Table 2.
Summary of best overall response per RECIST v1.1
| Patients with de novo advanced HR+, HER2− breast cancer n = 227 |
||
|---|---|---|
| Ribociclib + letrozole | Placebo + letrozole | |
| All patients, n | 114 | 113 |
| Confirmed BOR, n (%) | ||
| CR | 2 (2) | 1 (1) |
| PR | 52 (46) | 37 (33) |
| SD | 36 (32) | 34 (30) |
| NCRNPD | 16 (14) | 26 (23) |
| PD | 3 (3) | 9 (8) |
| Unknown | 5 (4) | 6 (5) |
| ORRa, n (%) [95% CI] |
54 (47) [38–57] |
38 (34) [25–42] |
| CBRb, n (%) [95% CI] |
95 (83) [77–90] |
87 (77) [69–85] |
| Patients with measurable disease at baseline, n | 96 | 83 |
| Confirmed BOR, n (%) | ||
| CR | 2 (2) | 0 |
| PR | 52 (54) | 37 (45) |
| SD | 36 (38) | 34 (41) |
| PD | 2 (2) | 8 (10) |
| Unknown | 4 (4) | 4 (5) |
| ORRa, n (%) [95% CI] |
54 (56) [46–66] |
37 (45) [34–55] |
| CBRb, n (%) [95% CI] |
79 (82) [75–90] |
64 (77) [68–86] |
BOR best overall response, CBR clinical benefit rate, CI confidence interval, CR complete response, HER2− human epidermal growth factor receptor 2-negative, HR+ hormone receptor-positive, NCRNPD neither complete response nor progressive disease (for non-measurable disease at baseline), ORR overall response rate, PD progressive disease, PR partial response, SD stable disease
aCR + PR
bCR + PR + (SD + NCRNPD ≥ 24 weeks)