Table 4.
Peritransplant 1,25(OH)2D3 discovery data | Peritransplant 1,25(OH)2D3 joint replication data | |||||
---|---|---|---|---|---|---|
#at risk/#TRM | HR (95% CI) | P | #at risk/#TRM | HR (95% CI) | P | |
Unadjusted | 143/23 | 365/66 | ||||
Serum level ≤139.5 pMa | 5.16 (2.12; 12.57) | <0.0005 | 3.51 (1.79; 6.88) | <0.0005 | ||
Adjusted I | 128/21 | 364/66 | ||||
Serum level ≤139.5 pMa | 6.10 (2.24; 16.63) | <0.0005 | 3.30 (1.70; 6.44) | <0.0005 | ||
Age [yr] | 1.08 (1.01; 1.15) | 0.018 | 1.05 (1.02; 1.07) | 0.001 | ||
Male sex | 0.45 (0.19; 1.10) | 0.081 | 0.92 (0.55; 1.54) | 0.749 | ||
Unrelated donorb | 0.99 (0.39; 2.54) | 0.986 | 2.77 (1.25; 6.13) | 0.012 | ||
Late tumor stagec | 1.81 (0.073; 4.46) | 0.197 | 1.03 (0.61; 1.72) | 0.919 | ||
Adjusted II | 128/21 | 361/63 | ||||
Serum level ≤139.5 pMa | 6.00 (2.16; 16.63) | 0.001 | 3.31 (1.68; 6.53) | 0.001 | ||
Age [yr] | 1.05 (0.99; 1.12) | 0.134 | 1.04 (1.01; 1.07) | 0.006 | ||
Male sex | 1.21 (0.44; 3.33) | 0.712 | 0.95 (0.56; 1.61) | 0.848 | ||
Unrelated donorb | 0.82 (0.31; 2.21) | 0.700 | 2.49 (1.11; 5.56) | 0.026 | ||
Late tumor stagec | 1.63 (0.63; 4.26) | 0.317 | 0.99 (0.58; 1.69) | 0.960 | ||
Severe aGvHDd | 16.18 (5.56; 47.07) | <0.0005 | 4.96 (2.91; 8.47) | <0.0005 |
Shown are results from Cox proportional hazards models based on the 143 patients (23 TRM) of the discovery cohort and 365 patients (66 TRM) combining the three replication cohorts. Models for the joint replication cohorts are stratified by cohort. P values ≤0.05 are marked in bold.
TRM treatment-related mortality, 1,25(OH)2D3 1,25-dihydroxyvitamin-D3, HR hazard ratio, aGvHD acute Graft-versus-Host disease.
a1,25(OH)2D3 level d-2–7 ≤/> cutoff 139.5 pM.
bPatients with unrelated donors versus patients with sibling donors.
cClassification according to EBMT risk score [50] late stage versus early/intermediate stage.
dAny occurrence of aGvHD 3–4 [14] within 1 year after HSCT versus no occurrence of aGvHD 3–4.