Clinical characteristics
| . | N (%) . | 2.5-y cumulative incidence of TE, % . | 95% CI . | P . |
|---|---|---|---|---|
| All patients | 1772 | 7.87 | 6.60-9.13 | — |
| Age groups | ||||
| 1.0-9.9 y | 1192 (67) | 3.73 | 2.64-4.80 | <.0001 |
| 10.0-17.9 y | 306 (17) | 15.5 | 11.3-19.4 | |
| 18.0-45.9 y | 274 (16) | 18.1 | 13.2-22.8 | |
| Sex | ||||
| Female | 786 (44) | 6.41 | 4.68-8.12 | .05 |
| Male | 986 (56) | 9.06 | 7.22-10.9 | |
| Immunophenotype | ||||
| BCP | 1492 (84) | 6.81 | 5.51-8.09 | .0002 |
| T-cell | 280 (16) | 13.6 | 9.43-17.6 | |
| WBC | ||||
| <100 × 109/L | 1535 (87) | 7.95 | 6.57-9.31 | .7 |
| ≥100 × 109/L | 237 (13) | 7.35 | 3.92-10.7 | |
| Mediastinal mass | ||||
| No | 1611 (91) | 6.97 | 5.70-8.22 | <.0001 |
| Yes | 139 (8) | 17.3 | 10.8-23.4 | |
| Missing | 22 (1) | — | — | |
| Palpable splenomegaly | ||||
| No | 1475 (83) | 7.66 | 6.28-9.02 | .4 |
| Yes | 262 (15) | 9.30 | 5.69-12.8 | |
| Missing | 35 (2) | — | — | |
| Enlarged lymph nodes ≥3 cm | ||||
| No | 1611 (91) | 7.15 | 5.87-8.41 | <.0001 |
| Yes | 132 (7) | 16.8 | 10.1-22.9 | |
| Missing | 29 (2) | — | — | |
| CNS status* | ||||
| CNS1 | 1544 (87) | 7.99 | 6.62-9.35 | .6 |
| CNS2/CNS3 | 219 (12) | 6.88 | 3.46-10.2 | |
| Missing | 9 (1) | — | — | |
| BMI | ||||
| ≤−2SD | 86 (5) | 8.31 | 2.22-14.0 | .4 |
| >−2SD to <+2SD | 1552 (87) | 7.61 | 6.27-8.93 | |
| ≥+2SD | 119 (7) | 11.2 | 5.24-16.7 | |
| Missing | 15 (1) | — | ||
| Induction† | ||||
| Prednisolone | 1382 (78) | 7.05 | 5.68-8.41 | .02 |
| Dexamethasone | 390 (22) | 10.8 | 7.60-13.9 | |
| All patients (delayed entry at day 29) | 1737 | |||
| Antithrombotic prophylaxis | ||||
| No | 1690 (97) | 7.04 | 5.80-8.26 | .1 |
| Yes | 47 (3) | 13.1 | 2.75-22.3 | |
| MRD day 29 | ||||
| <0.001 | 1145 (66) | 6.77 | 5.30--8.21 | .2 |
| ≥0.001 to <0.05 | 452 (26) | 8.26 | 5.68-10.8 | |
| ≥0.05 | 81 (5) | 16.5 | 0.00-30.8 | |
| Missing | 59 (3) | — | — | |
| Treatment group day 29 | ||||
| SR | 780 (45) | 5.53 | 3.91-7.13 | .04 |
| IR | 653 (37) | 8.97 | 6.74--11.1 | |
| HR/HR-SCT | 302 (17) | 7.93 | 4.62-11.1 | |
| Missing | 2 (1) | — | — |
| . | N (%) . | 2.5-y cumulative incidence of TE, % . | 95% CI . | P . |
|---|---|---|---|---|
| All patients | 1772 | 7.87 | 6.60-9.13 | — |
| Age groups | ||||
| 1.0-9.9 y | 1192 (67) | 3.73 | 2.64-4.80 | <.0001 |
| 10.0-17.9 y | 306 (17) | 15.5 | 11.3-19.4 | |
| 18.0-45.9 y | 274 (16) | 18.1 | 13.2-22.8 | |
| Sex | ||||
| Female | 786 (44) | 6.41 | 4.68-8.12 | .05 |
| Male | 986 (56) | 9.06 | 7.22-10.9 | |
| Immunophenotype | ||||
| BCP | 1492 (84) | 6.81 | 5.51-8.09 | .0002 |
| T-cell | 280 (16) | 13.6 | 9.43-17.6 | |
| WBC | ||||
| <100 × 109/L | 1535 (87) | 7.95 | 6.57-9.31 | .7 |
| ≥100 × 109/L | 237 (13) | 7.35 | 3.92-10.7 | |
| Mediastinal mass | ||||
| No | 1611 (91) | 6.97 | 5.70-8.22 | <.0001 |
| Yes | 139 (8) | 17.3 | 10.8-23.4 | |
| Missing | 22 (1) | — | — | |
| Palpable splenomegaly | ||||
| No | 1475 (83) | 7.66 | 6.28-9.02 | .4 |
| Yes | 262 (15) | 9.30 | 5.69-12.8 | |
| Missing | 35 (2) | — | — | |
| Enlarged lymph nodes ≥3 cm | ||||
| No | 1611 (91) | 7.15 | 5.87-8.41 | <.0001 |
| Yes | 132 (7) | 16.8 | 10.1-22.9 | |
| Missing | 29 (2) | — | — | |
| CNS status* | ||||
| CNS1 | 1544 (87) | 7.99 | 6.62-9.35 | .6 |
| CNS2/CNS3 | 219 (12) | 6.88 | 3.46-10.2 | |
| Missing | 9 (1) | — | — | |
| BMI | ||||
| ≤−2SD | 86 (5) | 8.31 | 2.22-14.0 | .4 |
| >−2SD to <+2SD | 1552 (87) | 7.61 | 6.27-8.93 | |
| ≥+2SD | 119 (7) | 11.2 | 5.24-16.7 | |
| Missing | 15 (1) | — | ||
| Induction† | ||||
| Prednisolone | 1382 (78) | 7.05 | 5.68-8.41 | .02 |
| Dexamethasone | 390 (22) | 10.8 | 7.60-13.9 | |
| All patients (delayed entry at day 29) | 1737 | |||
| Antithrombotic prophylaxis | ||||
| No | 1690 (97) | 7.04 | 5.80-8.26 | .1 |
| Yes | 47 (3) | 13.1 | 2.75-22.3 | |
| MRD day 29 | ||||
| <0.001 | 1145 (66) | 6.77 | 5.30--8.21 | .2 |
| ≥0.001 to <0.05 | 452 (26) | 8.26 | 5.68-10.8 | |
| ≥0.05 | 81 (5) | 16.5 | 0.00-30.8 | |
| Missing | 59 (3) | — | — | |
| Treatment group day 29 | ||||
| SR | 780 (45) | 5.53 | 3.91-7.13 | .04 |
| IR | 653 (37) | 8.97 | 6.74--11.1 | |
| HR/HR-SCT | 302 (17) | 7.93 | 4.62-11.1 | |
| Missing | 2 (1) | — | — |
CNS, central nervous system; SD, standard deviation.
CNS1 (no blasts on cytospin and no other signs of CNS leukemia), CNS2 (> 0 and <5 cells/µL cerebrospinal fluid with blasts on cytospin and no other signs of CNS leukemia), and CNS3 (≥ 5 cells/µL cerebrospinal fluid with blasts on cytospin, cranial nerve palsy, intracranial “leukemic” mass on magnetic resonance imaging (MRI), eye involvement confirmed by MRI, or a biopsy to reflect ALL).
Induction treatment included prednisolone (BCP-ALL and white blood cell count [WBC] <100 × 109/L) or dexamethasone (T-ALL and/or WBC ≥ 100 × 109/L).