Table 2: Multivariate Model.
Association of risk of death or non-relapsed mortality when controlling for change in busulfan dose based on 1st dose pharmacokinetics, and toxicities that were significant based on a univariate analysis. Separate multivariate models were fit to each toxicity.
| Risk of death* | Risk of NRM* | |||||
|---|---|---|---|---|---|---|
| HR (95% CI ) | P-value | HR (95% CI ) | P-value | |||
| Cardiovascular | 1.47 (0.81 to 2.67) | 0.201 | 2.66 (1.23 to 5.77) | 0.013 | ||
| Age | 1.03 (0.99 to 1.07) | 0.093 | 1.01 (0.96 to 1.05) | 0.73 | ||
| Busulfan Change | No change | (reference) | (reference) | |||
| Decrease | 2.59 (1.25 to 5.36) | 0.01 | 2.99 (1.27 to 7.06) | 0.012 | ||
| Increase | 0.89 (0.45 to 1.75) | 0.736 | 0.5 (0.19 to 1.33) | 0.164 | ||
| HCT-CI | 0 | (reference) | (reference) | |||
| 1–2 | 1.53 (0.53 to 4.39) | 0.43 | 1.01 (0.24 to 4.2) | 0.988 | ||
| >=3 | 2.34 (0.88 to 6.2) | 0.087 | 1.83 (0.52 to 6.48) | 0.348 | ||
| Hepatic | 4.97 (1.52 to 16.21) | 0.008 | ||||
| Age | 1.04 (1 to 1.08) | 0.036 | ||||
| Busulfan Change | No change | (reference) | ||||
| Decrease | 2.71 (1.31 to 5.6) | 0.007 | ||||
| Increase | 1.02 (0.52 to 2.01) | 0.952 | ||||
| HCT-CI | 0 | (reference) | ||||
| 1–2 | 1.61 (0.56 to 4.64) | 0.378 | ||||
| >=3 | 2.57 (0.98 to 6.73) | 0.054 | ||||
| Hematologic | 2.96 (1.63 to 5.35) | <0.001 | 7.58 (3.14 to 18.27) | <0.001 | ||
| Age | 1.05 (1.01 to 1.08) | 0.014 | 1.03 (0.99 to 1.08) | 0.146 | ||
| Busulfan Change | No change | (reference) | (reference) | |||
| Decrease | 2.36 (1.14 to 4.88) | 0.021 | 2.5 (1.06 to 5.91) | 0.037 | ||
| Increase | 0.94 (0.48 to 1.86) | 0.867 | 0.55 (0.2 to 1.46) | 0.229 | ||
| HCT-CI | 0 | (reference) | (reference) | |||
| 1–2 | 1.91 (0.66 to 5.48) | 0.231 | 1.61 (0.39 to 6.68) | 0.514 | ||
| >=3 | 2.87 (1.09 to 7.57) | 0.033 | 2.67 (0.76 to 9.39) | 0.126 | ||
| Neurologic | 2.38 (1.22 to 4.64) | 0.011 | 5.75 (2.52 to 13.13) | <0.001 | ||
| Age | 1.03 (0.99 to 1.06) | 0.141 | 0.99 (0.95 to 1.04) | 0.795 | ||
| Busulfan Change | No change | (reference) | (reference) | |||
| Decrease | 2.25 (1.07 to 4.72) | 0.032 | 2.1 (0.86 to 5.12) | 0.103 | ||
| Increase | 0.86 (0.44 to 1.69) | 0.66 | 0.45 (0.16 to 1.22) | 0.114 | ||
| HCT-CI | 0 | (reference) | (reference) | |||
| 1–2 | 1.46 (0.51 to 4.2) | 0.486 | 1.04 (0.25 to 4.33) | 0.96 | ||
| >=3 | 2.29 (0.87 to 6.04) | 0.093 | 1.94 (0.55 to 6.79) | 0.301 | ||
| Pulmonary | 2.99 (1.65 to 5.41) | <0.001 | 6.4 (2.96 to 13.82) | <0.001 | ||
| Age | 1.03 (0.99 to 1.07) | 0.117 | 1.01 (0.96 to 1.05) | 0.729 | ||
| Busulfan Change | No change | (reference) | (reference) | |||
| Decrease | 2.2 (1.06 to 4.57) | 0.034 | 2.18 (0.92 to 5.17) | 0.076 | ||
| Increase | 0.88 (0.45 to 1.74) | 0.717 | 0.52 (0.19 to 1.38) | 0.189 | ||
| HCT-CI | 0 | (reference) | (reference) | |||
| 1–2 | 1.56 (0.54 to 4.45) | 0.409 | 1.07 (0.26 to 4.39) | 0.93 | ||
| >=3 | 2.51 (0.95 to 6.6) | 0.062 | 2.05 (0.59 to 7.17) | 0.26 | ||
| Renal | 2.49 (1.14 to 5.48) | 0.023 | 3.73 (1.48 to 9.4) | 0.005 | ||
| Age | 1.03 (1 to 1.07) | 0.08 | 1.01 (0.97 to 1.06) | 0.641 | ||
| Busulfan Change | No change | (reference) | (reference) | |||
| Decrease | 2.18 (1.04 to 4.58) | 0.039 | 2.19 (0.91 to 5.29) | 0.082 | ||
| Increase | 1.03 (0.52 to 2.06) | 0.924 | 0.65 (0.24 to 1.77) | 0.398 | ||
| HCT-CI | 0 | (reference) | (reference) | |||
| 1–2 | 1.64 (0.57 to 4.69) | 0.355 | 1.26 (0.31 to 5.19) | 0.748 | ||
| >=3 | 2.2 (0.82 to 5.85) | 0.116 | 1.8 (0.5 to 6.43) | 0.366 | ||
*
within the first year. HCT-CI, HCT-CI, hematopoietic cell transplantation-comorbidity index