Table 6 Characteristics and outcomes of patients enrolled to the VIALE-A, VIALE-C and the ALLG NBCR receiving low-intensity therapy#.
Characteristics | VIALE-A (n = 286) | AZA-PBO (n = 145) | VIALE-C (n = 143) | LDAC-PBO (n = 68) | NBCR (n = 64) |
|---|---|---|---|---|---|
Age, years, median (range) | 76 (49–91) | 76 (60–90) | 76 (36–93) | 76 (41–88) | 77 (54–92) |
Age ≥75 years, n (%) | 174 (61) | 87 (60) | 82 (57) | 40 (59) | 38 (59) |
Male gender, n (%) | 172 (60) | 87 (60) | 78 (55) | 39 (57) | 41 (64) |
AML type | |||||
- De novo | 214 (75) | 110 (76) | 85 (59) | 45 (66) | 47 (73) |
- Secondary | 72 (25) | 35 (24) | 58 (41) | 23 (34) | 17 (27) |
Secondary AML type | |||||
- Therapy related | 26/72 (36) | 9/35 (26) | 6/58 (10) | 4/23 (17) | 6/17 (35) |
- Prior hematologic disorder | 46/72 (64) | 26/35 (74) | 52/58 (90) | 19/23 (83) | 11/17 (65) |
Cytogenetic risk according to NCCN version 2.2016, n (%) | |||||
- Favorable | - | - | 1 (1) | 3 (5) | - |
- Intermediate | 182 (64) | 89 (61) | 90 (65) | 43 (65) | 40/54 (74) |
- Adverse | 104 (36) | 56 (39) | 47 (34) | 20 (30) | 14/54 (26) |
NPM1 mutation, n (%) | 27/163 (17) | 17/86 (20) | 18 (16) | 7 (14) | 10/25 (40) |
FLT3 mutation, n (%) | 29/206 (14) | 22/108 (20) | 20 (18) | 9 (17) | 5/26 (19) |
Treatment response (%) | |||||
- CR/CRi | 66.4 | 28.3 | 48 | 13 | 31.6 |
- CR | 36.7 | 17.9 | 27 | 7 | 15.8 |
OS, months, median (95% CI) | 14.7 (11.9–18.7) | 9.6 (7.4–12.7) | 8.4 (5.9–10.1) | 4.1 (3.1–8.1) | 9.3 (5.3–19.3) |
