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

Robertson, John F.R.; Cheung, Kwok-Leung; Noguchi, Shinzaburo; Shao, Zhimin; Degboe, Arnold; Lichfield, Jasmine; Thirlwell, Jackie; Fazal, Mehdi; Ellis, Matthew J.

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.

• Journal Article Type: Article
• Acceptance Date: Feb 20, 2018
• Online Publication Date: Mar 22, 2018
• Publication Date: May 31, 2018
• Deposit Date: Mar 29, 2018
• Publicly Available Date: Mar 23, 2019
• Journal: European Journal of Cancer
• Print ISSN: 0959-8049
• Electronic ISSN: 0959-8049
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 94
• DOI: https://doi.org/10.1016/j.ejca.2018.02.026
• Keywords: Anastrozole; FALCON; Fulvestrant; Health-related quality of life; Locally advanced or metastatic breast cancer
• Public URL: https://nottingham-repository.worktribe.com/output/935949
• Publisher URL: http://www.ejcancer.com/article/S0959-8049(18)30233-8/fulltext