Table 3.
Common toxicities of CDK 4/6 inhibitors reported in pivotal trials
| Neutropenia | Febrile neutropenia | Leukopenia | Fatigue | Anemia | Thrombocytopenia | Arthralgia | Diarrhea | Nausea | Vomiting | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| All grades | Paloma-1 | 74 | NR | 43 | 40 | 35 | 16 | 23 | 21 | 25 | 14 |
| Grades 3/4 | 54 | 19 | 4 | 6 | 2 | 1 | 4 | 2 | 0 | ||
| All grades | Paloma-2 | 79.5 | 1.8 | 39 | 37.4 | 24.1 | 15.5 | 33.3 | 26.1 | 35.1 | 15.5 |
| Grades 3/4 | 66.5 | 24.8 | 1.8 | 5.4 | 1.6 | 0.7 | 1.4 | 0.2 | 0.5 | ||
| All grades | Paloma-3 | 78.8 | 1 | 45.5 | 38.0 | 26.1 | 19.4 | 13 | 19.1 | 29.0 | 14.5 |
| Grades 3/4 | 62.0 | 25.2 | 2.0 | 2.6 | 2.3 | 0.3 | 0 | 0 | 0.3 | ||
| All grades | Monarch-1 | 87.7 | 0.7 | 90.9 | 65.2 | 68.5 | 41.1 | NR | 90.2 | 64.4 | 34.8 |
| Grades 3/4 | 26.9 | 27.7 | 12.9 | 0 | 2.3 | NR | 19.7 | 4.5 | 1.5 | ||
| All grades | Monarch-2 | 46.0 | 0.9 | 28.3 | 39.9 | 29.9 | 15.6 | 11.6 | 86.4 | 45.1 | 25.9 |
| Grades 3/4 | 26.5 | 8.8 | 2.7 | 7.2 | 3.4 | 0.2 | 13.4 | 2.7 | 0.9 | ||
| All grades | Monarch-3 | 41.3 | 0.3 | 20.8 | 40.1 | 28.4 | 36.2 | NR | 81.3 | 38.5 | 28.4 |
| Grades 3/4 | 21.1 | 7.6 | 1.8 | 5.8 | 1.9 | NR | 9.5 | 0.9 | 1.2 | ||
| All grades | Monaleesa-2 | 74.3 | 1.5 | 32.0 | 36.5 | 18.6 | NR | 27.2 | 35.0 | 51.5 | 29.3 |
| Grades 3/4 | 59.3 | 21 | 2.4 | 1.2 | NR | 0.9 | 1.2 | 2.4 | 3.6 | ||
| All grades | Monaleesa-3 | 69.6 | 1.0 | 28.4 | 31.5 | 17.2 | NR | 24.0 | 29.0 | 45.3 | 26.7 |
| Grades 3/4 | 53.4 | 14.1 | 1.7 | 3.1 | NR | 0.6 | 0.6 | 1.4 | 1.4 | ||
| All grades | Monaleesa-7 | 76 | 2 | 31 | 23 | 21 | 6 | 30 | 20 | 32 | 19 |
| Grades 3/4 | 61 | 14 | 1 | 3 | 1 | 1 | 1 | 1 | 1 |