Table 4.
RECIST response according to ribociclib relative DI in patients receiving ribociclib with first-line endocrine treatment (FAS; investigator assessment).a,b
| Ribociclib relative DI | ||||||
|---|---|---|---|---|---|---|
| 0–71% relative DI (30th percentile) | 72–96% relative DI (60th percentile) | 97–100% relative DI (90th percentile) | ||||
| n | % (95% CI) | n | % (95% CI) | n | % (95% CI) | |
| Best overall response | ||||||
| Complete response | 7 | 2.9 | 5 | 2.0 | 14 | 4.3 |
| Partial response | 108 | 44.6 | 90 | 36.0 | 109 | 33.4 |
| Stable disease | 68 | 28.1 | 84 | 33.6 | 89 | 27.3 |
| Neither complete response nor progressive disease | 49 | 20.2 | 44 | 17.6 | 64 | 19.6 |
| Progressive disease | 7 | 2.9 | 22 | 8.8 | 20 | 6.1 |
| Unknown | 3 | 1.2 | 5 | 2.0 | 30 | 9.2 |
| Overall responsec | 115 | 47.5 (41.2–53.8) | 95 | 38.0 (32.0–44.0) | 123 | 37.7 (32.5–43.0) |
| Clinical benefitd | 212 | 87.6 (83.5–91.8) | 192 | 76.8 (71.6–82.0) | 240 | 73.6 (68.8–78.4) |
CI confidence interval, DI dose intensity, FAS full analysis set, RECIST Response Evaluation Criteria in Solid Tumours.
aPooled data: patients from MONALEESA-2 (ribociclib plus letrozole group), MONALEESA-3 (ribociclib plus fulvestrant group), and MONALEESA-7 (ribociclib plus non-steroidal aromatase inhibitor group).
bRelative DI = DI (mg/day)/planned DI (mg/day) × 100.
cIncludes complete and partial responses.
dIncludes complete and partial responses, stable disease lasting ≥24 weeks, and neither complete response nor progressive disease lasting ≥24 weeks.