Table 1 Patient characteristics and treatment outcome across VEN14, VEN21, and VEN28.
 | VEN 14 (n = 31) | VEN 21 (n = 51) | VEN 28 (n = 18) | p-value |
---|---|---|---|---|
Median age, year (range) | 79 (63–87) | 71 (61–88) | 76 (63–91) | 0.708 |
Male n (%) | 19 (61.3%) | 29 (56.9%) | 8 (44.4%) | 0.511 |
Median follow-up | 456 days (13–1141) | 384 days (19–1291) | 226 days (37–1155) | |
Secondary AML | 7 (22.6%) | 13 (25.5%) | 3 (16.7%) | 0.745 |
Prior MDS | 4 (12.9%) | 12 (23.5%) | 0 (0.0%) | 0.079 |
Therapy-related AML | 3 (9.7%) | 1 (2.0%) | 3 (1.7%) | 0.054 |
Cytogenetics | Â | Â | Â | 0.100 |
Normal | 15 (19.4%) | 19 (37.3%) | 6 (33.3%) | Â |
Complex | 2 (6.5%) | 13 (25.5%) | 7 (38.9%) | Â |
Others | 14 (45.2%) | 19 (37.3%) | 5 (27.8%) | Â |
Mutaions | ||||
 FLT3-ITD | 5 (16.1%) | 2 (3.9%) | 2 (11.1%) | 0.150 |
 NPM-1 | 3 (9.7%) | 4 (7.8%) | 5 (27.8%) | 0.086 |
 IDH1/IDH2 | 9 (29.0%) | 12 (23.5%) | 5 (27.8%) | 0.844 |
 N/KRAS | 0 (0.0%) | 2 (3.9%) | 0 (0.0%) | 0.681 |
 TP53 | 9 (29.0%) | 14 (27.5%) | 7 (38.9%) | 0.654 |
HLN risk stratification for AZA-VEN | Â | Â | Â | 0.304 |
 Sensitive (n = 32) | 12 (38.7%) | 14 (27.5%) | 6 (33.3%) |  |
 Intermediate (n = 39) | 13 (41.9%) | 22 (43.1%) | 4 (22.2%) |  |
 Unfavorable (n = 29) | 6 (19.4%) | 15 (29.4%) | 8 (44.4%) |  |
Azole prophylaxis in 1st cycle | 7 (22.6%) | 19 (37.3%) | 3 (16.7%) | 0.162 |
G-CSF in 1st cycle | 12 (38.7%) | 23 (45.1%) | 5 (27.8%) | 0.429 |
Median VEN dose (range) | 200 mg (50–400) | 400 mg (50–400) | 400 mg (50–400) | 0.021 |
CRc rate(%) | ||||
 All patients | 21 (67.7%) | 26 (51.0%) | 7 (38.9%) | 0.123 |
 VEN-sensitive (n = 32) | 10 (83.3%) | 10 (71.4%) | 5 (83.3%) | 0.857 |
 VEN-intermediate (n = 39) | 8 (61.5%) | 10 (45.6%) | 1 (25.0%) | 0.369 |
 VEN-unfavorable (n = 29) | 3 (50.0%) | 6 (40.0%) | 1 (12.5%) | 0.336 |
Grade 4 neutropenia (%) | 21 (67.7%) | 40 (78.4%) | 9 (50.0%) | 0.073 |
Febrile neutropenia (%) | 17 (54.8%) | 24 (47.1%) | 7 (38.9%) | 0.550 |
Documented infection (%) | 8 (25.8%) | 6 (11.7%) | 3 (16.7%) | 0.260 |
Duration of grade 4 neutropenia (days) | 29 days (21–57) | 32 days (24–52) | 33 days (20–63) | 0.731 |
Duration of febrile neutropenia (days) | 5 days (1–15) | 4 days (1–42) | 7 days (2–25) | 0.890 |
Median OS (days) | 481 days | 438 days | 240 days | 0.210 |