Main CR induction and trial results, according to randomization group
| . | ICE group (n = 286) . | sHD group (n = 286) . | RRR*/hazard ratio (95% CI) . | P . |
|---|---|---|---|---|
| CR induction course 1 (random 1), (%) | ||||
| CR† | 198 (69.2) | 233 (81.5) | 0.40 (0.19-0.55) | .0007 |
| NR | 72 (25.2) | 32 (11.2) | <.0001 | |
| ED | 16 (5.6) | 21 (7.3) | .39 | |
| CR induction course 2, n/N (%) | ||||
| CR | 33/46 (71.7) | 6/17 (35.3) | −1.29 (−3.09 to −0.28) | .008 |
| NR | 12/46 (26.1) | 11/17 (64.7) | .008 | |
| ED | 1/46 (2.2) | 0 | 1.0 | |
| Total CR (courses 1+2), n (%)‡ | 231 (80.8) | 239 (83.6) | 0.15 (−0.22 to 0.40) | .38 |
| Relapse and survival estimates | ||||
| 5-y incidence of relapse (95% CI), % | 55 (48-61) | 44 (37-50) | 0.77 (0.59-0.99) | .046 |
| 5-y incidence of death in CR (95% CI), % | 10 (6-14) | 8 (5-12) | 0.87 (0.48-1.60) | .66 |
| Overall survival | ||||
| Median, y | 2.2 | 4.5 | ||
| 5-y rate (95% CI), % | 39 (33-45) | 49 (42-55) | 0.79 (0.63-0.99) | .045 |
| Survival of CR patients | ||||
| Median, y | 3.6 | N/A | ||
| 5-y rate (95% CI), % | 46 (39-52) | 54 (47-61) | 0.81 (0.62-1.06) | .12 |
| Relapse-free survival | ||||
| Median, y | 1.5 | 3.4 | ||
| 5-y rate (95% CI), % | 36 (29-42) | 48 (41-54) | 0.77 (0.60-0.97) | .028 |
| . | ICE group (n = 286) . | sHD group (n = 286) . | RRR*/hazard ratio (95% CI) . | P . |
|---|---|---|---|---|
| CR induction course 1 (random 1), (%) | ||||
| CR† | 198 (69.2) | 233 (81.5) | 0.40 (0.19-0.55) | .0007 |
| NR | 72 (25.2) | 32 (11.2) | <.0001 | |
| ED | 16 (5.6) | 21 (7.3) | .39 | |
| CR induction course 2, n/N (%) | ||||
| CR | 33/46 (71.7) | 6/17 (35.3) | −1.29 (−3.09 to −0.28) | .008 |
| NR | 12/46 (26.1) | 11/17 (64.7) | .008 | |
| ED | 1/46 (2.2) | 0 | 1.0 | |
| Total CR (courses 1+2), n (%)‡ | 231 (80.8) | 239 (83.6) | 0.15 (−0.22 to 0.40) | .38 |
| Relapse and survival estimates | ||||
| 5-y incidence of relapse (95% CI), % | 55 (48-61) | 44 (37-50) | 0.77 (0.59-0.99) | .046 |
| 5-y incidence of death in CR (95% CI), % | 10 (6-14) | 8 (5-12) | 0.87 (0.48-1.60) | .66 |
| Overall survival | ||||
| Median, y | 2.2 | 4.5 | ||
| 5-y rate (95% CI), % | 39 (33-45) | 49 (42-55) | 0.79 (0.63-0.99) | .045 |
| Survival of CR patients | ||||
| Median, y | 3.6 | N/A | ||
| 5-y rate (95% CI), % | 46 (39-52) | 54 (47-61) | 0.81 (0.62-1.06) | .12 |
| Relapse-free survival | ||||
| Median, y | 1.5 | 3.4 | ||
| 5-y rate (95% CI), % | 36 (29-42) | 48 (41-54) | 0.77 (0.60-0.97) | .028 |
N/A, not achieved.
Proportion of failures that would be avoided with sHD in patients treated with ICE.
Treatment groups were well distributed by study center (n = 17; P = .5). By Cochran-Mantel-Haenszel χ2 test using center as stratification factor, the higher CR rate with sHD at random 1 remained statistically significant (P = .001). Similarly, stratified Cox models confirmed the treatment effect on OS (hazard ratio, 0.78; 95% CI, 0.62-0.99; P = .041) and relapse-free survival (hazard ratio, 0.75; 95% CI, 0.59-0.96; P = .022).
Including CR with incomplete hematological recovery: 3 in ICE group and 8 in sHD group (P = .12).