Table 5.

Multivariate Cox proportional hazards analysis of leukemia-free survival for all participating patients (n = 320) and patients in CR1 (n = 261)


Variable

Hazard ratio

95% CI

P*
All patients    
Treatment (HDC/IL-2 vs control)  0.69   (0.52-0.90)   < .01  
Age, y (≤ 60 vs > 60)   0.66   (0.50-0.88)   < .01  
Sex (men vs women)   1.31   (0.99-1.73)   .06  
FAB class     
M0/M1/M5/M6 (no vs yes)   1.23   (0.73-2.07)   .44  
M2/M3/M4 (no vs yes)   1.67   (0.99-2.80)   .05  
Karyotype (MRC)     
Favorable (no vs yes)   0.88   (0.50-1.57)   .67  
Intermediate (no vs yes)   1.03   (0.74-1.45)   .84  
Adverse (no vs yes)   0.50   (0.27-0.93)   .03  
Patients in CR1    
Treatment (HDC/IL-2 vs control)  0.67   (0.50-0.91)   .01  
Age, y (≤ 60 vs > 60)   0.75   (0.52-1.07)   .12  
FAB class     
M0/M1/M5/M6 (no vs yes)   1.04   (0.57-1.89)   .90  
M2/M3/M4 (no vs yes)   1.66   (0.91-3.04)   .10  
Karyotype (MRC)     
Favorable (no vs yes)   0.75   (0.40-1.40)   .37  
Intermediate (no vs yes)   0.96   (0.65-1.42)   .86  
Adverse (no vs yes)   0.52   (0.27-0.99)   < .05  
History of antecedent hematologic disorder (no vs yes)   0.76   (0.49-1.16)   .20  
High-dose cytarabine therapy (no vs yes)   1.43   (0.97-2.12)   .08  
Months from current CR to random assignment (≤ 6 vs > 6)
 
1.48
 
(1.01-2.16)
 
< .05
 

Variable

Hazard ratio

95% CI

P*
All patients    
Treatment (HDC/IL-2 vs control)  0.69   (0.52-0.90)   < .01  
Age, y (≤ 60 vs > 60)   0.66   (0.50-0.88)   < .01  
Sex (men vs women)   1.31   (0.99-1.73)   .06  
FAB class     
M0/M1/M5/M6 (no vs yes)   1.23   (0.73-2.07)   .44  
M2/M3/M4 (no vs yes)   1.67   (0.99-2.80)   .05  
Karyotype (MRC)     
Favorable (no vs yes)   0.88   (0.50-1.57)   .67  
Intermediate (no vs yes)   1.03   (0.74-1.45)   .84  
Adverse (no vs yes)   0.50   (0.27-0.93)   .03  
Patients in CR1    
Treatment (HDC/IL-2 vs control)  0.67   (0.50-0.91)   .01  
Age, y (≤ 60 vs > 60)   0.75   (0.52-1.07)   .12  
FAB class     
M0/M1/M5/M6 (no vs yes)   1.04   (0.57-1.89)   .90  
M2/M3/M4 (no vs yes)   1.66   (0.91-3.04)   .10  
Karyotype (MRC)     
Favorable (no vs yes)   0.75   (0.40-1.40)   .37  
Intermediate (no vs yes)   0.96   (0.65-1.42)   .86  
Adverse (no vs yes)   0.52   (0.27-0.99)   < .05  
History of antecedent hematologic disorder (no vs yes)   0.76   (0.49-1.16)   .20  
High-dose cytarabine therapy (no vs yes)   1.43   (0.97-2.12)   .08  
Months from current CR to random assignment (≤ 6 vs > 6)
 
1.48
 
(1.01-2.16)
 
< .05
 
*

Included in this model are variables selected from a backward selection process. P values were calculated using the Wald test and stratified by country and, if applicable, CR stratum.

Of the dichotomized groups, the second group is always the baseline.

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