Table 2.
Median EFS and HRs by treatment (HD vs SD), according to subgroup
| Subgroup | Standard dose (45 mg/m2 per day) | High dose (90 mg/m2 per day) | P for rlps† | Log-rank P for EFS | Univariate | Multivariable‡ | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4-year cum rlps rate* | Median EFS (months) (no. of events/total) | 4-year EFS | 4-y Cum Rlps Rate | Median EFS (months) (no. of events/total) | 4-year EFS | HR (95% CI) | Wald P | No. of events/total | HR (95% CI) | Wald P | |||
| All patients | 57% | 4.5 (272/330) | 20% | 55% | 11.3 (235/327) | 28% | .26 | <.0001 | 0.71 (0.60, 0.85) | .0001 | 503/650 | 0.70 (0.59, 0.84) | <.0001 |
| Age | |||||||||||||
| <50 years | 58% | 5.0 (152/188) | 20% | 51% | 13.9 (112/172) | 36% | .06 | <.0001 | 0.62 (0.48, 0.79) | .0001 | 263/359 | 0.63 (0.49, 0.82) | .0004 |
| ≥50 years | 54% | 4.0 (120/142) | 19% | 58% | 9.4 (123/155) | 19% | .70 | .15 | 0.83 (0.65, 1.07) | .15 | 240/294 | 0.83 (0.64, 1.08) | .16 |
| Cytogenetic | |||||||||||||
| Favorable | 54% | 14.0 (25/38) | 36% | 39% | 17.2 (28/51) | 44% | .21 | .33 | 0.77 (0.45, 1.32) | .34 | 53/89 | 0.75 (0.42, 1.31) | .31 |
| Intermediate | 56% | 3.7 (116141) | 20% | 55% | 16.1 (84/127) | 33% | .22 | .0002 | 0.59 (0.44, 0.78) | .0002 | 199/267 | 0.63 (0.47, 0.84) | .002 |
| Indeterminate | 59% | 4.9 (74/91) | 20% | 69% | 8.7 (69/85) | 18% | .42 | .55 | 0.91 (0.65, 1.26) | .55 | 142/175 | 0.90 (0.64, 1.26) | .53 |
| Unfavorable | 54% | 0.8 (56/59) | 8% | 49% | 4.5 (53/63) | 16% | .77 | .052 | 0.69 (0.47, 1.01) | .06 | 109/122 | 0.63 (0.43, 0.93) | .02 |
| Gene mutation | |||||||||||||
| NPM1 | 61% | 4.0 (56/65) | 18% | 46% | 21.0 (38/65) | 41% | .19 | <.0001 | 0.45 (0.30, 0.68) | .0002 | 94/130 | 0.44 (0.29, 0.69) | .0003 |
| FLT3-ITD | 70% | 1.9 (78/83) | 8% | 61% | 6.8 (47/64) | 23% | .24 | .0009 | 0.55 (0.38, 0.79) | .001 | 124/146 | 0.51 (0.34, 0.75) | .0007 |
| DNMT3A | NA | 4.4 (58/61) | 5% | 69% | 9.4 (46/58) | 21% | .84 | .03 | 0.66 (0.45, 0.97) | .04 | 103/118 | 0.70 (0.46, 1.05) | .09 |
| MLL-PTD | NA | 5.2 (16/16) | 0% | NA | 8.7 (12/15) | 20% | .81 | .19 | 0.60 (0.28, 1.31) | .20 | 27/30 | 0.71 (0.27, 1.87) | .49 |
cum rlps rate, cumulative relapse rate; NA, not applied due to no relapse time over 4 years on any patient in this group.
*
Among patients with complete remission reported.
†
Using the competing risk analysis by taking into account of death as a competing event.
‡
Adjusted for sex, age, hemoglobin level, leukocyte count, platelet count, and cytogenetics.