Table 2.
Clinical outcomes.
| All-risk | Low-risk (n = 88) | High-risk (n = 40) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| non-CHT (n = 62) | CHT (n = 66) | P | non-CHT (n = 41) | CHT (n = 47) | P | non-CHT (n = 21) | CHT (n = 19) | P | |
| ITT analysis | |||||||||
| CR | 60 (97%) | 64 (97%) | 1.00 | 41 (100%) | 47 (100%) | – | 19 (90%) | 17 (89%) | 1.00 |
| 2-year EFS | 59 (95%) | 60 (92%) | 0.39 | 41 (100%) | 46 (98%) | 0.36 | 18 (85%) | 14 (78%) | 0.44 |
| 2-year DFS | 59/60 (98%) | 62/64 (97%) | 0.62 | 41 (100%) | 47 (100%) | – | 18/19 (94%) | 15/17 (87%) | 0.52 |
| 2-year OS | 59 (95%) | 62 (94%) | 0.80 | 41 (100%) | 46 (98%) | 0.36 | 18 (85%) | 16 (83%) | 0.96 |
| PP analysis | |||||||||
| 2-year EFS | 56/58 (97%) | 56/61 (93%) | 0.32 | 39/39 (100%) | 43/44 (98%) | 0.36 | 17/19 (89%) | 13/17 (81%) | 0.39 |
| 2-year DFS | 56/56 (100%) | 58/59 (98%) | 0.34 | 39/39 (100%) | 44/44 (100%) | – | 17/17 (100%) | 14/15 (93%) | 0.30 |
| 2-year OS | 56/58 (97%) | 58/61 (95%) | 0.72 | 39/39 (100%) | 43/44 (98%) | 0.37 | 17/19 (89%) | 15/17 (88%) | 0.95 |
| Hospital stay during induction, median days (range) | 28 (14–41) | 29 (15–47) | 0.58 | 28 (14–41) | 28 (15–47) | 0.87 | 29 (16–39) | 32 (23–36) | 0.38 |
| IV antibiotics during induction, median days (range) | 17 (3–31) | 19 (7–33) | 0.57 | 16.5 (3–27) | 17 (7–33) | 0.82 | 17 (5–31) | 18 (14–32) | 0.07 |
CHT chemotherapy, CR complete remission, EFS event-free survival, OS overall survival, DFS disease-free survival.