Table 2.
Patient outcomes by CY dosing method1
| TBI 12 Gy + Standard CY dosing (120 mg/kg) (N = 100) |
TBI 12 Gy + Personalized CY dosing (N = 50) |
HR (95% CI) | p-value | |
|---|---|---|---|---|
| Total serum bilirubin values: | ||||
| Days 0–20 | 1.7 mg/dL (0.4 – 18.3) |
1.3 mg/dL (0.7 – 8.8) |
0.03 | |
| Day of maximum serum bilirubin (day 0–20) |
Day 11 (0–20) |
Day 10 (1 – 20) |
||
| Days 21–100 | 1.4 mg/dL2 (0.5 – 35.0) |
1.1 mg/dL3 (0.5 – 34.3) |
0.47 | |
| Day of maximum serum bilirubin (day 21–100) |
Day 27 (21 – 99) |
Day 47 (21 – 99) |
||
| Acute Kidney Injury4 | ||||
| No | 23 (23) | 19 (38) | ||
| Yes | 77 (77) | 31 (62) | 0.62 (0.40 – 0.95) | 0.03 |
| Overall survival | ||||
| Alive | 44 (44) | 26 (52) | ||
| Died | 56 (56) | 24 (48) | 0.89 (0.55– 1.44) | 0.63 |
| Non-relapse mortality | ||||
| No | 71 (71) | 37 (74) | ||
| Yes | 29 (29) | 13 (26) | 0.88 (0.46 – 1.70) | 0.70 |
| Relapse | ||||
| No | 66 (66) | 37 (74) | ||
| Yes | 34 (34) | 13 (26) | 0.81 (0.42 – 1.54) | 0.52 |
| Low and standard risk disease | ||||
| Total | 42 | 23 | ||
| Alive | 25 (60) | 16 (70) | ||
| Died | 17 (40) | 7 (30) | 0.95 (0.38 – 2.35) | 0.91 |
| High risk disease | ||||
| Total | 58 | 27 | ||
| Alive | 19 (33) | 10 (37) | ||
| Died | 39 (67) | 17 (63) | 0.88 (0.50 – 1.56) | 0.67 |
| Lymphoid disease | ||||
| Total | 56 | 28 | ||
| Alive | 26 (46) | 12 (43) | ||
| Died | 30 (54) | 16 (57) | 1.14 (0.62 – 2.11) | 0.67 |
| Myeloid disease | ||||
| Total | 44 | 22 | ||
| Alive | 18 (41) | 14 (64) | ||
| Died | 26 (59) | 8 (36) | 0.60 (0.27 – 1.34) | 0.21 |
1
Data presented as median (range) or number of patients (% of relevant population)
2
Evaluable in 96 patients
3
Evaluable in 48 patients
4
Acute kidney injury is defined as a doubling of baseline serum creatinine.