Outcome parameters according to randomization arm in the entire population of 592 patients
. | . | . | . | P values testing null hypothesis . | . | |
|---|---|---|---|---|---|---|
. | Arm A . | Arm B . | Arm C . | A = B . | A = C . | |
| No. patients | 197 | 198 | 197 | — | — | |
| Response to induction | ||||||
| CR, no. (%) | 151 (77) | 152 (77) | 146 (74) | .99 | .64 | |
| After induction, no. | 112 | 140 | 121 | ND | ND | |
| After induction + salvage, no. | 39 | 12 | 25 | < .001 | .09 | |
| Resistant disease, no. | 23 | 15 | 19 | ND | ND | |
| Induction death, no. (%) | 23 (12) | 31 (16) | 32 (16) | .30 | .25 | |
| Treatment-related death, no. (%) | 15 (8) | 24 (12) | 21 (11) | .18 | .38 | |
| First event after CR achievement | ||||||
| Allogeneic BMT in first CR, no. (%) | 17 (11) | 12 (8) | 19 (13) | — | — | |
| Death in first CR, no. (%) | 18 (12) | 26 (17) | 15 (10) | — | — | |
| Relapse, no. (%) | 90 (60) | 87 (57) | 73 (50) | — | — | |
| Cumulative incidence of relapse* | .39 | .15 | ||||
| 2-year estimate, % (95% Cl) | 53.6 (52.8-54.4) | 44.1 (43.3-44.9) | 44.6 (43.8-45.4) | — | — | |
| 5-year estimate, % (95% Cl) | 59.6 (58.8-60.4) | 56.0 (55.2-56.8) | 49.5 (48.6-50.3) | — | — | |
| Event-free survival† | ||||||
| Events, no. (%) | 154 (78) | 159 (80) | 139 (70) | .45 | .21 | |
| 2-year EFS, % (95% Cl) | 23.1 (17.6-30.3) | 31.8 (25.8-39.3) | 31.2 (25.1-39.0) | — | — | |
| 5-year EFS, % (95% Cl) | 15.9 (11.3-22.5) | 16.7 (12.0-23.1) | 25.1 (19.4-32.5) | — | — | |
| Overall survival‡ | ||||||
| Death, no. (%) | 150 (76) | 150 (76) | 137 (69) | .83 | .30 | |
| 2-year survival, % (95% Cl) | 42.1 (35.8-49.6) | 46.5 (40.0-54.0) | 47.7 (41.2-55.2) | — | — | |
| 5-year survival, % (95% Cl) | 27.9 (22.3-34.9) | 29.3 (23.6-36.4) | 32.3 (26.4-39.5) | — | — | |
. | . | . | . | P values testing null hypothesis . | . | |
|---|---|---|---|---|---|---|
. | Arm A . | Arm B . | Arm C . | A = B . | A = C . | |
| No. patients | 197 | 198 | 197 | — | — | |
| Response to induction | ||||||
| CR, no. (%) | 151 (77) | 152 (77) | 146 (74) | .99 | .64 | |
| After induction, no. | 112 | 140 | 121 | ND | ND | |
| After induction + salvage, no. | 39 | 12 | 25 | < .001 | .09 | |
| Resistant disease, no. | 23 | 15 | 19 | ND | ND | |
| Induction death, no. (%) | 23 (12) | 31 (16) | 32 (16) | .30 | .25 | |
| Treatment-related death, no. (%) | 15 (8) | 24 (12) | 21 (11) | .18 | .38 | |
| First event after CR achievement | ||||||
| Allogeneic BMT in first CR, no. (%) | 17 (11) | 12 (8) | 19 (13) | — | — | |
| Death in first CR, no. (%) | 18 (12) | 26 (17) | 15 (10) | — | — | |
| Relapse, no. (%) | 90 (60) | 87 (57) | 73 (50) | — | — | |
| Cumulative incidence of relapse* | .39 | .15 | ||||
| 2-year estimate, % (95% Cl) | 53.6 (52.8-54.4) | 44.1 (43.3-44.9) | 44.6 (43.8-45.4) | — | — | |
| 5-year estimate, % (95% Cl) | 59.6 (58.8-60.4) | 56.0 (55.2-56.8) | 49.5 (48.6-50.3) | — | — | |
| Event-free survival† | ||||||
| Events, no. (%) | 154 (78) | 159 (80) | 139 (70) | .45 | .21 | |
| 2-year EFS, % (95% Cl) | 23.1 (17.6-30.3) | 31.8 (25.8-39.3) | 31.2 (25.1-39.0) | — | — | |
| 5-year EFS, % (95% Cl) | 15.9 (11.3-22.5) | 16.7 (12.0-23.1) | 25.1 (19.4-32.5) | — | — | |
| Overall survival‡ | ||||||
| Death, no. (%) | 150 (76) | 150 (76) | 137 (69) | .83 | .30 | |
| 2-year survival, % (95% Cl) | 42.1 (35.8-49.6) | 46.5 (40.0-54.0) | 47.7 (41.2-55.2) | — | — | |
| 5-year survival, % (95% Cl) | 27.9 (22.3-34.9) | 29.3 (23.6-36.4) | 32.3 (26.4-39.5) | — | — | |
CR indicates complete remission; BMT, bone marrow transplantation; Cl, confidence interval; RFI, relapse-free interval; NA, not applicable; 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.