OS at 3 years from randomization by baseline characteristics and treatment arm
| Subgroups of ITT population . | n (DisC/RIST) . | 3-Year OS probability (95% CI) . | P value∗ . | |
|---|---|---|---|---|
| DisC . | RIST . | |||
| All patients | 140/141 | 55 (46-63) | 54 (46-62) | .95 |
| Age, y | ||||
| ≤60 | 69/67 | 68 (55-77) | 59 (46-70) | .28 |
| >60 | 71/74 | 42 (31-53) | 51 (39-61) | .32 |
| Disease status | ||||
| Poor response | 90/93 | 49 (38-58) | 54 (43-64) | .45 |
| Relapse | 50/48 | 66 (51-77) | 55 (40-68) | .26 |
| White blood cell count | ||||
| Below median | 64/74 | 54 (41-66) | 56 (44-67) | .85 |
| Median or higher (1.9 × 109/L) | 76/66 | 55 (43-65) | 53 (40-64) | .76 |
| Bone marrow blasts at randomization | ||||
| Below median (30%) | 66/63 | 65 (52-75) | 58 (45-69) | .40 |
| Median or higher | 73/75 | 46 (35-57) | 53 (41-64) | .42 |
| ELN 2022 risk | ||||
| Favorable | 22/20 | 91 (68-98) | 37 (17-59) | <.001 |
| Intermediate | 51/75 | 56 (42-69) | 64 (52-74) | .39 |
| Adverse | 67/46 | 42 (30-53) | 46 (31-59) | .68 |
| Adverse without TP53 abnormalities | 44/36 | 50 (35-64) | 50 (33-65) | 1.0 |
| Adverse with TP53 abnormalities | 23/10 | 26 (11-45) | 30 (7-58) | .82 |
| Genetic abnormality | ||||
| NPM1-mut | 22/25 | 68 (45-83) | 40 (21-58) | .043 |
| FLT3-ITD | 24/21 | 54 (33-71) | 42 (21-62) | .43 |
| Secondary-type mutations | 22/22 | 55 (32-72) | 64 (40-80) | .54 |
| Complex karyotype | 34/16 | 26 (13-42) | 31 (11-54) | .73 |
| abn(17p) or TP53 mutations | 23/10 | 26 (11-45) | 30 (7-58) | .82 |
| Diagnosis | ||||
| De novo AML | 110/102 | 59 (49-68) | 55 (45-64) | .54 |
| sAML/tAML | 30/39 | 40 (23-57) | 54 (37-68) | .26 |
| Sex | ||||
| Female | 64/61 | 56 (43-67) | 58 (44-69) | .88 |
| Male | 76/80 | 54 (42-64) | 52 (41-63) | .88 |
| ECOG | ||||
| 0 | 59/47 | 68 (54-78) | 66 (50-78) | .85 |
| 1-2 | 81/94 | 45 (34-56) | 49 (38-58) | .68 |
| HCT-CI | ||||
| <3 | 83/91 | 62 (51-72) | 58 (47-67) | .52 |
| ≥3 | 57/50 | 44 (31-56) | 49 (34-62) | .61 |
| Subgroups of ITT population . | n (DisC/RIST) . | 3-Year OS probability (95% CI) . | P value∗ . | |
|---|---|---|---|---|
| DisC . | RIST . | |||
| All patients | 140/141 | 55 (46-63) | 54 (46-62) | .95 |
| Age, y | ||||
| ≤60 | 69/67 | 68 (55-77) | 59 (46-70) | .28 |
| >60 | 71/74 | 42 (31-53) | 51 (39-61) | .32 |
| Disease status | ||||
| Poor response | 90/93 | 49 (38-58) | 54 (43-64) | .45 |
| Relapse | 50/48 | 66 (51-77) | 55 (40-68) | .26 |
| White blood cell count | ||||
| Below median | 64/74 | 54 (41-66) | 56 (44-67) | .85 |
| Median or higher (1.9 × 109/L) | 76/66 | 55 (43-65) | 53 (40-64) | .76 |
| Bone marrow blasts at randomization | ||||
| Below median (30%) | 66/63 | 65 (52-75) | 58 (45-69) | .40 |
| Median or higher | 73/75 | 46 (35-57) | 53 (41-64) | .42 |
| ELN 2022 risk | ||||
| Favorable | 22/20 | 91 (68-98) | 37 (17-59) | <.001 |
| Intermediate | 51/75 | 56 (42-69) | 64 (52-74) | .39 |
| Adverse | 67/46 | 42 (30-53) | 46 (31-59) | .68 |
| Adverse without TP53 abnormalities | 44/36 | 50 (35-64) | 50 (33-65) | 1.0 |
| Adverse with TP53 abnormalities | 23/10 | 26 (11-45) | 30 (7-58) | .82 |
| Genetic abnormality | ||||
| NPM1-mut | 22/25 | 68 (45-83) | 40 (21-58) | .043 |
| FLT3-ITD | 24/21 | 54 (33-71) | 42 (21-62) | .43 |
| Secondary-type mutations | 22/22 | 55 (32-72) | 64 (40-80) | .54 |
| Complex karyotype | 34/16 | 26 (13-42) | 31 (11-54) | .73 |
| abn(17p) or TP53 mutations | 23/10 | 26 (11-45) | 30 (7-58) | .82 |
| Diagnosis | ||||
| De novo AML | 110/102 | 59 (49-68) | 55 (45-64) | .54 |
| sAML/tAML | 30/39 | 40 (23-57) | 54 (37-68) | .26 |
| Sex | ||||
| Female | 64/61 | 56 (43-67) | 58 (44-69) | .88 |
| Male | 76/80 | 54 (42-64) | 52 (41-63) | .88 |
| ECOG | ||||
| 0 | 59/47 | 68 (54-78) | 66 (50-78) | .85 |
| 1-2 | 81/94 | 45 (34-56) | 49 (38-58) | .68 |
| HCT-CI | ||||
| <3 | 83/91 | 62 (51-72) | 58 (47-67) | .52 |
| ≥3 | 57/50 | 44 (31-56) | 49 (34-62) | .61 |
DisC, disease control strategy; RIST, remission induction strategy; ELN, European Leukemia Network 2022 classification1; sAML, secondary acute myeloid leukemia; tAML, therapy-related acute myeloid leukemia; ECOG, Eastern Co-operative Oncology Group Performance status; HCT-CI, hematopoietic cell transplantation – comorbidity index11,12; BM, bone marrow; alloHCT, allogeneic hematopoietic cell transplantation; 95%-CI, 95% confidence interval.
P value of z test.