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. 2018 Jun 6;32(12):2693–2697. doi: 10.1038/s41375-018-0148-3

Table 1.

Patient characteristics and outcomes

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