Outcome parameters according to randomization arm in the subgroup of 345 patients younger than 50
. | . | . | . | P values testing null hypothesis . | . | |
|---|---|---|---|---|---|---|
. | Arm A . | Arm B . | Arm C . | A = B . | A = C . | |
| No. patients | 110 | 114 | 121 | — | — | |
| Response to induction | ||||||
| CR, no. (%) | 93 (85) | 92 (81) | 97 (80) | .49 | .40 | |
| Resistant disease, no. | 10 | 12 | 11 | ND | ND | |
| Induction death, no. (%) | 7 (6) | 10 (9) | 13 (11) | .62 | .25 | |
| Treatment-related death, no. (%) | 7 (6) | 8 (7) | 9 (7) | .99 | .80 | |
| Relapse as first event after CR achievement | ||||||
| Relapse, no. (%) | 52 (56) | 46 (50) | 38 (39) | — | — | |
| Cumulative incidence of relapse* | .26 | .038 | ||||
| 2-year estimate, % (95% CI) | 50.3 (40.0-60.6) | 41.3 (31.1-51.4) | 36.1 (26.4-45.7) | — | — | |
| 5-year estimate, % (95% CI) | 55.9 (45.7-66.1) | 47.9 (37.6-58.2) | 39.3 (29.4-49.1) | — | — | |
| Event-free survival† | .60 | .14 | ||||
| Events, no. (%) | 77 (70) | 81 (71) | 70 (58) | — | — | |
| 2-year EFS, % (95% CI) | 27.9 (20.0-38.8) | 35.2 (27.0-45.9) | 40.9 (32.3-51.7) | — | — | |
| 5-year EFS, % (95% CI) | 20.9 (13.9-31.3) | 23.8 (16.7-33.9) | 35.3 (27.0-46.1) | — | — | |
| Overall survival‡ | .93 | .25 | ||||
| Deaths, no. (%) | 76 (69) | 78 (68) | 73 (60) | — | — | |
| 2-year survival, % (95% CI) | 48.2 (39.7-58.5) | 52.6 (44.2-62.6) | 56.2 (48.0-65.7) | — | — | |
| 5-year survival, % (95% CI) | 35.5 (27.6-45.6) | 35.1 (27.3-45.0) | 41.9 (33.9-51.7) | — | — | |
. | . | . | . | P values testing null hypothesis . | . | |
|---|---|---|---|---|---|---|
. | Arm A . | Arm B . | Arm C . | A = B . | A = C . | |
| No. patients | 110 | 114 | 121 | — | — | |
| Response to induction | ||||||
| CR, no. (%) | 93 (85) | 92 (81) | 97 (80) | .49 | .40 | |
| Resistant disease, no. | 10 | 12 | 11 | ND | ND | |
| Induction death, no. (%) | 7 (6) | 10 (9) | 13 (11) | .62 | .25 | |
| Treatment-related death, no. (%) | 7 (6) | 8 (7) | 9 (7) | .99 | .80 | |
| Relapse as first event after CR achievement | ||||||
| Relapse, no. (%) | 52 (56) | 46 (50) | 38 (39) | — | — | |
| Cumulative incidence of relapse* | .26 | .038 | ||||
| 2-year estimate, % (95% CI) | 50.3 (40.0-60.6) | 41.3 (31.1-51.4) | 36.1 (26.4-45.7) | — | — | |
| 5-year estimate, % (95% CI) | 55.9 (45.7-66.1) | 47.9 (37.6-58.2) | 39.3 (29.4-49.1) | — | — | |
| Event-free survival† | .60 | .14 | ||||
| Events, no. (%) | 77 (70) | 81 (71) | 70 (58) | — | — | |
| 2-year EFS, % (95% CI) | 27.9 (20.0-38.8) | 35.2 (27.0-45.9) | 40.9 (32.3-51.7) | — | — | |
| 5-year EFS, % (95% CI) | 20.9 (13.9-31.3) | 23.8 (16.7-33.9) | 35.3 (27.0-46.1) | — | — | |
| Overall survival‡ | .93 | .25 | ||||
| Deaths, no. (%) | 76 (69) | 78 (68) | 73 (60) | — | — | |
| 2-year survival, % (95% CI) | 48.2 (39.7-58.5) | 52.6 (44.2-62.6) | 56.2 (48.0-65.7) | — | — | |
| 5-year survival, % (95% CI) | 35.5 (27.6-45.6) | 35.1 (27.3-45.0) | 41.9 (33.9-51.7) | — | — | |
CR indicates complete remission; BMT, bone marrow transplantation; CI, confidence interval; RFI, relapse-free interval; and ND, not done.
Using the Gray test with allogeneic BMT in first CR and death in first CR considered as competing events.
Using the log-rank test with patients receiving allogeneic BMT in first CR censored at BMT time.
Using the log-rank test with patients receiving allogeneic BMT in first CR not censored at BMT time.