Table 2.
Variable | Median (range) | Median (range) |
---|---|---|
Discovery cohort AML97 | Arm A | Arm B |
Day 1 Ara-CTP | 0.28 (0.09–2.43) | 0.22 (0.01–0.88) |
DNA synthesis (100† day1/baseline) | 8.06 (1.27–62.59) | 19.7 (2.4–148) |
OS† | 0.368 (0.104) | 0.565 (0.10) |
EFS† | 0.368 (0.104) | 0.522 (0.10) |
Validation cohort AML02 | HDAC arm | LDAC arm |
IC50 | 0.28 (0.01–5.0) | 0.394 (0.0055–5.0) |
Day 22 MRD† | 12 neg, 4 int, 5 high | 15 neg, 2 int, 8 high |
OS‡ | 0.905 (0.068) | 0.706 (0.102) |
EFS‡ | 0.857 (0.081) | 0.640 (0.111) |
Intermediate: 0.1% ≤ MRD ≤ 1%; High: MRD >1%.
5-year OS or EFS estimates with Peto and Pike standard error.
3-year OS or EFS estimates with Peto and Pike standard error.
Ara-CTP: Cytarabine 5´-triphosphate; EFS: Event-free survival; HDAC: High-dose cytarabine; Int: Intermediate;
LDAC: Low-dose cytarabine; MRD: Minimal residual disease; Neg: Negative; OS: Overall survival; PROMISE: Projection onto the Most Interesting Statistical Evidence.