Comparative effect of remission induction therapy without (control) and with additional clofarabine on overall survival and event-free survival in relationship to patient age, white blood cell count at diagnosis, WHO performance status, secondary AML/therapy-related AML, and ELN prognostic category
| . | . | Overall survival at 4 years . | Event-free survival at 4 years . | |||||
|---|---|---|---|---|---|---|---|---|
| . | . | Treatment group . | . | Treatment group . | . | |||
| . | N . | Control (%) . | Clofarabine (%) . | P . | Control (%) . | Clofarabine (%) . | P . | |
| Total | 795 | 43% | 44% | .57 | 35% | 38% | .24 | |
| Age, y | ||||||||
| ≤45 | 220 | 60% | 61% | .59 | 47% | 54% | .22 | |
| 46-60 | 361 | 45% | 46% | 1.0 | 37% | 38% | .84 | |
| 61-65 | 214 | 20% | 26% | .47 | 17% | 24% | .38 | |
| WHO performance status | ||||||||
| WHO 0 | 384 | 40% | 52% | .04 | 36% | 44% | .04 | |
| WHO >0 | 411 | 45% | 38% | .30 | 33% | 33% | .80 | |
| Type of AML | ||||||||
| De novo | 687 | 44% | 46% | .43 | 35% | 41% | .10 | |
| sAML | 68 | 28% | 18% | .48 | 25% | 8% | .36 | |
| tAML | 40 | 42% | 47% | .99 | 39% | 37% | .66 | |
| ELN 2010 risk | ||||||||
| Favorable | 189 | 70% | 66% | .37 | 55% | 64% | .74 | |
| Intermediate I | 244 | 29% | 50% | <.001 | 26% | 40% | .002 | |
| Intermediate II | 187 | 54% | 44% | .40 | 41% | 37% | .75 | |
| Adverse | 175 | 15% | 16% | .49 | 16% | 13% | .91 | |
| Composite FLT3-ITD/NPM1 genotype | ||||||||
| NPM1wt/FLT3-ITD neg | 135 | 22% | 49% | <.001 | 18% | 40% | <.001 | |
| . | . | Overall survival at 4 years . | Event-free survival at 4 years . | |||||
|---|---|---|---|---|---|---|---|---|
| . | . | Treatment group . | . | Treatment group . | . | |||
| . | N . | Control (%) . | Clofarabine (%) . | P . | Control (%) . | Clofarabine (%) . | P . | |
| Total | 795 | 43% | 44% | .57 | 35% | 38% | .24 | |
| Age, y | ||||||||
| ≤45 | 220 | 60% | 61% | .59 | 47% | 54% | .22 | |
| 46-60 | 361 | 45% | 46% | 1.0 | 37% | 38% | .84 | |
| 61-65 | 214 | 20% | 26% | .47 | 17% | 24% | .38 | |
| WHO performance status | ||||||||
| WHO 0 | 384 | 40% | 52% | .04 | 36% | 44% | .04 | |
| WHO >0 | 411 | 45% | 38% | .30 | 33% | 33% | .80 | |
| Type of AML | ||||||||
| De novo | 687 | 44% | 46% | .43 | 35% | 41% | .10 | |
| sAML | 68 | 28% | 18% | .48 | 25% | 8% | .36 | |
| tAML | 40 | 42% | 47% | .99 | 39% | 37% | .66 | |
| ELN 2010 risk | ||||||||
| Favorable | 189 | 70% | 66% | .37 | 55% | 64% | .74 | |
| Intermediate I | 244 | 29% | 50% | <.001 | 26% | 40% | .002 | |
| Intermediate II | 187 | 54% | 44% | .40 | 41% | 37% | .75 | |
| Adverse | 175 | 15% | 16% | .49 | 16% | 13% | .91 | |
| Composite FLT3-ITD/NPM1 genotype | ||||||||
| NPM1wt/FLT3-ITD neg | 135 | 22% | 49% | <.001 | 18% | 40% | <.001 | |
Actuarial estimates and log-rank test P values for difference between both treatment groups within subgroups are given. ELN risk 2010 according to Döhner et al12 was slightly modified for bi-allelic CEBPA gene mutations, as detailed in the supplemental Appendix. NPM1 wild-type refers to nonmutated nuclephosmin-1 gene; FLT3-ITD negative refers to fms-like tyrosine kinase-3 with no internal tandem duplications. The composite NPM1wt/FLT3-ITD neg is of intermediate prognostic risk. ELN 2010 prognostic risk categories are described by Döhner et al.12 Bold values indicate significant statistical differences.
N, number of patients.