Table 3. Palbociclib in Premenopausal Patients: PALOMA-3.
Primary analysis | |
Premenopausal/perimenopausal women enrolled and treated with PAL, n | 72 |
≤ 40 y, n | 25 |
> 40–50 y, n | 29 |
> 50 y, n | 18 |
Median PFS in premenopausal patients, mo, experimental vs. control (PBO+FUL) (HR [95% CI]) | 9.5 vs. 5.6 (0.50 [0.29–0.87] p = .013 |
Extended analysis | |
Median PFS in premenopausal patients, mo, experimental vs. control (HR [95% CI]) | Not published |
Median OS in premenopausal patients, mo, experimental vs. control (HR [95% CI]) | 38.0 vs. 38.0 (1.07 [0.61–1.86]) |
Note. FUL = fulvestrant; HR = hazard ratio; OS = overall survival; PAL = palbociclib; PBO = placebo; PFS = progression-free survival (time to radiologically confirmed progression per RECIST v1.1 or death during the study); RECIST = Response Evaluation Criteria in Solid Tumors. Data from Loibl et al. (2017); Turner et al. (2015); Turner et al. (2018).