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.

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.

• Authors: John F R Robertson, Kwok-Leung Cheung, Shinzaburo Noguchi, Zhimin Shao, Arnold Degboe, Jasmine Lichfield, Jackie Thirlwell, Mehdi Fazal, Matthew J Ellis
• Journal: European journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 94 Pg. 206-215 (05 2018) ISSN: 1879-0852 [Electronic] England
• PMID: 29574365 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Chemical References

• Antineoplastic Agents, Hormonal
• Fulvestrant
• Anastrozole

Topics

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