Table 5.

Hazard ratio and relapse incidence at 3 PML-RARα NQ levels in follow-up period (FUP) samples from 70 INT0129 cases after completion of consolidation chemotherapy

NQ cutoffRelapses/patientsHR5-150,5-151P5-151
Greater than 10−5 10/13 17.5 < .001 
Less than 10−5 13/57   
Greater than 10−6 15/25 7.6 < .001 
Less than 10−6 8/45   
Greater than 10−11 19/46 5.8 .002 
Negative 4/24   
NQ cutoffRelapses/patientsHR5-150,5-151P5-151
Greater than 10−5 10/13 17.5 < .001 
Less than 10−5 13/57   
Greater than 10−6 15/25 7.6 < .001 
Less than 10−6 8/45   
Greater than 10−11 19/46 5.8 .002 
Negative 4/24   

Data are based on the analysis of at least one evaluable FUP sample with the patient entering the poor-risk category, as defined in Table 4, at the time point that the NQ rises above the indicated cutoff level. Abbreviations are explained in Table 4.

F5-150

The hazard ratio indicates the relative risk of relapse in poor-risk versus good-risk cases calculated at 3 selected cutoff levels.

F5-151

Adjusted for the maintenance treatment, PML-RARα type, and pretreatment WBC count.

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