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Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial

dc.contributor.authorRobertson, John F. R.
dc.contributor.authorBondarenko, Igor M.
dc.contributor.authorTrishkina, Ekaterina
dc.contributor.authorDvorkin, Mikhail
dc.contributor.authorPanasci, Lawrence
dc.contributor.authorManikhas, Alexey
dc.contributor.authorShparyk, Yaroslav
dc.contributor.authorCardona-Huerta, Servando
dc.contributor.authorCheung, Kwok-Leung
dc.contributor.authorPhilco-Salas, Manuel Jesus
dc.contributor.authorRuiz-Borrego, Manuel
dc.contributor.authorShao, Zhimin
dc.contributor.authorNoguchi, Shinzaburo
dc.contributor.authorRowbottom, Jacqui
dc.contributor.authorStuart, Mary
dc.contributor.authorGrinsted, Lynda M.
dc.contributor.authorFazal, Mehdi
dc.contributor.authorEllis, Matthew J.
dc.contributor.authoraffiliation[Robertson, John F. R.] Univ Nottingham, Royal Derby Hosp, Sch Med, Div Med Sci & Grad Entry Med, Derby, England
dc.contributor.authoraffiliation[Cheung, Kwok-Leung] Univ Nottingham, Royal Derby Hosp, Sch Med, Div Med Sci & Grad Entry Med, Derby, England
dc.contributor.authoraffiliation[Bondarenko, Igor M.] Dnipropetrovsk State Med Acad, Dept Oncol, Dnepropetrovsk, Ukraine
dc.contributor.authoraffiliation[Trishkina, Ekaterina] Leningrad Reg Oncol Dispensary, St Petersburg, Russia
dc.contributor.authoraffiliation[Dvorkin, Mikhail] Clin Oncol Dispensary, Omsk, Russia
dc.contributor.authoraffiliation[Panasci, Lawrence] Jewish Gen Hosp, Dept Oncol, Montreal, PQ, Canada
dc.contributor.authoraffiliation[Manikhas, Alexey] City Clin Oncol Dispensary, St Petersburg, Russia
dc.contributor.authoraffiliation[Shparyk, Yaroslav] Lviv State Oncol Reg Treatment & Diagnost Ctr, Lvov, Ukraine
dc.contributor.authoraffiliation[Cardona-Huerta, Servando] Tecnol Monterrey, Breast Canc Ctr, Monterrey, Mexico
dc.contributor.authoraffiliation[Philco-Salas, Manuel Jesus] Inst Oncol Lima, Unidad Invest, Lima, Peru
dc.contributor.authoraffiliation[Ruiz-Borrego, Manuel] Hosp Univ Virgen Rocio, Seville, Spain
dc.contributor.authoraffiliation[Shao, Zhimin] Fudan Univ, Shanghai Canc Ctr, Shanghai, Peoples R China
dc.contributor.authoraffiliation[Noguchi, Shinzaburo] Osaka Univ, Grad Sch Med, Dept Breast & Endocrine Surg, Osaka, Japan
dc.contributor.authoraffiliation[Rowbottom, Jacqui] AstraZeneca, Alderley Pk, Macclesfield, Cheshire, England
dc.contributor.authoraffiliation[Stuart, Mary] AstraZeneca, Alderley Pk, Macclesfield, Cheshire, England
dc.contributor.authoraffiliation[Grinsted, Lynda M.] AstraZeneca, Cambridge, England
dc.contributor.authoraffiliation[Fazal, Mehdi] AstraZeneca, Gaithersburg, MD USABaylor Coll Med, Lester & Sue Smith Breast Ctr, Houston, TX USA
dc.contributor.funderAstraZeneca
dc.date.accessioned2023-02-12T02:21:11Z
dc.date.available2023-02-12T02:21:11Z
dc.date.issued2016-12-17
dc.description.abstractBackground Aromatase inhibitors are a standard of care for hormone receptor-positive locally advanced or metastatic breast cancer. We investigated whether the selective oestrogen receptor degrader fulvestrant could improve progression-free survival compared with anastrozole in postmenopausal patients who had not received previous endocrine therapy.Methods In this phase 3, randomised, double-blind trial, we recruited eligible patients with histologically confi rmed oestrogen receptor-positive or progesterone receptor-positive, or both, locally advanced or metastatic breast cancer from 113 academic hospitals and community centres in 20 countries. Eligible patients were endocrine therapy-naive, with WHO performance status 0-2, and at least one measurable or non-measurable lesion. Patients were randomly assigned (1: 1) to fulvestrant (500 mg intramuscular injection; on days 0, 14, 28, then every 28 days thereafter) or anastrozole (1 mg orally daily) using a computer-generated randomisation scheme. The primary endpoint was progression-free survival, determined by Response Evaluation Criteria in Solid Tumors version 1 . 1, intervention by surgery or radiotherapy because of disease deterioration, or death from any cause, assessed in the intention-to-treat population. Safety outcomes were assessed in all patients who received at least one dose of randomised treatment (including placebo). This trial is registered with ClinicalTrials. gov, number NCT01602380.Findings Between Oct 17, 2012, and July 11, 2014, 524 patients were enrolled to this study. Of these, 462 patients were randomised (230 to receive fulvestrant and 232 to receive anastrozole). Progression-free survival was significantly longer in the fulvestrant group than in the anastrozole group (hazard ratio [HR] 0 . 797, 95% CI 0 . 637-0 . 999, p=0 . 0486). Median progression-free survival was 16 . 6 months (95% CI 13 . 83-20 . 99) in the fulvestrant group versus 13 . 8 months (11 . 99-16 . 59) in the anastrozole group. The most common adverse events were arthralgia (38 [17%] in the fulvestrant group vs 24 [10%] in the anastrozole group) and hot flushes (26 [11%] in the fulvestrant group vs 24 [10%] in the anastrozole group). 16 (7%) of 228 patients in in the fulvestrant group and 11 (5%) of 232 patients in the anastrozole group discontinued because of adverse events.Interpretation Fulvestrant has superior efficacy and is a preferred treatment option for patients with hormone receptor-positive locally advanced or metastatic breast cancer who have not received previous endocrine therapy compared with a third-generation aromatase inhibitor, a standard of care for first-line treatment of these patients.
dc.identifier.doi10.1016/S0140-6736(16)32389-3
dc.identifier.essn1474-547X
dc.identifier.issn0140-6736
dc.identifier.unpaywallURLhttps://nottingham-repository.worktribe.com/file/841656/1/Robertson_FALCON%20manuscript_Revision%202_08%20November%202016_CLEAN.pdf
dc.identifier.urihttp://hdl.handle.net/10668/18892
dc.identifier.wosID390112300032
dc.issue.number10063
dc.journal.titleLancet
dc.journal.titleabbreviationLancet
dc.language.isoen
dc.organizationHospital Universitario Virgen del Rocío
dc.page.number2997-3005
dc.publisherElsevier science inc
dc.rights.accessRightsopen access
dc.subjectFirst-line therapy
dc.subjectPostmenopausal women
dc.subjectEndocrine-therapy
dc.subject1st-line therapy
dc.subjectTamoxifen
dc.subjectLetrozole
dc.subjectSuperior
dc.subjectSurvival
dc.subjectEfficacy
dc.titleFulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial
dc.typeresearch article
dc.type.hasVersionAM
dc.volume.number388
dc.wostypeArticle
dspace.entity.typePublication

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