57.1 | |
| >170 | 266 | 43.7 | 135 | 39.7 | 20 | 32.8 | 27 | 71.1 | 81 | 49.7 | 3 | 42.9 | |
| UNK | 197 | 22 | 173 | 1 | 1 | ||||||||
| Median (Q1-Q3) | 154 (100-229) | 149 (93-208) | 134 (82-195) | 228 (161-283) | 170 (110-245) | 150 (124-300) | |||||||
| Albumin, g/dL | NA | ||||||||||||
| ≤3.5 | 114 | 22.7 | 64 | 21.9 | 2 | 15.4 | 9 | 27.3 | 39 | 24.7 | |||
| >3.5 | 388 | 77.3 | 228 | 78.1 | 11 | 84.6 | 24 | 72.7 | 119 | 75.3 | 6 | 100 | |
| UNK | 304 | 70 | 221 | 6 | 5 | 2 | |||||||
| Median (Q1-Q3) | 4 (3.6-4.4) | 4 (3.6-4.4) | 4.2 (3.7-4.5) | 4 (3.5-4.2) | 4 (3.6-4.5) | 4 (3.9-4) | |||||||
| Median aPTT, s (Q1-Q3) | 29 (26-34) | 28.4 (25.3-32) | 27 (24.2-32) | 29 (27-31) | 32 (29-37.5) | 34.5 (29-41) | NA | ||||||
| Median prothrombin time, INR (Q1-Q3) | 1.3 (1.2-1.5) | 1.3 (1.2-1.5) | 1.4 (1.2-1.5) | 1.3 (1.2-1.5) | 1.4 (1.3-1.6) | 1.5 (1.2-1.8) | |||||||
| Fever | NA | ||||||||||||
| No | 373 | 54 | 188 | 53.1 | 48 | 37.8 | 21 | 53.8 | 115 | 70.6 | 1 | 12.5 | |
| Yes | 318 | 46 | 166 | 46.9 | 79 | 62.2 | 18 | 46.2 | 48 | 29.4 | 7 | 87.5 | |
| UNK | 115 | 14.3 | 8 | 107 | |||||||||
| GI bleeding | <.001 | ||||||||||||
| Yes | 52 | 6.5 | 23 | 6.4 | 2 | 0.9 | 6 | 15.4 | 21 | 12.9 | |||
| No | 754 | 93.5 | 339 | 93.6 | 232 | 99.1 | 33 | 84.6 | 142 | 87.1 | 8 | 100 | |
| CNS bleeding | .32 | ||||||||||||
| Yes | 65 | 8.1 | 21 | 5.8 | 22 | 9.4 | 2 | 5.1 | 19 | 11.7 | 1 | 12.5 | |
| No | 741 | 91.9 | 341 | 94.2 | 212 | 90.6 | 37 | 94.9 | 144 | 88.3 | 7 | 87.5 | |
| GU bleeding | <.001 | ||||||||||||
| Yes | 99 | 12.3 | 62 | 17.1 | 9 | 3.8 | 7 | 17.9 | 21 | 12.9 | |||
| No | 707 | 87.7 | 300 | 82.9 | 225 | 96.2 | 32 | 82.1 | 142 | 87.1 | 8 | 100 | |
| Pulmonary bleeding | .017 | ||||||||||||
| Yes | 27 | 3.3 | 17 | 4.7 | 1 | 0.4 | 1 | 2.6 | 8 | 4.9 | |||
| No | 779 | 96.7 | 345 | 95.3 | 233 | 99.6 | 38 | 97.4 | 155 | 95.1 | 8 | 100 | |
| Thrombosis | <.001 | ||||||||||||
| No | 770 | 95.5 | 330 | 91.2 | 232 | 99.1 | 39 | 100 | 161 | 98.8 | 8 | 100 | |
| Yes | 36 | 4.5 | 32 | 8.8 | 2 | 0.9 | 2 | 1.2 | |||||
| UNK | 6 | 6 | |||||||||||
| Time from SX to DX | <.001 | ||||||||||||
| <24 h | 59 | 8.1 | 29 | 8.8 | 30 | 14.5 | |||||||
| 24-48 h | 110 | 15 | 23 | 7 | 82 | 39.6 | 5 | 3.2 | |||||
| 48-72 h | 76 | 10.4 | 10 | 3 | 62 | 30 | 4 | 2.6 | |||||
| 4-7 d | 105 | 14.3 | 48 | 14.5 | 24 | 11.6 | 12 | 36.4 | 20 | 12.8 | 1 | 16.7 | |
| 8-10 d | 55 | 7.5 | 35 | 10.6 | 3 | 1.4 | 4 | 12.1 | 11 | 7.1 | 2 | 33.3 | |
| >10 d | 327 | 44.7 | 185 | 56.1 | 6 | 2.9 | 17 | 51.5 | 116 | 74.4 | 3 | 50 | |
| UNK | 74 | 32 | 27 | 6 | 7 | 2 | |||||||
aPTT, activated partial thromboplastin clotting time; DX, diagnosis; INR, international normalized ratio; NA, not applicable; PS performance status; Q1/Q3, first quartile/third quartile; SX, symptoms; UNK, unknown.
Because of a small sample size, Uruguay is omitted from group comparison for P value calculation; NA: because of a high level of missing data in Chile, P values are not provided.