The advanced breast cancer hormone therapy ‘fulvestrant’ works better than the current standard drug treatment and reduces the risk of progression by 20%, according to a large clinical trial led by The University of Nottingham and Baylor College of Medicine in the US.
Key data presented on Saturday 8 October 2016 at the European Society for Medical Oncology showed that the fulvestrant drug Faslodex demonstrated better survival using a 500mg dose compared to the anastrozoledrug Arimidex in the first-line treatment of postmenopausal women with locally-advanced or metastatic breast cancer.
The FALCON trial was a Phase III, randomised, double-blind, multicentre clinical trial. It was carried out after positive results from the Phase II FIRST trial, which showed an average overall survival nearly six months longer with fulvestrant compared to anastrozole.
The trial enrolled 462 patients and showed that the average progression-free survival (PFS) was 2.8 months longer with fulvestrant than anastrozole. The average PFS was 16.6 months in the fulvestrant arm compared with 13.8 months in the anastrozole arm of the study. Aromatase inhibitors, such as anastrozole, are the current standard of care in 1st line treatment for postmenopausal women with hormone-receptor positive advanced breast cancer.
Professor of Surgery, John Robertson, from the Faculty of Medicine & Health Sciences at The University of Nottingham, said: “These data are important and I believe should be practice-changing. They demonstrate a further stepwise benefit in progression-free survival for women with locally advanced and metastatic breast cancer who are treated with fulvestrant, compared to the current standard of care. Even with the current improvements seen in FALCON, secondary breast cancer remains an incurable disease. Continued research is vital for exploring how we may continue to improve treatment and eventually find a cure for this disease in the future.”
The FALCON trial showed the safety and tolerability profile was in line with current experience with fulvestrant and anastrozole. The most commonly reported adverse events (AEs) in the fulvestrant and anastrozole arms were arthralgia (16.7% vs. 10.3%), hot flush (11.4% vs. 10.3%), and nausea (10.5% vs. 10.3%), respectively.
In February 2016, the Scottish Medicines Consortium accepted fulvestrant for use within NHS Scotland for patients with disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on therapy with an anti-oestrogen. It has been available through the NHS in England and Wales since 2004.
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Notes to editors: The University of Nottingham has 43,000 students and is ‘the nearest Britain has to a truly global university, with a “distinct” approach to internationalisation, which rests on those full-scale campuses in China and Malaysia, as well as a large presence in its home city.’ (Times Good University Guide 2016). It is also one of the most popular universities in the UK among graduate employers and was named University of the Year for Graduate Employment in the 2017 The Times and The Sunday Times Good University Guide. It is ranked in the world’s top 75 by the QS World University Rankings 2015/16, and 8th in the UK for research power according to the Research Excellence Framework 2014. It has been voted the world’s greenest campus for four years running, according to Greenmetrics Ranking of World Universities.
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