Table 1.
Characteristics and results of published randomized phase II or III trials of CDK4/6-inhibitors combined with ET in HR+/HER2-negative MBC
| Features | Published randomized Phase II or III trials |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| PALOMA 1 | PALOMA 2 | PALOMA 3 | MONALEESA 2 | MONALEESA 7 | MONALEESA 3 | MONARCH 3 | MONARCH 2 | MONARCH plus | |
| Phase | II | III | III | III | III | III | III | III | III |
| No. of patients | 165 | 666 | 521 | 668 | 672 | 726 | 493 | 669 | 463 |
| Treatment | Palbociclib + letrozole vs letrozole | Palbociclib + letrozole vs letrozole - | Palbociclib + fulvestrant vs fulvestrant (+ GnRHa in pre/peri pts) | Ribociclib + letrozole vs letrozole | Ribociclib + tamoxifen or AI + GnRHa vs tamoxifen or AI + GnRHa | Ribociclib + fulvestrant vs fulvestrant | Abemaciclib + NSAI vs NSAI | Abemaciclib + fulvestrant vs fulvestrant (+ GnRHa in pre/peri pts) | Abemaciclib + NSAI or fulvestrant vs NSAI or fulvestrant |
| Menopausal status at moment of trial enrollment | Post | Post | Pre/post | Post | Pre | Post | Post | Pre/post | Post |
| Setting | 1st line HR+ HER2− MBC | 1st line HR+ HER2− MBC | ≥1st line HR+ HER2− MBC | 1st line HR+ HER2− MBC | 1st line HR+ HER2− MBC | ≥1st line HR+ HER2− MBC | 1st line HR+ HER2− MBC | ≥1st line HR+ HER2− MBC | ≥1st line HR+ HER2− MBC |
| Median PFS, mo | 20.2 vs 10.2 | 24.8 vs 14.5 | 9.5 vs 4.6 | 25.3 vs 16.0 | 23.8 vs 13.0 | 20.5 vs 12.8 | NR vs 14.7 | 16.4 vs 9.3 | NR and 11.5 vs 14.7 and 5.6 |
| PFS HR (95% CI) | 0.49 (0.32 to 0.75) | 0.58 (0.46 to 0.72) | 0.46 (0.36 to 0.59) | 0.57 (0.46 to 0.70) | 0.55 (0.44 to 0.69) | 0.59 (0.48 to 0.73) | 0.54 (0.41 to 0.72) | 0.55 (0.45 to 0.68) | 0.50 (0.35 to 0.72) and 0.38 (0.24 to 0.59) |
| ORRa | 43% vs 33% | 42% vs 35% | 25% vs 11% | 43% vs 29% | 51% vs 36% | 41% vs 9% | 59% vs 44% | 48% vs 21% | 56% and 39% vs 30% and 8% |
| Median OS, mo | 37.5 vs 33.3 | NM | 35.0 vs 28.0 | NR | NR vs 40.9 | NR vs 40.0 | NM | 46.7 vs 37.3 | NM |
| OS HR (95% CI) | 0.81 (0.49 to 1.35) | NM | 0.81 (0.64 to 1.03) | 0.75 (0.52 to 1.08) | 0.71 (0.54 to 0.95) | 0.72 (0.57 to 0.92) | NM | 0.76 (0.61 to 0.95) | NM |
| Journal/Congressb | Lancet Oncol/J Clin Oncol | N Engl J Med | New Engl J Med | Ann Oncol | New Engl J Med | N Engl J Med | J Clin Oncol | JAMA Oncol | Ann Oncol |
| First authorb | Finn RS | Finn RS | Turner NC | Hortobagyi G | Im S-A | Slamon DJ | Goetz MP | Sledge GW | Jiang Z |
| Yearb | 2014/2017 | 2016 | 2018 | 2018 | 2019 | 2019 | 2017 | 2019 | 2019 |
Values are rounded. AI = aromatase inhibitor; CI = confidence interval; ET = endocrine therapy; GnRHa = gonadotropin-releasing hormone agonist; HER2- = human epidermal growth factor receptor 2 negative; HR = hazard ratio; HR+ = hormone receptor positive; MBC = metastatic breast cancer; NM = not mature; NR = not reached; NSAI = nonsteroidal aromatase inhibitor; ORR = overall response rate; OS = overall survival; peri = perimenopausal; PFS = progression-free survival; post = postmenopausal; pre = premenopausal; ESMO = European Society for Medical Oncology; ASCO = American Society of Clinical Oncology.
The citations refer to manuscripts with available OS results unless they have not been published yet.