Health-related quality of life from the FALCON phase III randomised trial of fulvestrant 500 mg versus anastrozole for hormone receptor-positive advanced breast cancer

Eur J Cancer. 2018 May:94:206-215. doi: 10.1016/j.ejca.2018.02.026. Epub 2018 Mar 22.

Abstract

Background: The phase III randomised FALCON trial (NCT01602380) demonstrated improved progression-free survival with fulvestrant 500 mg versus anastrozole 1 mg in endocrine therapy-naïve postmenopausal women with hormone receptor-positive (HR+) locally advanced or metastatic breast cancer (LA/MBC). Furthermore, overall health-related quality of life (HRQoL) was maintained and comparable for fulvestrant and anastrozole. Here, we present additional analyses of patient-reported HRQoL outcomes from FALCON.

Methods: Women with endocrine therapy-naïve HR+ LA/MBC were randomised 1:1 to fulvestrant (days 0, 14, 28, then every 28 d) or anastrozole (daily) until disease progression or discontinuation. HRQoL was assessed by FACT-B questionnaire (TOI and FACT-B total score) at randomisation and every 12 weeks during treatment. HRQoL data post-treatment (with or without progression) were also collected.

Results: In total, 462 patients were randomised (fulvestrant, n = 230; anastrozole, n = 232). Compliance to FACT-B overall ranged from 60.0 to 97.4%. Mean change from baseline in TOI and FACT-B total score remained broadly stable (approximately ± 3 points to week 132) and was similar between arms during treatment. HRQoL was also maintained in FACT-B subscales. Approximately one-third of patients had improved TOI (≥+6 points) and FACT-B (≥+8 points) total scores from baseline up to week 120 and 132, respectively, of treatment with fulvestrant (ranges 26.4-45.0% and 22.4-35.8%, respectively) and anastrozole (ranges 18.6-32.9%, and 22.7-37.9%, respectively).

Conclusions: Mean change from baseline in TOI and FACT-B total score was maintained for fulvestrant and anastrozole; similar proportions of patients in both arms had improved TOI and FACT-B total scores. CLINICALTRIALS.

Gov identifier: NCT01602380.

Keywords: Anastrozole; FALCON; Fulvestrant; Health-related quality of life; Locally advanced or metastatic breast cancer.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Anastrozole / therapeutic use*
  • Antineoplastic Agents, Hormonal / therapeutic use*
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / mortality
  • Disease-Free Survival
  • Double-Blind Method
  • Female
  • Fulvestrant / therapeutic use*
  • Humans
  • Middle Aged
  • Quality of Life*
  • Surveys and Questionnaires

Substances

  • Antineoplastic Agents, Hormonal
  • Fulvestrant
  • Anastrozole

Associated data

  • ClinicalTrials.gov/NCT01602380