Results of randomized patients
| . | L-DNR . | Idarubicin . | P* . |
|---|---|---|---|
| n | 257 | 264 | |
| ED (before d 42) | 5 (2) | 7 (3) | .59 |
| ED (before d 15) related to initial complications | 3 | 2 | |
| ED/TRM (d 15 or later) after induction | 2 | 5 | |
| Death in CCR (TRM) | 1 (0.4) | 6 (3) | .02 |
| TRM during intensification courses | 0 | 5 | |
| TRM after HSCT in first CR | 1 | 1 | |
| Total ED/TRM following induction treatment | 2 | 10 | .04 |
| Blasts >5% at d 15, n/total n (%) | 59/239 (25) | 35/235 (15) | .01 |
| Blasts >5% at d 28, n/total n (%) | 46/202 (23) | 37/206 (18) | .27 |
| Nonresponders | 24 (9) | 25 (10) | .97 |
| CR achieved | 228 (89) | 232 (88) | .79 |
| Relapse, cumulative incidence, n (% ± SE) | 74 (29 ± 3) | 79 (31 ± 3) | .79 |
| Secondary malignancies, cumulative incidence, n (% ± SE) | 1 (1 ± 1) | 3 (1 ± 1) | .29 |
| 5-y pOS, % ± SE | 76 (3) | 75 (3) | .65 |
| 5-y pEFS, % ± SE | 59 (3) | 53 (3) | .25 |
| . | L-DNR . | Idarubicin . | P* . |
|---|---|---|---|
| n | 257 | 264 | |
| ED (before d 42) | 5 (2) | 7 (3) | .59 |
| ED (before d 15) related to initial complications | 3 | 2 | |
| ED/TRM (d 15 or later) after induction | 2 | 5 | |
| Death in CCR (TRM) | 1 (0.4) | 6 (3) | .02 |
| TRM during intensification courses | 0 | 5 | |
| TRM after HSCT in first CR | 1 | 1 | |
| Total ED/TRM following induction treatment | 2 | 10 | .04 |
| Blasts >5% at d 15, n/total n (%) | 59/239 (25) | 35/235 (15) | .01 |
| Blasts >5% at d 28, n/total n (%) | 46/202 (23) | 37/206 (18) | .27 |
| Nonresponders | 24 (9) | 25 (10) | .97 |
| CR achieved | 228 (89) | 232 (88) | .79 |
| Relapse, cumulative incidence, n (% ± SE) | 74 (29 ± 3) | 79 (31 ± 3) | .79 |
| Secondary malignancies, cumulative incidence, n (% ± SE) | 1 (1 ± 1) | 3 (1 ± 1) | .29 |
| 5-y pOS, % ± SE | 76 (3) | 75 (3) | .65 |
| 5-y pEFS, % ± SE | 59 (3) | 53 (3) | .25 |
Data are n or n (%) unless stated otherwise. CCR, continuous complete remission.
By Gray test (except for 5-year pOS and pEFS, which are by log rank test).