RT Journal Article
T1 Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer.
A1 Slamon, Dennis J
A1 Neven, Patrick
A1 Chia, Stephen
A1 Fasching, Peter A
A1 De Laurentiis, Michelino
A1 Im, Seock-Ah
A1 Petrakova, Katarina
A1 Bianchi, Giulia V
A1 Esteva, Francisco J
A1 Martín, Miguel
A1 Nusch, Arnd
A1 Sonke, Gabe S
A1 De la Cruz-Merino, Luis
A1 Beck, J Thaddeus
A1 Pivot, Xavier
A1 Sondhi, Manu
A1 Wang, Yingbo
A1 Chakravartty, Arunava
A1 Rodriguez-Lorenc, Karen
A1 Taran, Tetiana
A1 Jerusalem, Guy
AB 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.).
YR 2019
FD 2019-12-11
LK http://hdl.handle.net/10668/14815
UL http://hdl.handle.net/10668/14815
LA en
DS RISalud
RD Apr 6, 2025