Table 2.
Grade 3 or higher toxicities in patients treated with venetoclax and decitabine or azacytidine
| Toxicity | ||||
|---|---|---|---|---|
| Toxicity Type | Total treatment coursesA (N = 55)B |
Decitabine-venetoclax (N = 34) |
Azacitidine-venetoclax (N = 21) |
Significance |
| Hematologic toxicities, grade ≥3 – no. (%) | ||||
| Leukopenia | 50 (90.9) | 31 (91.2) | 19 (90.5) | p > 0.999 |
| Neutropenia | 54 (98.2) | 34 (100.0) | 20 (95.2) | p = 0.382 |
| Lymphocytopenia | 43 (78.2) | 27 (79.4) | 16 (76.2) | p > 0.999 |
| Anemia | 48 (87.3) | 31 (91.2) | 17 (81.0) | p = 0.408 |
| Thrombocytopenia | 50 (90.9) | 32 (94.1) | 18 (85.7) | p = 0.359 |
| Non-hematologic toxicities, grade ≥3 – no. (%) | ||||
| Neutropenic fever | 22 (40.0) | 14 (41.2) | 8 (38.1) | p > 0.999 |
| Infection | 21 (38.2) | 13 (38.2) | 8 (38.1) | p > 0.999 |
| Hypotension | 5 (9.1) | 3 (8.8) | 2 (9.5) | p > 0.999 |
| Respiratory failure | 4 (7.3) | 3 (8.8) | 1 (4.8) | p > 0.999 |
| Hemorrhage | 3 (5.5) | 3 (8.8) | 0 (0) | p = 0.279 |
| Vomiting | 2 (3.6) | 2 (5.9) | 0 (0) | p = 0.519 |
| Diarrhea | 2 (3.6) | 2 (5.9) | 0 (0) | p = 0.519 |
| Nausea | 2 (3.6) | 2 (5.9) | 0 (0) | p = 0.519 |
| AST elevation | 2 (3.6) | 1 (2.9) | 1 (4.8) | p > 0.999 |
| ALT elevation | 1 (1.8) | 0 (0) | 1 (4.8) | p = 0.382 |
| DIC | 1 (1.8) | 1 (2.9) | 0 (0) | p > 0.999 |
| TLS | 1 (1.8) | 1 (2.9) | 0 (0) | p > 0.999 |
| Cardiomyopathy | 1 (1.8) | 1 (2.9) | 0 (0) | p > 0.999 |
| Creatinine increased | 1 (1.8) | 0 (0) | 1 (4.8) | p = 0.382 |
| Death during induction – no. (%)C | ||||
| Death within 30 days | 5 (8.8) | 4 (11.4) | 1 (4.5) | p = 0.639 |
| Death within 60 days | 12 (21.1) | 9 (25.7) | 3 (13.6) | p = 0.335 |
A:
A treatment course was defined as the initiation of venetoclax with decitabine or azacitidine, continued as maintenance with the same hypomethylating agent backbone in consecutive cycles
B:
Fifty-three of 57 patients had toxicity data available for analysis. One patient from the decitabine and azacitidine cohorts switched the hypomethylating agent during maintenance, accounting for one additional patient to each cohort
C:
Rates of death during induction were known in all 57 patients