Table 1.
Study | Treatment regimen | Evaluable patients | Indication | Median age (year) case, control | ECOG-PS (%) |
Prior chemotherapy (%) case, control | Duration of anti-CDK 4/6 Treatment median in months | |
---|---|---|---|---|---|---|---|---|
0 | 1 | |||||||
PALOMA-1, phase II1,7 | Palbociclib + letrozole versus letrozole alone | 165 (83 versus 77) |
Advanced breast cancer, no prior systemic treatment | 63, 64 | 55, 56 | 45, 44 | 40, 46 | 27.9, 29.6 |
PALOMA-2, phase III8 | Palbociclib + letrozole | 666 (444 versus 222) |
advanced breast cancer, no prior systemic treatment | 62, 61 | 58%, 46% | 40%, 53% | n/a | n/a |
PALOMA-3, Phase III9,20 | Fulvestrant + palbociclib or placebo | 517 (345 versus 172) |
endocrine-resistant MBC | 57, 56 | 207 (59.7), 115 (66.1) | 140 (40.3), 59 (33.9) | 251 (72.3%), 138 (79.3%) | 5.6 |
MONALEESA-2, phase III12 | Ribociclib + letrozole or placebo + letrozole | 668 | recurrent or MBC, no prior systemic therapy | 62, 63 | 61.4, 60.5 | 38.6, 39.5 | 43.7, 43.4 | 15.3 |
ECOG-PS, Eastern Cooperative Oncology Group Performance Status; n/a, not applicable; MBC, Metastatic Breast Cancer.