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.
Date
2022-06-01ICR Author
Author
Martín, M
Zielinski, C
Ruiz-Borrego, M
Carrasco, E
Ciruelos, EM
Muñoz, M
Bermejo, B
Margelí, M
Csöszi, T
Antón, A
Turner, N
Casas, MI
Morales, S
Alba, E
Calvo, L
de la Haba-Rodríguez, J
Ramos, M
Murillo, L
Santaballa, A
Alonso-Romero, JL
Sánchez-Rovira, P
Corsaro, M
Huang, X
Thallinger, C
Kahan, Z
Gil-Gil, M
Type
Journal Article
Metadata
Show full item recordAbstract
BACKGROUND: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: Palbociclib plus ET did not show a statistically superior OS compared to capecitabine in MBC patients progressing on aromatase inhibitors. TRIAL REGISTRATION: NCT02028507 (ClinTrials.gov), 2013-003170-27 (EudraCT).
Collections
Subject
CDK4/6 inhibitor
Capecitabine
Endocrine therapy
HER2–negative
Hormone receptor-positive metastatic breast cancer
Overall survival
Palbociclib
Antineoplastic Combined Chemotherapy Protocols
Aromatase Inhibitors
Breast Neoplasms
Capecitabine
Female
Fulvestrant
Humans
Piperazines
Postmenopause
Pyridines
Receptor, ErbB-2
Receptors, Estrogen
Research team
Molecular Oncology
Language
eng
Date accepted
2022-03-07
License start date
2022-06-01
Citation
European Journal of Cancer, 2022, 168 pp. 12 - 24
Publisher
ELSEVIER SCI LTD