Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer

Slamon DJ, Neven P, Chia S, Fasching P, De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Esteva FJ, Martin M, Nusch A, Sonke GS, De La Cruz-Merino L, Beck JT, Pivot X, Sondhi M, Wang Y, Chakravartty A, Rodriguez-Lorenc K, Taran T, Jerusalem G (2020)

Publication Type: Journal article

Publication year: 2020

Journal

New England Journal of Medicine Massachusetts Medical Society

Book Volume: 382

Pages Range: 514-524

Journal Issue: 6

DOI: 10.1056/NEJMoa1911149

Abstract

BACKGROUND In an earlier analysis of this phase 3 trial, ribociclib plus fulvestrant showed a greater benefit with regard to progression-free survival than fulvestrant alone in postmenopausal patients with hormone-receptor positive, human epidermal growth factor receptor 2 (HER2) negative advanced breast cancer. Here we report the results of a protocol-specified second interim analysis of overall survival. METHODS Patients were randomly assigned in a 2;1 ratio to receive either ribociclib or placebo in addition to fulvestrant as first-line or second-line treatment. Survival was evaluated by means of a stratified log-rank test and summarized with the use of Kaplan Meier methods. RES U ITS This analysis was based on 275 deaths: 167 among 484 patients (34.5%) receiving ribociclib and 108 among 242 (44.6 /o) receiving placebo. Ribociclib plus fulvestrant showed a significant overall survival benefit over placebo plus fulvestrant. The estimated overall survival at 42 months was 57.8% (95% confidence interval [CI], 52.0 to 63.2) in the ribociclib group and 45.9% (95% CI, 36.9 to 54.5) in the placebo group, for a 28 /0 difference in the relative risk of death (hazard ratio, 0.72; 95% Cl, 0.57 to 0.92; P=0.00455). The benefit was consistent across most subgroups. In a descriptive update, median progression-free survival among patients receiving first-line treatment was 33.6 months (95% CI, 27.1 to 41.3) in the ribociclib group and 19.2 months (95% Cl, 14.9 to 23.6) in the placebo group. No new safety signals were observed. CONCLUSIONS Ribociclib plus fulvestrant showed a significant overall survival benefit over placebo plus fulvestrant in patients with hormone-receptor positive, HER2-negative advanced breast cancer. (Funded by Novartis; MONALEESA-3 ClinicalTrials.gov number, NCT02422615.)

Authors with CRIS profile

Peter Fasching Professur für Translationale Frauenheilkunde und Geburtshilfe

Involved external institutions

University of California Los Angeles (UCLA) US United States (USA) (US) University Hospital Leuven (UZ) / Universitaire ziekenhuizen Leuven BE Belgium (BE) British Columbia Cancer Agency CA Canada (CA) Fondazione IRCCS: Istituto Nazionale dei Tumori IT Italy (IT) Seoul National University (SNU) / 서울대학교 KR Korea, Republic of (KR) Masaryk Memorial Cancer Institute (MMCI) / Masarykův onkologický ústav (MOÚ) CZ Czech Republic (CZ) NYU Langone Medical Center US United States (USA) (US) Universidad Complutense de Madrid (UCM) ES Spain (ES) Netherlands Cancer Institute (NKI) NL Netherlands (NL) University of Seville / Universidad de Sevilla ES Spain (ES) Highlands Oncology Group US United States (USA) (US) Institut régional du Cancer de Montpellier (ICM) FR France (FR) Novartis AG CH Switzerland (CH) Centre Hospitalier Universitaire de Liège (CHU Liège) BE Belgium (BE)

How to cite

APA:

Slamon, D.J., Neven, P., Chia, S., Fasching, P., De Laurentiis, M., Im, S.-A.,... Jerusalem, G. (2020). Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer. New England Journal of Medicine, 382(6), 514-524. https://doi.org/10.1056/NEJMoa1911149

MLA:

Slamon, Dennis J., et al. "Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer." New England Journal of Medicine 382.6 (2020): 514-524.

BibTeX: Download