Purpose This phase III study evaluated ribociclib plus fulvestrant in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer who were treatment naïve or had received up to one line of prior endocrine therapy in the advanced setting. Patients and Methods Patients were randomly assigned at a two-to-one ratio to ribociclib plus fulvestrant or placebo plus fulvestrant. The primary end point was locally assessed progression-free survival. Secondary end points included overall survival, overall response rate, and safety. Results A total of 484 postmenopausal women were randomly assigned to ribociclib plus fulvestrant, and 242 were assigned to placebo plus fulvestrant. Median progression-free survival was significantly improved with ribociclib plus fulvestrant versus placebo plus fulvestrant: 20.5 months (95% CI, 18.5 to 23.5 months) versus 12.8 months (95% CI, 10.9 to 16.3 months), respectively (hazard ratio, 0.593; 95% CI, 0.480 to 0.732; P < .001). Consistent treatment effects were observed in patients who were treatment naïve in the advanced setting (hazard ratio, 0.577; 95% CI, 0.415 to 0.802), as well as in patients who had received up to one line of prior endocrine therapy for advanced disease (hazard ratio, 0.565; 95% CI, 0.428 to 0.744). Among patients with measurable disease, the overall response rate was 40.9% for the ribociclib plus fulvestrant arm and 28.7% for placebo plus fulvestrant. Grade 3 adverse events reported in ≥ 10% of patients in either arm (ribociclib plus fulvestrant v placebo plus fulvestrant) were neutropenia (46.6% v 0%) and leukopenia (13.5% v 0%); the only grade 4 event reported in ≥ 5% of patients was neutropenia (6.8% v 0%). Conclusion Ribociclib plus fulvestrant might represent a new first- or second-line treatment option in hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer.

Dennis J Slamon University of California Los Angeles Medical Center Santa Monica CA; Patrick Neven Multidisciplinary Breast Centre Universitair Ziekenhuis Leuven; Guy Jerusalem Centre Hospitalier Universitaire de Liege and Liege University Liège Belgium; Stephen Chia British Columbia Cancer Agency Vancouver British Columbia Canada; Peter A Fasching University Hospital Erlangen Friedrich Alexander University Erlangen Nuremberg Erlangen; Arnd Nusch Practice for Hematology and Internal Oncology Velbert Germany; Michelino De Laurentiis Istituto Nazionale Tumori Fondazione G Pascale Naples; Giulia Val Bianchi Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori Milan Italy; Seock Ah Im Seoul National University Hospital Seoul National University College of Medicine Seoul Republic of Korea; Katarina Petrakova Masaryk Memorial Cancer Institute Brno Czech Republic; Francisco J Esteva New York University Langone Health New York NY; Miguel Martín Instituto de Investigacion Sanitaria Gregorio Marañon Centro de Investigación Biomédica en Red de Cáncer Grupo Español de Investigación en Cáncer de Mama Universidad Complutense Madrid; Luis De la Cruz Merino Hospital Universitario Virgen Macarena Seville Spain; Gabe S Sonke Netherlands Cancer Institute Borstkanker Onderzoek Groep Study Center Amsterdam the Netherlands; J Thaddeus Beck Highlands Oncology Group Fayetteville AR; Xavier Pivot Institut Régional du Cancer Strasbourg France; Gena Vidam Karen Rodriguez Lorenc Michelle Miller and Tetiana Taran Novartis Pharmaceuticals East Hanover NJ; and Yingbo Wang Novartis Pharma Basel Switzerland

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Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2- advanced breast cancer receiving first-line ribociclib plus fulvestrant

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ClinicalTrials.gov
NCT02422615