Publication: Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer.
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Date
2019-12-11
Authors
Slamon, Dennis J
Neven, Patrick
Chia, Stephen
Fasching, Peter A
De Laurentiis, Michelino
Im, Seock-Ah
Petrakova, Katarina
Bianchi, Giulia V
Esteva, Francisco J
Martín, Miguel
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Abstract
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.).
Description
MeSH Terms
Aged
Aminopyridines
Antineoplastic Combined Chemotherapy Protocols
Breast Neoplasms
Drug Administration Schedule
Female
Fulvestrant
Humans
Kaplan-Meier Estimate
Middle Aged
Postmenopause
Progression-Free Survival
Purines
Receptor, ErbB-2
Receptors, Estrogen
Receptors, Progesterone
Aminopyridines
Antineoplastic Combined Chemotherapy Protocols
Breast Neoplasms
Drug Administration Schedule
Female
Fulvestrant
Humans
Kaplan-Meier Estimate
Middle Aged
Postmenopause
Progression-Free Survival
Purines
Receptor, ErbB-2
Receptors, Estrogen
Receptors, Progesterone