Table 1 Best overall response
From: MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer
Best overall responsea | Abemaciclib plus nonsteroidal AI | Placebo plus nonsteroidal AI | p value | ||
|---|---|---|---|---|---|
n (%) | 95% CI | n (%) | 95% CI | ||
All patients, n | 328 | 165 | |||
CR | 9 (2.7) | 1.0, 4.5 | 1 (0.6) | -0.6, 1.8 | |
PR | 154 (47.0) | 41.6, 52.4 | 60 (36.4) | 29.0, 43.7 | |
SD | 128 (39.0) | 33.7, 44.3 | 82 (49.7) | 42.1, 57.3 | |
SD ≥ 6 months | 93 (28.4) | 23.5, 33.2 | 57 (34.5) | 27.3, 41.8 | |
Progressive disease | 12 (3.7) | 1.6, 5.7 | 12 (7.3) | 3.3, 11.2 | |
Not evaluable | 25 (7.6) | 4.8, 10.5 | 10 (6.1) | 2.4, 9.7 | |
Objective response rate (CR/PR)b | 163 (49.7) | 44.3, 55.1 | 61 (37.0) | 29.6, 44.3 | 0.005 |
Disease control rate (CR/PR/SD) | 291 (88.7) | 85.3, 92.1 | 143 (86.7) | 81.5, 91.9 | 0.501 |
Clinical benefit rate (CR/PR/SD ≥ 6 months) | 256 (78.0) | 73.6, 82.5 | 118 (71.5) | 64.6, 78.4 | 0.101 |
Patients with measurable disease at baseline, n | 267 | 132 | |||
CR | 9 (3.4) | 1.2, 5.5 | 0 | N/A | |
PR | 154 (57.7) | 51.8, 63.6 | 60 (45.5) | 37.0, 53.9 | |
SD | 76 (28.5) | 23.1, 33.9 | 54 (40.9) | 32.5, 49.3 | |
SD ≥ 6 months | 48 (18.0) | 13.4, 22.6 | 32 (24.2) | 16.9, 31.6 | |
Progressive disease | 10 (3.7) | 1.5, 6.0 | 12 (9.1) | 4.2, 14.0 | |
Not evaluable | 18 (6.7) | 3.7, 9.7 | 6 (4.5) | 1.0, 8.1 | |
Objective response rate (CR/PR)c | 163 (61.0) | 55.2, 66.9 | 60 (45.5) | 37.0, 53.9 | 0.003 |
Disease control rate (CR/PR/SD) | 239 (89.5) | 85.8, 93.2 | 114 (86.4) | 80.5, 92.2 | 0.310 |
Clinical benefit rate (CR/PR/SD ≥ 6 months) | 211 (79.0) | 74.1, 83.9 | 92 (69.7) | 61.9, 77.5 | 0.037 |
