Table 2.
Seminal trials of CDK4/6i in advanced breast cancer.
| First-Line | Second-Line | nth-Line | ||||||
|---|---|---|---|---|---|---|---|---|
| Trial | Paloma 2 | Monarch 3 | Monaleesa 2 | Monaleesa 7 | Paloma 3 | Monarch 2 | Monaleesa 3 | Monarch 1 |
| Drug | Palbociclib | Abemaciclib | Ribociclib | Ribociclib | Palbociclib | Abemaciclib | Ribociclib | Abemaciclib |
| Population (pre- or post-menopausal) | Post-M | Post-M | Post-M | Pre-M | Pre- and Post-M | Post-M | Post-M | Post-M |
| Endocrine therapy | AI | AI | AI | OS + AI/Tam | Ful 500 + OS (in Pre-M) | Ful 250 | Ful 500 | Nil |
| Phase | III | III | III | III | III | III | III | II |
| N | 666 | 493 | 668 | 660 | 521 | 669 | 484 | 132 |
| Randomisation | 2:1 | 2:1 | 2:1 | 2:1 | 2:1 | 2:1 | 2:1 | Single arm |
| PFS/TTP (mth) | 24.8 vs. 14.5 | 28.2 vs. 14.8 | 25.8 vs. 16.0 | 23.8 vs. 13.0 | 9.5 vs. 4.6 | 16.4 vs. 9.3 | 20.5 vs. 12.8 | 6 |
| HR | 0.58; p < 0.001 | 0.54; p < 0.001 | 0.57; p < 0.001 | 0.55; p < 0.001 | 0.46; p < 0.0001 | 0.55; p < 0.001 | 0.59; p < 0.001 | NA |
| OS (mth) | NR | NR | NR | Not reached vs. 40.9 | 34.9 vs. 28.0 | 46.7 vs. 37.3 | Not reached vs. 40.0 | 17.7 |
| HR | - | - | - | 0.71; p = 0.01 | 0.81; p = 0.09 | 0.76; p = 0.014 | 0.72; p = 0.05 | - |
| Reference | [31] | [32] | [19] | [17] | [16] | [33] | [34] | [35] |
AI: aromatase inhibitor; OS: ovarian suppression; Tam: tamoxifen; Ful: fulvestrant; NR: not reported; PFS: progression-free survival; TTP: time to progression; 95% CI: 95% confidence interval; HR: hazard ratio; OS: overall survival.