Median OS and HRs for death by treatment (HD vs SD), according to subgroup
| Subgroup . | Standard dose (45 mg/m2 per day) . | High dose (90 mg/m2 per day) . | Fisher’s exact P . | Log-rank P . | Univariate . | Multivariable* . | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CR rate . | Median OS (months) (no. of events/total) . | 4-year OS . | CR rate . | Median OS (months) (no. of events/total) . | 4-year OS . | HR (95% CI) . | Wald P . | No. of events/total . | HR (95% CI) . | Wald P . | |||
| All patients | 59% | 16.6 (246/330) | 31% | 71% | 25.4 (207/327) | 39% | .001 | .001 | 0.74 (0.61, 0.89) | 0.001 | 450/653 | 0.74 (0.61, 0.89) | .001 |
| Age | |||||||||||||
| <50 years | 61% | 20.7 (133/188) | 35% | 73% | 44.7 (96/172) | 48% | .02 | .002 | 0.66 (0.50, 0.85) | 0.002 | 228/359 | 0.67 (0.52, 0.88) | .004 |
| ≥50 years | 56% | 12.6 (113/142) | 25% | 68% | 17.6 (111/155) | 28% | .03 | .12 | 0.81 (0.62, 1.06) | 0.12 | 222/294 | 0.82 (0.63, 1.07) | .14 |
| Cytogenetic | |||||||||||||
| Favorable | 84% | 39.4 (24/38) | 46% | 80% | NR (19/51) | 64% | .78 | .02 | 0.51 (0.28, 0.93) | 0.03 | 43/89 | 0.44 (0.24, 0.82) | .01 |
| Intermediate | 56% | 20.1 (101/141) | 35% | 77% | 33.5 (71/127) | 45% | .0003 | .01 | 0.68 (0.50, 0.92) | 0.01 | 172/267 | 0.75 (0.55,1.03) | .08 |
| Indeterminate | 62% | 14.3 (66/91) | 29% | 67% | 21.3 (62/85) | 29% | .53 | .47 | 0.88 (0.62, 1.24) | 0.47 | 127/175 | 0.89 (0.63, 1.27) | .53 |
| Unfavorable | 44% | 10.2 (54/59) | 14% | 57% | 10.6 (54/63) | 19% | .20 | .22 | 0.79 (0.54, 1.16) | 0.23 | 108/122 | 0.66 (0.44, 0.98) | .04 |
| Gene mutation | |||||||||||||
| NPM1 | 60% | 16.9 (50/65) | 29% | 89% | 75.9 (31/65) | 52% | .0002 | .002 | 0.50 (0.32, 0.78) | 0.002 | 81/130 | 0.51 (0.32, 0.81) | .005 |
| FLT3-ITD | 48% | 10.1 (74/83) | 17% | 70% | 15.2 (44/64) | 28% | .008 | .009 | 0.61 (0.42, 0.89) | 0.009 | 117/146 | 0.50 (0.32, 0.77) | .002 |
| DNMT3A | 61% | 14.1 (55/61) | 13% | 79% | 16.5 (40/58) | 33% | .03 | .02 | 0.62 (0.41, 0.94) | 0.02 | 95/118 | 0.67 (0.42, 1.05) | .08 |
| MLL-PTD | 56% | 16.2 (16/16) | 6% | 60% | 20.6 (10/15) | 33% | 1.00 | .056 | 0.46 (0.21, 1.04) | 0.06 | 26/30 | 0.60 (0.24, 1.54) | .29 |
| Subgroup . | Standard dose (45 mg/m2 per day) . | High dose (90 mg/m2 per day) . | Fisher’s exact P . | Log-rank P . | Univariate . | Multivariable* . | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CR rate . | Median OS (months) (no. of events/total) . | 4-year OS . | CR rate . | Median OS (months) (no. of events/total) . | 4-year OS . | HR (95% CI) . | Wald P . | No. of events/total . | HR (95% CI) . | Wald P . | |||
| All patients | 59% | 16.6 (246/330) | 31% | 71% | 25.4 (207/327) | 39% | .001 | .001 | 0.74 (0.61, 0.89) | 0.001 | 450/653 | 0.74 (0.61, 0.89) | .001 |
| Age | |||||||||||||
| <50 years | 61% | 20.7 (133/188) | 35% | 73% | 44.7 (96/172) | 48% | .02 | .002 | 0.66 (0.50, 0.85) | 0.002 | 228/359 | 0.67 (0.52, 0.88) | .004 |
| ≥50 years | 56% | 12.6 (113/142) | 25% | 68% | 17.6 (111/155) | 28% | .03 | .12 | 0.81 (0.62, 1.06) | 0.12 | 222/294 | 0.82 (0.63, 1.07) | .14 |
| Cytogenetic | |||||||||||||
| Favorable | 84% | 39.4 (24/38) | 46% | 80% | NR (19/51) | 64% | .78 | .02 | 0.51 (0.28, 0.93) | 0.03 | 43/89 | 0.44 (0.24, 0.82) | .01 |
| Intermediate | 56% | 20.1 (101/141) | 35% | 77% | 33.5 (71/127) | 45% | .0003 | .01 | 0.68 (0.50, 0.92) | 0.01 | 172/267 | 0.75 (0.55,1.03) | .08 |
| Indeterminate | 62% | 14.3 (66/91) | 29% | 67% | 21.3 (62/85) | 29% | .53 | .47 | 0.88 (0.62, 1.24) | 0.47 | 127/175 | 0.89 (0.63, 1.27) | .53 |
| Unfavorable | 44% | 10.2 (54/59) | 14% | 57% | 10.6 (54/63) | 19% | .20 | .22 | 0.79 (0.54, 1.16) | 0.23 | 108/122 | 0.66 (0.44, 0.98) | .04 |
| Gene mutation | |||||||||||||
| NPM1 | 60% | 16.9 (50/65) | 29% | 89% | 75.9 (31/65) | 52% | .0002 | .002 | 0.50 (0.32, 0.78) | 0.002 | 81/130 | 0.51 (0.32, 0.81) | .005 |
| FLT3-ITD | 48% | 10.1 (74/83) | 17% | 70% | 15.2 (44/64) | 28% | .008 | .009 | 0.61 (0.42, 0.89) | 0.009 | 117/146 | 0.50 (0.32, 0.77) | .002 |
| DNMT3A | 61% | 14.1 (55/61) | 13% | 79% | 16.5 (40/58) | 33% | .03 | .02 | 0.62 (0.41, 0.94) | 0.02 | 95/118 | 0.67 (0.42, 1.05) | .08 |
| MLL-PTD | 56% | 16.2 (16/16) | 6% | 60% | 20.6 (10/15) | 33% | 1.00 | .056 | 0.46 (0.21, 1.04) | 0.06 | 26/30 | 0.60 (0.24, 1.54) | .29 |
NR, not reached.
Adjusted for sex, age, hemoglobin level, leukocyte count, platelet count, and cytogenetics.