%0 Journal Article
%A Slamon, Dennis J
%A Neven, Patrick
%A Chia, Stephen
%A Fasching, Peter A
%A De Laurentiis, Michelino
%A Im, Seock-Ah
%A Petrakova, Katarina
%A Bianchi, Giulia V
%A Esteva, Francisco J
%A Martín, Miguel
%A Nusch, Arnd
%A Sonke, Gabe S
%A De la Cruz-Merino, Luis
%A Beck, J Thaddeus
%A Pivot, Xavier
%A Sondhi, Manu
%A Wang, Yingbo
%A Chakravartty, Arunava
%A Rodriguez-Lorenc, Karen
%A Taran, Tetiana
%A Jerusalem, Guy
%T Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer.
%D 2019
%U http://hdl.handle.net/10668/14815
%X 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. 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. This analysis was based on 275 deaths: 167 among 484 patients (34.5%) receiving ribociclib and 108 among 242 (44.6%) 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% difference in the relative risk of death (hazard ratio, 0.72; 95% CI, 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% CI, 14.9 to 23.6) in the placebo group. No new safety signals were observed. 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.).
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