Table 5.
Summary of Multivariate Analysis of Study Endpoints in All Cohorts
| Endpoint | BM (Fresh = 456, Cryo = 154) | Related PBSC (Fresh = 3030, Cryo = 1051) | Unrelated PBSC (Fresh = 2028, Cryo = 678) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HR | CI | P | E-value | HR | CI | P | E-value | HR | CI | P | E-value | |
| Neutrophil recovery (day 28)* | 0.87 | 0.73–1.03 | .109 | 1.44 | 1.06 | 0.99–1.14 | .104 | 1.25 | 0.77 | 0.71–0.84 | <.001 | 1.69 |
| Platelet recovery (day 100)† | 0.81 | 0.66–0.98 | .028 | 1.58 | 0.73 | 0.68–0.78 | <.001 | 1.79 | 0.61 | 0.56–0.66 | <.001 | 2.16 |
| Treatment-related mortality‡ | 1.28 | 0.84–1.94 | .25 | 1.66 | 1.22 | 1.04–1.44 | .015 | 1.56 | 1.4 | 1.18–1.66 | <.001 | 1.84 |
| Relapse/Progression§ | 1.28 | 0.90–1.83 | .164 | 1.66 | 0.96 | 0.84–1.10 | .524 | 1.20 | 1.32 | 1.11–1.58 | .002 | 1.72 |
| Relapse/PFSǁ | 1.25 | 0.95–1.65 | .107 | 1.61 | 1.07 | 0.97–1.19 | .168 | 1.27 | 1.36 | 1.20–1.55 | <.001 | 1.78 |
| OSǀ | 1.34 | 1.00–1.80 | .052 | 1.75 | 1.12 | 1.00–1.25 | .045 | 1.38 | 1.38 | 1.22–1.58 | <.001 | 1.81 |
| aGVHD (day 100) | ||||||||||||
| Grade II-IV# | 1.09 | 0.73–1.65 | .668 | 1.32 | 1.27 | 1.09–1.48 | .002 | 1.64 | 0.96 | 0.81–1.15 | .683 | 1.2 |
| Grade III-IV** | 1.44 | 0.80–2.57 | .222 | 1.89 | 1.48 | 1.19–1.84 | <.001 | 1.95 | 1.12 | 0.87–1.44 | .381 | 1.38 |
Additional covariates adjusted for in multivariate analysis for neutrophil engraftment: BM: recipient age, donor age, donor type/matching, and GVHD prophylaxis; related PBSC: ATC/Campath use. conditioning regimen intensity, disease, donor-recipient CMV status, GVHD prophylaxis, KPS, use of TBI.
Additional covariates adjusted for in multivariate analysis for platelet engraftment: BM: donor type/matching, KPS; related PBSC: recipient age, disease, GVHD prophylaxis, HCT-CI, KPS, use of TBI; unrelated PBSC: recipient age, disease, donor-recipient CMV status, DRI, GVHD prophylaxis, HCT-CI, interval from diagnosis to HCT. KPS, year of HCT.
Additional covariates adjusted for in multivariate analysis for treatment-related mortality: BM: recipient age, donor type/matching, ethnicity; related PBSC: recipient age, disease, donor-recipient CMV status, DRI.ethnicity, GVHD prophylaxis, HCT-CI; unrelated PBSC: recipient age, conditioning regimen intensity, donor age, donor type/matching, donor-recipient CMV status, GVHD prophylaxis, HCT-CI, interval from diagnosis to HCT, KPS.
Additional covariates adjusted for in multivariate analysis for relapse/progression: BM: DRI, TBI use; related PBSC: disease, donor-recipient CMV status, DRI, HCT-CI, interval from diagnosis to HCT, year of HCT; unrelated PBSC: disease, ORI.interval from diagnosis o HCT, year of HCT.
Additional covariates adjusted for in multivariate analysis for relapse/PFS: BM: recipient age, DRI, ethnicity; related PBSC: recipient age, disease, DRI, donor-recipient sex matching, ethnicity, HCT-CI, interval from diagnosis to HCT, KPS, year of HCT; unrelated PBSC: recipient age, conditioning regimen intensity, donor age, disease, donor type/matching, donor-recipient CMV status, DRI, GVHD prophylaxis, HCT-CI, interval from diagnosis to HCT, KPS.
Additional covariates adjusted for in multivariate analysis for OS: BM: recipient age, DRI, ethnicity; related PBSC: recipient age, DRI, ethnicity, GVHD prophylaxis. HCT-CI, interval from diagnosis to HCT, KPS; unrelated PBSC: recipient age, conditioning regimen intensity, donor age, donor type/matching, donor-recipient CMV status, DRI, GVHD prophylaxis, HCT-CI, interval from diagnosis to HCT, KPS.
Additional covariates adjusted for in multivariate analysis for aGVHD grade II-IV: BM: donor type/matching, disease. GVHD prophylaxis, ATG/Campath use; related PBSC: race, disease, GVHD prophylaxis, conditioning regimen intensity. ATG/Campath use; unrelated PBSC: disease, conditioning regimen intensity, donor age, ATG/Campath use.
Additional covariates adjusted for in multivariate analysis for aGVHD grade III-IV: BM: donor type/matching; related PBSC: disease, GVHD prophylaxis; unrelated PBSC: sex, conditioning regimen intensity, donor type/matching, donor age, donor-recipient CMV status, ATG/Campath use.