Health-related quality of life with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive metastatic breast cancer: Patient-reported outcomes in the PEARL study

Eur J Cancer. 2021 Oct:156:70-82. doi: 10.1016/j.ejca.2021.07.004. Epub 2021 Aug 20.

Abstract

Background: The PEARL study showed that palbociclib plus endocrine therapy (palbociclib/ET) was not superior to capecitabine in improving progression-free survival in postmenopausal patients with metastatic breast cancer resistant to aromatase inhibitors, but was better tolerated. This analysis compared patient-reported outcomes.

Patients and methods: The PEARL quality of life (QoL) population comprised 537 patients, 268 randomised to palbociclib/ET (exemestane or fulvestrant) and 269 to capecitabine. Patients completed the European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BR23 and EQ-5D-3L questionnaires. Changes from the baseline and time to deterioration (TTD) were analysed using linear mixed-effect and stratified Cox regression models, respectively.

Results: Questionnaire completion rate was high and similar between treatment arms. Significant differences were observed in the mean change in global health status (GHS)/QoL scores from the baseline to cycle 3 (2.9 for palbociclib/ET vs. -2.1 for capecitabine (95% confidence interval [CI], 1.4-8.6; P = 0.007). The median TTD in GHS/QoL was 8.3 months for palbociclib/ET versus 5.3 months for capecitabine (adjusted hazard ratio, 0.70; 95% CI, 0.55-0.89; P = 0.003). Similar improvements for palbociclib/ET were also seen for other scales as physical, role, cognitive, social functioning, fatigue, nausea/vomiting and appetite loss. No differences were observed between the treatment arms in change from the baseline in any item of the EQ-5D-L3 questionnaire as per the overall index score and visual analogue scale.

Conclusion: Patients receiving palbociclib/ET experienced a significant delay in deterioration of GHS/QoL and several functional and symptom scales compared with capecitabine, providing additional evidence that palbociclib/ET is better tolerated.

Trial registration number: NCT02028507 (ClinTrials.gov).

Eudract study number: 2013-003170-27.

Keywords: CDK4/6 inhibitor; Endocrine therapy; Health-related quality of life; Hormone receptor–positive metastatic breast cancer; Palbociclib.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Androstadienes / therapeutic use
  • Antimetabolites, Antineoplastic / adverse effects
  • Antimetabolites, Antineoplastic / therapeutic use*
  • Antineoplastic Agents, Hormonal / adverse effects
  • Antineoplastic Agents, Hormonal / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Aromatase Inhibitors / therapeutic use
  • Breast Neoplasms / chemistry
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / mortality
  • Breast Neoplasms / pathology
  • Capecitabine / adverse effects
  • Capecitabine / therapeutic use*
  • Disease Progression
  • Estrogen Receptor Antagonists / therapeutic use
  • Europe
  • Female
  • Fulvestrant / therapeutic use
  • Health Status
  • Humans
  • Israel
  • Neoplasm Metastasis
  • Patient Reported Outcome Measures*
  • Piperazines / adverse effects
  • Piperazines / therapeutic use*
  • Postmenopause*
  • Progression-Free Survival
  • Protein Kinase Inhibitors / adverse effects
  • Protein Kinase Inhibitors / therapeutic use*
  • Pyridines / adverse effects
  • Pyridines / therapeutic use*
  • Quality of Life*
  • Time Factors

Substances

  • Androstadienes
  • Antimetabolites, Antineoplastic
  • Antineoplastic Agents, Hormonal
  • Aromatase Inhibitors
  • Estrogen Receptor Antagonists
  • Piperazines
  • Protein Kinase Inhibitors
  • Pyridines
  • Fulvestrant
  • Capecitabine
  • palbociclib
  • exemestane

Associated data

  • ClinicalTrials.gov/NCT02028507
  • EudraCT/2013-003170-27