Table 2.
Univariable and multivariable analyses of outcomes of interest based on patient characteristics in responding patients
| CIR | Cumulative incidence of composite end point (relapse or loss of BCA) | OS in responding patients | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Characteristic | Univariable | Multivariable | Univariable | Multivariable | Univariable | Multivariable | ||||||||||||
| HR | 95% CI | P | HR | 95% CI | P | HR | 95% CI | P | HR | 95% CI | P | HR | 95% CI | P | HR | 95% CI | P | |
| Sex | .13 | .40 | .10 | .69 | ||||||||||||||
| Female | Ref | Ref | Ref | Ref | ||||||||||||||
| Male | 0.64 | 0.36-1.13 | 0.81 | 0.50-1.31 | 0.51 | 0.23-1.13 | 0.83 | 0.35-2.01 | ||||||||||
| N of prior lines of therapy | 1.09 | 0.92-1.28 | .33 | 1.04 | 0.90-1.19 | .63 | 1.16 | 0.93-1.45 | .20 | |||||||||
| Time from diagnosis to infusion, mo | 0.99 | 0.99-1.00 | .20 | 1.00 | 0.99-1.00 | .22 | 0.99 | 0.98-1.00 | .31 | |||||||||
| Age at diagnosis, y | .005 | .075 | .052 | .21 | .011 | 0.14-0.80 | .010 | |||||||||||
| <1 or >10 | Ref | Ref | Ref | Ref | Ref | Ref | ||||||||||||
| 1-10 | 0.43 | 0.24-0.78 | 0.55 | 0.29-1.06 | 0.62 | 0.39-1.00 | 0.72 | 0.43-1.21 | 0.34 | 0.14-0.80 | 0.34 | |||||||
| Preinfusion disease burden | .006 | .001 | .014 | .005 | .013 | Ref | 1.20-7.00 | .013 | ||||||||||
| None or low | Ref | Ref | Ref | Ref | Ref | 2.90 | ||||||||||||
| High | 2.26 | 1.25-4.10 | 2.66 | 1.45-4.87 | 1.82 | 1.13-2.95 | 2.02 | 1.24-3.29 | 2.88 | 1.19-6.96 | ||||||||
| Initial cytogenetic risk | .43 | .54 | .41 | |||||||||||||||
| Favorable | Ref | Ref | Ref | |||||||||||||||
| Intermediate | 1.87 | 0.68-5.15 | 1.27 | 0.58-2.80 | 2.67 | 0.56-12.7 | ||||||||||||
| Unfavorable | 1.68 | 0.62-4.53 | 1.51 | 0.71-3.24 | 1.96 | 0.42-9.11 | ||||||||||||
| Prior HCT | .92 | .64 | .88 | |||||||||||||||
| No | Ref | Ref | Ref | |||||||||||||||
| Yes | 0.93 | 0.23-3.85 | 0.77 | 0.24-2.44 | 0.86 | 0.12-6.37 | ||||||||||||
| Prior CD19-directed therapy | .43 | .82 | .98 | |||||||||||||||
| No | Ref | Ref | Ref | |||||||||||||||
| Yes | 1.32 | 0.67-2.61 | 1.07 | 0.60-1.90 | 1.01 | 0.38-2.71 | ||||||||||||
| Prior relapse | .062 | .14 | .55 | .19 | ||||||||||||||
| ≥1 | Ref | Ref | Ref | Ref | ||||||||||||||
| Refractory | 0.42 | 0.15-1.17 | 0.49 | 0.18-1.38 | 1.22 | 0.64-2.33 | 0.42 | 0.10-1.80 | ||||||||||
| CNS or EM disease | .17 | .93 | .68 | |||||||||||||||
| No | Ref | Ref | Ref | |||||||||||||||
| Yes | 1.50 | 0.84-2.68 | 1.02 | 0.64-1.64 | 0.84 | 0.37-1.90 | ||||||||||||
| Race | .98 | .71 | .73 | |||||||||||||||
| Black/Hispanic | Ref | Ref | Ref | |||||||||||||||
| Other | 1.14 | 0.34-3.89 | 0.63 | 0.19-2.07 | 1.20 | 0.26-5.44 | ||||||||||||
| White | 1.02 | 0.55-1.88 | 0.75 | 0.33-1.73 | ||||||||||||||
| Cumulative fludarabine AUC, mg × h/L | .029 | .005 | .025 | .010 | .056 | .14 | ||||||||||||
| ≥13.8 | Ref | Ref | Ref | Ref | Ref | Ref | ||||||||||||
| <13.8 | 1.95 | 1.08-3.52 | 2.45 | 1.34-4.48 | 1.77 | 1.09-2.88 | 1.96 | 1.19-3.23 | 2.25 | 1.00-5.06 | 1.97 | 0.80-4.85 | ||||||
Bold font indicates significance.
CNS, central nervous system; HCT, hematopoetic cell transplantation; Ref, reference.