Univariate analysis of nonrelapse mortality in the cohort of patients analyzed
. | Number of patients . | Events . | Cumulative incidence . | 95% CI . | P . | HR* . | 95% CI . | P . |
---|---|---|---|---|---|---|---|---|
All patients | 343 | 49 | 15% | 11-19 | ||||
Sex | ||||||||
Male | 210 | 25 | 12% | 8-17 | .116 | |||
Female | 133 | 24 | 18% | 13-27 | 1.57 | 0.90-2.74 | .116 | |
Age at HSCT, y | ||||||||
<9.5 | 172 | 15 | 9% | 6-15 | .003 | |||
≥9.5 | 171 | 34 | 20% | 15-27 | 2.42 | 1.32-4.45 | .004 | |
<6 | 94 | 10 | 11% | 6-20 | .013 | |||
6-9.5 | 78 | 5 | 6% | 3-15 | 0.59 | 0.20-1.72 | .334 | |
9.5-13 | 80 | 13 | 16% | 10-27 | 1.59 | 0.69-3.65 | .274 | |
≥13 | 91 | 21 | 24% | 16-34 | 2.30 | 1.09-4.87 | .029 | |
<13 | 252 | 28 | 13% | 8-16 | .006 | |||
≥13 | 91 | 21 | 24% | 16-34 | 2.95 | 1.25-3.84 | .006 | |
Diagnosis | ||||||||
ALL | 237 | 37 | 16% | 12-21 | .281 | |||
AML | 106 | 12 | 12% | 7-20 | 0.79 | 0.37-1.34 | .280 | |
ALL phenotype | ||||||||
B-cell precursor | 191 | 29 | 16% | 11-22 | ||||
T-cell precursor | 47 | 8 | 17% | 9-32 | .744 | 1.15 | 0.52-2.53 | .732 |
Disease phase at HSCT | ||||||||
Only ALL patients | ||||||||
CR1† | 93 | 16 | 18% | 11-28 | .850 | |||
CR2 S1-S2† | 85 | 11 | 13% | 8-23 | 0.72 | 0.34-1.56 | .405 | |
CR2 S3-S4‡ | 49 | 8 | 16% | 9-31 | 0.93 | 0.40-2.17 | .865 | |
Other CR‡ | 11 | 2 | 18% | 5-64 | 1.98 | 0.24-4.83 | .920 | |
Only AML patients | ||||||||
CR1† | 82 | 8 | 10% | 5-19 | .531 | |||
CR2† | 22 | 4 | 18% | 8-45 | 1.94 | 0.59-6.35 | .273 | |
Prognosis†,‡ | ||||||||
Good prognosis† | 282 | 39 | 14% | 11-19 | .581 | |||
Poor prognosis‡ | 61 | 10 | 16% | 9-29 | 1.21 | 0.60-2.44 | .583 | |
MRD, all patients | ||||||||
<1 × 10−3 | 143 | 16 | 11% | 7-18 | .855 | |||
≥1 × 10−3 | 20 | 2 | 10% | 3-37 | 0.87 | 0.20-3.73 | .855 | |
Neg | 119 | 14 | 12% | 7-19 | .842 | |||
Pos <1 × 10−3 | 24 | 2 | 8% | 2-31 | 0.66 | 0.16-2.80 | .578 | |
Pos ≥1 × 10−3 | 20 | 2 | 10% | 3-37 | 0.82 | 0.19-3.55 | .792 | |
MRD, only patients with ALL | ||||||||
<1 × 10−3 | 121 | 15 | 12% | 8-20 | .743 | |||
≥1 × 10−3 | 11 | 1 | 9% | 1-59 | 0.72 | 0.10-5.33 | .744 | |
Neg | 98 | 13 | 13% | 8-22 | .756 | |||
Pos <1 × 10−3 | 23 | 2 | 9% | 2-33 | 0.61 | 0.14-2.59 | .503 | |
Pos ≥1 × 10−3 | 11 | 1 | 9% | 1-59 | 0.66 | 0.09-4.99 | .678 | |
MRD, only patients with AML | ||||||||
<1 × 10−3 | 22 | 1 | 5% | 1-31 | .524 | |||
≥1 × 10−3 | 9 | 1 | 11% | 2-71 | 2.39 | 0.16-35.82 | .529 | |
Neg | 21 | 1 | 5% | 1-32 | .802 | |||
Pos ≥1 × 10−3 | 9 | 1 | 11% | 2-71 | 2.28 | 0.15-34.09 | ||
Donor | ||||||||
MUD | 245 | 40 | 17% | 13-22 | .085 | |||
Haploidentical | 98 | 9 | 9% | 5-17 | 0.54 | 0.26-1.11 | .092 | |
HLA compatibility | ||||||||
MUD | 127 | 8 | 6% | 3-12 | <.001 | |||
MMUD | 118 | 32 | 28% | 21-37 | 4.76 | 2.19-10-36 | <.001 | |
Haploidentical | 98 | 9 | 9% | 5-17 | 1.46 | 0.56-3.79 | .435 | |
Stem cell source | ||||||||
BM | 187 | 30 | 16% | 12-23 | .267 | |||
PBSC | 156 | 19 | 12% | 8-19 | 0.72 | 0.41-1.28 | .268 | |
Conditioning regimen | ||||||||
TBI-based | 204 | 31 | 16% | 11-21 | .827 | |||
Busulfan-based | 115 | 16 | 14% | 9-22 | 0.92 | 0.50-1.67 | .774 | |
Treosulfan-based | 21 | 2 | 10% | 3-36 | 0.64 | 0.15-2.79 | .553 | |
Conditioning regimen, ALL patients | ||||||||
TBI-based | 189 | 29 | 16% | 11-22 | .904 | |||
Busulfan-based | 34 | 6 | 18% | 9-36 | 0.21 | 0.49-2.99 | .673 | |
Treosulfan-based | 12 | 2 | 17% | 5-59 | 0.16 | 0.25-5.19 | .846 | |
Conditioning regimen, AML patients | ||||||||
TBI-based | 15 | 2 | 13% | 4-48 | .733 | |||
Busulfan-based | 81 | 10 | 13% | 7-23 | 0.93 | 0.21-4.24 | ||
Treosulfan-based | 9 | 0 | 0% | — | 0.00 | — | <.001 |
. | Number of patients . | Events . | Cumulative incidence . | 95% CI . | P . | HR* . | 95% CI . | P . |
---|---|---|---|---|---|---|---|---|
All patients | 343 | 49 | 15% | 11-19 | ||||
Sex | ||||||||
Male | 210 | 25 | 12% | 8-17 | .116 | |||
Female | 133 | 24 | 18% | 13-27 | 1.57 | 0.90-2.74 | .116 | |
Age at HSCT, y | ||||||||
<9.5 | 172 | 15 | 9% | 6-15 | .003 | |||
≥9.5 | 171 | 34 | 20% | 15-27 | 2.42 | 1.32-4.45 | .004 | |
<6 | 94 | 10 | 11% | 6-20 | .013 | |||
6-9.5 | 78 | 5 | 6% | 3-15 | 0.59 | 0.20-1.72 | .334 | |
9.5-13 | 80 | 13 | 16% | 10-27 | 1.59 | 0.69-3.65 | .274 | |
≥13 | 91 | 21 | 24% | 16-34 | 2.30 | 1.09-4.87 | .029 | |
<13 | 252 | 28 | 13% | 8-16 | .006 | |||
≥13 | 91 | 21 | 24% | 16-34 | 2.95 | 1.25-3.84 | .006 | |
Diagnosis | ||||||||
ALL | 237 | 37 | 16% | 12-21 | .281 | |||
AML | 106 | 12 | 12% | 7-20 | 0.79 | 0.37-1.34 | .280 | |
ALL phenotype | ||||||||
B-cell precursor | 191 | 29 | 16% | 11-22 | ||||
T-cell precursor | 47 | 8 | 17% | 9-32 | .744 | 1.15 | 0.52-2.53 | .732 |
Disease phase at HSCT | ||||||||
Only ALL patients | ||||||||
CR1† | 93 | 16 | 18% | 11-28 | .850 | |||
CR2 S1-S2† | 85 | 11 | 13% | 8-23 | 0.72 | 0.34-1.56 | .405 | |
CR2 S3-S4‡ | 49 | 8 | 16% | 9-31 | 0.93 | 0.40-2.17 | .865 | |
Other CR‡ | 11 | 2 | 18% | 5-64 | 1.98 | 0.24-4.83 | .920 | |
Only AML patients | ||||||||
CR1† | 82 | 8 | 10% | 5-19 | .531 | |||
CR2† | 22 | 4 | 18% | 8-45 | 1.94 | 0.59-6.35 | .273 | |
Prognosis†,‡ | ||||||||
Good prognosis† | 282 | 39 | 14% | 11-19 | .581 | |||
Poor prognosis‡ | 61 | 10 | 16% | 9-29 | 1.21 | 0.60-2.44 | .583 | |
MRD, all patients | ||||||||
<1 × 10−3 | 143 | 16 | 11% | 7-18 | .855 | |||
≥1 × 10−3 | 20 | 2 | 10% | 3-37 | 0.87 | 0.20-3.73 | .855 | |
Neg | 119 | 14 | 12% | 7-19 | .842 | |||
Pos <1 × 10−3 | 24 | 2 | 8% | 2-31 | 0.66 | 0.16-2.80 | .578 | |
Pos ≥1 × 10−3 | 20 | 2 | 10% | 3-37 | 0.82 | 0.19-3.55 | .792 | |
MRD, only patients with ALL | ||||||||
<1 × 10−3 | 121 | 15 | 12% | 8-20 | .743 | |||
≥1 × 10−3 | 11 | 1 | 9% | 1-59 | 0.72 | 0.10-5.33 | .744 | |
Neg | 98 | 13 | 13% | 8-22 | .756 | |||
Pos <1 × 10−3 | 23 | 2 | 9% | 2-33 | 0.61 | 0.14-2.59 | .503 | |
Pos ≥1 × 10−3 | 11 | 1 | 9% | 1-59 | 0.66 | 0.09-4.99 | .678 | |
MRD, only patients with AML | ||||||||
<1 × 10−3 | 22 | 1 | 5% | 1-31 | .524 | |||
≥1 × 10−3 | 9 | 1 | 11% | 2-71 | 2.39 | 0.16-35.82 | .529 | |
Neg | 21 | 1 | 5% | 1-32 | .802 | |||
Pos ≥1 × 10−3 | 9 | 1 | 11% | 2-71 | 2.28 | 0.15-34.09 | ||
Donor | ||||||||
MUD | 245 | 40 | 17% | 13-22 | .085 | |||
Haploidentical | 98 | 9 | 9% | 5-17 | 0.54 | 0.26-1.11 | .092 | |
HLA compatibility | ||||||||
MUD | 127 | 8 | 6% | 3-12 | <.001 | |||
MMUD | 118 | 32 | 28% | 21-37 | 4.76 | 2.19-10-36 | <.001 | |
Haploidentical | 98 | 9 | 9% | 5-17 | 1.46 | 0.56-3.79 | .435 | |
Stem cell source | ||||||||
BM | 187 | 30 | 16% | 12-23 | .267 | |||
PBSC | 156 | 19 | 12% | 8-19 | 0.72 | 0.41-1.28 | .268 | |
Conditioning regimen | ||||||||
TBI-based | 204 | 31 | 16% | 11-21 | .827 | |||
Busulfan-based | 115 | 16 | 14% | 9-22 | 0.92 | 0.50-1.67 | .774 | |
Treosulfan-based | 21 | 2 | 10% | 3-36 | 0.64 | 0.15-2.79 | .553 | |
Conditioning regimen, ALL patients | ||||||||
TBI-based | 189 | 29 | 16% | 11-22 | .904 | |||
Busulfan-based | 34 | 6 | 18% | 9-36 | 0.21 | 0.49-2.99 | .673 | |
Treosulfan-based | 12 | 2 | 17% | 5-59 | 0.16 | 0.25-5.19 | .846 | |
Conditioning regimen, AML patients | ||||||||
TBI-based | 15 | 2 | 13% | 4-48 | .733 | |||
Busulfan-based | 81 | 10 | 13% | 7-23 | 0.93 | 0.21-4.24 | ||
Treosulfan-based | 9 | 0 | 0% | — | 0.00 | — | <.001 |
Subgroups including fewer than 5 patients were not shown in the table.
The Cox regression model was used to estimate the HR, and the first subgroup of patients of each independent variable was used as reference value.
The good prognosis group included patients affected by ALL in first CR, ALL in second CR after a relapse belonging to the S1-S2 risk groups and patients with AML in first CR.
The poor prognosis group included patients affected by ALL in second CR after a relapse belonging to the S3-S4 risk groups, ALL in third or subsequent CR, and patients with AML in second CR.