Overall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study

• DOI: 10.1016/j.ejca.2022.03.006
• Publication Date: 2022-04-13T23:16:56Z
• Authors: Miguel Martín; Christoph Zielinski; Manuel Ruiz-Borrego; Eva Carrasco; Eva M. Ciruelos; Montserrat Muñoz; Begoña Bermejo; Mireia Margelí; Tibor Csöszi; Antonio Antón; Nicholas Turner; María I. Casas; Serafín Morales; Emilio Alba; Lourdes Calvo; Juan de la Haba-R...; Manuel Ramos; Laura Murillo; Ana Santaballa; José L. Alonso-Ro...; Pedro Sánchez-Rovira; Massimo Corsaro; Xin Huang; Christiane Thalli...; Zsuzsanna Kahan; Miguel Gil-Gil
• Keywords: Palbociclib; Fulvestrant; Exemestane

An earlier analysis of the PEARL phase III study showed that palbociclib plus endocrine therapy (ET) does not improve progression-free survival (PFS) over capecitabine in aromatase inhibitor-resistant, hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer (MBC) patients. Here, we report final overall (OS) analysis.Postmenopausal patients (N = 601) were randomized 1:1 to or ET (exemestane, Cohort 1; fulvestrant, 2). OS was analysed 2, wild-type ESR1 population and population. Additionally, subsequent systemic therapies explored PFS2 (time from randomization end first therapy/death).OS 31.1 months for fulvestrant 32.8 (adjusted hazard ratio [aHR] 1.10, 95% confidence interval [CI] 0.81-1.50, P 0.550). In population, 37.2 34.8 (aHR 1.06, CI 0.81-1.37, 0.683). analyses, no subgroup superiority capecitabine. 32.6 30.9 (P 0.995). Subsequent given 79.8% 82.9% with capecitabine, respectively. Median similar between arms (Cohort 0.941; 0.827). No new safety findings observed.Palbociclib did show a statistically superior compared MBC progressing on inhibitors.NCT02028507 (ClinTrials.gov), 2013-003170-27 (EudraCT).