First-line palbociclib and endocrine therapy

PALOMA-2 (NCT01740427) confirmed the results of the phase II PALOMA-1 trial.[10] This phase III, double-blind trial compared placebo plus letrozole with palbociclib plus letrozole as initial therapy for ER-positive postmenopausal patients with advanced disease (n = 666). The primary end point was investigator-assessed progression-free survival (PFS).[11]

PALOMA-2 (NCT01740427) confirmed the results of the phase II PALOMA-1 trial.[10] This phase III, double-blind trial compared placebo plus letrozole with palbociclib plus letrozole as initial therapy for ER-positive postmenopausal patients with advanced disease (n = 666). The primary end point was investigator-assessed progression-free survival (PFS).[11]

The median PFS was 24.8 months in the palbociclib-plus-letrozole group compared with 14.5 months in the placebo-plus-letrozole group (hazard ratio [HR], 0.58; 95% confidence interval [CI], 0.46–0.72; P < .001).[11][Level of evidence B1]

PALOMA-2 (NCT01740427) confirmed the results of the phase II PALOMA-1 trial.[10] This phase III, double-blind trial compared placebo plus letrozole with palbociclib plus letrozole as initial therapy for ER-positive postmenopausal patients with advanced disease (n = 666). The primary end point was investigator-assessed progression-free survival (PFS).[11]

Overall survival (OS) data are not yet mature.

PALOMA-2 (NCT01740427) confirmed the results of the phase II PALOMA-1 trial.[10] This phase III, double-blind trial compared placebo plus letrozole with palbociclib plus letrozole as initial therapy for ER-positive postmenopausal patients with advanced disease (n = 666). The primary end point was investigator-assessed progression-free survival (PFS).[11]

Patients who received palbociclib experienced more frequent cytopenias (66.4% grade 3 to 4 in palbociclib-treated patients vs. 1.4% in placebo-treated patients). Other common adverse events included nausea, arthralgia, fatigue, and alopecia. The most common grade 3 to 4 adverse events other than neutropenia included leukopenia (24.8% vs. 0%), anemia (5.4% vs. 1.8%), and fatigue (1.8% vs. 0.5%).