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) |
#N represents the total population; for individual variables, some data were not measured/reported, and the appropriate denominator is specified in these instances. Some percentages do not add up to 100 due to rounding.
AML acute myeloid leukemia, AZA azacitidine, CR complete remission, CRi CR with incomplete hematologic recovery, LDAC low-dose cytarabine, NCCN National Comprehensive Cancer Network, OS overall survival, PBO placebo.