Table 2

Prognostic significance of baseline molecular and clinical factors for therapeutic outcome prediction for CP-CML patients with T315I by univariate regression analysis

Clinical and molecular factorsMCyRCCyRMMRFFSPFS
MCyR by 12 mo (%)*No. of eventsHR (95% CI)PCCyR by 18 mo (%)*No. of eventsHR (95% CI)PMMR by 18 mo (%)*No. of eventsHR (95% CI)PFFS at 18 mo (%)*No. of eventsHR (95% CI)PPFS at 18 mo (%)*No. of eventsHR (95% CI)P
Age at study entry, y    .18    .07    .12    .13    .21 
 <54 (median), n = 31 77 24  77 24  65 20  84  90  
 ≥54 (median), n = 32 63 20 0.69 (0.40-1.19)  53 17 0.58 (0.32-1.04)  44 15 0.6 (0.31-1.15)  69 13 2.02 (0.80-5.12)  72 10 2 (0.68-5.86)  
No. of prior TKI therapies    .16    .25    .2    .07    .37 
 1, n = 11 91 10  82  73  100  100  
 2, n = 29 76 22 0.86 (0.51-1.46)  72 21 0.95 (0.51-1.75)  48% 14 0.54 (0.26-1.09)  79 3.46 (0.43-27.72)  79 3.11 (0.38-25.30)  
 3, n = 23 52 12 0.51 (0.25-1.02)  48 11 0.54 (0.25-1.18)  52 12 0.62 (0.29-1.34)  61 11 6.8 (0.88-52.82)  72 4.11 (0.50-33.41)  
Years since diagnosis    .55    .54    .18    .32    .42 
 <5 (median), n = 31 77 24  70 22  65 21  84  87  
 ≥5 (median), n = 32 63 20 0.85 (0.49-1.47)  59 19 0.84 (0.47-1.48)  44 14 0.63 (0.32-1.24)  69 12 1.58 (0.64-3.86)  75 1.52 (0.54-4.28)  
Average daily ponatinib dose    .52    .8    .3    .59    .89 
 ≤15 mg/day, n = 3 33  33  33  67  67  
 15-30 mg/day, n = 20 75 16 2.77 (0.26-29.9)  70 14 2.21 (0.21-23.8)  45 1.32 (0.15-11.6)  75 0.429 (0.083-2.22)  80 0.63 (0.070-5.61)  
 >30 mg/day, n = 40 68 27 2.16 (0.20-23.1)  65 26 2.05 (0.19-21.7)  60 25 2.23 (0.27-18.4)  77 13 0.551 (0.12-2.45)  82 10 0.79 (0.10-6.17)  
Mutation status by MS    .03    .01    .08    .02    .09 
 T315I alone, n = 43 79 34  74 32  63 28  86 10  88  
 T315I plus additional mutation(s), n = 20 50 10 0.48 (0.25-0.94)  45 0.42 (0.21-0.82)  35 0.46 (0.20-1.09)  55 10 2.72 (1.13-6.55)  63 2.35 (0.85-6.50)  
Clinical and molecular factorsMCyRCCyRMMRFFSPFS
MCyR by 12 mo (%)*No. of eventsHR (95% CI)PCCyR by 18 mo (%)*No. of eventsHR (95% CI)PMMR by 18 mo (%)*No. of eventsHR (95% CI)PFFS at 18 mo (%)*No. of eventsHR (95% CI)PPFS at 18 mo (%)*No. of eventsHR (95% CI)P
Age at study entry, y    .18    .07    .12    .13    .21 
 <54 (median), n = 31 77 24  77 24  65 20  84  90  
 ≥54 (median), n = 32 63 20 0.69 (0.40-1.19)  53 17 0.58 (0.32-1.04)  44 15 0.6 (0.31-1.15)  69 13 2.02 (0.80-5.12)  72 10 2 (0.68-5.86)  
No. of prior TKI therapies    .16    .25    .2    .07    .37 
 1, n = 11 91 10  82  73  100  100  
 2, n = 29 76 22 0.86 (0.51-1.46)  72 21 0.95 (0.51-1.75)  48% 14 0.54 (0.26-1.09)  79 3.46 (0.43-27.72)  79 3.11 (0.38-25.30)  
 3, n = 23 52 12 0.51 (0.25-1.02)  48 11 0.54 (0.25-1.18)  52 12 0.62 (0.29-1.34)  61 11 6.8 (0.88-52.82)  72 4.11 (0.50-33.41)  
Years since diagnosis    .55    .54    .18    .32    .42 
 <5 (median), n = 31 77 24  70 22  65 21  84  87  
 ≥5 (median), n = 32 63 20 0.85 (0.49-1.47)  59 19 0.84 (0.47-1.48)  44 14 0.63 (0.32-1.24)  69 12 1.58 (0.64-3.86)  75 1.52 (0.54-4.28)  
Average daily ponatinib dose    .52    .8    .3    .59    .89 
 ≤15 mg/day, n = 3 33  33  33  67  67  
 15-30 mg/day, n = 20 75 16 2.77 (0.26-29.9)  70 14 2.21 (0.21-23.8)  45 1.32 (0.15-11.6)  75 0.429 (0.083-2.22)  80 0.63 (0.070-5.61)  
 >30 mg/day, n = 40 68 27 2.16 (0.20-23.1)  65 26 2.05 (0.19-21.7)  60 25 2.23 (0.27-18.4)  77 13 0.551 (0.12-2.45)  82 10 0.79 (0.10-6.17)  
Mutation status by MS    .03    .01    .08    .02    .09 
 T315I alone, n = 43 79 34  74 32  63 28  86 10  88  
 T315I plus additional mutation(s), n = 20 50 10 0.48 (0.25-0.94)  45 0.42 (0.21-0.82)  35 0.46 (0.20-1.09)  55 10 2.72 (1.13-6.55)  63 2.35 (0.85-6.50)  
*

Point estimates of response by 12 (MCyR) or 18 (CCyR, MMR, FFS, PFS) mo.

The 95% confidence interval (95% CI) is shown for the hazard ratio (HR).

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