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 factors | MCyR | CCyR | MMR | FFS | PFS | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MCyR by 12 mo (%)* | No. of events | HR† (95% CI) | P | CCyR by 18 mo (%)* | No. of events | HR† (95% CI) | P | MMR by 18 mo (%)* | No. of events | HR† (95% CI) | P | FFS at 18 mo (%)* | No. of events | HR† (95% CI) | P | PFS at 18 mo (%)* | No. of events | HR† (95% CI) | P | |
| Age at study entry, y | .18 | .07 | .12 | .13 | .21 | |||||||||||||||
| <54 (median), n = 31 | 77 | 24 | 1 | 77 | 24 | 1 | 65 | 20 | 1 | 84 | 7 | 1 | 90 | 5 | 1 | |||||
| ≥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 | 1 | 82 | 9 | 1 | 73 | 9 | 1 | 100 | 1 | 1 | 100 | 1 | 1 | |||||
| 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 | 8 | 3.46 (0.43-27.72) | 79 | 7 | 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 | 7 | 4.11 (0.50-33.41) | |||||
| Years since diagnosis | .55 | .54 | .18 | .32 | .42 | |||||||||||||||
| <5 (median), n = 31 | 77 | 24 | 1 | 70 | 22 | 1 | 65 | 21 | 1 | 84 | 8 | 1 | 87 | 6 | 1 | |||||
| ≥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 | 9 | 1.52 (0.54-4.28) | |||||
| Average daily ponatinib dose | .52 | .8 | .3 | .59 | .89 | |||||||||||||||
| ≤15 mg/day, n = 3 | 33 | 1 | 1 | 33 | 1 | 1 | 33 | 1 | 1 | 67 | 2 | 1 | 67 | 1 | 1 | |||||
| 15-30 mg/day, n = 20 | 75 | 16 | 2.77 (0.26-29.9) | 70 | 14 | 2.21 (0.21-23.8) | 45 | 9 | 1.32 (0.15-11.6) | 75 | 5 | 0.429 (0.083-2.22) | 80 | 4 | 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 | 1 | 74 | 32 | 1 | 63 | 28 | 1 | 86 | 10 | 1 | 88 | 7 | 1 | |||||
| T315I plus additional mutation(s), n = 20 | 50 | 10 | 0.48 (0.25-0.94) | 45 | 9 | 0.42 (0.21-0.82) | 35 | 7 | 0.46 (0.20-1.09) | 55 | 10 | 2.72 (1.13-6.55) | 63 | 8 | 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).