Table 3.
Dose modifications by preexisting condition.
| Dose Modification, % | Gastrointestinal |
Musculoskeletal |
Metabolic |
Vascular/Cardiac |
Vascular |
Cardiac |
≥4 Preexisting Conditions |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PAL + LET (n = 176) | PBO + LET (n = 100) | PAL + LET (n = 252) | PBO + LET (n = 138) | PAL + LET (n = 254) | PBO + LET (n = 128) | PAL + LET (n = 254) | PBO + LET (n = 128) | PAL + LET (n = 232) | PBO + LET (n = 122) | PAL + LET (n = 65) | PBO + LET (n = 29) | PAL + LET (n = 51) | PBO + LET (n = 34) | |
| Dose reduction | ||||||||||||||
| No dose reduction | 55.1 | 98.0 | 59.5 | 97.1 | 59.7 | 98.6 | 58.7 | 99.2 | 58.6 | 99.2 | 63.1 | 100 | 58.8 | 100 |
| ≥1 dose reduction | 44.9 | 2.0 | 40.5 | 2.9 | 40.3 | 1.4 | 41.3 | 0.8 | 41.4 | 0.8 | 36.9 | 0 | 41.2 | 0 |
| Median time to first dose reduction, d | 99.0 | – | 97.5 | – | 91.0 | – | 99.0 | 1136 | 98.5 | 1136 | 157 | – | 179 | – |
| 1 dose reduction | 23.9 | 2.0 | 22.2 | 2.9 | 22.6 | 1.4 | 26.0 | 0.8 | 25.4 | 0.8 | 26.2 | 0 | 21.6 | 0 |
| 2 dose reductions | 21.0 | 0 | 18.3 | 0 | 17.7 | 0 | 15.4 | 0 | 15.9 | 0 | 10.8 | 0 | 19.6 | 0 |
| Discontinuations and dose modifications due to AEs | ||||||||||||||
| Discontinuation due to an AE | 12.5 | 5.0 | 13.1 | 4.4 | 12.9 | 4.1 | 12.2 | 5.5 | 12.5 | 5.7 | 12.3 | 10.3 | 19.6 | 2.9 |
| Dose reduction | ||||||||||||||
| Due to AE | 44.9 | 2 | 40.1 | 2.9 | 40.3 | 1.4 | 40.9 | 0.8 | 41.0 | 0.8 | 36.9 | 0 | 41.2 | 0 |
| Discontinued due to treatment-related AE | 6.8 | 0 | 6.8 | 0 | 4.3 | 0 | 5.5 | 0 | 5.6 | 0 | 4.6 | 0 | 7.8 | 0 |
| Dose interruption or delay | ||||||||||||||
| Due to AE | 81.3 | 17.0 | 79.4 | 19.6 | 79 | 23.3 | 78.4 | 19.5 | 78.5 | 19.7 | 72.3 | 10.3 | 78.4 | 14.7 |
| Discontinued due to treatment-related AE | 8.5 | 1.0 | 9.5 | 1.5 | 8.6 | 2.7 | 7.5 | 1.6 | 7.8 | 1.6 | 6.2 | 0 | 9.8 | 0 |
AE = adverse event; LET = letrozole; PAL = palbociclib; PBO = placebo.