Table 2A.
Analysis of Risk Factors: BMT CTN 0501 (TCF regimen) compared to Non-trial TCF regimen and Non-trial regimens
| Outcome | Hazard Ratio (95% confidence interval) | P-value |
|---|---|---|
| Overall Mortality | ||
| TCF regimen | 1.00 | |
| Non-trial TCF regimen | 1.27 (0.74 – 2.18) | 0.37 |
| Non-trial TBI regimen | 1.97 (1.30 – 2.99) | 0.001 |
| Non-trial chemotherapy only regimen | 1.88 (1.18 – 2.98) | 0.007 |
| Other factors associated with mortality | ||
| Age | ||
| 1 – 5 years | 1.00 | |
| 6 – 21 years | 1.29 (0.96 – 1.72) | 0.08 |
| Cytomegalovirus serostatus | ||
| Serostatus negative | 1.00 | |
| Serostatus positive | 1.44 (1.08 – 1.90) | 0.011 |
| Disease | ||
| Acute lymphoblastic leukemia | 1.00 | |
| Acute myeloid leukemia | 1.65 (1.19 – 2.28) | 0.002 |
| Disease status | ||
| 1st complete remission | 1.00 | |
| 2nd complete remission/relapse | 1.79 (1.34 – 2.40) | <0.001 |
| Relapse | ||
| TCF regimen | 1.00 | |
| Non-trial TCF regimen | 1.15 (0.59 – 2.25) | 0.66 |
| Non-trial TBI regimen | 1.17 (0.71 – 1.96) | 0.52 |
| Non-trial chemotherapy only regimen | 1.88 (1.08 – 3.27) | 0.025 |
| Other factors associated with relapse | ||
| Age | ||
| 1 – 5 years | 1.00 | |
| 6 – 21 years | 0.65 (0.45 – 0.93) | 0.020 |
| Disease status | ||
| 1st complete remission | 1.00 | |
| 2nd complete remission/relapse | 2.69 (1.80 – 4.01) | <0.001 |
| Non-relapse Mortality | ||
| TCF regimen | 1.00 | |
| Non-trial TCF regimen | 1.09 (0.52 – 2.28) | 0.81 |
| Non-trial TBI regimens | 1.69 (0.99 – 2.90) | 0.053 |
| Non-trial chemotherapy only regimens | 1.75 (0.91 – 3.33) | 0.09 |
| Other factors associated with non-relapse mortality | ||
| Age | ||
| 1 – 5 years | 1.00 | |
| 6 – 21 years | 2.10 (1.32 – 3.35) | 0.002 |
| Cytomegalovirus serostatus | ||
| Serostatus negative | 1.00 | |
| Serostatus positive | 1.66 (1.09 – 2.52) | 0.016 |
| Treatment failure (inverse of LFS) | ||
| TCF regimen | 1.00 | |
| Non-trial TCF regimen | 1.12 (0.68 – 1.85) | 0.63 |
| Non-trial TBI regimens | 1.41 (0.97 – 2.04) | 0.07 |
| Non-trial chemotherapy only regimens | 1.86 (1.22 – 2.83) | 0.003 |
| Other factors associated with treatment failure | ||
| Cytomegalovirus serostatus | ||
| Serostatus negative | 1.00 | |
| Serostatus positive | 1.45 (1.11 – 3.39) | 0.019 |
| Disease status | ||
| 1st complete remission | 1.00 | |
| 2nd complete remission/relapse | 1.76 (1.34 – 2.32) | <0.001 |
Abbreviation:
TCF = total body irradiation (1320 cGy), cyclophosphamide (120 mg/kg), fludarabine (75 mg/m2)
TBI = total body irradiation
LFS = leukemia-free failure