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
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)....
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| Format: | Article |
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Elsevier
2018
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| Online Access: | https://eprints.nottingham.ac.uk/50821/ |
| _version_ | 1848798349074890752 |
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| author | Robertson, John F.R. Cheung, Kwok-Leung Noguchi, Shinzaburo Shao, Zhimin Degboe, Arnold Lichfield, Jasmine Thirlwell, Jackie Fazal, Mehdi Ellis, Matthew J. |
| author_facet | Robertson, John F.R. Cheung, Kwok-Leung Noguchi, Shinzaburo Shao, Zhimin Degboe, Arnold Lichfield, Jasmine Thirlwell, Jackie Fazal, Mehdi Ellis, Matthew J. |
| author_sort | Robertson, John F.R. |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | 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. |
| first_indexed | 2025-11-14T20:18:21Z |
| format | Article |
| id | nottingham-50821 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T20:18:21Z |
| publishDate | 2018 |
| publisher | Elsevier |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-508212020-05-04T19:39:13Z https://eprints.nottingham.ac.uk/50821/ 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. 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. Elsevier 2018-05-31 Article PeerReviewed Robertson, John F.R., Cheung, Kwok-Leung, Noguchi, Shinzaburo, Shao, Zhimin, Degboe, Arnold, Lichfield, Jasmine, Thirlwell, Jackie, Fazal, Mehdi and Ellis, Matthew J. (2018) 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. European Journal of Cancer, 94 . pp. 206-215. ISSN 0959-8049 Anastrozole; FALCON; Fulvestrant; Health-related quality of life; Locally advanced or metastatic breast cancer http://www.ejcancer.com/article/S0959-8049(18)30233-8/fulltext doi:10.1016/j.ejca.2018.02.026 doi:10.1016/j.ejca.2018.02.026 |
| spellingShingle | Anastrozole; FALCON; Fulvestrant; Health-related quality of life; Locally advanced or metastatic breast cancer Robertson, John F.R. Cheung, Kwok-Leung Noguchi, Shinzaburo Shao, Zhimin Degboe, Arnold Lichfield, Jasmine Thirlwell, Jackie Fazal, Mehdi Ellis, Matthew J. 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Anastrozole; FALCON; Fulvestrant; Health-related quality of life; Locally advanced or metastatic breast cancer |
| url | https://eprints.nottingham.ac.uk/50821/ https://eprints.nottingham.ac.uk/50821/ https://eprints.nottingham.ac.uk/50821/ |