Table 1.
DClo | FLAG-Ida | OR/HR, 95% CI | p Value | |
---|---|---|---|---|
Number randomised | 207 | 104 | ||
Age group (years) | ||||
15–29 (16%) | 6 (3%) | 7 (7%) | ||
30–39 (20%) | 17 (8%) | 8 (8%) | ||
40–49 (19%) | 29 (14%) | 14 (13%) | ||
50–59 (29%) | 95 (46%) | 46 (44%) | ||
60+ (37%) | 60 (29%) | 29 (28%) | ||
Gender | ||||
Female | 66 (32%) | 35 (34%) | ||
Male | 141 (68%) | 69 (66%) | ||
Type of disease | ||||
De novo | 147 (71%) | 74 (71%) | ||
Secondary | 38 (18%) | 20 (19%) | ||
High-risk MDS | 22 (11%) | 10 (10%) | ||
Performance status | ||||
0 | 149 (72%) | 75 (72%) | ||
1 | 50 (24%) | 24 (23%) | ||
2 | 5 (2%) | 2 (2%) | ||
3 | 3 (1%) | 3 (3%) | ||
4 | 0 | 0 | ||
Induction treatment | ||||
ADE (NR) | 11 (5%) | 6 (6%) | ||
ADE | 14 (7%) | 8 (8%) | ||
ADE + GO3 | 20 (10%) | 9 (9%) | ||
ADE + GO6 | 20 (10%) | 10 (10%) | ||
DA + GO3 | 23 (11%) | 12 (12%) | ||
DA + GO6 | 15 (7%) | 7 (7%) | ||
DA60 | 52 (25%) | 26 (25%) | ||
DA90 | 52 (25%) | 26 (25%) | ||
Cytogenetics | ||||
Favourable | 0 | 0 | ||
Intermediate | 102 (49%) | 49 (47%) | ||
Adverse | 105 (51%) | 55 (53%) | ||
NK | 0 | 0 | ||
FLT3-ITD | ||||
WT | 195 (94%) | 96 (92%) | ||
Mutant | 4 (2%) | 1 (1%) | ||
Not known | 8 (4%) | 7 (7%) | ||
NPM1 | ||||
WT | 173 (84%) | 87 (84%) | ||
Mutant | 25 (12%) | 9 (9%) | ||
Not known | 9 (4%) | 8 (8%) | ||
MRD status post C1 | ||||
−ve | 21 (10%) | 8 (8%) | ||
+ve | 43 (21%) | 16 (15%) | ||
Not in CR | 65 (31%) | 31 (30%) | ||
Not known | 78 (38%) | 49 (47%) | ||
MRD status post C2 | ||||
CR/CRi, MRD −ve | 20 (11%) | 12 (13%) | MRD −ve vs. MRD +ve vs. no CR, p = 0.08 | |
CR/CRi, MRD +ve | 29 (15%) | 18 (20%) | ||
CR/CRi, MRD unk | 93 (49%) | 49 (53%) | ||
Not in CR | 47 (25%) | 13 (14%) | ||
Not known | 18 | 12 | ||
ORR (CR + Cri) | 83% | 86% | 1.24 (0.66–2.34) | 0.5 |
CR | 68% | 72% | 1.23 (0.74–2.05) | 0.4 |
CRi | 15% | 13% | ||
30-day mortality | 2% | 4% | 0.61 (0.15–2.45) | 0.5 |
60-day mortality | 9% | 10% | 0.95 (0.44–2.06) | 0.9 |
5-year OS | 26% | 44% | 1.40 (1.05–1.86) | 0.02 |
4-year OS censored at SCT | 15% | 28% | 1.27 (0.87–1.85) | 0.2 |
5-year CIR | 51% | 39% | 1.38 (0.95–2.01) | 0.09 |
5-year CIDCR | 24% | 17% | 1.45 (0.83–2.51) | 0.19 |
5-year RFS | 25% | 44% | 1.40 (1.03–1.91) | 0.03 |
Number within parentheses indicates the percentage of non-APL patients in each age group who entered the high-risk randomisation expressed as a proportion of all patients entering the AML17 Trial
CR complete remission, APL acute promyelocytic leukaemia, AML acute myeloid leukaemia, FLT3 fms-like tyrosine kinase 3, ITD internal tandem duplication, MRD minimal/measurable residual disease, CRi complete remission with incomplete count recovery, NPM1 nucleophosmin member 1, NK natural killer, WT wild type, OR odds ratio, CI confidence interval, OS overall survival, ORR overall response ratio, SCT stem cell transplant, CIR cumulative incidence of relapse, MDS myelodysplastic syndrome, CIDCR cumulative incidence of death in remission, RFS relapse-free survival