Cyclin E1 Expression and Palbociclib Efficacy in Previously Treated Hormone Receptor-Positive Metastatic Breast Cancer
Nicholas C Turner, Yuan Liu, Zhou Zhu, Sherene Loi, Marco Colleoni, Sibylle Loibl, Angela DeMichele, Nadia Harbeck, Fabrice Andre, Mohamed Amine Bayar, Stefan Michiels, Zhe Zhang, Carla Giorgetti, Monica Arnedos, Cynthia Huang Bartlett, Massimo Cristofanilli
JOURNAL OF CLINICAL ONCOLOGY | AMER SOC CLINICAL ONCOLOGY | Published : 2019
PURPOSE: A large-panel gene expression analysis was conducted to identify biomarkers associated with the effectiveness of adding palbociclib to fulvestrant. METHODS: The PALOMA-3 ( ClinicalTrials.gov identifier: NCT01942135) trial randomly assigned 521 endocrine-pretreated patients with metastatic breast cancer to receive palbociclib plus fulvestrant or placebo plus fulvestrant. Primary analysis was first conducted on 10 genes on the basis of pathway biology and evidence from previous studies followed by a systematic panel-wide search among 2,534 cancer-related genes. The association of gene expression with the effect of palbociclib on progression-free survival (PFS) was evaluated using Cox ..View full abstract
Supported by Pfizer. The Preoperative Palbociclib trial was sponsored by and analyzed at Institut Gustave Roussy. Editorial support was provided by Anny Wu, PharmD, of Complete Healthcare Communications (North Wales, PA), a CHC Group company, and was funded by Pfizer.