Outcome of consolidation trial according to cytogenetic and molecular characteristics
| Patient population . | HDAraC (P1 arm) . | TSC (P2 arm) . | P . | ||||
|---|---|---|---|---|---|---|---|
| Median EFS, mo . | Patients . | 5-y EFS, % . | Median EFS, mo . | Patients . | 5-y EFS, % . | ||
| All patients | 23.3 | 117 | 41 | 13.7 | 120 | 35 | .24 |
| Risk groups | |||||||
| Favorable-risk group | NR | 32 | 67 | NR | 39 | 50 | .10 |
| Favorable cytogenetics | NR | 12 | 67 | NR | 19 | 53 | .45 |
| Favorable intermediate-risk* | NR | 20 | 67 | 14.0 | 20 | 49 | .12 |
| Poor-risk group | 15.1 | 79 | 31 | 11.0 | 67 | 21 | .13 |
| Poor intermediate-risk† | 25.9 | 51 | 42 | 11.9 | 52 | 23 | .06 |
| Unfavorable cytogenetics | 12.2 | 28 | 12 | 7.5 | 15 | 13 | .53 |
| Cytogenetic groups | |||||||
| Favorable cytogenetics | NR | 12 | 67 | NR | 19 | 53 | .45 |
| Intermediate cytogenetics | 32.8 | 71 | 49 | 14.8 | 72 | 29 | .02 |
| Unfavorable cytogenetics | 12.2 | 28 | 12 | 7.5 | 15 | 13 | .53 |
| CN-AML | 29.6 | 59 | 48 | 13.7 | 55 | 31 | .04 |
| MLL AML | 12.2 | 12 | 25 | 5.9 | 7 | — | .03 |
| Patient population . | HDAraC (P1 arm) . | TSC (P2 arm) . | P . | ||||
|---|---|---|---|---|---|---|---|
| Median EFS, mo . | Patients . | 5-y EFS, % . | Median EFS, mo . | Patients . | 5-y EFS, % . | ||
| All patients | 23.3 | 117 | 41 | 13.7 | 120 | 35 | .24 |
| Risk groups | |||||||
| Favorable-risk group | NR | 32 | 67 | NR | 39 | 50 | .10 |
| Favorable cytogenetics | NR | 12 | 67 | NR | 19 | 53 | .45 |
| Favorable intermediate-risk* | NR | 20 | 67 | 14.0 | 20 | 49 | .12 |
| Poor-risk group | 15.1 | 79 | 31 | 11.0 | 67 | 21 | .13 |
| Poor intermediate-risk† | 25.9 | 51 | 42 | 11.9 | 52 | 23 | .06 |
| Unfavorable cytogenetics | 12.2 | 28 | 12 | 7.5 | 15 | 13 | .53 |
| Cytogenetic groups | |||||||
| Favorable cytogenetics | NR | 12 | 67 | NR | 19 | 53 | .45 |
| Intermediate cytogenetics | 32.8 | 71 | 49 | 14.8 | 72 | 29 | .02 |
| Unfavorable cytogenetics | 12.2 | 28 | 12 | 7.5 | 15 | 13 | .53 |
| CN-AML | 29.6 | 59 | 48 | 13.7 | 55 | 31 | .04 |
| MLL AML | 12.2 | 12 | 25 | 5.9 | 7 | — | .03 |
For risk groups: Test for heterogeneity between subgroups by arm: P = .09 (not significant); and Mantel-Haenszel test for consolidation randomization: P < .0001. For cytogenetic groups: Test for heterogeneity between subgroups by arm: P = .06 (not significant); and Mantel-Haenszel test for consolidation randomization: P = .0002.
NR indicates not reached; MLL, mixed-lineage leukemia gene; and —, not applicable.
Included CN-AML NPM1+ or CEBPA+wt FLT3-ITD.
Included patients with intermediate cytogenetics other than CN-AML NPM1+ or CEBPA+wt FLT3-ITD.