Table 2.
Cox proportional hazard model for predictive impact of genomic AML classes on hazard of death or event after treatment with midostaurin in the cohort of 451 of 475 patients, in which subcategorization into genomic AML classes was possible.
| Overall survival | Event-free survival | |||
|---|---|---|---|---|
| Variable | HR [CI. 95] | p value | HR [CI. 95] | p value |
| Age | 1.01 [0.99; 1.02] | 0.357 | 1.00 [0.99; 1.01] | 0.841 |
| Sex | ||||
| Male | Reference | |||
| Female | 1.01 [0.77; 1.33] | 0.940 | 1.34 [1.06; 1.69] | 0.013 |
| FLT3 mutation type | ||||
| TKD | Reference | |||
| ITD < 0.5 allelic ratio | 1.15 [0.75; 1.76] | 0.533 | 1.36 [0.96; 1.93] | 0.085 |
| ITD ≥ 0.5 allelic ratio | 1.58 [1.09; 2.28] | 0.016 | 1.52 [1.12; 2.05] | 0.007 |
| ECOG (0–1 vs. 2) | 1.27 [0.84; 1.91] | 0.261 | 0.90 [0.62; 1.31] | 0.595 |
| log2WBC | 1.08 [1.00; 1.17] | 0.046 | 1.08 [1.01; 1.16] | 0.018 |
| Allogeneic HCT in CR1 | 0.59 [0.41; 0.84] | 0.004 | 0.71 [0.48; 1.04] | 0.077 |
| NPM1 | ||||
| Midostaurin vs. Placebo | 0.65 [0.45; 0.93] | 0.018 | 0.76 [0.57; 1.03] | 0.077 |
| CBF | ||||
| Midostaurin vs. Placebo | 1.37 [0.23; 8.23] | 0.729 | 0.88 [0.24; 3.29] | 0.853 |
| TP53-aneuploidy | ||||
| Midostaurin vs. Placebo | 1.11 [0.32; 3.86] | 0.866 | 0.39 [0.15; 1.02] | 0.055 |
| Chromatin-Spliceosome | ||||
| Midostaurin vs. Placebo | 0.52 [0.29; 0.92] | 0.026 | 0.48 [0.28; 0.82] | 0.007 |
| No Class | ||||
| Midostaurin vs. Placebo | 0.55 [0.28; 1.07] | 0.079 | 0.64 [0.36; 1.13] | 0.123 |
| Placebo | ||||
| CBF vs. NPM1 | 0.46 [0.11; 1.92] | 0.289 | 0.77 [0.31; 1.91] | 0.569 |
| TP53-aneuploidy vs. NPM1 | 1.42 [0.51; 3.93] | 0.499 | 5.40 [2.58; 11.29] | <0.001 |
| Chromatin-Spliceosome vs. NPM1 | 2.52 [1.58; 4.03] | <0.001 | 2.38 [1.55; 3.66] | <0.001 |
| No Class vs. NPM1 | 2.31 [1.31; 4.05] | 0.004 | 2.71 [1.66; 4.44] | <0.001 |
| Midostaurin | ||||
| CBF vs. NPM1 | 0.99 [0.31; 3.20] | 0.985 | 0.89 [0.32; 2.44] | 0.816 |
| TP53-aneuploidy vs. NPM1 | 2.45 [1.11; 5.42] | 0.027 | 2.74 [1.37; 5.47] | 0.004 |
| Chromatin-Spliceosome vs. NPM1 | 2.02 [1.22; 3.34] | 0.006 | 1.49 [0.96; 2.32] | 0.073 |
| No Class vs. NPM1 | 1.96 [1.14; 3.36] | 0.014 | 2.28 [1.48; 3.51] | <0.001 |
A hazard ratio of >1 indicates a higher and a hazard ratio of <1 a lower risk of death or event, respectively.
CBF Core-binding factor AML, CI. 95 95% confidence interval, CR1 first complete remission, ECOG Eastern Cooperative Oncology Group, HR hazard ratio, HCT hematopoietic cell transplantation, WBC white blood cell count.