Predictors of prolonged benefit from palbociclib plus fulvestrant in women with endocrine-resistant hormone receptor–positive/human epidermal growth factor receptor 2–negative metastatic breast cancer in PALOMA-3

M. Cristofanilli, A. DeMichele, C. Giorgetti, N.C. Turner, D.J. Slamon, S.-A. Im, N. Masuda, S. Verma, S. Loi, M. Colleoni, K.P. Theall, X. Huang, Y. Liu, C.H. Bartlett

Research output: Contribution to journalArticle

Abstract

Background: The addition of palbociclib to fulvestrant improved clinical outcomes over placebo-fulvestrant in endocrine-pretreated metastatic breast cancer (MBC) patients in PALOMA-3. Here, we examined factors predictive of long-term benefit. Methods: Premenopausal-peri/postmenopausal patients with endocrine-resistant, hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative MBC were randomised 2:1 to fulvestrant (500 mg) and either palbociclib (125 mg/d; 3/1 schedule; n = 347) or placebo (n = 174). Baseline characteristics, mutation status and HR expression levels were compared in patients with and without prolonged benefit (treatment duration ≥18 months). Results: By August 2016, 100 patients (29%) on palbociclib-fulvestrant and 26 (15%) on placebo-fulvestrant demonstrated prolonged benefit, with long-term responders in both arms sharing common clinical characteristics. They usually had less disease burden at baseline versus those treated
Original languageEnglish
Pages (from-to)21-31
Number of pages11
JournalEuropean journal of cancer
Volume104
DOIs
Publication statusPublished - 2018

Keywords

  • Advanced breast cancer
  • Fulvestrant
  • HR+/HER2–
  • Long-term response
  • Palbociclib
  • estrogen receptor
  • fulvestrant
  • palbociclib
  • placebo
  • progesterone receptor
  • adult
  • aged
  • Article
  • cancer hormone therapy
  • cancer patient
  • clinical outcome
  • controlled study
  • disease burden
  • esr1 gene
  • female
  • gene mutation
  • human
  • major clinical study
  • metastatic breast cancer
  • multicenter study
  • mutation rate
  • pik3ca gene
  • postmenopause
  • premenopause
  • priority journal
  • randomized controlled trial
  • treatment response
  • tumor gene

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