RT Journal Article
T1 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.
A1 Martin, Miguel
A1 Zielinski, Christoph
A1 Ruiz-Borrego, Manuel
A1 Carrasco, Eva
A1 Ciruelos, Eva M
A1 Muñoz, Montserrat
A1 Bermejo, Begoña
A1 Margeli, Mireia
A1 Csöszi, Tibor
A1 Anton, Antonio
A1 Turner, Nicholas
A1 Casas, Maria I
A1 Morales, Serafin
A1 Alba, Emilio
A1 Calvo, Lourdes
A1 de la Haba-Rodriguez, Juan
A1 Ramos, Manuel
A1 Murillo, Laura
A1 Santaballa, Ana
A1 Alonso-Romero, Jose L
A1 Sanchez-Rovira, Pedro
A1 Corsaro, Massimo
A1 Huang, Xin
A1 Thallinger, Christiane
A1 Kahan, Zsuzsanna
A1 Gil-Gil, Miguel
K1 CDK4/6 inhibitor
K1 Capecitabine
K1 Endocrine therapy
K1 HER2–negative
K1 Hormone receptor-positive metastatic breast cancer
K1 Overall survival
K1 Palbociclib
AB 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.
PB Elsevier
YR 2022
FD 2022-03-07
LK http://hdl.handle.net/10668/22172
UL http://hdl.handle.net/10668/22172
LA en
NO Martín M, Zielinski C, Ruiz-Borrego M, Carrasco E, Ciruelos EM, Muñoz M, et al.  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. Eur J Cancer. 2022 Jun;168:12-24
DS RISalud
RD Apr 8, 2025