Table 2.
Univariable analyses of outcomes according to ASXL1 mutation status in primary CN-AML patients aged 60 years or older
| ASXL1-mut | ASXL1-wt | P | OR/HR (95% CI) | |
|---|---|---|---|---|
| All patients (n = 220) | ||||
| No. of patients | 38 | 182 | ||
| CR, no. (%) | 20 (53) | 129 (71) | .04 | 0.46 (0.22-0.93) |
| Death in CR, no. (%) | 0/20 (0) | 5/129 (4) | 1.0 | — |
| DFS | .03 | 1.71 (1.06-2.77) | ||
| Median, y | 0.6 | 1.0 | ||
| % disease-free at 3 y (95% CI) | 10 (2-27) | 19 (12-26) | ||
| OS | .006 | 1.64 (1.14-2.43) | ||
| Median (y) | 0.9 | 1.2 | ||
| % alive at 3 y (95% CI) | 5 (1-15) | 23 (17-39) | ||
| EFS | .002 | 1.74 (1.22-2.49) | ||
| Median, y | 0.4 | 0.7 | ||
| % event-free at 3 y (95% CI) | 5 (1-16) | 14 (9-18) | ||
| ELN Favorable group*(n = 99) | ||||
| No. of patients | 12 | 87 | ||
| CR, no. (%) | 6 (50) | 71 (82) | .02 | 0.23 (0.06-0.79) |
| DFS | ND† | — | ||
| Median, y | 0.4 | 1.2 | ||
| % disease-free at 3 y (95% CI) | 0 | 27 (17-37) | ||
| OS | < .001 | 5.15 (2.63-10.10) | ||
| Median, y | 0.8 | 1.6 | ||
| % alive at 3 y (95% CI) | 0 | 34 (25-44) | ||
| EFS | < .001 | 4.01 (2.09-7.68) | ||
| Median, y | 0.2 | 1.1 | ||
| % event-free at 3 y (95% CI) | 0 | 22 (14-31) | ||
| ELN Intermediate-I group*(n = 121) | ||||
| No. of patients | 26 | 95 | ||
| CR, no. (%) | 14 (54) | 58 (61) | .51 | 0.74 (0.31-1.78) |
| DFS | .95 | 1.02 (0.56-1.84) | ||
| Median, y | 0.7 | 0.6 | ||
| % disease-free at 3 y (95% CI) | 14 (2-37) | 10 (4-20) | ||
| OS | .73 | 0.93 (0.60-1.44) | ||
| Median, y | 1.1 | 0.8 | ||
| % alive at 3 y (95% CI) | 8 (1-22) | 13 (7-20) | ||
| EFS | .68 | 1.09 (0.71-1.69) | ||
| Median, y | 0.5 | 0.4 | ||
| % event-free at 3 y (95% CI) | 8 (1-22) | 6 (3-12) |
The median follow-up for those alive is 5.0 years (range, 2.3-11.6 years). The median follow-up for those who have not had an event is 5.1 years (range, 3.7-11.6 years). An OR > 1.0 (< 1.0) means a higher (lower) CR rate for ASXL1-mut patients compared with ASXL1-wt patients. A HR > 1.0 (< 1.0) corresponds to a higher (lower) risk of an event for ASXL1-mut patients compared with ASXL1-wt patients.
ND indicates not determined; and —, not applicable.
Within CN-AML, the ELN Favorable group is defined as patients with mutated CEBPA and/or mutated NPM1 without FLT3-ITD. All remaining CN-AML patients (ie, those with wild-type CEBPA, and FLT3-ITD and/or wild-type NPM1) belong to the ELN Intermediate-I category.27
A P value for DFS in the ELN Favorable group was not calculated because only 6 ELN Favorable/ASXL1 mutated patients achieved CR.