Summary of clinical outcomes
| Outcome . | Total (N = 184) . | Developmental cohort (n = 128) . | Validation cohort (n = 56) . | P value . |
|---|---|---|---|---|
| Cumulative incidence, % (95% CI) | ||||
| aGVHD, day +100 | ||||
| GR2-4 | 48.9 (41.5-55.9) | 49.2 (40.3-57.6) | 48.2 (34.5-60.6) | .87 |
| GR3-4 | 8.7 (5.2-13.3) | 8.6 (4.5-14.3) | 8.9 (3.2-18.2) | .93 |
| Steroid refractory | 9.2 (5.6-14.0) | 11.7 (6.9-18.0) | 3.6 (0.7-11.0) | .08 |
| cGVHD, d +365 | ||||
| Mild to severe | 49.5 (42.0-56.5) | 52.3 (43.3-60.6) | 42.9 (29.6-55.4) | .27 |
| Moderate to severe | 41.3 (34.1-48.3) | 44.5 (35.7-52.9) | 33.9 (21.8-46.4) | .22 |
| aGFS, d +180 | 9.8 (6.0-14.6) | 9.4 (5.1-15.2) | 10.7 (4.3-20.5) | .08 |
| GRFS, d +365 | 14.1 (9.5-19.6) | 14.8 (9.3-21.6) | 12.5 (5.4-22.7) | .70 |
| Overall survival, d +365 | 17.9 (12.8-23.8) | 20.3 (13.8-27.7) | 12.5 (5.4-22.6) | .20 |
| Nonrelapse mortality, d +365 | 10.3 (6.5-15.2) | 11.7 (6.9-18.0) | 7.1 (2.3-15.9) | .34 |
| Relapse, d +365 | 15.9 (10.9-21.7) | 16.4 (10.4-23.5) | 14.6 (6.8-25.3) | .79 |
| CMV infection | ||||
| >300 copies per mL | 39.5 (32.1-46.7) | 43.0 (33.9-51.7) | 31.2 (19.4-43.8) | .29 |
| Invasive disease | 6.9 (3.7-11.3) | 8.2 (4.2-14.0) | 3.8 (0.7-11.5) | .27 |
| Any EBV viremia | 45.5 (35.7-54.7) | 44.0 (32.2-55.3) | 48.0 (31.6-62.6) | .30 |
| Day, median (95% CI) | ||||
| Neutrophil engraftment | 17.0 (11.6-29.9) | 17.0 (11.2-32.1) | 19.0 (12.0-28.6) | .24 |
| Platelets engraftment | 20.0 (11.0-59.7) | 19.5 (2.8-55.4) | 22.0 (14.0-79.8) | .07 |
| Outcome . | Total (N = 184) . | Developmental cohort (n = 128) . | Validation cohort (n = 56) . | P value . |
|---|---|---|---|---|
| Cumulative incidence, % (95% CI) | ||||
| aGVHD, day +100 | ||||
| GR2-4 | 48.9 (41.5-55.9) | 49.2 (40.3-57.6) | 48.2 (34.5-60.6) | .87 |
| GR3-4 | 8.7 (5.2-13.3) | 8.6 (4.5-14.3) | 8.9 (3.2-18.2) | .93 |
| Steroid refractory | 9.2 (5.6-14.0) | 11.7 (6.9-18.0) | 3.6 (0.7-11.0) | .08 |
| cGVHD, d +365 | ||||
| Mild to severe | 49.5 (42.0-56.5) | 52.3 (43.3-60.6) | 42.9 (29.6-55.4) | .27 |
| Moderate to severe | 41.3 (34.1-48.3) | 44.5 (35.7-52.9) | 33.9 (21.8-46.4) | .22 |
| aGFS, d +180 | 9.8 (6.0-14.6) | 9.4 (5.1-15.2) | 10.7 (4.3-20.5) | .08 |
| GRFS, d +365 | 14.1 (9.5-19.6) | 14.8 (9.3-21.6) | 12.5 (5.4-22.7) | .70 |
| Overall survival, d +365 | 17.9 (12.8-23.8) | 20.3 (13.8-27.7) | 12.5 (5.4-22.6) | .20 |
| Nonrelapse mortality, d +365 | 10.3 (6.5-15.2) | 11.7 (6.9-18.0) | 7.1 (2.3-15.9) | .34 |
| Relapse, d +365 | 15.9 (10.9-21.7) | 16.4 (10.4-23.5) | 14.6 (6.8-25.3) | .79 |
| CMV infection | ||||
| >300 copies per mL | 39.5 (32.1-46.7) | 43.0 (33.9-51.7) | 31.2 (19.4-43.8) | .29 |
| Invasive disease | 6.9 (3.7-11.3) | 8.2 (4.2-14.0) | 3.8 (0.7-11.5) | .27 |
| Any EBV viremia | 45.5 (35.7-54.7) | 44.0 (32.2-55.3) | 48.0 (31.6-62.6) | .30 |
| Day, median (95% CI) | ||||
| Neutrophil engraftment | 17.0 (11.6-29.9) | 17.0 (11.2-32.1) | 19.0 (12.0-28.6) | .24 |
| Platelets engraftment | 20.0 (11.0-59.7) | 19.5 (2.8-55.4) | 22.0 (14.0-79.8) | .07 |
GRFS, GVHD-relapse-free survival (ie, survival without relapse, aGVHD GR3-4, or moderate-to-severe cGVHD).