%0 Journal Article
%A Martin, Miguel
%A Zielinski, Christoph
%A Ruiz-Borrego, Manuel
%A Carrasco, Eva
%A Ciruelos, Eva M
%A Muñoz, Montserrat
%A Bermejo, Begoña
%A Margeli, Mireia
%A Csöszi, Tibor
%A Anton, Antonio
%A Turner, Nicholas
%A Casas, Maria I
%A Morales, Serafin
%A Alba, Emilio
%A Calvo, Lourdes
%A de la Haba-Rodriguez, Juan
%A Ramos, Manuel
%A Murillo, Laura
%A Santaballa, Ana
%A Alonso-Romero, Jose L
%A Sanchez-Rovira, Pedro
%A Corsaro, Massimo
%A Huang, Xin
%A Thallinger, Christiane
%A Kahan, Zsuzsanna
%A Gil-Gil, Miguel
%T 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.
%D 2022
%U http://hdl.handle.net/10668/22172
%X 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 the final overall survival (OS) analysis. Postmenopausal patients (N = 601) were randomized 1:1 to capecitabine or palbociclib plus ET (exemestane, Cohort 1; fulvestrant, Cohort 2). OS was analysed in Cohort 2, the wild-type ESR1 population and the overall population. Additionally, we analysed subsequent systemic therapies and explored PFS2 (time from randomization to the end of the first subsequent therapy/death). OS was 31.1 months for palbociclib plus fulvestrant and 32.8 months for capecitabine (adjusted hazard ratio [aHR] 1.10, 95% confidence interval [CI] 0.81-1.50, P = 0.550). In the wild-type ESR1 population, OS was 37.2 months for palbociclib plus ET and 34.8 months for capecitabine (aHR 1.06, 95% CI 0.81-1.37, P = 0.683). In OS analyses, no subgroup showed superiority for palbociclib plus ET over capecitabine. OS in the overall population was 32.6 months for palbociclib plus ET and 30.9 months for capecitabine (P = 0.995). Subsequent systemic therapy was given to 79.8% and 82.9% of patients with palbociclib plus ET and capecitabine, respectively. Median PFS2 was similar between study arms (Cohort 2, P = 0.941; wild-type ESR1 population, P = 0.827). No new safety findings were observed. Palbociclib plus ET did not show a statistically superior OS compared to capecitabine in MBC patients progressing on aromatase inhibitors.
%K CDK4/6 inhibitor
%K Capecitabine
%K Endocrine therapy
%K HER2–negative
%K Hormone receptor-positive metastatic breast cancer
%K Overall survival
%K Palbociclib
%~