Outcomes by individual group
| . | 60 mg (n = 26) . | 40 mg (n = 27) . | 30 mg (n = 28) . | 20 mg (n = 25) . | Total (n = 106) . | P . |
|---|---|---|---|---|---|---|
| Graft-versus-host disease | ||||||
| Grade II-IV aGVHD events, n (%) | 1 (4) | 2 (7) | 1 (4) | 4 (16) | 8 (8) | .006 |
| HR (95% CI) | 1 (ref) | NA | NA | NA | ||
| Grade III-IV aGVHD events, n (%) | 0 (0) | 0 (0) | 1 (4) | 3 (12) | 4 (4) | .008 |
| HR (95% CI) | 1 (ref) | NA | NA | NA | ||
| Extensive cGVHD events, n (%) | 5 (19) | 1 (4) | 1 (4) | 6 (24) | 13 (12) | .003 |
| HR (95% CI) | 1 (ref) | 0.1 (0.01-1.0) | 0.1 (0.01-0.9) | 1.3 (0.4-4.1) | ||
| Grade III-IV/ext cGVHD events, n (%) | 5 (19) | 1 (4) | 2 (7) | 9 (36) | 17 (16) | < .001 |
| HR (95% CI) | 1 (ref) | 0.1 (0.01-0.9) | 0.2 (0.03-0.96) | 2.3 (0.8-7.1) | ||
| Nonrelapse mortality | ||||||
| 100 d, % (95% CI) | 0 (0-0) | 7 (1-21) | 0 (0-0) | 12 (3-28) | 5 (2-10) | NS |
| 1 y, % (95% CI) | 12 (3-27) | 11 (3-26) | 7 (1-20) | 20 (7-37) | 12 (7-19) | NS |
| 2 y, % (95% CI) | 20 (7-37) | 19 (7-36) | 7 (1-20) | 20 (7-37) | 17 (10-24) | NS |
| Progression-free survival | ||||||
| 2 y, % (95% CI) | 48 (28-66) | 58 (37-74) | 71 (51-85) | 51 (23-74) | 59 (48-68) | NS |
| Overall survival | ||||||
| 2 y, % (95% CI) | 64 (43-80) | 73 (51-86) | 82 (62-92) | 72 (50-86) | 72 (63-80) | NS |
| Full donor chimerism (%) | ||||||
| 3 mo | 45 | 39 | 36 | 37 | 39 | NS |
| 2 y | 90 | 74 | 64 | 74 | 75 | NS |
| Infections | ||||||
| Total, median/patient (IQR) | 3 (1-4) | 2 (1-4) | 2 (1-4) | 2 (1-4) | 2 (1-4) | NS |
| CMV re-activation (%) | 78 | 75 | 83 | 60 | 75 | NS |
| CMV disease (%) | 17 | 8 | 6 | 0 | 8 | NS |
| Median lymphocyte count, ×109/L (IQR) | ||||||
| 1 mo | 0.1 (0.1-0.4) | 0.1 (0.1-0.3) | 0.2 (0.1-0.3) | 0.3 (0.2-0.5) | 0.2 (0.1-0.4) | NS |
| 3 mo | 1.0 (0.3-1.7) | 0.9 (0.4-1.2) | 0.8 (0.4-1.9) | 0.7 (0.4-1.1) | 0.7 (0.4-1.3) | NS |
| 6 mo | 1.1 (0.7-1.7) | 0.8 (0.5-1.3) | 0.9 (0.7-2.0) | 0.8 (0.4-1.8) | 1.0 (0.6-1.7) | NS |
| 12 mo | 1.2 (0.9-2.0) | 1.3 (0.8-1.6) | 1.7 (1.1-2.5) | 1.2 (1.0-1.7) | 1.3 (1.0-1.8) | .04 |
| . | 60 mg (n = 26) . | 40 mg (n = 27) . | 30 mg (n = 28) . | 20 mg (n = 25) . | Total (n = 106) . | P . |
|---|---|---|---|---|---|---|
| Graft-versus-host disease | ||||||
| Grade II-IV aGVHD events, n (%) | 1 (4) | 2 (7) | 1 (4) | 4 (16) | 8 (8) | .006 |
| HR (95% CI) | 1 (ref) | NA | NA | NA | ||
| Grade III-IV aGVHD events, n (%) | 0 (0) | 0 (0) | 1 (4) | 3 (12) | 4 (4) | .008 |
| HR (95% CI) | 1 (ref) | NA | NA | NA | ||
| Extensive cGVHD events, n (%) | 5 (19) | 1 (4) | 1 (4) | 6 (24) | 13 (12) | .003 |
| HR (95% CI) | 1 (ref) | 0.1 (0.01-1.0) | 0.1 (0.01-0.9) | 1.3 (0.4-4.1) | ||
| Grade III-IV/ext cGVHD events, n (%) | 5 (19) | 1 (4) | 2 (7) | 9 (36) | 17 (16) | < .001 |
| HR (95% CI) | 1 (ref) | 0.1 (0.01-0.9) | 0.2 (0.03-0.96) | 2.3 (0.8-7.1) | ||
| Nonrelapse mortality | ||||||
| 100 d, % (95% CI) | 0 (0-0) | 7 (1-21) | 0 (0-0) | 12 (3-28) | 5 (2-10) | NS |
| 1 y, % (95% CI) | 12 (3-27) | 11 (3-26) | 7 (1-20) | 20 (7-37) | 12 (7-19) | NS |
| 2 y, % (95% CI) | 20 (7-37) | 19 (7-36) | 7 (1-20) | 20 (7-37) | 17 (10-24) | NS |
| Progression-free survival | ||||||
| 2 y, % (95% CI) | 48 (28-66) | 58 (37-74) | 71 (51-85) | 51 (23-74) | 59 (48-68) | NS |
| Overall survival | ||||||
| 2 y, % (95% CI) | 64 (43-80) | 73 (51-86) | 82 (62-92) | 72 (50-86) | 72 (63-80) | NS |
| Full donor chimerism (%) | ||||||
| 3 mo | 45 | 39 | 36 | 37 | 39 | NS |
| 2 y | 90 | 74 | 64 | 74 | 75 | NS |
| Infections | ||||||
| Total, median/patient (IQR) | 3 (1-4) | 2 (1-4) | 2 (1-4) | 2 (1-4) | 2 (1-4) | NS |
| CMV re-activation (%) | 78 | 75 | 83 | 60 | 75 | NS |
| CMV disease (%) | 17 | 8 | 6 | 0 | 8 | NS |
| Median lymphocyte count, ×109/L (IQR) | ||||||
| 1 mo | 0.1 (0.1-0.4) | 0.1 (0.1-0.3) | 0.2 (0.1-0.3) | 0.3 (0.2-0.5) | 0.2 (0.1-0.4) | NS |
| 3 mo | 1.0 (0.3-1.7) | 0.9 (0.4-1.2) | 0.8 (0.4-1.9) | 0.7 (0.4-1.1) | 0.7 (0.4-1.3) | NS |
| 6 mo | 1.1 (0.7-1.7) | 0.8 (0.5-1.3) | 0.9 (0.7-2.0) | 0.8 (0.4-1.8) | 1.0 (0.6-1.7) | NS |
| 12 mo | 1.2 (0.9-2.0) | 1.3 (0.8-1.6) | 1.7 (1.1-2.5) | 1.2 (1.0-1.7) | 1.3 (1.0-1.8) | .04 |
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.