Table 1.
Demographic and baseline disease characteristics.
| MONALEESA-2 | MONALEESA-3 | MONALEESA-7 | Pooled data | |||||
|---|---|---|---|---|---|---|---|---|
| Ribociclib + letrozolea, n = 334 | Placebo + letrozole, n = 334 | Ribociclib + fulvestranta, n = 484 | Placebo + fulvestrant, n = 242 | Ribociclib + endocrine therapya, n = 248 | Placebo + endocrine therapy, n = 247 | Ribociclib + endocrine therapya, n = 1066 | Placebo + endocrine therapy, n = 823 | |
| Age, median (range), years | 61 (23–91) | 62 (29–88) | 63 (31–89) | 63 (34–86) | 42 (25–58) | 44 (29–58) | 58 (23–91) | 57 (29–88) |
| Race, n (%)b | ||||||||
| Caucasian | 269 (81) | 280 (84) | 406 (84) | 213 (88) | 139 (56) | 136 (55) | 814 (76) | 629 (76) |
| Asian | 28 (8) | 23 (7) | 45 (9) | 18 (7) | 82 (33) | 84 (34) | 155 (15) | 125 (15) |
| Otherc | 37 (11) | 31 (9) | 33 (7) | 11 (5) | 27 (11) | 27 (11) | 97 (9) | 69 (8) |
| Weight, mean (SD), kg | 72 (16) | 72 (16) | 71 (15) | 72 (17) | 66 (16) | 68 (18) | 70 (16) | 71 (17) |
| ECOG performance status, n (%)d | ||||||||
| 0 | 204 (61) | 202 (61) | 310 (64) | 158 (65) | 183 (74) | 191 (77) | 697 (65) | 551 (67) |
| 1 | 130 (39) | 132 (40) | 173 (36) | 83 (34) | 63 (25) | 55 (22) | 366 (34) | 270 (33) |
| Metastatic disease status, n (%) | ||||||||
| De novoe | 114 (34) | 113 (34) | 95 (20) | 42 (17) | 72 (29) | 70 (28) | 281 (26) | 225 (27) |
| Non-de novo (relapsed) | 220 (66) | 221 (66) | 280 (58) | 158 (65) | 176 (71) | 177 (72) | 676 (63) | 556 (68) |
| Disease-free interval, n (%)f | ||||||||
| ≤12 months | 4 (1) | 10 (3) | 9 (2) | 5 (2) | 17 (7) | 9 (4) | 30 (3) | 24 (3) |
| >12 and ≤24 months | 14 (4) | 15 (4) | 25 (5) | 9 (4) | 31 (13) | 29 (12) | 70 (7) | 53 (6) |
| >24 months | 202 (60) | 195 (58) | 246 (51) | 144 (60) | 128 (52) | 139 (56) | 576 (54) | 478 (58) |
| Selected metastatic sites, n (%) | ||||||||
| Bone | 246 (74) | 244 (73) | 276 (57) | 145 (60) | 178 (72) | 178 (72) | 700 (66) | 567 (69) |
| Bone only | 69 (21) | 78 (23) | 86 (18) | 41 (17) | 57 (23) | 54 (22) | 212 (20) | 173 (21) |
| Lung or liver | 182 (54) | 191 (57) | 177 (37) | 100 (41) | 136 (55) | 130 (53) | 495 (46) | 421 (51) |
ECOG Eastern Cooperative Oncology Group.
aPatients from MONALEESA-2 (ribociclib plus letrozole group), MONALEESA-3 (ribociclib plus fulvestrant first-line group), and MONALEESA-7 (ribociclib plus non-steroidal aromatase inhibitor group).
bUnknown race was reported for n = 42 (ribociclib plus endocrine therapy arm) and n = 35 (placebo plus endocrine therapy arm).
cOther race includes Black, Native American, Pacific Islander and other/unknown.
dECOG performance status data missing for n = 3 (ribociclib plus endocrine therapy arm) and n = 2 (placebo plus endocrine therapy arm).
eDe novo disease in the MONALEESA-2 study referred to there being no date of first recurrence/progression or the first recurrence/progression occurring within 90 days of initial diagnosis with no prior antineoplastic therapy received, including medication and radiation. De novo disease in the MONALEESA-3 and -7 studies followed the same definition as MONALEESA-2, except the criterion of no prior antineoplastic therapy was restricted to medication only.
fDisease-free interval in patients with non-de novo metastatic disease was defined as the time from the initial diagnosis to first recurrence/progression; n = 1 (placebo plus endocrine therapy arm) had an unknown disease-free interval.