Outcomes of the 20-mg group versus the > 20-mg group
| . | > 20 mg (n = 81) . | 20 mg (n = 25) . | P . |
|---|---|---|---|
| Graft-versus-host disease | |||
| Grade II-IV aGVHD events, n (%) | 4 (5) | 4 (16) | .012 |
| HR (95% CI) | 1 (ref) | 16.6 (1.8-150) | |
| Grade III-IV aGVHD events (%) | 1 (1.2) | 3 (12) | .04 |
| HR (95% CI) | 1 (ref) | NA | |
| Extensive cGVHD events | 7 (9) | 6 (24) | .001 |
| HR (95% CI) | 1 (ref) | 4.1 (1.4-12.4) | |
| Grade III-IV/ext cGVHD events (%) | 8 (10) | 9 (36) | < .001 |
| HR (95% CI) | 1 (ref) | 6.7 (2.5-18.3) | |
| Non-relapse mortality | |||
| 100 d, % (95% CI) | 2 (0-8) | 12 (3-28) | NS |
| 1 y, % (95% CI) | 10 (5-18) | 20 (7-37) | NS |
| 2 y, % (95% CI) | 15 (8-23) | 20 (7-37) | NS |
| Progression-free survival | |||
| 2 y, % (95% CI) | 60 (48-69) | 51 (23-74) | NS |
| Overall survival | |||
| 2 y, % (95% CI) | 73 (62-82) | 72 (50-86) | NS |
| Full donor chimerism (%) | |||
| 3 mo | 40 | 37 | NS |
| 2 y | 81 | 74 | NS |
| Infections | |||
| Total, median/patient (IQR) | 2 (1-4) | 2 (1-4) | NS |
| CMV reactivation, % | 79 | 60 | NS |
| CMV disease, % | 10 | 0 | NS |
| Median lymphocyte count, ×109/L (IQR) | |||
| 1 mo | 0.2 (0.1-0.4) | 0.3 (0.2-0.5) | NS |
| 3 mo | 0.9 (0.4-1.4) | 0.7 (0.4-1.1) | NS |
| 6 mo | 1.0 (0.7-1.7) | 0.8 (0.4-1.8) | NS |
| 12 mo | 1.3 (1.0-1.9) | 1.2 (1.0-1.7) | NS |
| . | > 20 mg (n = 81) . | 20 mg (n = 25) . | P . |
|---|---|---|---|
| Graft-versus-host disease | |||
| Grade II-IV aGVHD events, n (%) | 4 (5) | 4 (16) | .012 |
| HR (95% CI) | 1 (ref) | 16.6 (1.8-150) | |
| Grade III-IV aGVHD events (%) | 1 (1.2) | 3 (12) | .04 |
| HR (95% CI) | 1 (ref) | NA | |
| Extensive cGVHD events | 7 (9) | 6 (24) | .001 |
| HR (95% CI) | 1 (ref) | 4.1 (1.4-12.4) | |
| Grade III-IV/ext cGVHD events (%) | 8 (10) | 9 (36) | < .001 |
| HR (95% CI) | 1 (ref) | 6.7 (2.5-18.3) | |
| Non-relapse mortality | |||
| 100 d, % (95% CI) | 2 (0-8) | 12 (3-28) | NS |
| 1 y, % (95% CI) | 10 (5-18) | 20 (7-37) | NS |
| 2 y, % (95% CI) | 15 (8-23) | 20 (7-37) | NS |
| Progression-free survival | |||
| 2 y, % (95% CI) | 60 (48-69) | 51 (23-74) | NS |
| Overall survival | |||
| 2 y, % (95% CI) | 73 (62-82) | 72 (50-86) | NS |
| Full donor chimerism (%) | |||
| 3 mo | 40 | 37 | NS |
| 2 y | 81 | 74 | NS |
| Infections | |||
| Total, median/patient (IQR) | 2 (1-4) | 2 (1-4) | NS |
| CMV reactivation, % | 79 | 60 | NS |
| CMV disease, % | 10 | 0 | NS |
| Median lymphocyte count, ×109/L (IQR) | |||
| 1 mo | 0.2 (0.1-0.4) | 0.3 (0.2-0.5) | NS |
| 3 mo | 0.9 (0.4-1.4) | 0.7 (0.4-1.1) | NS |
| 6 mo | 1.0 (0.7-1.7) | 0.8 (0.4-1.8) | NS |
| 12 mo | 1.3 (1.0-1.9) | 1.2 (1.0-1.7) | NS |
aGVHD indicates acute graft-versus-host disease; HR, hazard ratio; CI, confidence interval; ref, reference; NA, not applicable; cGVHD, chronic graft-versus-host disease; NS, not significant; IQR, interquartile range; and CMV, cytomegalovirus.