Table 3.
Ribociclib dose reductions in patients receiving first-line endocrine therapy (safety set).
| MONALEESA-2 | MONALEESA-3 | MONALEESA-7 | ||||
|---|---|---|---|---|---|---|
| Ribociclib 600 mg + letrozole, n = 334 | Ribociclib 600 mg + fulvestrant, n = 238 | Ribociclib 600 mg + NSAI, n = 246 | ||||
| n | % | n | % | n | % | |
| Dose reductions | ||||||
| 0 | 142a | 42.5 | 146 | 61.3 | 155 | 63.0 |
| 1 | 115 | 34.4 | 76 | 31.9 | 66 | 26.8 |
| 2 | 70 | 21.0 | 15 | 6.3 | 23 | 9.3 |
| ≥3 | 7 | 2.1 | 1 | 0.4 | 2 | 0.8 |
| Reason for dose reductionb | ||||||
| AE | 182 | 54.5 | 78 | 32.8 | 82 | 33.3 |
| Dosing error | 8 | 2.4 | 7 | 2.9 | 6 | 2.4 |
| Lack of efficacy | 1 | 0.3 | 0 | 0 | 0 | 0 |
| Physician decision | 7 | 2.1 | 5 | 2.1 | 4 | 1.6 |
| Patient/guardian decision | 8 | 2.4 | 1 | 0.4 | 1 | 0.4 |
| Technical issue | 0 | 0 | 1 | 0.4 | 0 | 0 |
| Most common all-grade AEs for dose reduction | ||||||
| Neutropenia | 111 | 33.2 | 47 | 19.7 | 58 | 23.4 |
AE adverse event, NSAI non-steroidal aromatase inhibitor.
an = 142 patients with no dose reduction. For the efficacy evaluations data from 165 patients (61.2%) were used. This included 23 patients who had dose interruptions where the dose was reduced from 600 to 0 mg.
bIn MONALEESA-2, more than one reason for dose reduction may have been reported.