Introduction
Patients and methods
Study design and participants
Randomization
Treatment and procedures
Outcomes
Assessments
Results
Patient characteristics
≤ Q1 (N = 111) | Q1–Q2 (N = 112) | Q2–Q3 (N = 110) | > Q3 (N = 111) | |||||
---|---|---|---|---|---|---|---|---|
Ribociclib + letrozole (n = 74) | Placebo + letrozole (n = 37) | Ribociclib + letrozole (n = 63) | Placebo + letrozole (n = 49) | Ribociclib + letrozole (n = 51) | Placebo + letrozole (n = 59) | Ribociclib + letrozole (n = 43) | Placebo + letrozole (n = 68) | |
Age, median (range), y | 59.5 (23.0–82.0) | 64.0 (29.0–80.0) | 62.0 (35.0–85.0) | 61.0 (37.0–78.0) | 64.0 (43.0–82.0) | 65.0 (31.0–88.0) | 65.0 (40.0–91.0) | 63.0 (30.0–80.0) |
Race, n (%) | ||||||||
Caucasian | 60 (81.1) | 33 (89.2) | 44 (69.8) | 37 (75.5) | 43 (84.3) | 49 (83.1) | 36 (83.7) | 58 (85.3) |
Asian | 6 (8.1) | 1 (2.7) | 9 (14.3) | 7 (14.3) | 3 (5.9) | 6 (10.2) | 3 (7.0) | 6 (8.8) |
Black | 2 (2.7) | 1 (2.7) | 2 (3.2) | 1 (2.0) | 3 (5.9) | 1 (1.7) | 2 (4.7) | 0 |
Other/unknown | 6 (8.2) | 2 (5.4) | 8 (12.7) | 4 (8.2) | 2 (4.0) | 3 (5.1) | 2 (4.7) | 4 (5.9) |
ECOG performance status, n (%) | ||||||||
0 | 54 (73.0) | 25 (67.6) | 34 (54.0) | 30 (61.2) | 32 (62.7) | 37 (62.7) | 26 (60.5) | 43 (63.2) |
1 | 20 (27.0) | 12 (32.4) | 29 (46.0) | 19 (38.8) | 19 (37.3) | 22 (37.3) | 17 (39.5) | 25 (36.8) |
Disease stage at study entry, n (%) | ||||||||
III | 0 | 0 | 0 | 0 | 1 (2.0) | 2 (3.4) | 0 | 0 |
IV | 74 (100) | 37 (100) | 63 (100) | 49 (100) | 50 (98.0) | 57 (96.6) | 43 (100) | 68 (100) |
Hormone receptor status, n (%) | ||||||||
ER-positive | 73 (98.6) | 37 (100) | 62 (98.4) | 49 (100) | 51 (100) | 59 (100) | 43 (100) | 68 (100) |
PgR-positive | 63 (85.1) | 33 (89.2) | 56 (88.9) | 44 (89.8) | 36 (70.6) | 51 (86.4) | 30 (69.8) | 56 (82.4) |
Disease-free interval, n (%) | ||||||||
De novo | 28 (37.8) | 13 (35.1) | 24 (38.1) | 20 (40.8) | 25 (49.0) | 20 (33.9) | 10 (23.3) | 17 (25.0) |
Non-de novo | 46 (62.2) | 24 (64.9) | 39 (61.9) | 29 (59.2) | 26 (51.0) | 39 (66.1) | 33 (76.7) | 51 (75.0) |
≤ 12 months | 1 (1.4) | 0 | 1 (1.6) | 2 (4.1) | 0 | 2 (3.4) | 1 (2.3) | 2 (2.9) |
> 12 to ≤ 24 months | 3 (4.1) | 1 (2.7) | 2 (3.2) | 1 (2.0) | 2 (3.9) | 0 | 3 (7.0) | 7 (10.3) |
> 24 months | 42 (56.8) | 23 (62.2) | 36 (57.1) | 26 (53.1) | 24 (47.1) | 37 (62.7) | 29 (67.4) | 41 (60.3) |
Number of metastatic sites, n (%) | ||||||||
0 | 1 (1.4) | 0 | 0 | 0 | 1 (2.0) | 1 (1.7) | 0 | 0 |
1 | 11 (4.9) | 12 (32.4) | 16 (25.4) | 13 (26.5) | 9 (17.6) | 10 (16.9) | 12 (27.9) | 21 (30.9) |
2 | 32 (43.2) | 6 (16.2) | 19 (30.2) | 15 (30.6) | 18 (35.3) | 26 (44.1) | 17 (39.5) | 25 (36.8) |
≥ 3 | 30 (40.5) | 19 (51.4) | 28 (44.4) | 21 (42.9) | 23 (45.1) | 22 (37.3) | 14 (32.6) | 22 (32.3) |
Site of metastases, n (%) | ||||||||
Breast | 5 (6.8) | 1 (2.7) | 2 (3.2) | 3 (6.1) | 0 | 4 (6.8) | 1 (2.3) | 2 (2.9) |
Bone | 43 (58.1) | 16 (43.2) | 41 (65.1) | 34 (69.4) | 36 (70.6) | 39 (66.1) | 33 (76.7) | 44 (64.7) |
Bone only | 3 (4.1) | 0 | 4 (6.3) | 2 (4.1) | 5 (9.8) | 8 (13.6) | 7 (16.3) | 10 (14.7) |
Viscerala | 47 (63.5) | 31 (83.8) | 44 (69.8) | 34 (69.4) | 35 (68.6) | 44 (74.6) | 31 (72.1) | 45 (66.2) |
Lymph nodes | 40 (54.1) | 20 (54.1) | 35 (55.6) | 19 (38.8) | 24 (47.1) | 22 (37.3) | 14 (32.6) | 28 (41.2) |
Otherb | 14 (18.9) | 2 (5.4) | 8 (12.7) | 4 (8.1) | 5 (9.8) | 6 (10.2) | 2 (4.7) | 3 (4.4) |
Tumor response
Duration of response
Tumor shrinkage
Pain reduction
Week 8 HRQoL | Ribociclib + Letrozole | Placebo + Letrozole |
---|---|---|
Median percentage change from baseline in EORTC QLQ-C30 pain score | − 40% | − 29% |
Mean change from baseline in EORTC QLQ-C30 pain score | − 6.3a | − 2.7 |
Mean change from baseline in EORTC QLQ-C30 pain score in patients with measurable disease at baseline who achieved clinical benefit | − 7.0a | − 1.3 |