Table 1.
Baseline characteristics, treatments and responses
| Characteristic | All (n=428) | Dp (n=186) | Ho-Tr (n=27) | HeH (n=24) | Cx (n=32) | MLL (n=24) | P |
|---|---|---|---|---|---|---|---|
| Age, years | 40 (13-86) | 39 (15-84) | 62 (18-78) | 40 (19-78) | 38 (19-72) | 42 (22-76) | 0.01 |
| Female n (%) | 186 (44) | 66 (35) | 14 (52) | 11 (45) | 11 (34) | 17 (70) | 0.02 |
| Male n (%) | 242 (56) | 120 (65) | 13 (48) | 13 (55) | 21(66) | 7 (30) | 0.02 |
| WBC, 109/L | 4.0 (0.4-602) | 3.9 (0.4-216) | 2.5 (0.7-86) | 2.5 (0.6-22) | 3.9 (0.5-87) | 9 (1-316) | 0.01 |
| Hg, g/L | 9.3 (3.5-16) | 9.3 (3.5-16) | 9.0 (4-11) | 9.2 (6.1-14) | 9.4 (5-14) | 9 (3.6-11.1) | 0.53 |
| Platelets, 109/L | 45 (0-626) | 65 (1-626) | 25 (7-233) | 46 (8-171) | 36 (0-361) | 33 (7-362) | 0.01 |
| Creatinine, mg/dL | 0.83 (0.3-4.0) | 0.9 (0.3-4.0) | 0.7 (0.4-2.3) | 0.9 (0.5-1.2) | 0.8 (0.5-2) | 0.8 (0.5-1.4) | 0.21 |
| Bilirubin, mg/dL | 0.5 (0.1-11) | 0.5 (0.1-8) | 0.65 (0.2-1.9) | 0.45 (0.2-1.3) | 0.6 (0.1-5) | 0.4 (0.2-1.7) | 0.25 |
| Albumin, mg/dL | 3.5 (1.9-5.2) | 3.6 (2.2-5.0) | 3.2 (2.5-4.4) | 3.4 (2.4-5.2) | 3.4 (1.9-4.1) | 3.5 (2.1-4.5) | 0.17 |
| Blasts in BM (%) | 84 (0-100) | 79 (0-99) | 80 (20-96) | 86 (26-99) | 88 (29-98) | 90 (28-96) | 0.01 |
| B-ALL, n (%) | 358 (84) | 150 (78) | 27 (100) | 24 (100) | 23 (72) | 24 (100) | 0.01 |
| T-ALL, n (%) | 70 (16) | 41 (22) | 0 (0) | 0 (0) | 9 (28.2) | 0 (0) | 0.01 |
| ECOG PS ≥ 2, n (%) | 56 (13) | 18 (9) | 8 (29) | 3 (12) | 3 (9) | 2 (8) | 0.12 |
| Treatment-related characteristics, n (%) | 0.08 | ||||||
| Hyper-CVAD | 330 (77) | 146 (78) | 25 (92) | 21 (87) | 23 (72) | 19 (79) | |
| Augmented BFM | 98 (23) | 40 (22) | 2 (8) | 3 (13) | 9 (28) | 5 (21) | |
| Morphologic response, n (%) | 0.57 | ||||||
| CR | 389 (91) | 174 (92) | 23 (86) | 22 (92) | 27 (85) | 21 (88) | |
| CRp | 11 (2) | 3 (2) | 2 (7) | 0 (0) | 2 (6) | 0 (0) | |
| PR | 3 (1) | 3 (2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | |
| NR | 12 (3) | 3 (2) | 0 (0) | 2 (8) | 2 (6) | 0 (0) | |
| Early death | 13 (3) | 3 (2) | 2 (7) | 0 (0) | 1 (3) | 3 (12) | |
| MRD at CR, n (%) | 0.28 | ||||||
| Positive | 96 (34) | 44 (37) | 3 (19) | 3 (16) | 12 (50) | 4 (29) | |
| Negative | 178 (62) | 70 (60) | 13 (81) | 13 (68) | 11 (46) | 9 (64) | |
| Indeterminate | 11 (4) | 4 (3) | 0 | 3 (16) | 1 (4) | 1 (7) | |
Continuous variables in the table are presented as median values and ranges. Abbreviations: y, years; Ho-Tr, Low hypodiploidy/near-triploidy HeH, high hyperdiploidy Cx, complex; MRD, ECOG PS, Eastern Cooperative Group performance status; Hyper-CVAD, hyperfractionated cyclophosphamide, vincristine, doxorubicin and dexamethasone; augmented BFM, augmented Berlin-Frankfurt-Munster. CR, complete response; CRp complete response with incomplete platelet recovery; PR, partial response; NR, no response. P is when all subgroups are compared.