Clinical outcomes
| Outcomes and engraftment . | Fresh (n = 203) . | Cryopreserved (n = 101) . | P . |
|---|---|---|---|
| OS, % (95% CI) | .22 | ||
| 100 d | 96.5 (93, 98) | 96 (90, 98) | |
| 6 mo | 89 (84, 93) | 89 (81, 94) | |
| PFS, % (95% CI) | .93 | ||
| 100 d | 88 (83, 92) | 84 (75, 90) | |
| 6 mo | 79 (73, 84) | 78 (68, 85) | |
| NRM, % (95% CI) | .23 | ||
| 100 d | 2 (0.7, 5) | 2 (0.4, 6) | |
| 6 mo | 4.6 (2, 8) | 2 (0.4, 6) | |
| Relapse, % (95% CI) | .94 | ||
| 100 d | 12 (8, 17) | 16 (10, 24) | |
| 6 mo | 20 (15, 26) | 22 (14, 31) | |
| Acute grade II-IV GVHD, % (95% CI) | .014 | ||
| 100 d | 9 (5, 13) | 17 (10, 25) | |
| 6 mo | 10.5 (7, 15) | 21 (13, 30) | |
| Acute grade III-IV GVHD, % (95% CI) | .17 | ||
| 100 d | 4.5 (2.2, 8) | 6 (2.5, 12) | |
| 6 mo | 5.5 (3, 9) | 10 (5, 17) | |
| Neutrophil engraftment | .08* | ||
| No engraftment, n (%) | 1 (0.5) | 3 (3) | |
| Engrafted, n (%) | 199 (97.5) | 98 (97) | |
| Days to engraftment, median (range) | 14 (6, 28) | 15 (10, 33) | .02† |
| Never nadir, n (%) | 4 (2) | 0 (0) | |
| Platelet engraftment | .14* | ||
| No engraftment, n (%) | 5 (2.5) | 7 (6.9) | |
| Engrafted, n (%) | 138 (68) | 69 (68.3) | |
| Days to engraftment, median (range) | 18 (9, 109) | 21 (10, 139) | .044† |
| Never nadir, n (%) | 60 (29.6) | 25 (24.8) | |
| Graft failure | .11 | ||
| No, n (%) | 195 (96.1) | 92 (91.1) | |
| Yes, n (%) | 7 (3.4) | 9 (8.9) | |
| Died prior to count recovery, n (%) | 1 (0.5) | 0 (0) | |
| Graft failure: early vs late | .04 | ||
| Early (<100 d), n | 3 | 7 | |
| Late (>100 d), n | 4 | 2 | |
| Effect of age of product on graft failure | sHR (95% CI) | P | |
| Overall age of product: ≥48 h vs <48 h | 4.57 (1.71, 12.3) | .0025 | |
| HLA matching: 10/10 vs <10/10 | 1.2 (0.35, 4.2) | .77 | |
| Outcomes and engraftment . | Fresh (n = 203) . | Cryopreserved (n = 101) . | P . |
|---|---|---|---|
| OS, % (95% CI) | .22 | ||
| 100 d | 96.5 (93, 98) | 96 (90, 98) | |
| 6 mo | 89 (84, 93) | 89 (81, 94) | |
| PFS, % (95% CI) | .93 | ||
| 100 d | 88 (83, 92) | 84 (75, 90) | |
| 6 mo | 79 (73, 84) | 78 (68, 85) | |
| NRM, % (95% CI) | .23 | ||
| 100 d | 2 (0.7, 5) | 2 (0.4, 6) | |
| 6 mo | 4.6 (2, 8) | 2 (0.4, 6) | |
| Relapse, % (95% CI) | .94 | ||
| 100 d | 12 (8, 17) | 16 (10, 24) | |
| 6 mo | 20 (15, 26) | 22 (14, 31) | |
| Acute grade II-IV GVHD, % (95% CI) | .014 | ||
| 100 d | 9 (5, 13) | 17 (10, 25) | |
| 6 mo | 10.5 (7, 15) | 21 (13, 30) | |
| Acute grade III-IV GVHD, % (95% CI) | .17 | ||
| 100 d | 4.5 (2.2, 8) | 6 (2.5, 12) | |
| 6 mo | 5.5 (3, 9) | 10 (5, 17) | |
| Neutrophil engraftment | .08* | ||
| No engraftment, n (%) | 1 (0.5) | 3 (3) | |
| Engrafted, n (%) | 199 (97.5) | 98 (97) | |
| Days to engraftment, median (range) | 14 (6, 28) | 15 (10, 33) | .02† |
| Never nadir, n (%) | 4 (2) | 0 (0) | |
| Platelet engraftment | .14* | ||
| No engraftment, n (%) | 5 (2.5) | 7 (6.9) | |
| Engrafted, n (%) | 138 (68) | 69 (68.3) | |
| Days to engraftment, median (range) | 18 (9, 109) | 21 (10, 139) | .044† |
| Never nadir, n (%) | 60 (29.6) | 25 (24.8) | |
| Graft failure | .11 | ||
| No, n (%) | 195 (96.1) | 92 (91.1) | |
| Yes, n (%) | 7 (3.4) | 9 (8.9) | |
| Died prior to count recovery, n (%) | 1 (0.5) | 0 (0) | |
| Graft failure: early vs late | .04 | ||
| Early (<100 d), n | 3 | 7 | |
| Late (>100 d), n | 4 | 2 | |
| Effect of age of product on graft failure | sHR (95% CI) | P | |
| Overall age of product: ≥48 h vs <48 h | 4.57 (1.71, 12.3) | .0025 | |
| HLA matching: 10/10 vs <10/10 | 1.2 (0.35, 4.2) | .77 | |
Due to the small number of events (N = 16), univariable analysis was performed using the Fine and Gray model treating death without GF as a competing event.
P value for comparison for 3 categories (no engraftment, engrafted, never nadir).
P value for comparison of time to engraftment for engrafted only.