Table 4.
Comparison for characteristics and outcomes of high-dose PTCY group and low-dose PTCY group
| high-dose PTCY group (n = 17) | low-dose PTCY group (n = 14) | p value | ||
|---|---|---|---|---|
| Age, years | 6.12 (SD = 3.66) | 5.96 (SD = 2.48) | 0.890 | |
| sex, n | male | 12 | 11 | 0.613 |
| female | 5 | 3 | ||
| Weight, kg | 19.7(SD = 9.0) | 18.9 (SD = 5.3) | 0.759 | |
| Primary diagnosis, n | AML | 11 | 8 | 0.436 |
| ALL | 6 | 5 | ||
| others | 0 | 1 | ||
| Remission status, n | CR1 | 14 | 13 | 0.385 |
| CR2 | 3 | 1 | ||
| HLA matching 2, n | 7/10 or 8/10 | 11 | 6 | 0.224 |
| 9/10 or 10/10 | 6 | 8 | ||
| TNC,107/kg (range) | 7.1 (3.39, 13.9) | 6.8 (1.0, 15.3) | 0.795 | |
| CD34+, 105/kg (range) | 3.4 (1.26, 10.72) | 3.6 (2.26, 6.61) | 0.767 | |
| Median follow-up, months (range) | 18.5 (4.4, 30.0) | 13.0 (1.8, 18.1) | 0.032 | |
| PTCY dose | ||||
| 40 mg/kg, n | 7 | |||
| 29 mg/kg, n | 10 | |||
| 20 mg/kg, n | 3 | |||
| 10 mg/kg, n | 11 | |||
| Neutrophil engraftment, days (range) | 18(13, 38) | 14 (12,33) | 0.251 | |
| PLT engraftment, days (range) | 32 (12, 61) | 31(14, 45) | 0.735 | |
| Graft failure, n (%) | 1 (6) | 0 (0) | 0.356 | |
| PES, n (%) | 13 (77) | 12 (86) | 0.517 | |
| Acute GvHD, n (%) | 11 (65) | 13 (93) | 0.062 | |
| Grade 3 to 4 Acute GvHD, n (%) | 5 (29) | 8 (57) | 0.119 | |
| HC, n (%) | 2 (12) | 5 (36) | 0.134 | |
| Chronic GvHD, n (%) | 5 (29) | 8 (57) | 0.119 | |
| CMV activity, n (%) | 3 (18) | 2 (14) | 0.597 | |
| pneumonia, n (%) | 6 (35) | 4 (29) | 0.497 | |
| Fungal infection, n (%) | 3 (18) | 4 (29) | 0.383 | |
| Sepsis or bacteremia, n (%) | 8 (47) | 2 (14) | 0.058 | |
| TRM, n (%) | 2 (12) | 1 (7) | 0.665 | |
| Relapse, n (%) | 6 (35) | 0 (0) | 0.013 | |
| Event-free survival, n (%) | 9 (53) | 13 (93) | 0.015 | |
| RFS, mean (95%CI) | 52.9 (29.18, 76.61) | 92.9 (79.38, 100) | 0.047 | |
| OS, mean (95%CI) | 64.7 (41.96, 87.43) | 92.9 (79.38, 100) | 0.281 | |
PTCY posttransplant cyclophosphamide, SD Standard deviation, AML Acute myeloid leukemia, ALL acute lymphoblastic leukemia; others, mixed lineage leukemia, CR1 first complete remission, CR2 second complete remission, HLA human lymphocyte antigen, TNC total nucleated cell, CD34+ CD 34+ cell counts, PLT platelet, GvHD graft-versus-host-disease, HC hemorrhagic cystitis, CMV Cytomegalovirus, PES peri-engraftment syndrome, TRM transplantation related mortality, OS overall survival, RFS relapse-free survival, SE Standard error, 95% CI 95% confidence interval