Outcome of 109 patients randomized in the 2 trials
. | Trial 1 . | Trial 2 . | ||||
---|---|---|---|---|---|---|
No ATG . | ATG 7.5 (mg/kg) . | P . | No ATG . | ATG 15 (mg/kg) . | P . | |
No. of patients | 25 | 29 | 28 | 27 | ||
Engraftment | ||||||
Patients with PMN counts ≥ 0.5 × 109/L (%) | 84 | 83 | 89 | 89 | ||
Days to reach PMN count = 0.5 × 109/L | 17 (13-28)* | 18 (13-35) | 3 | 19 (14-32) | 19 (13-36) | .6 |
Patients with Plt counts ≥ 50 × 109/L (%) | 76 | 76 | 61 | 60 | ||
Days to reach Plt count = 50 × 109/L | 21 (15-203) | 24 (16-91) | 3 | 23 (16-79) | 38 (17-92) | .02 |
CMV antigenemia (%) | 88 | 83 | 5 | 67 | 78 | .2 |
Acute GVHD (no. of patients) | ||||||
0-I | 7 | 9 | 6 | 17 | ||
II | 9 | 8 | 8 | 7 | ||
III-IV | 9 (36%) | 12 (41%) | 8 | 14 (50%) | 3 (11%) | .001* |
Chronic GVHD (%) | 65 | 38 | .08 | 59 | 41 | .3 |
Patients surviving (%) | 52 | 55 | 46 | 41 | ||
Causes of death | ||||||
GVHD (%) | 32 | 28 | 39 | 11 | ||
Infections (%) | 8 | 7 | 7 | 30 | ||
MOF (%) | 0 | 7 | 4 | 0 | ||
Leukemia (%) | 8 | 3 | 7 | 4 | 18 | .07 |
Follow-up (median days) | ||||||
Surviving patients | 1040 | 855 | 540 | 530 | ||
Deceased patients | 150 | 70 | 66 | 68 |
. | Trial 1 . | Trial 2 . | ||||
---|---|---|---|---|---|---|
No ATG . | ATG 7.5 (mg/kg) . | P . | No ATG . | ATG 15 (mg/kg) . | P . | |
No. of patients | 25 | 29 | 28 | 27 | ||
Engraftment | ||||||
Patients with PMN counts ≥ 0.5 × 109/L (%) | 84 | 83 | 89 | 89 | ||
Days to reach PMN count = 0.5 × 109/L | 17 (13-28)* | 18 (13-35) | 3 | 19 (14-32) | 19 (13-36) | .6 |
Patients with Plt counts ≥ 50 × 109/L (%) | 76 | 76 | 61 | 60 | ||
Days to reach Plt count = 50 × 109/L | 21 (15-203) | 24 (16-91) | 3 | 23 (16-79) | 38 (17-92) | .02 |
CMV antigenemia (%) | 88 | 83 | 5 | 67 | 78 | .2 |
Acute GVHD (no. of patients) | ||||||
0-I | 7 | 9 | 6 | 17 | ||
II | 9 | 8 | 8 | 7 | ||
III-IV | 9 (36%) | 12 (41%) | 8 | 14 (50%) | 3 (11%) | .001* |
Chronic GVHD (%) | 65 | 38 | .08 | 59 | 41 | .3 |
Patients surviving (%) | 52 | 55 | 46 | 41 | ||
Causes of death | ||||||
GVHD (%) | 32 | 28 | 39 | 11 | ||
Infections (%) | 8 | 7 | 7 | 30 | ||
MOF (%) | 0 | 7 | 4 | 0 | ||
Leukemia (%) | 8 | 3 | 7 | 4 | 18 | .07 |
Follow-up (median days) | ||||||
Surviving patients | 1040 | 855 | 540 | 530 | ||
Deceased patients | 150 | 70 | 66 | 68 |
MOF, multiorgan failure; PMN, neutrophils; Plt, platelets.
Median and range, χ2 test.